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Vol 18, No. 3, October 2011 tagline NEWS ON THE FIGHT FOR BETTER TREATMENT, A VACCINE, AND A CURE FOR AIDS Cure Research Momentum Accelerates

By Richard Jefferys

The research effort to discover a original plan, which reflects a transplants to create HIV-resistant cure for HIV infection continues number of factors: the commitment immune cells (Kiem has developed to gain momentum, with several of NIAID to the goal of curing HIV; a macaque model for evaluating important developments having the activism of community-based this type of approach). Jerome occurred since the last issue of groups such as TAG, AIDS Policy is also pursuing the potential use tagline. Project, amfAR, and Project Inform; of proteins called endonucleases and the quality of the requests for to excise the HIV genome from In July, the National Institute of funding that were submitted by latently infected cells. Allergy and Infectious Diseases researchers. (NIAID) announced the award of Principal investigator David three multimillion dollar five-year Grantees include the Fred Margolis at the University of North grants under the aegis of the Hutchinson Cancer Research Carolina at Chapel Hill is leading Martin Delaney Collaboratory, a Center in Seattle, where coprincipal the largest of the groups, program named in memory of the investigators Keith R. Jerome and consisting of 15 scientific projects longtime AIDS activist and founder Hans-Peter Kiem are overseeing at nine different academic research of Project Inform, who died in five projects, including a collabora- centers throughout the U.S. Merck 2009. The awards represent a tion with Sangamo Biosciences on Research Laboratories is a key part significant expansion of the the use of hematopoietic cell of this team, but will not be receiving funding from the National Institutes of Health (NIH). The A Golden Decade of major goals are to improve the understanding of HIV persistence Antiretroviral Drug Development despite antiretroviral therapy and to develop therapies to target and eliminate viral reservoirs. Success rate for new ARVs entering phases II–III surpassed 32% U.S. ADAP Prescribing Practices Closely Match Recent ARV Guidelines Continued on page 2 By Polly Clayden and Mark Harrington As we were putting together the To preface this year’s Pipeline, we 2011 Pipeline Report this summer, decided to look at the series of WHAT’S INSIDE we decided to look back at the detailed pipeline reports since previous years’ reports on anti-HIV 2003. We wanted to examine drug development. Treatment several questions: What We Need to Action Group (TAG) has been Cure AIDS? 3 covering the antiretroviral (ARV) • Whether the HIV drug pipeline drug pipeline since our founding; is drying up; Ending the Neglect of in the past two years we have Childhood TB 7 joined forces with HIV i-Base (UK) • What the success rate is for to deepen and broaden our new ARV drugs entering phases TAG’s 2011 Research In coverage. II–III to assess the likelihood Action Awards 8

Continued on page 5 page 1 Vol 18, No. 3, October 2011

Cure Research Continued from page 1

Lastly, a triumvirate of principal The online version of the statement The i-Base/TAG 2011 Pipeline investigators—Steve Deeks and currently has 4,479 signatories. Report also contains a section Mike McCune at University of You can sign it here: http:// describing the current status of California, San Francisco, and www.iasociety.org/Default. cure-related clinical research, Rafick-Pierre Sekaly at the Vaccine aspx?pageId=583. The conference available online at: http://www. and Gene Therapy Institute of itself offered further evidence of treatmentactiongroup.org/ Florida—are overseeing seven the increased profile of HIV cure pipeline-report/2011. projects aiming to delineate where research, with multiple sessions HIV reservoirs are located in the and satellite meetings addressing Finally, a group of community- body and how they are created the topic. based organizations sent a letter and maintained, with the ultimate to the NIH and the U.S. Food and goal of developing therapies that Another research funding Drug Administration (FDA) asking can eliminate reservoirs without development came from amfAR, them to convene a national causing excessive immune which announced a second round dialogue on how best to move activation. of grants—albeit of far smaller forward with AIDS cure research. amounts than those bestowed by The letter is printed below. The announcement of the Martin NIAID—under its amfAR Research Delaney Collaboratory grants Consortium for HIV Eradication 9 August 2011 occurred just a week ahead of the (ARCHE) program. The funding 2011 International AIDS Society will support several scientists who Jack Whitescarver, Ph.D. (IAS) Conference on HIV are already part of ARCHE and Associate Director for AIDS Pathogenesis, Treatment and two new additions to the group: Research, National Institutes of Prevention in Rome, at which the Adriana Andrade at Johns Hopkins Health (NIH) IAS launched “The Rome Statement and Una O’Doherty at the Director, Office of AIDS Research, for an HIV Cure” calling for an University of Pennsylvania. NIH acceleration of cure research. The Andrade is conducting a small statement was initiated by clinical trial of the FDA-approved Margaret A. Hamburg, M.D. members of an IAS Advisory alcoholism treatment disulfiram Commissioner, U.S. Food and Drug Board working to develop a global (Antabuse), following up on work Administration (FDA) scientific strategy for the field, and by ARCHE researcher Bob lists three key objectives: Siliciano suggesting that the drug The undersigned organizations might be able to awaken latent are writing to request that the NIH • Recognizing the importance HIV reservoirs. O’Doherty plans and FDA collaborate to convene of developing a safe, to compare different approaches a workshop on clinical trials and accessible, and scalable HIV to evaluating the size of the HIV regulatory issues pertaining to cure as a therapeutic and reservoir, in hopes of identifying HIV cure research. We are keenly preventive strategy against the most accurate and practical interested in anticipating and HIV infection and to help methods. overcoming obstacles to moving control the AIDS epidemic. cure research forward at the O’Doherty’s study addresses fastest pace that is justified in • Committing to stimulating important questions identified at the context of both science and international and multi- a workshop on cure-related HIV safety concerns, and believe that disciplinary research collabo- research that took place in interagency discussions on the rations in the field of HIV cure Baltimore in April, sponsored by subject—perhaps similar to those research. AIDS Policy Project, amfAR, that have taken place regarding • Encouraging other stake- Project Inform, and TAG. A full stem cell research—can play a vital holders, international leaders, report and list of recommendations role. and organizations to contrib- from the workshop will be posted ute to accelerating HIV cure online soon. For a frequently At a recent community-sponsored research through their own updated list of resources on HIV meeting on HIV cure-related initiatives and/or by endorsing cure research, including links to clinical research, a number of key this statement and supporting articles, scientific papers, and issues were identified that we the alliance that the Advisory clinical trials, see TAG’s website: believe could form the basis for a Board is building. http://www.treatmentactiongroup. productive, non-product-specific org/cure/resources. dialogue involving appropriate officials from your two agencies. Continued on page 3 page 2 tagline Vol 18, No. 3, October 2011

Cure Research Continued from page 2 These include: • The need for government with NIH, researchers, and agencies to actively engage community representatives in • The need for interagency the diverse array of stake- dealing with the regulatory, discussions to broaden holders, including and scientific, and ethical issues knowledge and awareness especially people with related to cure research. of the current status of HIV HIV/AIDS, in decision-making cure-related research about research ethics and Thank you for your consideration, access to clinical trials • Appropriate pre-clinical AIDS Policy Project milestones to justify We envision that such a workshop amfAR advancing approaches into would be the first of an ongoing Project Inform clinical trials series of steps to engage the FDA Treatment Action Group •

• Evaluating and prioritizing assays with the potential to be used as trial endpoints What We Need to Cure AIDS? • The use of analytical treatment interruptions—and exploration By Mark Harrington of valid alternatives—to

evaluate the effects of A cure for HIV is possible: one 1. Scientific commitment. The U.S. interventions, and appropriate man, the so-called Berlin patient, National Institutes of Health, the parameters for ensuring has already been cured of chronic French National AIDS Research participant safety HIV infection with an immune Agency, the Foundation for AIDS system transplant with cells Research (amfAR), and a handful • Methods of improving uptake genetically resistant to HIV. After of drug companies including BMS, of gene-modified cells in four years, the man remains free Gilead, Johnson & Johnson, Merck, clinical trials of detectable HIV, and his HIV and Sangamo are all committed to antibodies are disappearing. AIDS cure research; some of the • Appropriate trial populations However, this approach is smartest experienced and younger for the different types of dangerous (potentially fatal), scientists are working tirelessly to interventions under costly, and not scalable to the 34 discover and develop a safe, consideration million people currently living with effective, feasible, and scalable HIV. HIV cure. • Facilitating cross-trial comparisons and specimen A cure for HIV is necessary: 34 2. Scientific resources. Curing HIV sharing million people worldwide are living will require a massive investment with HIV, and 25 million more will of scientific resources including • The level of risk that is be infected in each of the coming grant money, animal models, appropriate for trials where decades (a total of 300 million by laboratory tests, and expensive the potential benefits to 2100). The lifelong treatment of and long-term clinical trials. individual participants may be these 334 million people would Experts estimate that over $800 negligible but the benefits to be logistically difficult, expensive, million a year will be needed to advancing the science—and and could result in drug resistance, fully fund the most promising therefore to the wider treatment failure, and onward opportunities in AIDS cure research. community of HIV-positive transmission of drug-resistant Currently less than $100 million people—may be significant HIV—a public health nightmare per year is available for this effort. without end. Full funding for the NIH and its • Ethics and informed consent AIDS research budget, overseen Five things are needed to cure and coordinated by the NIH Office • Educational initiatives for HIV: of AIDS Research, will be institutional review boards and necessary to achieve a cure for community advisory boards AIDS.

Continued on page 4

page 3 tagline Vol 18, No. 3, October 2011

What We Need Continued from page 3 A Golden Decade Continued from page 1

3. An informed, educated, and that current candidates will with regulatory action likely later motivated community of progress toward approval; and in 2012, which, if it leads to participants for HIV cure clinical approval, would bring the success trials. Currently, many people with • How rapidly which new drugs rate to 39.1% (18/46). HIV are interested in enrolling in and combinations enter prac- cure-related clinical trials. However, tice in one industrialized coun- So much for those who say investing to ensure their continued willing- try, the United States. in HIV treatment is a bad bet. ness to engage in studies that will be long-term, high-risk, and may The global ARV treatment market Rapid implementation and uptake involve deferring, interrupting, is estimated at $13 billion in market of new therapies provides rapid or going off highly effective volume this year, with most of the return on investment. antiretroviral therapy, continued profits made in industrialized community education, involvement, countries, while most of the Another remarkable feature of the and participation in cure research people in need of treatment live in HIV treatment landscape is the at all levels (planning, implemen- developing ones. tation, evaluation, community rapidity with which new drugs and outreach and education, resource combinations are incorporated The past decade has indeed been into the standards of HIV care in mobilization, and advocacy) will a golden age of ARV drug be required. developed countries. In the United development. Of the 30 new States, this process has been 4. A flexible, rigorous, and chemical entities approved by the facilitated since the late 1990s by inclusive regulatory approach to U.S. Food and Drug Administration the establishment of the standing cure-related clinical trials. Just (FDA) to treat HIV infection since Department of Health and Human as the U.S. Food and Drug 1986, half (15/30) were approved Services (DHHS) Panel on Anti- Administration (FDA)—after many in the years since 2003. Thirty- retroviral Guidelines for Adults activist demonstrations and seven drugs and fixed-dose and Adolescents and the Panel interventions—created a flexible combinations (FDCs) are FDA- on Antiretroviral Therapy and regulatory environment that approved for sale in the United Medical Management of HIV- allowed the rapid study of anti-HIV States; a further 132 drugs and Infected Children (http://aidsinfo. drugs, accelerated their approval FDCs (including adult and nih.gov/Guidelines/Default.aspx). based on changes in so-called pediatric formulations) are surrogate markers such as CD4 tentatively approved under the The Adult and Adolescent Guide- cell counts and HIV-RNA levels FDA’s generic registration program (viral load), and expanded access lines Panel meets monthly by to facilitate global access through teleconference, once yearly in to experimental agents for those programs such as the President’s lacking valid therapeutic options, person (usually at the annual Emergency Program for AIDS so HIV cure research will require retrovirus conference CROI), and Relief (PEPFAR). Please see the coordinated, flexible, and issues updated online treatment data series from the TAG ARV scientifically advanced regulatory recommendations at least oversight by the FDA working pipelines dating from 2003 to the annually, with changes highlighted across departments involving present (See Table 1 on page 5). in yellow to make navigating the drugs, therapeutic vaccines, ever-changing treatment land- monoclonal antibodies, and cell The success rate for new ARV scape easier. A review of data and gene therapies. drugs and FDCs that have entered generously provided by the U.S. phase II or further studies since 5. Public understanding and National Association of State and 2003 is an astonishing 32.6% Territorial AIDS Directors (NASTAD) commitment to curing AIDS. (15/46). Most recently, in 2011, the The HIV cure research effort will demonstrates the astonishing FDA approved (Edurant), fidelity of U.S. AIDS Drug be long-term, high-risk, and will extended-release include many failed studies and Assistance Program (ADAP) (Viramune XR), and the FDC prescribing practices in 2009 to approaches before it succeeds in rilpivirine/TDF/FTC (Complera). discovering and delivering a safe, the most recent iteration of the effective, feasible, and globally U.S. HIV treatment guidelines In the first quarter of 2012, Gilead scalable HIV cure. Public support (See Table 2 on page 6). is expected to file with regulatory and understanding of this effort are essential to secure the authorities for approval of the Among the many striking features research funding and political , of the 2009 ADAP reported data support that will be required for the pharmacokinetic booster on ARV usage are: this effort to succeed. • , and the FDC elvitegra- vir/cobicistat/TDF/FTC (“Quad”), Continued on page 7 page 4 tagline Vol 18, No. 3, October 2011 TABLE 1 . HIV Treatment Pipeline 2003–2011 Sources: Camp 2003–2006; Huff 2007; TAG 2008; Huff 2009; Collins 2010–2011 . FDC FDC FDC PK booster MI Class FDC FDC PK booster NNRTI NRTI NRTI NRTI NRTI II II NNRTI NNRTI NRTI NRTI NRTI NRTI NRTI NRTI Anti-CD4 Mab II II CCR5RI FI NNRTI AI CCR5RI/CCR2RI CCR5RI CCR5RI PI PI PI PI PI NNRTI NNRTI NNRTI AI NNRTI AI ELV/CBS/FTC/TDF RLV/FTC/TDF EFV/FTC/TDF PA-457, MPC-4326 GS 9350 Drug name FTC/TDF ABC/3TC SPI-251 DPC-083, AI-183 DAPD ACH-126,443 SPD 754, AVX754, DOT MIV-310, FLT GSK-1265744 GSK-1349572 TMC-125 OBP-601 PMPA, GS-7340 (TDF prodrug) FTC AG1549 D-D4FC, DPC-817 TNX 355, Hu5A8 GS-9137/JTK-303 MK-0518 SCH-C, SCH 351125 T-20 GSK-2248761/IDX889 PRO 542 TAK-652, TBR-652 UK-427,857 SCH D, SCH 417 GSK-640385 VX-175/GW-433908 TMC-114 UK-453,061 BILR 355/r BS TMC-278 PRO 140 BMS663068 Quad Cobicistat Generic name Amdoxivir Apricatibine Festinavir Reverset Elvitegravir Cenicriviroc Vicroviroc Lersivirine Rilpivirine Complera (2011) Atripla (2006) Truvada (2004) Epzicom (2003) Brand name Intelence (2008) Emtriva (2003) Isentress (2007) Fuzeon (2003) Selzentry (2007) Reyataz (2003) Aptivus (2005) Lexiva (2003) Prezista (2006) Edurant (2011) Viramune XR (2011) Gilead Gilead/Tibotec BMS/Gilead Gilead GSK Gilead Sponsor Panacos, Vitex, Myriad Sequoia Gilead, Emory, RFS Pharm Achillion Shire Biochem, Avexa GSK/Shionogi/ViiV Tibotec Advanced Life Sciences/Sarawak MediChem BMS BMS Triangle/Gilead Agouron/Pfizer BI, Medivir, Beijing Mefuvir Pharmasset Pharmasset/Incyte Tanox, Biogen, Taimed Gilead GSK/Shionogi Merck Trimeris/Roche Gilead Takeda/Tobira Pfizer Schering-Plough Schering-Plough GSK BMS Boehringer Ingelheim Vertex/GSK Tibotec Pfizer Tibotec GSK/Idenix Progenics Boehringer Ingelheim Boehringer Ingelheim Progenics BMS approved 2003 IIb II II II II approved III II I I approved I I/II approved III approved I/II II approved I 2004 to Emory II I II discontinued III I Ib I I stopped III II

Ib 2005 to RFS II II Ib Ib I II II discontinued II II Ib I II II approved III Ib approved II 2006 Ib Ib Ib II III III discontinued II I II II II III approved Ib Ib II 2007 II II II II II approved III II discontinued III II approved II II 2008 II to Mefuvir II III approved II III III II II 2009 II II II III II II II III II III II III III discontinued III III 2010 discontinued II discontinued III I II II III II stopped

II III approved III

2011 II III II III II II II approved II approved

II

LEGEND NRTI = nucleoside reverse transcriptase inhibitor; NNRTI = non-nucleoside RTI; PI = protease inhibitor; FI = fusion inhibitor; CCR5RI = CCR5 receptor inhibitor; CCR2RI = CCR2 receptor inhibitor II = integrase inhibitor; AI = attachment inhibitor; MI = ; PK booster = pharmocokinetic booster; FDC = fixed-dose combination

page 5 tagline Vol 18, No. 3, October 2011 TABLE 2. U.S. ADAP Antiretroviral Market Share by Drug in 2009 Source: NASTAD Sponsor Gilead Gilead BMS Abbott Merck Tibotec Gilead BMS Gilead drugs subtotal All recommended first-line ARV GSK Abbott GSK GSK GSK BI Tibotec Pfizer GSK GSK Roche Roche Pfizer BMS BI Merck BMS GSK Pfizer All other ARV drugs subtotal All ADAP drugs 2009 total Brand name Atripla Truvada Reyataz Kaletra Isentress Prezista Viread Sustiva Emtriva Epzicom Norvir Combivir Trizivir Lexiva Viramune Intelence Viracept Ziagen Epivir Invirase Fuzeon Selzentry Zerit Aptivus Crixivan Videx/Videx EC Retrovir Rescriptor Generic name /emtricitabine/tenofovir emtricitabine/tenofovir atazanavir / raltegravir darunavir tenofovir DF efavirenz emtricitabine / ritonavir lamivudine/ abacavir/lamivudine/zidovudine fosamprenavir nevirapine etravirine abacavir lamivudine enfuvirtide maraviroc tipranavir zidovudine

Abbreviation EFV/FTC/TDF FTC/TDF ATV LPV/r RAL DRV TDF EFV FTC ABC/3TC RTV 3TC/AZT ABC/3TC/AZT APV NVP ETV NFV ABC 3TC SQV T-20 MVC d4T TPV IDV ddI AZT DLV Class NNRTI+2NRTIs 2NRTIs PI PI II PI NRTI NNRTI NRTI 2NRTIs PI 2NRTIs 3NRTIs PI NNRTI NNRTI PI NRTI NRTI PI FI CCR5RI NRTI PI PI NRTI NRTI NNRTI expenditures 2009 ADAP reported $348,729,057 $236,929,054 $147,703,662 $72,149,642 $51,950,133 $44,983,885 $44,983,885 $35,870,178 $28,472,290 $28,472,290 $1,563,801 $968,351,702 $968,351,702 $69,922,861 $53,948,036 $49,600,002 $31,622,256 $31,622,256 $30,610,979 $20,823,184 $13,510,660 $13,024,714 $10,735,553 $8,218,373 $8,218,373 $6,189,161 $5,323,713 $5,323,713 $4,401,282 $4,401,282 $1,983,721 $1,650,208 $1,650,208 $1,526,234 $1,526,234 $1,146,738 $831,340 $831,340 $191,901 $325,260,916 $325,260,916 $1,293,612,618 $1,293,612,618 2009 expenditures adjusted for missing $376,753,577 $255,969,116 $159,573,405 $77,947,727 $56,124,943 $48,598,874 $38,752,794 $30,868,413 $1,689,471 $1,046,278,320 $1,046,278,320 $75,541,993 $58,283,402 $53,585,951 $34,163,481 $33,070,934 $22,496,574 $14,597,402 $14,071,404 $11,598,282 $11,598,282 $8,878,817 $6,686,533 $5,751,537 $4,754,977 $2,094,520 $2,094,520 $1,782,822 $1,782,822 $1,648,885 $1,648,885 $1,238,892 $1,238,892 $898,148 $207,323 $351,351,877 $351,351,877 $1,397,630,197 % of total 26.96% 18.31% 11.42% 5.58% 4.02% 3.48% 2.77% 2.21% 0.12% 74.86% 5.41% 4.17% 3.83% 2.44% 2.37% 1.61% 1.04% 1.01% 0.83% 0.64% 0.48% 0.41% 0.34% 0.15% 0.13% 0.12% 0.09% 0.06% 0.01% 25.14% 100.00% Year FDA approved 2005 2004 2003 2000 2007 2006 2001 1998 2003 2004 1996 1997 2000 2003 1996 2008 1997 1998 1995 1995 2003 2007 1994 2005 1996 1991 1987 1997

page 6 tagline Vol 18, No. 3, October 2011

A Golden Decade Continued from page 4

1. 75% of sales were for drugs We urge the World Health everywhere have access to the recommended as preferred Organization (WHO) as well as best possible treatment options. first-line antiretroviral therapy national guidelines-defining (ART) regimens in the federal groups in countries affected by In next year’s Pipeline we look guidelines; HIV to urgently implement such forward to documenting further forward-looking practices to progress. • 2. Of the nine drugs and FDCs ensure that people living with HIV included among the U.S. first- line recommendations, eight were approved by the FDA in the past decade; just one Ending the Neglect of Childhood TB (efavirenz) was approved in the 1990s; By Claire Wingfield 3. Two drugs approved in 2006 and 2007—darunavir and It is estimated that of the nine TB research to ensure that they raltegravir, respectively—were million new cases of tuberculosis also benefit from scientific approved by the FDA for first- (TB) each year, one million occur advances. line indications less than two among children under the age of years after initial recommenda- 15. Yet advocacy for prevention, Thanks in part to the efforts of tion in salvage patients; diagnosis, and treatment of TB in TAG, childhood TB is finally children has been largely absent getting some attention from the 4. Both of those drugs soon from the global public health scientific community. Protocols after were included by the U.S. agenda. In fact, the true global are being developed for studies guidelines panel among the burden of TB in children is unknown that would evaluate the safety preferred recommended because of the lack of child- and pharmacokinectics—how regimens for antiretroviral- friendly diagnostic tools, and drugs are absorbed, distributed, naive patients; and inadequate surveillance and metabolized, and eliminated in the 5. Prescribing practice rapidly reporting of childhood TB cases. body—of two TB drugs in infants evolved to incorporate the National TB programs and research and children. Institutions like the newest data on the newest efforts have ignored TB in children U.S. Centers for Disease Control drugs. for a variety of reasons, among and Prevention (CDC) and the them that children are less likely U.S. National Institute of Allergy These data demonstrate the to spread disease. However, the and Infectious Diseases (NIAID) effective interaction of research, stark reality is that children with in collaboration with several regulation, normative guidelines, TB infection today represent the academic institutions and an practice, and implementation in reservoir of TB disease tomorrow. industry partner are taking the the United States, despite its highly first steps to initiate TB treatment fragmented health care system If TB is going to be eliminated, trials in children. and the fact that those receiving research needs to address the treatment through ADAP are, by unique aspects of childhood TB. Confirming a TB diagnosis in a definition, not rich. Children are more susceptible child can be very challenging and than adults to advancing from is therefore a major complication However, the fact that 8,785 TB exposure to infection and to for pediatric TB treatment trials. individuals in 10 states are currently disease, yet none of the current Current methods of diagnosis on waiting lists to receive treatment clinical trials evaluating new or using microscopy and culture through ADAP reveals that the existing drugs in TB disease produce mediocre results at best. United States continues to be a include children. The reasons cited But there has been some recent global disgrace when it comes to for not including children in drug progress on improving diagnosis universal access or health equity. trials are numerous, but they tend in children. In December 2010, the to range from insufficient funding World Health Organization (WHO) In any case, it is clear that HIV to lack of childhood TB expertise recommended the Xpert MTB/ therapeutics has room for to concern about confirming TB RIF—a new rapid diagnostic test— considerable improvement, and diagnosis. Despite this, we still be used in place of the most that improvements will be rapidly have a moral obligation to common TB diagnostic tests in diffused and their investors will more proactively address these cases of suspected HIV-associated enjoy a substantial return on their challenges and include children in and drug-resistant TB in adults. investment. Continued on page 8 page 7 tagline Vol 18, No. 3, October 2011

Childhood TB Continued from page 7 BOARD OF DIRECTORS

The Xpert MTB/RIF has the Given the historical and systematic PRESIDENT potential to significantly improve neglect of children affected by TB, Barbara Hughes TB diagnosis and get patients there is a need for urgent action onto appropriate treatment more from all who are committed to SECRETARY & TREASURER quickly. At the time of the WHO’s reducing the global burden of TB. Laura Morrison announcement, there were no New evidence must be generated Joy Episalla data on how best to use this new on how best to prevent, diagnose, Roy Gulick, M.D. technology in children. However, in and treat TB in children. To that Kevin Goetz July 2011, the first study providing end, researchers must include chil- Richard Lynn, Ph.D. evidence that Xpert MTB/RIF was dren in high-quality basic, clinical, Alby Maccarone reliable in diagnosing TB in children and operational research. Lastly, Jason Osher was published. Hopefully, this but most importantly, advocates Frank Rappa one study will pave the way for and community members must James Saakvitne more data-gathering to increase continue to sound the alarm about David Sigal Monte Steinman the number of children receiving the challenges of childhood TB Robert Monteleone timely and accurate TB diagnoses. and demand greater support and resources for these efforts. • EXECUTIVE DIRECTOR Mark Harrington

COMMUNICATIONS & 2011 Research In Action Awards ADVOCACY DIRECTOR Lei Chou

TAG’s annual Research in Action Awards (RIAA) honors activists, SENIOR POLICY ASSOCIATE scientists, philanthropists, and creative artists who have made Coco Jervis, JD extraordinary contributions in the fight against AIDS. RIAA is a fundraiser to support TAG’s programs, and provides a forum to honor MICHAEL PALM BASIC heroes of the epidemic. Now in its fifteenth year, the 2011 RIAA will be SCIENCE, VACCINES, & held on Sunday, December 11, from 6 to 8pm at the MidTown Loft, NYC. PREVENTION PROJECT COORDINATOR This year’s Awardees are: Richard Jefferys SENIOR RESEARCHER • John Benjamin Hickey, Winner of the 2011 Tony Award for best Eleonora Jiménez-Levi featured actor in a play for his performance in the revival of Larry Kramer’s The Normal Heart; HEPATITIS/HIV PROJECT DIRECTOR • Dr. Polly Harrison, Founder of the Alliance for Microbicide Tracy Swan Development; and TB/HIV PROJECT DIRECTOR • Dr. Robert F. Siliciano, Medical Investigator at the Howard Hughes Javid Syed, MPH Medical Institute and Professor of Medicine at the Johns Hopkins University School of Medicine. ADMINISTRATOR Joseph McConnell To purchase tickets or to sponsor this year’s RIAA, please go to:

www.treatmentactiongroup.org/riaa Treatment Action Group 261 Fifth Avenue, Suite 2110 New York, NY 10016 Tel 212.253.7922 About TAG Fax 212.253.7923 [email protected] Treatment Action Group is an independent AIDS research and policy www.treatmentactiongroup.org think tank fighting for better treatment, a vaccine, and a cure for AIDS. TAG works to ensure that all people with HIV receive lifesaving treatment, care, and information. We are science-based treatment TAG is a nonprofit, tax-exempt 501(c)(3) organization. E.I.N. 13-3624785 activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end AIDS . page 8