Slate the CDC Comes out Swinging for Truvada, an HIV-Preventing

Slate

The CDC Comes Out Swinging for Truvada, an HIV-Preventing Miracle Drug http://www.slate.com/blogs/outward/2014/05/15/cdc_supports_truvada_a_drug_that_preven ts_hiv.html?wpisrc=burger_bar

By Mark Joseph Stern

Truvada, which prevents HIV infection with a single daily pill, is the miracle drug that almost nobody takes. It prevents HIV more reliably than condoms, which can break. It has exceedingly minimal side effects. It’s covered by most private insurers and state Medicaid programs. But because of its novelty, doctors have been wary of prescribing it—and because of the absurd stigma it still carries, its target audience has been hesitant to take it.

That’s all about to change. This week, as part of its cheerfully named Morbidity and Mortality Weekly Report, the CDC came out swinging for Truvada, unequivocally encouraging health care professionals to prescribe the drug to numerous at-risk groups. So far, those groups include anybody in a serodiscordant relationship, non-monogamous gay and bi men who sometimes have unprotected sex, straight men and women who sometimes have unprotected sex with drug users or bi men, and anybody who injects illicit drugs.

To my mind, these categories are still a bit under-inclusive. It’s alarmingly easy to get HIV through anal sex: Condoms are more likely to break during anal intercourse than vaginal intercourse, and the HIV transmission risk from anal sex is 18 times higher than from vaginal penetration. As I’ve written before, there’s nothing inherently unhealthy about anal sex. But unless you’re in a monogamous relationship with someone who’s HIV-negative, the risk of HIV transmission during gay anal intercourse is always going to be a little higher than you’re probably comfortable with.

Of course, I understand why the CDC didn’t simply recommend Truvada for all sexually active gay men: That’d be going too far, too soon, and might carry an insulting, even condescending undertone. But the spirit of the new guidelines clearly leans in that direction. Truvada isn’t necessary for every man who has sex with another man. But if you’re a man who has sex with men, plural, you should consider getting a prescription. By this point, the science on Truvada is largely settled. It’s only the stigma that continues to prevent gay Americans from fully embracing a drug that could save their lives.

Mark Joseph Stern is a writer for Slate. He covers science, the law, and LGBTQ issues.

---

Time http://time.com/100266/cdc-anti-hiv-pill-recommendation/

CDC Recommends Anti-HIV Pill for High-Risk Groups

The daily medication, sold in generic form as Truvada, could transform AIDS prevention in America The U.S. government has officially recommended that hundreds of thousands of people at risk for AIDS take a daily drug that is effective in preventing the virus.

The Centers for Disease Control and Prevention issued an official recommendation Wednesday that people at high-risk of contracting AIDS take Pre-exposure prophylaxis (PrEP), which is known to help prevent infection with HIV, the virus that causes the disease. If taken regularly, the drug can reduce risk of infection in high-risk populations by up to 92%.

PreP comes in a generic version called Truvada and is used widely in AIDS treatment programs in poor countries, The CDC’s recommendation could, if followed widely, increase the number of people taking the drug in the U.S. from fewer than 10,000 to half a million, the New York Times reports.

The CDC recommends the drug, in combination with condom use, to gay men who have sex without using condoms, heterosexuals who sleep with intravenous drug users or bisexuals, and anyone who has sex with someone they know to be HIV-positive, as well as anyone who shares needles or injects drugs.

HIV rates have held stubbornly flat for the past decade, and a sharp decline in condom usage has raised concerns among health officials.

---

NBCNews.com http://www.nbcnews.com/health/health-news/use-daily-pill-prevent-hiv-infections-cdc- recommends-n105766

Use Daily Pill to Prevent HIV Infections, CDC Recommends

U.S. health officials recommend that people at high risk for HIV infection be given daily antiretroviral drugs, such as Truvada.

U.S. health officials recommended Wednesday that people at high risk for HIV infection be given daily pills to help prevent it.

The new guidelines, issued by the Centers for Disease Control and Prevention, urge health care providers to consider pre-exposure prophylaxis, or PrEP, which provides daily antiretroviral drugs to those at risk of infection.

“HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States,” CDC Director Dr. Tom Frieden said. “PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the U.S.”

The recommendation follows a 2010 study that found that Truvada, Gilead Science’s pill already used to treat HIV — human immunodeficiency virus — was more than 90 percent effective at preventing HIV infections among those who took the drugs. In 2012, the federal Food and Drug Administration approved the daily drug combination of 300 milligrams of tenofovir disoproxil fumarate and 200 milligrams of emtricitabine for prevention treatment.

The strategy should be recommended to certain people at substantial risk for infection, the CDC said, including people in an ongoing sexual relationship with someone with HIV and those who don’t use condoms and have sex with people at risk for HIV, including injection drug users.

The guidelines offer the first comprehensive instructions from CDC for PrEP. Users should have an HIV test before they start treatment to make sure they’re not already infected, the guidelines say.

About 1.2 million people in the U.S. live with HIV and about 50,000 new infections are diagnosed each year, the CDC says.

---

Daily Digest News http://dailydigestnews.com/2014/05/cdc-makes-controversial-decision-to-urge-daily-pill-for- preventing-hiv-infection/

CDC makes controversial decision to urge daily pill for preventing HIV infection

By John Tyburski, Daily Digest News

The U.S. Centers for Disease Control and Prevention (CDC) has endorsed a pharmaceutical pre- exposure prophylaxis, or PrEP, and is recommending its daily use by those at risk for getting human immunodeficiency virus, or HIV, the virus that causes Acquired Immune Deficiency Syndrome, or AIDS. The CDC recommends the pills be used by at-risk individuals in combination with other preventive methods such as condoms and regular HIV screening.

Truvada is recommended for people who do not have HIV and are at substantial risk for getting HIV through sexual transmission and injection drug use. Details for defining substantial risk are listed on the CDC’s PrEP online resource page. People who use Truvada must do so every day in order for the pills to work to their potential. The CDC recommends HIV screening and follow-up with a health care provider every three months.

An estimated 50,000 new HIV cases are reported each year, and there is no vaccine or cure now or expected in the foreseeable future. Since the mid-1990s, more people live with HIV because of the reduction of AIDS brought about by highly-active antiretroviral therapy, or HAART. An estimated 1.1 million people currently live with HIV in the U.S. Among these, almost 500,000 are eligible for PrEP.

The pills are marketed under the name Truvada by Gilead Sciences Inc. in Foster City, California, and consist of two active drugs, emtricitabine and tenofovir disoproxil fumarate. Fewer than 10,000 people are prescribed Truvada, which costs about $15,000 per year. The drug combination is sold worldwide and has generated approximately $3.1 billion in sales last year alone for Gilead. Not all experts in the HIV/AIDS battle are supportive the CDC’s decision. Experts with the AIDS Healthcare Foundation (AFP), a Los-Angeles-based non-profit organization that provides health care to over 300,000 patients, worry that the push for PrEP may lead to a decline in condom use and subsequent increases in other sexually transmitted disease cases.

“This is a position I fear the CDC will come to regret,” said AFP president Michael Weinstein in a statement. Through this recommendation, ’’the CDC has abandoned a science-driven, public health approach to disease prevention—a move that will likely have catastrophic consequences in the fight against AIDS in this country,’’ he said.

The side effects reported for Truvada are bone weakness over time, upset stomach, loss of appetite, and renal issues in those with underlying metabolic conditions such as diabetes and hypertension.

---

Techsonia http://www.techsonia.com/prescription-drug-may-revolutionize-hiv-prevention/197941/

Prescription drug may revolutionize HIV prevention

For years, we’ve been told the best way – and the only way – to prevent HIV is by practicing safe sex, and avoid coming into contact with used needles.

However, on Wednesday, Federal Health Authorities advocated that those at risk of HIV infection talk to their doctors about Truvada, a once-a-day prescription medication that has been shown to prevent HIV infection. Multiple studies of gay men, drug users, and heterosexual couples have shown that when taken daily, Truvada can significantly decrease the risk of HIV infection.

For this reason, health authorities recommend Pre-exposure prophylaxis, also known as PrEP for anyone who shares needles or is an intravenous drug user, gay men who have unprotected sex, and heterosexuals who have high-risk sexual partners.

If use of Truvada becomes widespread, it could revolutionize the HIV prevention strategy in the United States. Instead of relying on condom use - often unpopular with gay men, it would rely on medication.

This was applauded by the Center for Disease control, which has been increasingly frustrated with the rate of new HIV infections, which has not changed in over a decade, despite 30 years of advocating for condom use to reduce HIV transmission.

While some approve of the use of Truvada to prevent HIV infection, others are worried that it will lead to a decrease in condom use, which may put people at risk of contracting other STIs.

---

Al Jazeera http://america.aljazeera.com/articles/2014/5/14/truvada-hiv-cdc.html CDC RECOMMENDS HIV-PREVENTION DRUG TO PEOPLE AT HIGH RISK OF INFECTIONS

U.S. health officials Wednesday issued new recommendations urging health care workers to consider offering an HIV prevention pill to healthy individuals who are at substantial risk of infection by the virus.

The guidelines, issued by the U.S. Centers for Disease Control and Prevention and the U.S. Public Health Service, involve the use of pre-exposure prophylaxis, or PrEP – a strategy in which at-risk individuals take a daily dose of an antiretroviral drug to reduce their risk of HIV infection.

The strategy builds on a landmark 2010 study that found Truvada — a pill already widely used to treat HIV — was more than 90 percent effective at preventing HIV infections among test subjects who took the drug as prescribed.

According to the new guidelines, health care providers should consider PrEP for anyone who meets specific risk criteria, such as being in a relationship with an HIV-infected partner or having sex without condoms with partners known to be at risk for HIV, such as injecting drug users.

The guidelines offer the first comprehensive guidance from the CDC, replacing interim guidance that emerged after studies showed PrEP to be effective in different patient populations.

The CDC now estimates that as many as 275,000 uninfected gay men and 140,000 heterosexual couples, in which one partner is HIV-infected, could benefit from PrEP.

Some 1.2 million people in the United States live with HIV, and new infections are estimated at 50,000 each year.

According to The New York Times, the announcement from the CDC is likely to mean a massive increase in the number of prescriptions written for the drug each year, up to 500,000 from its previous level of 10,000 a year.

The HIV infection rate in the U.S. has remained roughly the same at 50,000 new infections each year, despite 30 years of widespread outreach campaigns promoting the use of condoms to block transmission of the disease, leaving researchers frustrated at the lack of progress.

There is hope that it will make a significant impact in the gay community, particularly because of a sudden increase in unprotected sex.

Results from a CDC survey released in November showed the number of gay men that reported having unprotected sex increased almost 20 percent from 2005 to 2011.

Potential problems

But not everyone feels PrEP is the right answer. AIDS Healthcare Foundation President Michael Weinstein told Al Jazeera that he has been vehemently against Truvada — also referred to as PrEP — saying test studies have offered insufficient proof that the drug really prevents HIV transmission as it claims. Weinstein said he sees the government sanctioning of the drug as using young gay men as “guinea pigs. “This will lead to more infections,” Weinstein told Al Jazeera. “You don't have to give gay men more excuses not to use condoms.”

Kathy Brown, HIV Program medical director at the Seattle-based health care nonprofit organization Group Health, told Al Jazeera she disagrees with critics who think Truvada will promote risky behaviors.

When Brown prescribes Truvada to her patients, she says, “they feel like they have more control over their risk and in some cases may take less risks, because they no longer have this fatalistic thought that ‘it doesn't matter what I do, I'm going to get infected sooner or later.’”

But Brown cautioned that the regular use of Truvada presents other risks. Among a slew of potential side effects, Brown says, some patients have experienced nausea and “severe kidney problems” that appear to have reversed since they stopped using the drug. Others have reportedly complained of resulting health complications affecting blood, liver and bone density.

The notification on Truvada suggests that patients discuss taking it with their physicians, but for many, that is not proving very helpful.

In a report from the health care advocacy group Health HIV, nearly half of all personal care providers said that they do not provide clinical HIV care, and that a lack of knowledge about HIV treatment and prevention is “a significant barrier” to providing care.

Some state health departments have been making an effort to teach doctors how to properly prescribe Truvada and to provide better counseling on HIV issues. Many state health official are devising plans to more effectively do so as well.

Al Jazeera and wire services. Massoud Hayoun contributed to this report.

---

Daily Beast http://www.thedailybeast.com/cheats/2014/05/15/cdc -recommends-daily-hiv- pill.html

HEALTH CRISIS CDC Recommends Daily HIV Pill May 15, 2014

For the first time, federal health officials at the Centers for Disease Control and Prevention recommended Wednesday that Americans at risk of HIV/AIDS take a daily pill that has shown to prevent infection of HIV. That drug, Truvada, is currently used by fewer than 10,000 people, and would likely increase to 500,000 a year if the new guidelines are followed. The guidelines tell doctors to consider the drug regimen, called PrEP, short for pre-exposure prophylaxis, for gay men who have sex without condoms; heterosexuals with high-risk partners, such as drug injectors or male bisexuals who have unprotected sex; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs. HIV infection rates in the U.S. have remained steady at 50,000 a year over the past decade, despite official advice to rely on condoms. Read it at The New York Times

---

The Week Speed Reads http://theweek.com/speedreads/index/261592/speedreads-high-risk-groups-urged-to-take-pill- to-prevent-hiv-infection

MEDICINE—High-risk groups urged to take pill to prevent HIV infection

On Wednesday, the Centers for Disease Control and Prevention recommended that people most at risk for contracting HIV take a daily pill that has been shown to prevent being infected by the virus.

The CDC's new guidelines state that the drug regimen pre-exposure prophylaxis (PrEP) should be used by gay men who have sex without condoms, anyone who shares needles or injects drugs, heterosexuals with high-risk partners (such as male bisexuals or an intravenous drug user) who have unprotected sex, and people who regularly have sex with partners who are infected, The New York Times reports. The drug Truvada — a mix of tenofovir and emtricitabine that has few side effects and is already used to treat patients in poor countries — costs $13,000 a year and is covered by most health insurers.

"On average, it takes a decade for a scientific breakthrough to be adopted," Dr. Jonathan Mermin, director of the CDC's national center for AIDS and other sexually transmitted diseases, told The Times. "We hope we can shorten that time frame and increase people's survival."

With condom use down among gay men and the HIV infection rate in the U.S. barely changing in a decade, the CDC felt action was necessary. While the regimen should be used along with condoms, many health officials believe people who take Truvada will stop using them. If broadly followed, The Times reports, the drugs will be prescribed to 500,000 people a year, up from fewer than 10,000 now. - - Catherine Garcia

---

Out Magazine http://www.out.com/entertainment/popnography/2014/05/15/aids-breakthrough-weve-been- waiting-0

The HIV Breakthrough We've Been Waiting For?

In a week that saw the premiere of Ryan Murphy's The Normal Heart, based on Larry Kramer's excoriating 1985 play on the impact of AIDS on New York City, the decision yesterday by Federal Health officials to advocate the use of PrEP for gay men who have sex without condoms is a dramatic game-changer that may herald the end of AIDS. Despite fierce resistance from some AIDS activists, who argue that reliance on PrEP (pre-exposure prophylaxis) will lead to a decrease in condom use and an increase in other sexually transmitted diseases, the wind is now firmly in the sails of the pro-PrEP lobby. Yesterday, in a tweet picked up by Anderson Cooper, the activist Peter Staley, wrote, "Anti- PrEPers are losing because they are fighting sound science." And Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, told The New York Times that "I strongly support the C.D.C. doing this."

Although doctors advise patients to take the PrEP pill, Truvada, in conjunction with condoms, the move is an acknowledgement that after decades of public health education, condom use is in sharp decline among gay men. A C.D.C survey last November showed that the number of gay men reporting unprotected sex had risen nearly 20 percent from 2005 to 2011. Given the stigma around admitting to unprotected sex, that figure is probably much higher. Now, the hope is that by encouraging gay men who have unprotected sex to take Truvada, the number of new infections will continue to fall as scientists continue to hunt for a cure.

Last September, in article for Out, "Is This The New Condom?," writer Tim Murphy spoke to advocates who compared the impact of PrEP on HIV to the impact of the Pill on unwanted pregnancies in the 1960s. The article sparked a storm of controversy as readers argued over the pros and cons.

In recent weeks, some supporters of PrEP have taken to wearing #Truvada Whore T-shirts to challenge the moral indignation from activists who are "slut shaming" them by linking PrEP with promiscuity. The term comes from an article witten by David Duran for Huffington Post in 2012 that is highly critical of PrEP. Duran has since changed his mind.

----

Instinct Magazine http://instinctmagazine.com/post/cdc-officially-endorses-use-prep-drug-truvada-hiv-prevention

CDC Officially Endorses Use Of PrEP Drug, Truvada, For HIV Prevention

Could this move by the Center for Disease Control and Prevention (CDC) be a game changer in HIV prevention?

On Wednesday, the CDC has officially endorsed the use of Truvada, an antiretroviral drug that when taken as a daily pill can serve as pre-exposure prophylaxis (PrEP). Truvada has been proven to prevent HIV in 99% of individuals when used properly.

The New York Times reports:

If broadly followed, the advice could transform AIDS prevention in the United States — from reliance on condoms, which are effective but unpopular with many men, to a regimen that relies on an antiretroviral drug.

It would mean a 50-fold increase in the number of prescriptions for the drug, Truvada — to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it.

The guidelines tell doctors to consider the drug regimen, called PrEP, for pre-exposure prophylaxis, for gay men who have sex without condoms; heterosexuals with high-risk partners such as drug injectors or male bisexuals who have unprotected sex; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs.

The CDC is officially encouraging the use of PrEP in conjunction with condoms as Truvada does not prevent infection from other sexually transmitted infections such as gonorrhea and syphilis.

The CDC acknowledges that some gay men will choose to use PrEP in lieu of condoms, citing the 20 percent rise in unprotected sex amongst gay men between 2005 and 2011, according to a November CDC survey.

Still, the CDC maintains that the potential benefits of HIV prevention outweigh the costs of an increase in curable STDs.

“Making the perfect the enemy of the good is something we’ve got to get over,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases and the country’s best-known AIDS doctor. “I strongly support the C.D.C. doing this.”

The new guidelines issued by the CDC still have their critics:

Michael Weinstein, president of the AIDS Healthcare Foundation, has called Truvada a “party drug” and argued that the drug regimen would encourage men to avoid condoms and thus increase the infection rate. He called the release of the guidelines “a shameful chapter in the history of the C.D.C.”

Ultimately, individuals will have to make their own decisions regarding how they choose to protect their sexual health. Undoubtedly this endorsement of PrEP by the CDC will have a major impact.

Dr. Jonathan Mermin, director of the C.D.C.’s national center for AIDS and other sexually transmitted diseases, said the new guidelines should save many lives.

“On average, it takes a decade for a scientific breakthrough to be adopted,” he said. “We hope we can shorten that time frame and increase people’s survival.”

While Truvada is expensive, private insurers and state Medicaid programs have generally covered such prescriptions, and Gilead--the producer of Truvada-- has a program that covers co- pays and gives Truvada to the uninsured. PrEP may be in reach for those that want it.

What are your thoughts on the new developments, Instincters? Will the CDC's endorsement of PrEP encourage you to take on the drug regimen? Will it impact your condom usage?

Let us know what you think!

---

NewsMax http://www.newsmax.com/Newsfront/CDC-AIDS-Truvada-condoms/2014/05/15/id/571456/

Feds Recommend Daily Pill to Prevent AIDS Federal health authorities are advocating that people at risk for HIV infection take a daily dose of Truvada to prevent AIDS, The New York Times reported.

The move is a reversal of policy by the Centers for Disease Control and Prevention, which had urged at-risk men to rely on condoms.

Health authorities have been unable to persuade men vulnerable to the virus to always use condoms. The rate of prophylactic use has steadily declined among gay men while the number of HIV infections has persisted at 50,000 annually.

Public health educators have spent the past three decades urging the use of condoms to block HIV transmission. Still, the number of gay men who said they engaged in unprotected sex has risen by almost 20 percent, the Times reported.

While officially the new CDC policy calls for the use of both condoms and the pill, health experts are aware that many gay men will feel encouraged to shift completely away from condom use. This is expected to lead to an increase in venereal disease rates.

Public health experts have nevertheless concluded that the pill is the best way to stop the spread of AIDS.

"Making the perfect the enemy of the good is something we've got to get over," Dr. Anthony Fauci, one of the foremost AIDS experts in the country, told the Times. "I strongly support the CDC doing this."

Some 500,000 men are expected to seek prescriptions for Truvada which costs about $13,000 a year. The drug is covered by most insurers and by state Medicaid.

High-risk groups include homosexual men who engage in unprotected sex, heterosexuals with high-risk partners, and drug addicts who share needles.

For now, Truvada is the only pill approved by the Food and Drug Administration for AIDS prevention. The drug combines tenofovir and emtricitabine and is considered comparatively safe, the Times reported.

The protocol requires pre- and follow-up testing for those taking the medication.

Not everyone in the healthcare community supports the change in CDC policy. Michael Weinstein, president of the AIDS Healthcare Foundation, described Truvada as a "party drug" according to the Times.

He added that use of the pill would encourage condom-less sex and more STDs. He noted that many people who have HIV have never been tested for the disease.

"Finding those individuals and linking them into care and treatment would do far more to break the chain of new HIV infections" than switching policy away from condoms to a daily pill, he said, according to the Times.

---

MedPageToday http://www.medpagetoday.com/HIVAIDS/HIVAIDS/45783

Morning Break: HHS Nominee Wins GOP Fans, Preventing HIV

Published: May 15, 2014 | Updated: May 15, 2014

Sylvia Mathews Burwell, the Obama administration's nominee to replace Kathleen Sebelius as Secretary of Health and Human Services, picked up more Republican support during a Senate Finance Committee hearing on Wednesday.

The CDC has recommended Truvada as pre-exposure prophylaxis of HIV for at-risk individuals, as reported by The New York Times. Check back later this morning for a complete MedPage Today analysis.

Snipped

---

MedPageToday http://www.medpagetoday.com/HIVAIDS/HIVAIDS/45784

CDC Guidelines Codify HIV Prophylaxis

Published: May 15, 2014

By Michael Smith, North American Correspondent, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania

For people at high risk of acquiring HIV, doctors should consider prescribing antiretroviral drugs as a preventive measure, the CDC said.

In clinical practice guidelines, the agency says evidence supports what has been dubbed pre- exposure prophylaxis, or PrEP, in several groups at high risk.

The 67-page guideline document combines advice dispensed piecemeal over the past few years as evidence became available, according to Dawn Smith, MD, of the agency's division of HIV/AIDS prevention and who led guideline development.

And it adds detailed guidance for physicians on how identify patients at risk as well as how to prescribe and monitor PrEP, Smith told MedPage Today.

The idea of PrEP is that HIV-negative people with a small amount of anti-HIV drug in their systems would be protected against the virus if they were exposed.

The medication approved for PrEP is the single-pill combination of 300 milligrams of tenofovir co-formulated with 200 milligrams of emtricitabine (Truvada).

Clinical trials have demonstrated that the approach is safe and effective in men who have sex with men, injection drug users, and people whose regular sexual partner has the infection, Smith said "What we're telling doctors is that there is now solid evidence that PrEP works, if people take the medication," she said, "and it's safe for people who don't have HIV to take this particular medication."

Estimates are that about 500,000 people in the U.S. are at high enough risk "that PrEP might make sense for them," Smith said. "We would like (doctors) to offer those patients PrEP."

The CDC hopes that PrEP can be an important tool in cutting the annual toll of new HIV cases in the U.S., she added. The HIV epidemic has been "stalled" at about 50,000 new infections a year for several years, Smith noted.

PrEP Challenges

The idea of PrEP has been controversial, with critics fearing increases in risky sexual behavior, adverse effects of the drugs, and the possibility of drug resistance.

Those fears are justified but can be addressed by careful counseling and monitoring of patients on PrEP, Smith said, and the guidelines suggest ways doctors can mitigate the risks.

PrEP has also been criticized as a diversion from other ways of slowing or halting the HIV/AIDS pandemic.

Julio Montaner, MD, of the B.C. Centre for Excellence in HIV/AIDS in Vancouver has said it will only have value as a "very targeted" approach to prevention in small groups of people.

Montaner -- a former president of the International AIDS Society -- has consistently argued that simply increasing the number of HIV-positive people on full-scale three-drug treatment would be a more effective prevention strategy.

Studies have shown that full-scale therapy for HIV-positive people renders them almost completely noninfectious, as well as treating the disease itself.

In that context, using HIV drugs for PrEP looks like a wasteful diversion of resources, Montaner has said.

"From the CDC perspective, we would like both things to happen," Smith said, adding: "we don't think treatment-as-prevention is going to solve the entire problem."

Among other things, she noted that, for various reasons, only about one U.S. HIV patient in three actually is on treatment and has suppressed the virus to the point of being noninfectious.

The guidelines say there is top-level evidence that PrEP is appropriate as "one prevention option" for sexually-active adult men who have sex with men, adult heterosexually active men and women, and adult injection drug users if they are at "substantial risk" of HIV.

Identifying the Population

Exactly how to determine who is eligible for PrEP has been difficult; the guideline document provides a box that, for each group, defines:

What would constitute "substantial risk" Who is clinically eligible

What the prescription should be

What follow-up services are needed

Doctors should discuss PrEP with heterosexually-active women and men whose partners are HIV-positive as one of several options to protect the uninfected partner during conception and pregnancy, the guidelines say.

On the other hand, data are insufficient on the efficacy and safety of PrEP for adolescents, so the risks and benefits should be "weighed carefully," taking into account local laws about medical autonomy for minors.

For all the risk groups, the guidelines offer a series of sample questions that can be used to help doctors determine the degree of risk faced by an HIV-negative patient.

The questions cover such things as number of sex partners, type of sexual activity, and use of condoms.

Doctors should also take into account any history of bacterial sexually transmitted diseases, alcohol abuse, or the use of noninjection drugs of abuse, such as amyl nitrate.

The local epidemiological picture is also important, since acts that are risky when local HIV prevalence is high might be less dangerous if prevalence is low.

Taking a single HIV drug while infected leads universally to drug resistance, the guidelines note. So a key first step before PrEP is prescribed is to exclude pre-existing HIV infection, the guidelines note. Doctors should take a symptom history and order HIV blood tests.

For the same reason, patients should have an HIV test every 3 months while on PrEP, the guidelines say.

The tenofovir/emtricitabine combination is the only FDA-approved PrEP medication, and the guidelines urge that -- with one exception -- others should not be used.

The exception is that -- in trials among injection drug users and heterosexually active adults -- tenofovir showed efficacy by itself and therefore "can be considered" as an alternative.

But it has not been studied in men who have sex with men and shouldn't be used in that group.

The guidelines also warn that PrEP needs to be used continuously, rather than being timed for periods of sexual activity.

Tenofovir can have renal adverse effects, so kidney function should be assessed when starting PrEP and every 6 months afterward.

Specifically, a serum creatinine test should be done, and creatinine clearance estimated with the Cockcroft-Gault formula; a clearance rate of less than 60 milliliter per minute should rule out PrEP. As well, the guidelines note that active hepatitis B is a safety issue when taking tenofovir/emtricitabine, so tests for the virus are needed before prescribing PrEP.

The guidelines also urge doctors, when PrEP is prescribed, to provide access to risk-reduction services and to encourage patients to use other prevention methods as well.

Smith said it's hard to know how widely PrEP is currently being used.

The Time Is Right

Many physicians, she said, have been reluctant to start patients on PrEP in the absence of comprehensive guidelines and others may not be aware of the approach.

"In the past year, we have become aware of a lot more providers who are interested in PrEP," she said, but in 2013 it's likely that fewer then 10,000 people in the U.S. were on PrEP.

"We need to ramp up the numbers of providers who are aware of PrEP and are comfortable with it," she said, "and we need more awareness on the part of patients."

Full-scale anti-HIV therapy is expensive and cost can be a barrier to treatment, but Smith noted that many public and private insurers are paying for PrEP.

She said the CDC is not aware of many cases in which lack of insurance coverage has prevented people from getting PrEP.

The guideline development was supported by the CDC. Smith is an employee of the agency.

---

SF Gate Tech Chronicles http://blog.sfgate.com/techchron/2014/05/15/gilead-scores-another-victory-as-federal-agency- backs-hiv-prevention-pill/

Gilead scores another victory as federal agency backs HIV-prevention pill

The Centers for Disease Control and Prevention said Wednesday that Americans at risk for HIV should take a daily pill to prevent infection, a recommendation that could significantly drive sales for the drug’s maker, Gilead Sciences.

The Foster City company’s Truvada costs $13,000 a year, and is the only preventative therapy of its kind on the market. The CDC’s recommendation could boost sales by 50-fold, The New York Times reports. Right now, fewer than 10,000 patients use Truvada, but if the new guidelines are adopted, that could balloon to 500,000.

Mid-day Thursday, Gilead’s stock was down about 1.4 percent from the day before, to $79.84, but the company’s stock has been struggling along with other biotechnology stocks for the last few months.

The CDC seemingly made its recommendation out of a frustration that HIV rates in the United States have been relatively stable since the mid-1990s, and condom use has continued to fall. It’s another big stroke of fortune in a short amount of time for Gilead. The company has already been breaking records with its best-selling new hepatitis C drug, Sovaldi, which racked up $2.3 billion in worldwide sales in the first three months of the year.

In the same period, Truvada generated $759 million in sales, an 8 percent increase over last year. It won federal approval in July 2012.

Truvada is a PrEP (pre-exposure prophylaxis) drug intended for people who test negative for HIV but are considered at risk, such as gay men who have sex without condoms, patients who regularly have sex with anyone they know is infected, and anyone who shares needles or injects drugs. Truvada is supposed to be used in combination with safe-sex practices, such as condom use, to help prevent risk — not alone. But some health experts have worried that some people using the drug might engage in riskier behavior because they believe they are protected.

---

Think Progress http://thinkprogress.org/health/2014/05/15/3438360/cdc-hiv-prevention-recommendations/

The Obscure Federal Policy Change That Could Transform The Way We Fight AIDS

By Tara Culp-Ressler May 15, 2014

On Wednesday, federal health officials released new guidelines related to HIV treatment that, for the first time, officially endorse the use of a daily pill as a preventative measure against contracting the virus. The subtle shift in policy signals a move toward a different approach to addressing the AIDS epidemic, which has claimed more than 630,000 lives over the past several decades.

The pill, known as Truvada, was officially approved by the FDA in 2012 after a landmark study found the medication is more than 90 percent effective at preventing HIV infections among individuals who take the drug as prescribed. That method of protecting people against contracting the virus is technically called “pre-exposure prophylaxis,” or PrEP.

Over the past couple of years, public health advocates have been hopeful about Truvada, along with the the other medications that have been developed to prevent the transmission of HIV from mother to child, eventually shifting the course of the epidemic. Some people are cautiously optimistic that Truvada could be the “new condom,” especially since studies have consistently shown that gay men in the U.S. — along with most men around the world — aren’t always using condoms.

But norms are slow to change. Even though the vast majority of infectious disease specialists in North America support PrEP, a recent survey found that just nine percent of them have actually recommended it to their patients. In human terms, that means among the 500,000 people in the U.S. who become newly infected with HIV every year, fewer than 10,000 of them are prescribed Truvada as a prevention strategy.

Now, the CDC hopes that the new guidelines will encourage more doctors to prescribe PrEP treatment — which is almost always already covered by insurers — to the rest of those 500,000 at-risk individuals. That could include someone who’s in a sexual relationship with an HIV- positive person, someone who uses intravenous drugs, or men who regularly have sex with men without using a condom.

In short, the CDC is hoping to save lives. “On average, it takes a decade for a scientific breakthrough to be adopted,” Dr. Jonathan Mermin, director of the CDC’s national center for sexually transmitted diseases, explained to the New York Times. “We hope we can shorten that time frame and increase people’s survival.”

Many public health advocates are celebrating the news, and welcoming the federal announcement as an important step in legitimizing Truvada as an HIV prevention tool.

“These guidelines are a terrific and significant step forward in normalizing oral PrEP as a key component of high-impact HIV prevention in the United States,” Mitchell Warren, the executive director of AVAC: Global Advocacy for HIV Prevention, told ThinkProgress. “PrEP can have significant personal and public health impact, and it is so great to see this amplified by CDC!”

This isn’t the first step forward CDC has recently taken in this area. In February, the federal health agency officially switched to using “condomless sex” instead of “unprotected sex” to refer to sex without a condom — a shift that reflects the reality that some gay men who aren’t using condoms are taking Truvada, so they’re not actually completely unprotected against the virus. The change was the result of pressure from advocacy groups trying to encourage more acceptance for PrEP.

“As discussions about HIV prevention strategies evolve, the terminology needs to evolve as well,” a CDC spokesperson acknowledged at the time.

But PrEP isn’t without its controversies in the public health community. Michael Weinstein, the president of the AIDS Healthcare Foundation, has emerged as Truvada’s biggest skeptic. He’s called it a “party drug” and critiqued the government for endorsing it, saying that move will “give gay men more excuses not to use condoms.” Unlike barrier methods such as condoms, Truvada doesn’t protect against other sexually transmitted infections, and Weinstein thinks that’s a public health disaster waiting to happen. Some members of the gay community have taken that stance, too.

Not many other HIV prevention groups have aligned themselves with Weinstein. They argue that the benefits of taking Truvada outweigh the potential risk of dissuading Americans from using condoms, and point to one large clinical trial that didn’t actually find any link between Truvada and increased risky sexual behavior. On Thursday afternoon, a group of 68 leading HIV/AIDS and health organizations signed onto an open letter in support of the CDC’s new guidelines.

“No intervention is for everyone, but these guidelines will help providers, policy makers, advocates, and potential users to cut through the noise in the system to make true, evidence- based decisions,” Warren noted.

Pink News (UK) http://www.pinknews.co.uk/2014/05/15/us-cdc-updates-guidelines-for-hiv-prevention-drug- prep/ US: CDC guidelines recommend more groups use PrEP for HIV prevention

The Centre for Disease Control has updated its guidelines for a controversial HIV-preventative drug, expanding the list of groups recommended to take it.

According to studies, Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV transmission by up to 90%, if preventative drugs such as Truvada are taken consistently.

Truvada was granted FDA approval in the US in 2012.

CDC Director Tom Frieden told the New York Times: “HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States.

“PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.”

PrEP is recommended for:

- Anyone who is in an ongoing sexual relationship with an HIV-infected partner.

- A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.

- A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative.

Last month the president of the AIDS Healthcare Foundation Michael Weinstein attracted criticism for labelling Truvada a ‘party drug’, claiming it would wrongly be seen as an alternative to condoms.

He also condemned the CDC’s move today, saying in a statement: “This is a position I fear the CDC will come to regret.

“By recommending widespread use of PrEP for HIV prevention despite research studies amply chronicling the inability to take it as directed, and showing a limited preventive effect at best, the CDC has abandoned a science-driven, public health approach to disease prevention—a move that will likely have catastrophic consequences in the fight against AIDS in this country.”

The drug has to be taken orally once a daily to be effective.

At the moment in the UK, PrEP is considered an experimental prevention method.

---

Helio.com http://www.healio.com/infectious-disease/hiv-aids/news/online/%7B86726ebc-3d9c-4351- a587-15644e062ff2%7D/new-guidelines-recommend-prep-for-those-at-substantial-risk New guidelines recommend PrEP for those at substantial risk

The US Public Health Service released the first comprehensive clinical practice guidelines for pre-exposure prophylaxis, or PrEP, for use in the prevention of HIV.

The new federal guidelines recommend that PrEP be considered for people who are HIV- negative and at substantial risk for HIV. They include clear criteria for determining a person’s HIV risk and indications for PrEP use. Studies have shown that when taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90%.

PrEP should be considered for HIV-uninfected patients with any of the following indications:

Anyone who is in an ongoing sexual relationship with a partner who is HIV-positive.

A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past 6 months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.

A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.

Anyone who has during the past 6 months injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

The guidelines underscore importance of counseling about adherence and HIV risk reduction, including encouraging condom use for additional protection. In addition, the guidelines recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors.

Accompanying the guidelines is a supplement that includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.

The new guidelines build on interim guidance issued by CDC following the release of research findings on PrEP for men who have sex with men, heterosexuals, and people who inject drugs. In 2012, the FDA approved the drug combination of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine (TDF/FTC; Truvada, Gilead) for use as PrEP in combination with safer sex practices.

“While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the US HIV epidemic today,” Jonathan Mermin, MD, MPH, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said in a press release. “These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances.”

The guidelines were developed by a federal inter-agency working group led by CDC, and reflect input from providers, HIV patients, partners, and affected communities, according to a CDC press release.

The CDC and other organizations are currently conducting pilot implementation studies and demonstration projects to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection, according to the release.

Click here to view the complete guidelines.

For more information:

USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: A Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf. Updated May 14, 2014. Accessed May 15, 2014.

USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: Clinical Providers’ Supplement. http://www.cdc.gov/hiv/pdf/PrEPProviderSupplement2014.pdf. Updated May 14, 2014. Accessed May 15, 2014.

---

LGBT Weekly http://lgbtweekly.com/2014/05/15/new-cdc-guidelines-recommend-daily-hiv-prevention-pill- for-those-at-substantial-risk/

New CDC guidelines recommend daily HIV prevention pill for those at substantial risk

Posted by Associate Editor

Thursday, May 15th, 2014

Health care providers should consider advising the use of anti-HIV drugs by uninfected patients who are at substantial risk of infection, according to new clinical guidelines, released by Centers of Disease Control and Prevention (CDC).

PrEP, or pre-exposure prophylaxis, could reduce HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90 percent. Inconsistent use results in much lower levels of protection.

“HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States,” said CDC Director Tom Frieden, M.D., M.P.H. “PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the US.”

The guidelines were developed by CDC in partnership with other federal health agencies, public health experts and community leaders. The guidelines say PrEP should be considered for HIV-uninfected patients with any of the following indications:

Anyone who is in an ongoing sexual relationship with an HIV-infected partner.

A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.

A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative.

Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

“While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today,” said Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances.”

The guidelines offer providers specific advice on how to give people the support they need to take their pills regularly. Given the need for high adherence and the lack of complete protection from HIV with PrEP or any other single strategy, the guidelines encourage providers to promote and support its use in combination with condoms and other proven risk-reduction strategies. Accompanying the guidelines is a supplement that includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.

The guidelines build on interim guidance issued by CDC following the release of research findings on PrEP for men who have sex with men (MSM), heterosexuals, and people who inject drugs. In 2012, the U.S. Food and Drug Administration (FDA) approved the drug combination of 300 milligrams tenofovir disoproxil fumarate and 200 milligrams emtricitabine (TDF/FTC) for use as PrEP in combination with safer sex practices.

Consistent with FDA labeling, the guidelines stress the importance of HIV testing before PrEP is prescribed and at three-month intervals while a patient is using PrEP. Regular testing ensures that anyone on PrEP who becomes infected with HIV discontinues PrEP use in order to minimize the risk that the virus could become resistant to the drugs. Such patients then can begin receiving HIV treatment.

“PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing,” said Dawn K. Smith, M.D., M.P.H., the epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the development of the guidelines. “Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection.” In addition to providing guidelines and tools to assist providers in effectively prescribing and supporting PrEP use, CDC and other organizations are conducting pilot implementation studies and demonstration projects throughout the country. These projects aim to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection.

The guidelines were announced today in CDC’s Morbidity and Mortality Weekly Report. The 67- page guidelines and 43-page clinical providers’ supplement are published in full at http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf and http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf .

VOA http://www.voanews.com/content/us-physicians-hail-use-of-hiv-drug-for- prevention/1915432.html

US Physicians Hail Use of HIV Drug for Prevention

Physicians who work with HIV patients are hailing a new federal recommendation that. Proponents say that could transform AIDS prevention from reliance solely on condoms to a regimen that includes the anti-retroviral drug.

The number of new HIV infections in the United States has stubbornly remained steady at 50,000 a year. Public health officials have advocated the use of condoms almost exclusively for preventing the spread of the virus. It is mostly transmitted by young, homosexual men who do not use condoms.

So doctors who treat patients infected with the AIDS virus are applauding the new federal recommendation that the antiretroviral drug Truvada be used to contain the spread of HIV and protect uninfected individuals.

Richard Elion is clinical research director at Washington, D.C.'s Whitman Walker Clinic.

"To have a biological prevention is incredibly important to people who do not have lifestyles exactly as they should. So, I think it is a valuable addition in the fight against HIV and to push us toward the day when we will have an AIDS-free generation," said Elion.

Studies have shown that Truvada is 99 percent effective in preventing HIV infection. At Whitman-Walker, doctors have prescribed the drug to about 170 patients, although they, and public health officials, continue to recommend that condoms be used in conjunction with the drug regimen. Generic versions of Truvada are made in India, and it has become the mainstay of AIDS treatment in poor countries.

Some doctors denounce the widespread use of the drug as encouraging promiscuity. But Elion says it is a small, vocal minority that is against using the antiretroviral drug for HIV prevention.

"It really bothers me when I see people who object to people being offered an additional tool, not the only tool, but an additional tool to prevent HIV," he said. In the United States, almost half of those who take Truvada are women. The drug is recommended as pre-exposure prophylaxis, or PrEP, for those at high risk of infection, including people who have sex with bisexual partners, gay men who do not use condoms and IV drug abusers.

Currently, those who prescribe Truvada for HIV protection in the U.S. are primarily doctors working with AIDS patients, like Elion. But he hopes in time family doctors will see the value of making it available to those who are at high risk for infection with HIV.

---

CNN.com http://edition.cnn.com/2014/05/15/health/truvada-hiv-recommendation/index.html

Daily HIV prevention pill recommended for those at risk

(CNN) -- For years the message was simple: Use condoms to prevent HIV. But if you are at high risk of contracting the virus, health experts want you to consider an additional strategy -- taking a pill every day to reduce your chance of being infected.

New guidelines published by the Centers for Disease Control and Prevention say pre-exposure prophylaxis, or PrEP, should be taken daily by people who are at high risk for contracting HIV.

The recommendation is based on several large national and international studies, which were done in varying at-risk populations, such as gay and bisexual men, heterosexual couples where one person is HIV-positive (the other is not) and injection drug users.

The studies all showed that this drug can help reduce infection rates by more than 90% when taken daily.

"While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today," Dr.Jonathan Mermin, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said in a statement.

"These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances."

According to the guidelines, those circumstances would be anyone who:

• has had sex without a condom;

• is not infected with HIV but is in a sexual relationship with an HIV-infected partner;

• is a gay or bisexual man who has had a sexually transmitted disease within the last six months and is not in a mutually exclusive relationship with a recently tested HIV-negative partner;

• is a heterosexual man or woman who does not always use condoms when having sex with partners already at risk, and who isn't in a mutually exclusive relationship with a recently tested HIV-negative partner; or

• has injected drugs or shared drug paraphernalia in the past six months

In 2012, the Food and Drug Administration approved Truvada, a pill that combines two antiretroviral drugs for the prevention of HIV. It was first approved in 2004 as an HIV treatment and is still the only FDA-approved medication for PrEP.

Truvada isn't cheap. A month's supply can cost you anywhere from $1,300 to $1,700, according to Drugs.com. But insurance may cover the bill.

To be effective, this pill must be taken every day.

Dr. Anthony Fauci, an immunologist who has been at the forefront of HIV/AIDS research for decades, called it a highly effective approach to preventing the spread of the virus that causes AIDS.

"(It's) one that benefits not only the individual patient at risk for HIV infection but also will help to reduce the number of new HIV infections across the United States," said Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. "It should be used together with -- and complementary to -- condoms and not as a substitute for condoms."

The new guidelines replace interim ones published two years ago; they provide a comprehensive place where doctors and patients can find information on PrEP and come with a supplement that provides checklists for physicians, giving them step-by-step support for dealing with patients who might be considered for prophylactic treatment.

"Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection."

There are 1.1 million people in the United States living with HIV, according to the CDC. An estimated nearly one in six do not know they're infected.

Men who have sex with men are the hardest hit -- while they make up 2% of the U.S. population, they account for 63% of all new infections each year, according to the CDC. Heterosexuals make up 25% of all new annual infections; 9% are injection drug users.

"HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States," said Dr. Tom Frieden, the CDC's director, in a statement. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States."

---

The Health Site http://www.thehealthsite.com/news/now-prevent-hiv-if-you-think-youve-been-exposed-to-the- virus/

Now, prevent HIV if you think you’ve been exposed to the virus

Nirmalya Dutta May 15, 2014

The US Centers for Disease Control and Prevention (CDC) believes that people who are at a higher risk of contracting HIV should take anti-HIV medicines which will cut transmission risk. The CDC announced the new stance on Wednesday. This approach is called pre-exposure prophylaxis (PrEP) and has been found to reduce HIV infection rates by 90%.

‘HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States,’ CDC director Dr. Tom Frieden said in a news release from the agency. ‘PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.’

The new guidelines stem from a 2012 approval by the USFDA of combo drug called Truvada for PrEP along with safe sex practices.

The new guidelines are tied to the 2012 approval by the U.S. Food and Drug Administration of a combo drug called Truvada for use as PrEP, along with safe sex practices. Researchers first reported that Truvada could prevent people from contracting HIV in 2010. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 percent, when accompanied by condoms and counselling.

A separate study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not. Since Truvada is already in the market to manage HIV, some doctors already prescribe it as a preventive measure. But an approval from the FDA would allow Gilead Sciences to formally market the drug for that use.

‘While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today,’ Dr Jonathan Mermin, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said in the news release.

The new guidelines say that PreP should be considered for the following groups:

The new guidelines say that the use of the PrEP regimen should be considered by the following groups:

Anyone involved in an ongoing relationship with a person who is already infected with HIV;

Any gay or bisexual man who has had sex without a condom or who has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with someone who recently tested HIV-negative; A heterosexual person who does not always use condoms when having sex with people who might be at high risk for HIV (injection drug users or bisexual male partners whose HIV status is unknown) and is also not involved with an HIV-negative person in a mutually monogamous relationship;

Anyone who has abused injected, illicit drugs over the past six months, shared needles or other equipment tied to injected drug abuse, or been in a drug abuse treatment program.

The CDC will be offering PrEP providers with support to make that people on regimen follow it closely, since irregularity can result in inefficacy. The agency also notes that safe sex practices along with condoms remain a very important aspect of combating HIV.

‘We applaud the CDC for acknowledging the effectiveness of PrEP to reduce the risk of HIV infection among those individuals at greatest risk of HIV transmission,’ said Dr. Michael Mullen, professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, in New York City.

‘However, it must be emphasized that PrEP cannot and should not be used alone as prophylaxis against HIV infection — rather, PrEP must be used in combination with other proven preventive measures, including practicing safe sex, being tested regularly for STDs, and knowing your and your partner’s HIV status,’ he said.

Dr Dawn Smith, the epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the development of the guidelines stressed that, ‘individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection.’

But the strategy will require teamwork, she added. ‘PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing,’ Smith said.

The new guidelines were published May 14 in the CDC journal Morbidity and Mortality Weekly Report.

Some other approaches to cure/tackle/prevent HIV:

The Berlin Patient Case – Leukaemia

For a long time researchers believed there was no cure. Even five years ago, a scientist who wanted to work on HIV cure research was laughed at. But all that changed with Timothy Brown aka the Berlin Patient. Brown – an HIV-positive man who developed leukaemia. After first-line cancer treatments failed, a bone marrow transplant procedure was done. Two transplants later, not only was his leukaemia in remission, his immune system actually managed to ward off HIV. Brown no longer takes antiretroviral drugs or tests positive for HIV. Essentially, he was cured. Read more about the Berlin Patient…

Bee venom to cure HIV? A study suggested that bee venom might have the potency to kill the human immunodeficiency virus (HIV). Researchers at the Washington University School of Medicine had demonstrated that a toxin called melittin which is found in bee venom is the reason for this. The researchers used nanoparticle technology to target the virus. Particles smaller than HIV were infused with bee venom and since HIV cells are smaller than normal body cells the nanoparticles only targeted HIV.

‘Melittin on the nanoparticles fuses with the viral envelope,’ said research instructor Joshua L. Hood, MD, PhD. ‘The melittin forms little pore-like attack complexes and ruptures the envelope, stripping it off the virus.’ Adding, ‘We are attacking an inherent physical property of HIV. Theoretically, there isn’t any way for the virus to adapt to that. The virus has to have a protective coat, a double-layered membrane that covers the virus.’

Stem cell therapy to overcome HIV?

In a path-breaking breakthrough two American were believed to have overcome HIV after undergoing stem-cell therapy! The news has met with widespread elation with experts believing that a cure might be on the cards. Doctors from the Brigham and Women’s Hospital in Boston announced on Wednesday night that two previously HIV-positive patients no longer had detectable virus levels in their blood or tissue after having bone marrow stem-cell transplants to treat cancer between two and four years ago, the Age reported. (Read more…)

Aggressive antiretroviral treatment – the Mississippi baby case

There were reports in March 2013 of a toddler who was completely cured of the virus after being born of it. She has been cured of the disease after following an aggressive regime of drugs. This was the second documented case of a person being completely cured of the virus after an adult known as the Berlin Patient was cured as a result of bone-marrow transplant. This startling piece of information was discovered when the baby’s mother stopped treatment and doctors lost track of the baby who was given a bout of heavy drugs (current procedure suggests only a modest daily dose of antiretroviral treatment) about 30 hours after she was born at a rural Mississippi hospital, doctors said at a medical meeting in Atlanta. However, a doctor poured cold water on cold water on what was termed ‘the greatest medical breakthrough of the century’.

In his piece, Dr Siedner pointed out in his column, exposure to HIV doesn’t mean that the baby will have HIV. ‘We will likely never know if those cells were from the child or maternal cell that has been transmitted during pregnancy or birth.’ When a child is born, he or she has some maternal cells in his system so it’s impossible to tell whether the child actually had HIV or not, or the tests detected the maternal HIV positive cells.

The MX2 gene

According to a study published in the journal Nature, scientists have discovered a new gene which can inhibit the HIV virus from spreading after it has entered the body. The study was led by Dr Caroline Goujon and Professor Mike Malim at the Department of Infectious Diseases, King’s College London. It was conducted by introducing the virus to two separate lines of human cells. On one line, they introduced the MX2 gene along with the virus, while on the other they didn’t. The line on which the MX2 gene was introduced, it was seen that the virus had stopped replicating. (Read more.) What is HIV?

The human immunodeficiency virus (HIV) is a retrovirus that destroys or impairs the function of the body’s immune system making the person more susceptible to infections. Unless treated, it develops into full-blown acquired immunodeficiency syndrome (AIDS). The virus infects humans when it comes in contact with tissues lining the vagina, anal area, mouth and eyes, or through a break in the skin. There are two main types – HIV-1 and HIV-2. HIV-2 is typically found in Africa and parts of Asia. HIV-2 is typically found in Africa and parts of Asia. Asia can thus no longer be considered free of HIV-2, and testing for HIV-2 appears mandatory, at least in India. Worldwide, when people refer to HIV they are usually referring to HIV-1. (Read: Getting tested for HIV)

What is AIDS?

Acquired immune deficiency syndrome (AIDS) isn’t a disease in itself. It is a condition in caused by HIV in which the body’s immune system fails to battle foreign microorganisms. This leads to various opportunistic infections and/or certain cancers. It is the most advanced stage of HIV infection. (Read: AIDS causes, symptoms, treatment)

---

Yottafire.com http://yottafire.com/2014/05/truvada-the-aids-prevention-drug-caught-up-in-a-storm/

Truvada-the AIDS Prevention Drug Caught up in a Storm

Finally, an AIDS preventive drug has been formally recommended by the US health officials. This drug is said to reduce the risk of infection by 90% in people who are healthy but, have a high risk for HIV infection. Manufactured by Gilead Sciences and named Truvada, this pill is recommended for daily intake against the AIDS virus.

It is recommended for and in fact, urged to be in taken by people who are undergoing ‘injection medicine’ usage treatments, having HIV-infected partners and also use illicit drugs, stated the Centres for Disease Control and Prevention.

Agency further added that it is also recommended for people who do not use condoms with at- risk partners, both men and women who are heterosexual, and are not in a mutually exclusive relationship, bisexual men or gay men who do not use condoms.

Director of the Centre for Disease Control’s AIDS Prevention, Jonathan Mermin stated that as there is no cure or even a vaccine for HIV, prevention is vital.

Every year, 50,000 new people get infected with AIDS in the United States alone. Pre-exposure prophylaxis (PrEP) is the only way to combat this dreadful disease as there is no possibility of cure in the near future. Approved for usage in the year 2012 by the Food and Drug Administration, Truvada is recommended as a part of preventive strategy along with regular HIV testing and safe sex practices.

This pill has two active ingredients tenofovir disoproxil fumarate and emtricitabine. Less than 10,000 people are prescribed as the cost is around $ 15,000 per year. However, this is sold across world and the company has generated sales of $ 3.1 million last year alone. Cost is not the only reason why the sale is less because there are many experts in HIV or AIDS prevention who are not in complete agreement with CDC’s decision. Though this drug is effective, AIDS Healthcare Foundation- Los Angeles feels that when people start using this medication, there is a possibility of decline in usage of condoms, which will result in the increase of other sexually transmitted diseases. Further, this will come with certain side effects like loss of appetite, weakness of bone, renal issues, stomach upsets and even cause or aggravate hypertension and diabetes issues.

---

Yottafire.com http://yottafire.com/2014/05/cdc-recommends-usage-of-daily-pills-to-prevent-aids/

CDC Recommends Usage of Daily Pills To Prevent AIDS

On Wednesday, the officials at the U.S. CDC recommended Americans who are at a risk for AIDS to take a daily pill that has proved beneficial in preventing HIV infections.

The CDC is of the view that people in the US are over-dependent on condoms. They, therefore, suggested the antiretroviral drug, Truvada. The treatment, however, will cost around $13,000 a year.

As per the recent guidelines by CDC, doctors should consider the drug regimen, called PrEP, also known as pre-exposure prophylaxis, for gays who have unprotected sex, intravenous drug injectors, and bisexuals.

Truvada, manufactured by Gilead Sciences, is a mixture of tenofovir and emtricitabine. This drug is considered relatively safe with least side-effects. It has become the only drug to be used in treating AIDS. However, the common side effects include weight loss, headache and stomach pain.

Since 2010, three studies have proved that, when taken daily, Truvada can significantly reduce the chances of HIV infection.

In the study called iPrEx, 99 percent of gay men were found to be protected after having taken the pills.

As a part of observation after treatment, patients should be retested every three months to be sure that they are still HIV-negative.

Around 1,175 infectious disease specialists in the Canada and US were surveyed, out of which, almost 74 percent supported PrEP, but, to everyone’ surprise, only 9 percent had actually prescribed it.

Gilead, after analyzing pharmacy databases, has found that Truvada was prescribed for PrEP to 2319 patients, rather than the treatment of AIDS.

Jonathan Mermin, the director of the CDC’s national center for HIV/AIDS prevention, emphasized the old saying that “Prevention is better than Cure”. In short, PrEP has proved to be a vital step toward combating HIV that infects 50,000 people every year in the US.

HIV rates have been flat for the past decade but a sharp decline in use of condoms has raised several health concerns.

---

PressTV http://www.presstv.ir/detail/2014/05/15/362720/hiv-pill-advised-to-atrisk-americans/

US CDC advises at-risk Americans to take HIV pill

The US Centers for Disease Control and Prevention (CDC) and the US Public Health Service have urged healthcare workers to consider offering an HIV prevention pill to at-risk individuals.

Upon widespread application, the method could shift AIDS prevention in the United States from reliance on condoms.

The new guidelines involve the use of pre-exposure prophylaxis or PrEP, a strategy in which at- risk individuals take a daily dose of an antiretroviral drug to reduce their risk of HIV infection.

The strategy builds on a landmark 2010 study that found Gilead Sciences Inc's Truvada - a pill already widely used to treat the human immunodeficiency virus - was more than 90 percent effective at preventing HIV infections among test subjects who took the drug as prescribed.

Some 1.2 million people in the United States live with HIV, and new infections are estimated at 50,000 each year.

For HIV, “there’s no vaccine and cure in the near horizon. Prevention is key,” said Jonathan Mermin, director of the CDC’s national center for HIV/AIDS, Viral Hepatitis, STD and TB prevention.

---

RIA http://en.ria.ru/world/20140515/189841194/US-Health-Authorities-Call-for-Wider-AIDS- Prevention-Drug-Use.html

US Health Authorities Call for Wider AIDS-Prevention Drug Use

MOSCOW, MAY 15 (RIA Novosti) – US health authorities announced new recommendations Wednesday for people at risk of contracting HIV to take a daily AIDS prevention pill in an effort to limit the spread of one of the deadliest infections in recent decades. The US Centers for Disease Control and Prevention (CDC) and the US Public Health Service posted guidelines that instruct healthcare workers to offer the pre-exposure prophylaxis, or PrEP, pill to patients "at substantial risk for HIV."

The risk group involves those in an ongoing relationship – homosexual or heterosexual – with an HIV-positive partner, and people taking illicit drugs. The pill may also help prevent infecting the future child of a person with AIDS during conception and pregnancy.

The drug only works as a preventative measure, whereas another, post-exposure pill called PEP can be taken after sexual interaction or needle-sharing with an infected person.

The US Food and Drug Administration (FDA) approved PrEP in 2012. It is based on another drug, Truvada, which has been used to treat HIV-infected patients for a decade, and has the potential to prevent hundreds of thousands of new HIV cases if taken consistently.

The recommendations are based on clinical trials in which different groups of people received either the PrEP pill or a placebo. The study showed that PrEP reduced the risk of infection by up to 92 percent among gay and bisexual men and nearly the same in HIV discordant couples, by 62 percent among heterosexual men and women, and by 49 percent among injection drug users, according to the CDC.

Although PrEP can be used as a stand-alone measure, health professionals say it is more effective when combined with other prevention tools, such as condoms.

HIV infects 50,000 people in the US every year, and more than 15,000 died from AIDS in 2010.

Some 34 million people are currently living with what is the sixth deadliest disease in the world, accounting for more than three percent of all deaths, according to the World Health Organization (WHO).

---

Delhi Daily News http://www.delhidailynews.com/news/US--CDC-recommends-daily-HIV-pill-for-those-at-risk- 1400156112/

US: CDC recommends daily HIV pill for those at-risk

DDN Correspondent Posted on 15 May, 2014 at 11:36:AM

Washington DC: A Daily Pill That Is Being Touted As A Preventive Measure For Hiv Infection, May Take Over The Prescription Drug Market By Storm.

Truvada is prescribed in less than 10,000 cases and the new breakthrough may increase its prescription by 50-fold to over 500,000 prescriptions a year. Truvada costs $13,000 a year and is covered by most insurers. Federal health officials have given their recommendation for the pill on Wednesday. The recommendation may change the course of AIDS prevention from relying on condoms to an anti-retroviral drug. The drug regimen is called PrEP (Pre-exposure pophylaxis) and will be especially considered for gay men who copulate without condoms, heterosexuals who have high-risk partners, and those who copulate with infected persons and those who share needles or inject drugs. The US Centers for Disease Control and Prevention has been exasperated with the negligible change in the number of HIV infections over a decade- approximately 50,000 a year. Despite their being 3 decades of official advice to use condoms, surprisingly condom use is going down. The CDC reported that currently the rate of unprotected sex has gone up in gay men by 20 percent since 2005. While there are no promises that gay men will take to this drug regimen, advocates of the drug are happy with CDC?s statement.

---

Democratic Underground http://www.democraticunderground.com/10024957205

Does Gilead Know Someone in the CDC?

Just asking. Two years ago, the CDC recommended that every baby boomer get screened for Hepatitis C, even if they had no risk factors. They made this recommendation one year before Gilead was scheduled to introduce its new, blockbuster, easy to take, tres cher (expensive) Hep C drug which costs $1000 a pill or $84,000 for a course. And now, the CDC has recommended that everyone who uses IV drugs and shares needles, has unprotected gay sex with men, has a partner infected with HIV or has an IV drug using or bisexual partner (or does not know what their partner does in his free time) should be on a $13,000 a year Gilead drug forever to prevent HIV. Note that taking the drug does not guarantee that you will not get HIV and Gilead still recommends that you not share needles and that you not have unprotected sex. So, if you are using only clean needles and you are using condoms (correctly) every single time, do you really want to take a medication that can have some pretty serious side effects? If you partner is HIV positive this is a great medication. Or is you are a professional sex worker, yeah, sure. But risking your liver on the off chance that a condom might break and that the partner you are sleeping with when the condom breaks is HIV positive? Is it really worth it? Since there is no way to know if your partner is bisexual or using IV drugs do you just assume that they are? Should every 16 year old girl go down to Planned Parenthood and say "I want some birth control pills and I want some anti-HIV pills, too?"

Note that the VA, which has not been doing a very good job of getting our Vets timely appointments, has rounded up the funds to get the Hep C drug on its formulary. Is this their way of taking care of our vets or their way of showing thanks to Gilead's old owner, Former Defense Secretary Donald Rumsfeld? The drug to prevent HIV is already covered by many insurers, though I am not certain if they cover as many people as the CDC is now recommending take it--- one source says this will increase usage 50 fold.

Which has me wondering: Who will be the first person at the CDC to leave through the revolving door and get a job at Gilead.

Ok, I am ready for the long list of testimonials from all the folks at DU whose 1) Hep C was cured by the drug above 2) HIV was prevented by the durg above or 3) are absolutely pumped knowing that these medications are available and will be covered by their insurer. But if anyone is at all interested in how private industry uses government regulatory bodies in order to increase their profits--and then turns around and hires former US government officials by way of payment (the so called revolving door), I would be happy to hear from you. In case people think that this stuff doesn't happen here is a link to a link to some old stuff I wrote about Glaxo-Smith Kline and Dan Troy. http://foro.univision.com/t5/Democratas-Mas-Temas-Relacionados/Drug-Whores-How-Bush- FDA-Serviced-Glaxo-Smith-Kline-and-Big/td-p/399921973

Links about Gildead. http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/05/sovaldi-veterans-affairs- hepatitis-c-gilead-gild.html http://www.truvada.com/ http://www.bizjournals.com/sanfrancisco/blog/biotech/2014/05/gilead-hiv-aids-gild-prep- prophylaxis-truvada.html

PS. Oh, and by all means, buy Gilead stock. If they know someone at the CDC, they are going to make a gazillion dollars. This is meant to be sarcastic in case anyone wonders. I do not bet on stocks or give stock tips. Just thought it was funny that so much medical news pops up in business journals first when you do a google.

Response: 2. Gee, they also recommended it for Hepatitis A and B. In fact they recommend that all school age children get the Hepatitis B vaccine also.

Now you may not think that Hepatitis C is a problem, but guess what, it is a world wide problem. In fact that CDC recommendation has been on for at least several years, but NO ONE IS FORCED TO BE SCREENED if they don't want to. It is a recommendation, just like the Hepatitis A and B vaccine.

As far as Gilead, what they have done is develop a drug that actually cures Hepatitis C for those that have it, and it is far cheaper for the one year treatment than for the yearly interferon or other treatments that occur for the rest of a person's life. Again, anyone who has hepatitis C is NOT forced to take the treatment, just like anyone with any illness is not forced to take treatment.

As for the recommendation for folks that engage in high risk behavior, it is only a recommendation. The fact remains that people who share needles, and have unprotected sex with a lot of partners would probably not even follow that recommendation.

It is the CDCs job to make recommendations for public health. They also make recommendations on the influenza and other vaccines. In addition they make recommendations for protected sex in non monogamous relationships.

There job is to make recommendations so people remain healthy.

You don't want to be screened for Hepatitis C or be vaccinated, then don't do it

---

FiercePharma http://www.fiercepharma.com/story/cdc-backing-preventive-truvada-could-multiply-gileads- scripts-50-fold/2014-05-15

CDC backing for preventive Truvada could multiply Gilead's scripts 50-fold

What to do when HIV-infection rates stop going down--and condom use continues to fall? If you're U.S. health officials, you recommend that Americans at high risk of infection take a pill: Gilead Sciences' ($GILD) Truvada, an AIDS fighter that's the only drug approved for HIV prevention.

It's something of an about-face for the Centers for Disease Control and Prevention (CDC), which had declined to recommend the drug to stave off HIV infection, despite its 2012 FDA approval for that use.

For Gilead, it's a victory that could boost sales by 50-fold, The New York Times reports. Right now, fewer than 10,000 patients use Truvada; if the new guidelines are adopted, that could shoot up to 500,000. And at a sticker price of $50,000 per year, that's a lot of additional revenue.

Gilead has been on a roll the past couple of years, with this groundbreaking preventive approval for Truvada; an FDA nod for its four-in-one HIV fighter Stribild; and the agency's blessing for its breakthrough hepatitis C therapy Sovaldi, which immediately broke the blockbuster barrier and has since set a new record for the fastest drug launch ever.

The preventive payoff for Truvada could take some time, however, as Dr. Jonathan Mermin, director of the CDC center for AIDS, tells the NYT. "On average, it takes a decade for a scientific breakthrough to be adopted," Mermin told the newspaper. "We hope we can shorten that time frame and increase people's survival."

Beyond the usual lag in adopting new treatment approaches, Truvada faces some other obstacles. Infectious-disease physicians have written very few prescriptions for the drug for preventive use; in one survey, almost three-fourths of doctors said they were in favor of the idea, but fewer than 10% had actually written a script.

Then there's the cost of treatment. At $13,000, it's far less than Sovaldi's much-debated $84,000-per-treatment-course price. But Truvada would be used indefinitely, year after year, whereas Sovaldi is a once-off cure. Medicaid programs and private insurers have tended to cover preventive treatment, the NYT notes. But if the scripts start surging, that could change--or pressure for lower prices or larger rebates could build.

The prevention idea isn't without opposition in the gay community, either. Some stigma is attached to that use. Plus there's the worry that Truvada-takers would then stop using condoms, putting them at risk of syphilis or gonorrhea. But prevention advocates say those diseases are treatable with antibiotics--if less so, with gonorrhea, than in the past--but HIV infection is for life.

- read the NYT piece

Towleroad

TowleRoad http://www.towleroad.com/2014/05/cdc-releases-new-guidelines-for-prep.html

CDC RELEASES NEW GUIDELINES FOR PREP

The Centers for Disease Control and Prevention have issued a new set of guidelines for the use of PrEP as an HIV preventative after having determined that PrEP is an effective method of HIV prevention. Said Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention,

While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today. These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances.

The guidelines acknowledge that PrEP is an additional strategy to be used for HIV prevention, and while over 90% effective at reducing HIV transmission on its own, it is most effective when used in combination with condoms and other risk-reduction practices.

---

Chicago Defender http://chicagodefender.com/2014/05/15/hiv-prevention-pill-health-officials-encourage-use/

HIV Prevention Pill, Health Officials Encourage Use

Healthcare workers should start offering an HIV prevention pill to people who are at substantial risk for contracting HIV, U.S. health officials recommended Wednesday, May 14.

The U.S. Centers for Disease Control and Prevention and the U.S. Public Health Service do have set guidelines. The individual would take an antiretroviral drug once a day, called Pre-exposure prophylaxis, or PrEP. This would lower their chances of getting HIV. The CDC recommends that PrEP should be taken by people who don’t have HIV.

When tested, the risk of contracting the virus was 92% lower for those who took the pill consistently.

For more information on PrEP, click HERE.

---

Medical Daily http://www.medicaldaily.com/prep-hiv-prevention-pill-recommended-all-risk-individuals-92- effective-protection-hiv-282682

PrEP, the HIV Prevention Pill, Recommended For All At-Risk Individuals; 92% Effective At Protection From HIV

U.S. health officials have issued a statement recommending the use of an HIV prevention pill for all at-risk, uninfected individuals. The prevention treatment, which involves taking a daily dose of the antiretroviral drug PrEP, will help the lives of the millions of HIV-negative individuals worldwide who are in a relationship with an HIV positive partner.

These guidelines were issued by the Centers for Disease Control and Prevention and the U.S. Public Health Service, and were released yesterday in the Morbidity and Mortality Weekly Report. They are largely based on the results from a 2010 study on the HIV treatment pill, PrEP. The pill, which is already widely used to treat HIV, was found to also be more than 90 percent effective at preventing the viral infection. "These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances, said Dr. Jonathon Mermin, director of CDC’s National Center for HIV/AIDS, Medscape reported.

What is PrEP?

The antiretroviral drug recommended is a pre-exposure prophylaxis. When taken at the prescribed dosage, it will help to reduce the risk of HIV infection. According to data released by the CDC, if someone is exposed to the HIV virus, this treatment can help to prevent the virus from becoming permanent. When taken consistently, the medication has been shown to reduce the risk of HIV infection by up to 92 percent.

Health care providers are advised to consider PrEP for uninfected individuals who meet the following criteria:

A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted disease within the past six months and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative

A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (e.g., injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative

Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use

Living with an HIV-positive partner

HIV does not discriminate against those it infects, and many times couples will find themselves in an HIV-discordant relationship where one partner is positive and the other negative for the virus. Medscape reports that in the United States there are as many as 275,000 uninfected gay and bisexual men and 140,000 uninfected heterosexual partners in an HIV-discordant relationship. In cases like this, PrEP can be used along with condoms to help minimize the risk for passing on the virus. The World Health Organization reports that some countries in Africa have already introduced HIV testing and counseling for couples in an effort to help them support one another. “If you are positive, love each other and take your medication at the right time. We have lives with our status as a discordant couple for the past 18 years because we support each other,” said Godfrey Mtonga, who is HIV-positive, while his wife of 32 years is not.

Side Effects

When someone who is already HIV-positive is given PrEP, there is a risk of them developing an antiretroviral therapy-resistant virus. "This highlights the benefits of testing for HIV with a test that detects antigen, or viral RNA, as well as antibodies, before initiating PrEP. Patients should be retested every 2 to 3 months to confirm that they do not have HIV," Mermin explained to Medscape.

Side effects also include mild nausea and vomiting in the first month. There are also reports of mild reductions in creatinine clearance test, which can translate as a problem with the kidneys.

Source: Grant RM, Lama JR, Anderson PL, et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. The New England Journal of Medicine. 2010.

---

IAS

CDC Advises Clinicians To Consider PrEP for People With High HIV Risk

Author: Mark Mascolini

16 May 2014

With a strong endorsement and detailed guidelines, the US Centers for Disease Control and Prevention (CDC) now recommend that healthcare professionals consider preexposure prophylaxis (PrEP) for people who run a high risk getting infected with HIV. “PrEP has the potential to alter the course of the US epidemic, if targeted to populations in need and used as directed,” the CDC says in announcing new guidelines. “In fact, CDC estimates that as many as 275,000 uninfected gay men and 140,000 discordant heterosexual couples [in the United States] could potentially benefit from this intervention.” Worldwide, the CDC observes, 2.7 million people become infected with HIV every year. “Safe and effective new approaches to prevent HIV are urgently needed to reduce the toll of the disease,” the CDC maintains. New guidelines recommend PrEP with the once-daily pill Truvada (tenofovir plus emtricitabine) for these groups: 1. Anyone in an ongoing relationship with an HIV-infected partner. 2. Anyone not in a mutually monogamous relationship with a partner who recently tested HIV-negative and who is (a) a gay or bisexual man who has had sex without a condom or been diagnosed with a sexually transmitted infection within the past 6 months, or (b) a heterosexual man or woman who does not regularly use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status). 3. People who have injected illicit drugs in the past 6 months and shared equipment or been in drug treatment in the past 6 months. In endorsing daily PrEP for high-risk people, the CDC notes that success in preventing HIV depends on several interrelated factors including (1) “acceptability to users, (2) how effectively it is delivered by health care providers, including support for patients to achieve high medication adherence and to prevent increases in risk behavior, and (3) access to the drug by those at substantial risk of HIV.” Since no HIV prevention strategy is 100% effective, the CDC advises PrEP users to employ additional protective measures, such as using condoms. New PrEP regimens being studied now may prove effective as once-monthly or even less frequent injections instead of once-daily pills. Detailed guidelines and supplemental materials and tools for clinicians who prescribe PrEP and people who use it can be accessed at the link below. Source: Centers for Disease Control and Prevention. CDC e-HAP FYI Updates: New guidelines recommend daily HIV prevention pill for those at substantial risk. 14 May 2014.

For the CDC bulletin For CDC PrEP guidelines

--- hivandhepatitis.com http://www.hivandhepatitis.com/hiv-prevention/hiv-prep/4689-new-cdc-guidelines-people-at- risk-for-hiv-should-consider-pre-exposure-prophylaxis-prep

New CDC Guidelines: People at Risk for HIV Should Consider Truvada PrEP

Healthcare providers should advise people at "substantial risk" for HIV infection about post- exposure prophylaxis (PrEP) using tenofovir/emtricitabine, or Truvada, according to new guidelines issued by the U.S. Centers for Disease Control and Prevention (CDC). This includes HIV negative people in an ongoing sexual relationship with HIV positive partners, gay or bisexual men who have had sex without condoms during the past 6 months, heterosexual men and women who have sex without condoms with at-risk partners, and injection drug users.

The U.S. Food and Drug Administration (FDA) approved Truvada for PrEP in July 2012. Only Truvada taken every daily has been approved for HIV prevention. Taking it sporadically before sex or as a "morning after pill" has not been proven effective. HIV testing is important before starting PrEP, as a person who already has HIV and takes Truvada without other antiretrovirals could develop drug-resistant virus.

The guidelines reflect research showing the effectiveness of PrEP for different populations. The iPrEx trial of mostly gay and bisexual men found that taking Truvada once-daily reduced the risk of HIV infection by 42% overall, rising to 92% among participants with blood drug levels indicating regular use. Similarly, the Partners PrEP and TDF2 trials, which looked at heterosexual couples in Africa, found that PrEP using Truvada or tenofovir alone reduced the risk of HIV acquisition by about 65%-75%. The Bangkok Tenofovir Study showed that daily tenofovir alone reduced HIV acquisition among people who inject drugs by about 50%. Effectiveness was lower among African women in the Fem-PrEP and VOICE due to lack of adherence.

Below is an edited excerpt from a CDC press release summarizing the new guidelines. The full guidelines are available online.

New Guidelines Recommend Daily HIV Prevention Pill for Those at Substantial Risk

Could have significant impact on the U.S. epidemic if targeted and used as directed

Health care providers should consider advising the use of anti-HIV drugs by uninfected patients who are at substantial risk of infection, according to new clinical guidelines. PrEP, or pre-exposure prophylaxis, could reduce HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90 percent. Inconsistent use results in much lower levels of protection.

"HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States," said CDC Director Tom Frieden, MD, MPH. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.

The guidelines were developed by CDC in partnership with other federal health agencies, public health experts and community leaders.

The guidelines say PrEP should be considered for HIV-uninfected patients with any of the following indications:

Anyone who is in an ongoing sexual relationship with an HIV-infected partner.

A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status), and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative.

Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

"While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today," said Jonathan Mermin, MD, MPH, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances."

"PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing," said Dawn K. Smith, MD, MPH, the epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the development of the guidelines. "Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection."

In addition to providing guidelines and tools to assist providers in effectively prescribing and supporting PrEP use, CDC and other organizations are conducting pilot implementation studies and demonstration projects throughout the country. These projects aim to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection.

5/14/14

Reference

Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2014: A Clinical Practice Guideline. May 2014.

Other Source

Centers for Disease Control and Prevention. New Guidelines Recommend Daily HIV Prevention Pill for Those at Substantial Risk. Press release. May 14, 2014.

---

Gawker http://gawker.com/the-c-d-c-made-a-statement-in-support-of-prep-pre-exp- 1576805490?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+gawker% 2Ffull+%28Gawker%29

The C.D.C. made a statement in support of PrEP (pre-exposure prophylaxis in the form of the pill Truvada) on Wednesday. The institute recommends PrEP for people "at substantial risk for HIV," including men who have sex with men without condoms, HIV negative people in serodiscordant couples, and intravenous drug users.

Links to a March article: What Is Safe Sex? The Raw and Uncomfortable Truth About Truvada

---

Pride Source http://www.pridesource.com/

Michigan LGBT And HIV Leaders Praise New Guidance On PrEP

Feds Approve Broad New Clinical Guidance

By Todd Heywood

Originally printed 5/15/2014 (Issue 2220 - Between The Lines News)

The CDC on Wednesday released a comprehensive clinical guidance for use of the anti-HIV drug Truvada in preventing new HIV infections. The new guidance is the most comprehensive clinical guidance issued by a government agency since the FDA approved the drug for prevention in July of 2012.

The new guidance says PrEP (which stands for Pre-Exposure Prophylaxis) should be considered for HIV-uninfected persons who fit any of the follow risk categories: are in an ongoing sexual relationship with HIV-infected partner, is a gay, bisexual or other man who has sex with men or a transgender woman who has had sex without a condom or has been diagnosed with a sexual transmitted infection in the previous six months and is not in a mutually monogamous relationship with a partner who recently tested negative for HIV; a heterosexual man or woman who does not always use condoms and is not in a mutually monogamous relationship with a person who has recently tested HIV-negative; and anyone who has injected illicit drugs and shared equipment or has been in treatment for injection drug use in the past six months.

The guidance was developed through a partnership between the CDC, other federal health authorities, public health agencies, health experts and community leaders.

"While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today," a press release from the CDC quoted Jonathan Mermin, M.D., M.P.H., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention as saying. "These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances."

Mermin was not alone his assessment of the importance of the new guidance.

"HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States," said CDC Director Tom Frieden, M.D., M.P.H, in a press release. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the US."

New Guidances Praised

LGBT and HIV service organizations in Michigan are praising the new.

Bryan Victor, victim advocate at Equality Michigan and the organizations point person on HIV issues praised the new guidance saying it was "welcome" and "an incredibly important tool."

"Both public and private health insurers have already opened a pathway to PrEP use by offering coverage of the drug. We now need health care professionals - and primary care providers in particular - to take these CDC guidelines seriously and begin prescribing PrEP when clinically indicated," Victor said in a press statement emailed to the organization's membership. "Transgender women, gay men, and bisexual men deserve access to the full range of options that will allow them to have safe and fulfilling sex. Equality Michigan will continue to work with our partners throughout Michigan to make PrEP as accessible as possible."

In Lansing, Jake Distel, executive director of Lansing Area AIDS Network, said the guidance was welcome, but noted there remained structural issues to accessing the prevention pill.

"There seems to be no conformity relative to the prescribing of PrEP, nor access to the regimen, through either specialty providers (Infectious Disease Clinics), local health departments, or primary care providers," Distel said. "This appears to be true not only in Michigan but in other states across the country. LAAN case managers report, for example, that the agency has been advised that there are no protocols or guidances in place under which to comfortably prescribe, and provide access to PrEP. This is unfortunate."

He said the staff at LAAN is keenly aware of people living with HIV who are in serodiscordant relationships - that's where one partner is HIV-positive and the other is HIV-negative - and the lack of conformity hampers attempts by these couples to access the prevention regime.

Distel noted the new guidance should "alter past processes and decisions" related to PrEP. At the very least, he said, the new guidance should foster a discussion among local and state partners on the prevention.

On The Ground In Michigan

Unfortunately, the federal guidance may not translate to on the ground support in Michigan. The Michigan Department of Community Health has declined to issue guidance on PrEP. The agency says while the science behind the intervention is interesting, officials are still waiting for more information before committing to PrEP.

The department had similar problems several years ago when an investigation revealed the agency had no set guidance for prescribe post-exposure prophylaxis (n-PEP) for persons who may have been exposed to HIV as a result of sexual activity, sexual assault or drug use. The lack of state guidance and policy resulted in a mishmash of scenarios across the state. Where in the state someone lived often dictated whether or not a person would be prescribed the drugs.

In n-PEP, a physician prescribes a person exposed to HIV a month long course of anti-HIV medications in order to prevent infections. The regiment must be started within 72 hours of exposure to be effective.

After the news reports on the lack of policy came out, it took the health agency 18 months to issue a state guidance on the intervention, and the new guidance was similar to federal guidance on the drug intervention.

Ironically, despite the state's refusal to promote the intervention, which can be more than 90 percent effective in preventing new infections if used daily, the Medicaid program will pay for the drug for low-income residents who are prescribed the prevention intervention. The cost of the drug is about $12,000 a year, and requires routine blood work to monitor HIV status as well as the function of internal organs to detect any possible side effects from the drugs. Angela Minicuci, spokesperson for MDCH, issued a press statement saying they will follow the CDC guidance, "PrEP is an important tool in the prevention of HIV and the CDC guidance in support of PrEP is a major step forward. MDCH will follow the CDC guidance on PrEP and the prevention and treatment of HIV. As we are still reviewing the recommendation, we will be determining how this information will be distributed. On a cautionary note, PrEP does not prevent bacterial, sexually transmitted diseases, such as syphilis, gonorrhea and chlamydia. Condoms reduce the risk of HIV and STDs so we will continue to recommend those as well," said Minicuci.

CDC press release: http://www.cdc.gov/nchhstp/newsroom/2014/PrEP-Guidelines-Press- Release.html

Federal Guidance: http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf

Link to the supplement for the guidelines: http://www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf

---

YourTango http://www.yourtango.com/2014216349/sex-education-cdc-advises-take-pill-daily-prevent-hiv- infection-aids

This Just In: Could Taking This Pill Daily Prevent HIV Infection?

Find out what pill the CDC is recommending.

Although our society has gone pretty far in lowering HIV infection and death by AIDS there is progress to be made. HIV rates are still high due to decreasing condom use. Why oh why is this decreasing?! Don’t we know that safe sex is not only safe, but sexy? Being healthy after all is definitely sexier than being sickly, and we even came up with how to make safe sex sexier!

In order to address this troubling situation, Federal Health Officials are targeting at risk groups like gay men, illicit drug users, and heterosexuals with at-risk partners, by advising to take a certain pill daily! This change in policy is of course controversial. There are 10,000 people currently taking this medication in the US, but if more people start taking this regimen then that number could jump to 500,000.

Find out what pill the CDC is recommending here: Major CDC Shift: Use Pill to Block AIDS

---

Washington Blade http://www.washingtonblade.com/2014/05/15/cdc-recommendations-prep-praised-aids- groups/

AIDS groups praise CDC recommendations on PrEp HIV/AIDS groups are jointly praising new recommendations from the Centers for Disease Control encouraging gay and bisexual men to take medication designed to block them from contracting HIV.

In a joint statement on Thursday, 68 groups announced their “strong support” for the CDC guidance promoting use of oral pre-exposure prophylaxis, also known as PrEP for those vulnerable to HIV infection — including gay and bisexual men not in monogamous relationships who have had sex without a condom.

“PrEP has the potential to help many individuals in the U.S. and around the world protect themselves from HIV,” the statement says. “Failure to strategically, effectively and responsibly implement this scientifically sound strategy as part of comprehensive prevention and treatment programs in our fight against HIV would be a true catastrophe.”

Among the signatories to the statement are amfAR, the AIDS Institute, the National Minority AIDS Council and the New York City-based Gay Men’s Health Crisis.

On Wednesday, the CDC issued new recommendations on PrEP, saying health care providers should consider advising use of the drug for uninfected patients who are at substantial risk of infection, including men who have sex with men.

According to both the HIV/AIDS groups and CDC, PrEP can reduce the risk of HIV infection by more than 90 percent when taken daily as directed, although inconsistent use results in much lower levels of protection.

CDC Director Tom Frieden said in a statement PrEP can be an effective tool to stop contraction of HIV when used with other prevention methods.

“HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States,” Freiden said. “PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the United States.

The recommendations from the CDC come two years after the U.S. Food & Drug Administration approved the oral drug Truvada for HIV prevention. The agency reviewed data from multiple, multinational clinical trials of PrEP use among individuals with different risks for HIV infection. Donnica Smalls, a CDC spokesperson, said the guidelines are meant to replace interim guidance CDC has issued through the years as trial results showing efficacy have become available and are the first formal recommendations offering comprehensive information about PrEP.

But not every AIDS group is happy with the CDC recommendations. Michael Weinstein, president of the AIDS Healthcare Foundation, which has already taken hits for objecting to the FDA’s approval of PrEP, issued a statement saying the CDC recommendations are “ill-advised.”

“This is a position I fear the CDC will come to regret,” Weinstein said. “By recommending widespread use of PrEP for HIV prevention despite research studies amply chronicling the inability to take it as directed, and showing a limited preventive effect at best, the CDC has abandoned a science-driven, public health approach to disease prevention — a move that will likely have catastrophic consequences in the fight against AIDS in this country.”

Weinstein said the recommendations will lead individuals to engage in sex without condoms, which could make them vulnerable to other sexually transmitted diseases, such as syphilis, which has shown to be on the rise and with new infections mostly among men-who-have-sex- with-men.

“The CDC would be better advised to put its weight behind HIV testing and linkage to treatment for the estimated 20 percent of the 1.3 million people living with HIV in this country today who have never been tested for the disease,” Weinstein said.

According to the AIDS Healthcare Foundation, only about 10,000 individuals have been prescribed once-daily Truvada as PrEP to reduce the risk of HIV transmission. It’s also an expensive drug; it costs $13,000 a year, although many insurers already cover it, according to the New York Times. Moreover, Gilead, the manufacturer of Truvada, doesn’t advertise the drug as a prophylactic, although it does advertise the medication for HIV treatment.

But the 68 groups that jointly praised the CDC recommendations also criticized Weinstein, saying his assertion that PrEP will lead the way to sex without condoms isn’t based on sound science.

“In fact, initial studies suggest the opposite, and Weinstein’s assertion underestimates the capacity of informed individuals to make decisions about their health and sex lives,” the groups said. “We all must do more to reinvigorate the approach to correct and consistent condom use and underscore that PrEP and condoms are complimentary interventions to the prevention of all STDs, including HIV.”

The groups say Weinstein fails to realize condoms aren’t consistently or correctly used “for a host of reasons” and PrEP now provides “an additional option that also provides significant protection against HIV.”

The Boston-based LGBT and HIV/AIDS organization known as Fenway Health issued its own statement praising the CDC for the guidance, saying it was involved with PrEP research since the first safety studies were conducted in the United States more than five years ago, and was one of two iPrex study sites in the country.

“As rates of HIV infection continue to increase in gay and bisexual men, we need to make sure we are using all of the tools available to us to combat that increase. PrEP is a proven and important new tool that should be part of those efforts,” Boswell said. “The CDC guidelines are helpful, since they clearly suggest that PrEP should be part of a comprehensive national prevention strategy.”

---

BuzzFeed http://www.buzzfeed.com/tonymerevick/hiv-prevention-pill-gets-cdc-endorsement-advocates- hail-wond

HIV Prevention Pill Gets CDC Endorsement, Advocates Hail "Wonderful" Decision And Slam Critics

Sixty-eight of the nation’s leading HIV/AIDS healthcare organizations have endorsed new U.S. federal health guidelines saying doctors should consider a daily drug, which has been shown to prevent HIV infection, for patients at “substantial risk.”

The Centers for Disease Control and Prevention (CDC), in its new guidelines to doctors, said Wednesday that pre-exposure prophylaxis, or PrEP, could reduce HIV infection rates when taken daily as directed. Some advocates say the guidelines will dramatically change the way primary doctors and clinicians address the risk of HIV infection with HIV-negative patients and provide confidence to health care providers in prescribing the pill.

When taken daily, PrEP, manufactured by Gilead Sciences with the market name of Truvada, has been shown to reduce HIV infection by 90%. “PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the U.S.,” said CDC Director Tom Frieden, M.D., in a statement. Currently, new HIV infections are at 50,000 per year.

In the letter endorsing the decision, the organizations hailed the CDC guidelines as “critical information to help healthcare providers and patients understand the suitability of oral PrEP as an HIV prevention option and ensure that those who choose PrEP have the support – including ongoing monitoring, counseling, adherence support and frequent HIV and STD testing – necessary for PrEP to be effective.”

Among the organizations represented in the letter are the AIDS Foundation of Chicago, Gay Mens Health Crisis, and San Francisco AIDS Foundation, among others.

“The guidance makes this a standard for primary care, not just for HIV doctors,” said Dr. Demetre Daskalakis, medical director of Ambulatory HIV Services at Mount Sinai Hospital in New York City who serves on the board of GMHC, in an interview with BuzzFeed. “Ultimately, the subtext is that health care providers need to have a frank conversations with patients to see if they are at risk.”

The extensive new guidelines, in summary, tell doctors to consider the drug for patients who are in a sexual relationship with an HIV-infected partner; gay and bisexual men who have condomless sex; heterosexual men and women with sexual partners at high risk such as injection drug users or bisexual men; and anyone who uses injection drugs or shares needles. The guidelines also say that patients should be tested for HIV before being prescribed the regimen. Much of the focus among advocates for PrEP has been on gay men, who are at the highest risk, according to Jim Pickett, director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago. “It’s been framed with gay men because that’s where a new intervention is needed,” he said. Unprotected sex among men who have sex with men increased between 2005 and 2011, according to a November 2013 report from the CDC. However, the drug is yet to catch on, with the CDC estimating that fewer than 10,000 have been prescribed the regimen, which it said could rise to 500,000 under the new guidance.

The new guidelines come two years after Truvada was approved by the U.S. Food and Drug Administration as a method for HIV prevention in combination with safer sex practices and builds on interim guidance previously issued by the CDC on PrEP for men who have sex with men, people who inject drugs, and heterosexuals at risk.

Taking Truvada as PrEP is no small commitment, considering it must be taken daily and patients must check in with their medical providers every three months. Additionally, the pill costs $15,000 per year in the U.S., but most insurers usually cover the drug and Gilead offers financial assistance to patients in need who may not be covered by insurance.

The numerous organizations also condemned what they view as “harmful misrepresentations” of PrEP by Michael Weinstein, president of the AIDS Healthcare Foundation, who has long been critical of prescribing the drug for HIV prevention and, as a result, come under fire for those views.

In a statement Wednesday, Weinstein said the CDC “abandoned a science-driven, public health approach to disease prevention” and that the guidelines “will likely have catastrophic consequences in the fight against AIDS in this country.”

“What about other STDs like syphilis, which has seen a resurgence approaching epidemic proportions in some of the same communities that the CDC wants to target for PrEP?” Weinstein said. “Despite CDC and FDA requirements for risk-reduction counseling and condom use while taking PrEP, the government-sanctioned widespread deployment of PrEP will be accompanied with a shift to condom-less sex. The CDC would be better advised to put its weight behind HIV testing and linkage to treatment for the estimated 20% of the 1.3 million people living with HIV in this country today who have never been tested for the disease.”

The signing organizations contend that Weinstein’s views “are not based in science,” and said that none are advocating for PrEP to replace condoms.

“The CDC PrEP guidelines underscore that PrEP is not for everyone,” the letter states. “Neither CDC nor any of our organizations are advocating for indiscriminate use of PrEP. Neither is anyone suggesting that oral PrEP is a replacement for condoms; rather it is an additional option from which individuals should be able to choose.”

As for the next step following the CDC guidelines, health advocates like Pickett say organizations and health officials must now help doctors implement information in their practices so that people who are in need of PrEP will get it.

“So we have this wonderful set of guidance, this great road map,” says Pickett. “And now we really have to work hard to make sure that PrEP is implemented smartly and strategically and that we’re getting it to the people who most need it.” The AIDS Healthcare Foundation said Weinstein was out of the country Thursday. A message was left with his assistant seeking additional comment.

---

Advocate http://www.advocate.com/health/2014/05/15/cdc-recommends-truvada-hiv-prevention

CDC Recommends Truvada for HIV Prevention

The Centers for Disease Control and Prevention Wednesday announced new clinical guidelines that recommend anyone who is at an elevated risk for contracting HIV use the drug Truvada as a preventive measure to help protect themselves from being infected with the virus, which can cause AIDS.

The federal health agency recommended the use of Truvada,, an antiretroviral medication that is also used to treat HIV, as a form of pre-exposure prophylaxis, of PrEP, for gay and bisexual men who have sex without condoms, anyone who regularly has sex with partners who are HIV- positive, intravenous drug users or anyone who shares needles, and heterosexuals partnered with high-risk individuals, including IV drug users and bisexual men who have sex without condoms.

The CDC's guidelines still recommend that PrEP be used in conjunction with safer-sex practices, including the use of condoms, though some acknowledge the likelihood of that is low. While Truvada can help prevent HIV infection, eschewing condoms still puts an individual at risk for other sexually transmitted infections, including syphilis and gonorrhea.

"Making the perfect the enemy of the good is something we’ve got to get over," Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the country’s best-known AIDS doctor, told The New York Times. "I strongly support the CDC doing this."

According to the Times, the new guidelines, if followed, could have a ripple effect on the way Americans fight HIV and AIDS, shifting the conversation around prevention from focusing on condoms to focusing on use of the antiretroviral drug. The Times notes that strict adherence to the guidelines would result in "a 50-fold increase in the number of prescriptions for the drug … to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it."

Truvada, which has been used to treat HIV-positive individuals since 2004, was approved by the Food and Drug Administration as a tool to prevent HIV in 2012, after studies revealed a 75 percent success rate in preventing new infections in serodiscordant couples (where one partner is HIV-positive, the other HIV-negative) who used the drug correctly. Another study of gay men showed that 99 percent of those who took the medication daily as prescribed were protected from HIV. Although the daily, one-pill regimen has been proven to reduce the risk of HIV transmission, it must be taken consistently.

Truvada, manufactured by Gilead, is a mix of tenofivir and emtricitabine and is generally considered safe. During clinical trials of its use as PrEP, some people said they experienced diarrhea, nausea, abdominal pain, headache, and weight loss. A small segment of users experienced kidney problems. Despite its efficacy, the use of Truvada as PrEP has been dogged by controversy, with detractors claiming the drug will lead to unsafe sex practices, even spawning the phrase "Truvada whore" to describe someone who takes the drug to have guilt-free sex without condoms. Some advocates, however, are already working to reclaim the term, wearing T-shirts with the hashtag #TruvadaWhore in an effort to stop what they call "slut-shaming" of those who use PrEP.

Last September an article for The Advocate's sibling publication Out asked of the drug, "Is This the New Condom?" Writer Tim Murphy spoke to advocates who compared the impact of PrEP on HIV to the impact of the birth control pill on unwanted pregnancies in the 1960s. The article sparked a storm of controversy as readers argued over the pros and cons.

A recent op-ed published at The Advocate makes the case for use of Truvada as protection. Writer Antonio David Garcia refuses to be shamed out of taking PrEP:

"Some critics say Truvada is a 'party pill,' outrageously equating it with recreational drugs, and that those who use it will have more unsafe sex and higher rates of HIV. To be sure, some gay men will use Truvada without condoms. Some gay men will choose not to wear condoms nor take Truvada at all. Being on an effective PrEP regimen is a good thing, and Truvada is another tool in the toolbox to protect yourself from HIV. So I’m going to take it."

For more information about Truvada, check out the resources gathered by another of our sibling publications, HIV Plus Magazine.

---

SF Gate http://www.sfgate.com/business/article/Gilead-s-HIV-drug-Truvada-gets-boost-from-CDC-nod- 5481840.php

Gilead's HIV drug Truvada gets boost from CDC nod

Gilead Sciences' winning streak may run even longer after its pill to prevent HIV infection scored a federal health agency's endorsement this week.

The Centers for Disease Control and Prevention said Wednesday that Americans at risk for HIV should consider using Gilead's drug, Truvada, to avoid infection. The Foster City company's daily pill is the first and only medication for HIV prevention, and it has been hailed as a breakthrough in the battle to slow the AIDS epidemic.

Truvada, with its annual price of $15,000, has a vast potential market. About 50,000 Americans become newly infected every year, a rate that, despite health outreach efforts, has remained virtually the same since the mid-1990s. And most insurers cover the drug.

Still, analysts do not expect Truvada to be Gilead's biggest drug of the year - not by a long shot.

The company is already enjoying the blockbuster success of Sovaldi, a hepatitis C drug priced at $84,000 for a 12-week regimen. When the pill generated $2.3 billion in worldwide sales in the first three months of 2014, it set a record as the best-selling new drug in history. Relatively speaking, the CDC's recommendation of Truvada is "not really a huge boon, particularly since hepatitis C is really the huge, huge driver of the company," said Michael Yee, an analyst at RBC Capital Markets. Sovaldi alone, he predicts, could double Gilead's total sales over the next two years.

Truvada generated upward of $3 billion in sales last year. At least 2,300 people were prescribed Truvada for HIV prevention in 2012 and 2013, not including those who use the drug to battle existing HIV infections, Gilead said.

On Thursday, the company's stock was down 87 cents, about 1 percent, closing at $80.10. The stock, like other biotechnology stocks, has been struggling this spring, but in the last month, it has steadily climbed back toward its February high of about $84.

Truvada first won approval in 2004 for patients infected with HIV. In July 2012, it was approved for people who test negative for HIV but are at risk. These include gay men who have sex without condoms, patients who regularly have sex with anyone they know is infected, and anyone who shares needles or injects drugs.

Part of an HIV prevention method called pre-exposure prophylaxis, Truvada has been shown to reduce the risk of HIV infection by more than 90 percent. The drug is supposed to be used along with safe-sex practices, such as condom use, to help prevent risk.

Some experts worry that people using the drug might engage in riskier behavior because they believe they are protected. But in a December study of 2,500 men and transgender women at risk for HIV infection worldwide, taking Truvada did not appear to lead to an increase in risky sexual behavior.

Stephanie M. Lee is a San Francisco Chronicle staff writer. E-mail: [email protected] Twitter: @stephaniemlee