Strategies, tools and policies to get the best HIV treatment to more people, sooner Contents

1. Where are we now? 1

2. Methods and results 2

3. Timing is everything 5

4. Strategies: reaching more people with treatment 7

5. Tools: improving quality of care 10

6. Policies: enabling affordable and rapid scale-up 12

7. Conclusion 15

Annex 1 16

Annex 2 20

References 22

This document was produced with financial support of UNAIDS. The opinions expressed in this paper are those of the authors and do not necessarily reflect the views, opinions and policies of the UNAIDS Secretariat or its Cosponsors.

Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner Where are we now? 1 For over a decade, people living with HIV, treatment advocates, clinicians, and health ministries have been grappling with how to ensure increased access to quality antiretroviral therapy in resource-limited settings.

Although there have been enormous scale-up and improve care. Nevertheless, financial support dedicated to addressing strides over the past decade, constrained the adoption and implementation of these and reversing the epidemic. budgets and sub-optimal policies that strategies, tools and policies are lagging in The last 12 years of antiretroviral therapy are only slowly changing are impeding some countries. in resource-limited settings have shown the effort to reach all people in need. The survey results provide a mixed that, when treatment is offered close In addition, too many people are still picture: 11 of 23 countries have reached to home and before people get sick, dying because they do not know they 1, 2 antiretroviral therapy coverage of 60% their chances of survival increase. are living with HIV. And many people or more. Some countries have already In many countries, health facilities are are being diagnosed with HIV late or made or are making strides towards their often overburdened and difficult to reach. fall out of care before starting treatment. In response, several treatment strategies own national targets of reaching 80% of were developed to provide care within This report outlines some of the strategies, people in need with antiretroviral therapy. communities, and these have shown tools and policies that have supported the On the other side of the spectrum, promising results. Such efforts to simplify scaling up of treatment during the past six countries are still only reaching and decentralize treatment need to decade as well as those that can address one third of the people in need or less. accelerate to reach even more people with persistent or new challenges. The results As the international norms for HIV move durable, high-quality care. are presented from a 23-country survey of towards better and earlier treatment how consistently these strategies are being and technological advancements in To continue to make meaningful progress, implemented. (See Annex 1) The findings diagnostics are becoming available, it is affected and donor countries will have demonstrate encouraging progress by important to shore up and strengthen to fulfil commitments made at the 2011 some health ministries in adopting many the remaining key success factors that United Nations High Level Meeting on HIV/ of the enabling policies needed to facilitate risk being compromised: political and AIDS, when governments pledged to reach 15 million people with treatment by 2015.3 This target may well need to be revised upwards if earlier initiation of antiretroviral therapy for clinical benefit or for reduction of transmission becomes a global goal. Nevertheless, current antiretroviral therapy coverage is only halfway there: meeting the goal means getting an additional seven million people onto life-saving treatment in the next three years and helping them remain in care. Rapidly increasing the number of people living with HIV receiving antiretroviral therapy and supporting retention in care are major challenges, but the potential to start reversing the epidemic by scaling up treatment provides new motivation and represents an opportunity that must be seized. © Zethu Mlobeli

Teboho Haborone started antiretroviral treatment when his CD4 count was 25. He now works at the clinic in Motsekuoa, Lesotho, as an HIV/TB lay counsellor helping nurses with clinic tasks.

July 2012 msfaccess.org 1 Methods and results 2 This survey examined 25 HIV indicators in 23 countries, 18 of which are in sub-Saharan Africa.

Study description and methods The data for this study were collected from March to June 2012 with the objective of assessing the status of key policies and operational practices relevant to HIV and (TB) treatment programmes in 23 countries.

Médecins San Frontières (MSF) is an emergency medical humanitarian organization that works in more than 60 countries worldwide and that currently provides HIV treatment to 220,000 people in more than 20 countries. Of the countries included in this survey, MSF has HIV projects in 16. MSF field teams collected data for the countries where MSF has HIV projects. Data for the remaining seven countries were collected from similar national and international sources with the support of UNAIDS.

In 2011, MSF published “Getting Ahead Of The Wave: Lessons for the Next Decade of the AIDS Response”4, providing facts and figures on the implementation and progress of HIV treatment policies in

16 countries. The present report is an © Brendan Bannon attempt to enlarge the scope of the above- mentioned publication. The 25 indicators Brian, seven years old, is enrolled in the HIV/AIDS programme in Epworth, included in the study were assembled an urban settlement outside Harare, Zimbabwe. with input from MSF and UNAIDS. Data were collected mostly from national For countries where MSF does not have in reliable national and international government sources, primarily the health HIV operations, UNAIDS was asked sources. In some cases there is a delay ministry and HIV programme coordinating to assist in the process of information bodies. Documents included national between the establishment of normative collection and validation. The main HIV and TB guidelines as well as national best practices and adopting and adapting international source was the Global programme updates from departments them into revised national guidelines. HIV/AIDS response: epidemic update and responsible for the programmes related Similarly, even when national guidelines health sector progress towards universal to HIV, TB, preventing mother-to-child reflect new normative standards, access, Progress report 2011.5 Citations transmission or human resources for health. implementation may lag. for the sources of survey results as well Alternatively, where reliable data were as a more detailed methodology can be not obtained from national documents, As an emergency medical humanitarian found at www.msfaccess.org. MSF teams conducted interviews with organization, it is not within MSF’s national authorities and/or used verifiable The information presented is thus largely purview to validate officially reported information sourced locally. reported by governments and published figures or data.

2 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner UNAIDS, the Joint United Nations UNAIDS, as well as other partners, is UNAIDS therefore supported MSF in Programme on HIV/AIDS, has endorsed continuing to support the mobilization surveying 23 countries facing high-burden robust goals for continuing the rapid of resources and the innovations that HIV epidemics, focusing on the status of expansion of antiretroviral therapy to are embedded in Treatment 2.0, the implementation of national policies that achieve universal access by 2015 and, WHO/UNAIDS programmatic approach, facilitate the implementation of Treatment as well, to eliminating new HIV infections structured on five pillars: optimizing 2.0 and eliminating new HIV infections among children and keep their mothers drug regimens; developing point-of-care among children. The outcomes of the alive. Achieving these goals depends and simplified laboratory platforms; current publication provide a clear picture on several factors, including mobilizing innovating service delivery; reducing of the national policy framework and sufficient resources from domestic and costs; and mobilizing communities. implementation status of the domains international sources, adopting national These activities are occurring in important to monitor and advocate for policy frameworks that are consistent many venues, including research and policy and programme change and growth. with international best practices and development, international forums and We hope that it serves as a powerful normative guidelines and innovating support for and the dissemination of tool for policy-makers and programme service delivery to facilitate greatly innovative best practices. managers to inspire them in scaling up expanded HIV care and treatment in antiretroviral therapy (ART). low- and middle-income countries.

Key results

Of the 23 countries surveyed, nine have Of the 18 countries surveyed in Only eight countries’ guidelines antiretroviral therapy coverage below sub-Saharan Africa, 11 allow nurses allow for multiple (two or three) 50%. The coverage rates of services to initiate antiretroviral therapy. month refills, rather than monthly, for preventing mother-to-child Six of these countries changed their for people in stable condition. transmission of HIV are greater policies to allow nurses to initiate Of the 23 countries surveyed, four than 80% in six of the countries antiretroviral therapy in the past two require viral load before switching surveyed, but eight are still below years. Only 13 of the 23 countries to second-line or further regimens, 50% coverage. Only eight of the have policies allowing nurses to but the technology is only widely 20 countries for which data was prescribe and provide TB treatment. available in four countries. available provide antiretroviral In many countries, policies are still not therapy in 30% or more of public- in place to support the provision of sector facilities. basic HIV-related tasks by lay workers: Almost all countries are in accordance only 14 of 23 countries allow lay with WHO-recommended protocols workers to provide HIV counselling and for antiretroviral therapy initiation testing and adherence counselling. and first-line drug regimens, although implementation in some countries has faltered due to funding gaps.

Continued overleaf

July 2012 msfaccess.org 3 Policies and Progress in 18 Sub-Saharan African Countries

Nigeria Central Ethiopia African Republic

Guinea Uganda Kenya Cameroon Democratic Republic of Congo

Tanzania

Malawi

Nurses can initiate TB treatment Zambia

Nurses cannot initiate TB treatment Mozambique

Nurses can initiate ART Zimbabwe Namibia Nurses cannot initiate ART Botswana

ART coverage over 50%

ART coverage at or below 30% Swaziland PMTCT coverage over 50%

PMTCT coverage at or below 30% South Africa

Percentage of health facilities in country offering ART over 50% Lesotho

Percentage of health facilities in country offering ART at or below 30%

4 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner Timing is everything 3 Recent scientific findings confirm that in addition to prolonging the lives of individuals, HIV treatment is itself a key component of HIV prevention. The landmark HPTN 052 study showed that providing HIV treatment earlier helps to stave off opportunistic infections and reduces the risk of sexual transmission to HIV-negative partners by 96%.2

Time is a critical factor: getting treatment all pregnant women living with HIV for for treatment and prevention in to people before their disease progresses preventing mother-to-child transmission couples7 recommends treatment for everyone and for their own health. This protocol, is important both for their own health and living with HIV who has an HIV-negative known as option B+, is easier to manage in for preventing further infections. partner (serodiscordant couples), regardless many settings than the current practice for HIV treatment policy is quickly responding preventing mother-to-child transmission of their CD4 count, to help prevent the to this new evidence. In April 2012, the of starting and stopping antiretroviral sexual transmission of HIV. World Health Organization (WHO) issued therapy with each pregnancy. It is also These two interventions targeting specific two critical new pieces of guidance on better for mothers and babies, especially populations, when considered in addition HIV treatment. Firstly, its April 2012 in places where women have multiple to efforts based on growing evidence of programmatic update Use of antiretroviral pregnancies but may not be accessing services for preventing mother-to-child drugs for treating pregnant women and clinical benefit to reach others earlier in their transmission of HIV early enough. preventing HIV infection in infants6 points disease progression, collectively constitute to the benefits and momentum behind Second, WHO’s Guidance on couples HIV testing a care package referred to as accelerated offering lifelong antiretroviral therapy to and counselling including antiretroviral therapy antiretroviral therapy (see box).

Accelerated Accelerated treatment can result in A Decline antiretroviral in New HIV Infections therapy includes: Accelerated Scale-up Base Case initiating antiretroviral therapy 140,000 at an early stage of disease (at CD4 count of 350 per mm3 or higher); 120,000

immediate initiation of 100,000 antiretroviral therapy for people living with HIV who have active TB; 80,000

early initiation of treatment 60,000 for people living with HIV who have HIV-negative partners 40,000 (treatment as prevention) which reduces the risk of transmission by 96% for 20,000 serodiscordant couples; and 0 lifelong treatment for pregnant 2010 2011 2012 2013 2014 2015 women and breastfeeding mothers living with HIV, Under the scenario of today’s scale-up pace and treatment access rates, incident HIV regardless of CD4 count. infections in Kenya are expected to remain relatively constant at or above 120,000 new cases per year. With accelerated treatment scale-up, new HIV infections could be driven down to around 86,500 by 2015. Source: John Blandford, PhD, CDC

Continued overleaf

July 2012 msfaccess.org 5 Timing is everything continued

Scaling up antiretroviral therapy now would have significant benefits both for individuals and communities:

Scaling up treatment to meet the Accelerated treatment is expected to In northern KwaZulu-Natal, South “15 by 15” commitment would, have a community-level impact and African researchers found that according to United Nations estimates, provoke an even steeper drop in every percentage point increase prevent seven million people from dying the incidence of new HIV infections. in antiretroviral therapy coverage and 12 million people from acquiring The United States Centers for Disease among adults living with HIV was HIV by 2020.8 Control and Prevention used data associated with a 1.7% decline in from Kenya to model treatment the risk of an HIV-negative adult Every 1,000 people given treatment acceleration and demonstrated that acquiring HIV. People living in areas per year averts 228 people dying, extending HIV treatment to an with higher antiretroviral therapy 61 people becoming newly infected additional 323,000 Kenyans by 2015, coverage (30 – 40%) were 38% less with HIV through sexual transmission above the current pace, would reduce likely to acquire HIV than people in and 26 infants from acquiring the number of people newly infected low-coverage areas (coverage less infection.9 with HIV by 31% by 2015 (see graph).9 than 10%).10

Progress in scaling up and implementing WHO-recommended improved treatment protocols for earlier initiation varied across the 23 countries surveyed:

Of the 23 countries surveyed, nine have The coverage rates of services for as recommended by WHO in its April antiretroviral therapy coverage below preventing mother-to-child transmission 2012 update,6 plus Kenya, where it is 50%. Botswana and Swaziland provide of HIV are greater than 80% in six of the offered as an option among all three antiretroviral therapy to 80% or more of countries surveyed, but eight are still protocols for facilities to decide. those who need treatment. below 50% coverage. Although limited data were available, the All but one country surveyed have All countries surveyed have adopted median CD4 count when antiretroviral adopted WHO recommendations to start protocols for services for preventing therapy was initiated was less than treatment at CD4 count of 350 per mm3 mother-to-child transmission of HIV as 170 per mm3 in the six countries with or lower and for all people coinfected recommended by WHO:1 12 countries available data. with HIV and TB, irrespective of CD4. implement option A; six countries Zambia has moved to provide early implement option B; two countries Reaching children with treatment antiretroviral therapy in cases of allow either protocol; some of these continues to lag across many of the serodiscordant partners regardless of countries are considering a change countries surveyed. Children represent CD4 count; additional countries are to from option A to B or B+; only two an average of 7% of the people receiving considering such a policy change. countries have option B+ as policy – treatment in the 23 countries. © Sven Torfinn

Charles Sako, 41, started ARV treatment in 2005 and now lives with his partner and three-year old daughter in Kibera, Nairobi.

6 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner 4 Strategies: reaching more people with treatment

1) Making testing and treatment accessible A major challenge in increasing access to if funding levels are not increased. According care is that most people with HIV do to the survey results, all 23 countries have not know their HIV status.11 Of the policies providing antiretroviral drugs for 23 countries in the study, 21 offer provider- free, but this policy is not being consistently initiated testing and counselling, which is followed everywhere. For example, in the mostly still conducted at the health facility Democratic Republic of the Congo, Central level. Implementation, however, lags behind. African Republic and Zimbabwe, people are A recent study from Malawi of clinic-based being charged according to MSF teams on HIV counselling and testing12 showed that the ground. In two countries (Cameroon only 13% of clinic attendances included and Myanmar), the policy of providing HIV counselling and testing. A growing drugs free of user charges does not include number of countries16 now allow lay health the diagnostic and monitoring tests required with care, and in three countries

workers to administer HIV testing, although Bernard © P ierre-Yves not all of these 16 have implemented this (China, Kenya, and Myanmar), the policy policy to the point of being standard practice. does not include drugs needed to treat opportunistic infections. In Mozambique, “I train nurses who work in Ensuring that treatment is available free a nominal fee is charged to all outpatients local health clinics and are of charge is also essential. And although for prescriptions and consultations. able to start patients on user fees and other charges passed down In Zimbabwe, the government is proposing antiretroviral treatment and to service users are a documented barrier charging people for antiretroviral therapy also TB treatment. In many to access,13 there is a risk that treatment to make up for funding shortfalls, since clinics where the nurses work, free of user charges might be reversed international donors have reduced support. there is no doctor available so task-shifting allows patients to be seen every day.”

2) Scaling-up facility-based treatment Nolitha Mabandlela, Nurse mentor, Khayelitsha, South Africa Getting treatment Shifting health into every clinic care tasks Decentralization – getting care out of One of the key obstacles to decentralized to those initiated by clinical officers centralized hospitals and into community treatment has been reluctance on the part and medical assistants; in fact, people clinics and local health posts – has been of some policy-makers to shift health care started on treatment by non-physicians the cornerstone of expanding access to tasks from doctors to nurses and nurses to were more likely to remain in care.14 antiretroviral therapy. Nevertheless, only eight lay health workers. Nevertheless, this has A randomized trial in South Africa15 of the 20 countries for which data were changed in some countries. found task-shifting of HIV treatment from available provide antiretroviral therapy in doctors to nurses to be safe and effective. 30% or more public-sector facilities. Five of In Malawi, an estimated one million people the 16 countries with an adult prevalence of are living with HIV, but there are just Of the 18 countries surveyed in sub- HIV infection above 2% have decentralized 1.2 doctors and 28 nurses for every Saharan Africa, 11 allow nurses to initiate treatment and care to the extent that at least 100,000 people. To cope with this antiretroviral therapy. During the past two 40% of public-sector health facilities offer critical shortage, the government started years, six of these countries have changed antiretroviral therapy. Making treatment shifting tasks such as initiating treatment their policies to allow nurse-led initiation: available in more health facilities has allowed from physicians to non-physicians, Kenya, South Africa, Swaziland, Uganda, more people to be reached in countries like including nurses. The results are positive. Zambia and Zimbabwe. Three of the Lesotho, Malawi and South Africa, where facility In Chiradzulu district, three-year treatment seven African countries that do not allow coverage is more than 60% and antiretroviral outcomes for people whose treatment nurses to initiate antiretroviral therapy therapy coverage is more than 50%. was initiated by nurses were comparable do allow them to provide follow-up

Continued overleaf

July 2012 msfaccess.org 7 Shifting health care tasks continued

for people on antiretroviral therapy. Integrating In Lesotho, although more than 90% of Of the countries surveyed, Mozambique is antiretroviral therapy public-sector facilities are reported to be the one with the highest HIV prevalence with other health providing antiretroviral therapy and nurses that has yet to allow nurses to initiate services can provide both antiretroviral therapy and and manage antiretroviral therapy, even TB treatment, the initiation of TB treatment Optimizing antiretroviral therapy delivery is not decentralized to the primary care though it suffers from a severe human also requires providing treatment within health centres. In Uganda, the reverse resources crisis and nurses comprise settings where people can have their situation – nurses are not allowed to provide 70% of the health workforce. Medical broader health care needs addressed at the antiretroviral therapy and TB treatment technicians (tecnicos de medicina) are the same time, in one location, and from the is more decentralized than antiretroviral only non-physicians permitted to perform same health worker. This means addressing therapy – gives the same result: integrating these tasks but are not often found at the health needs beyond HIV. decentralized HIV and TB care is more primary care level. difficult. Of the 23 countries, only 13 have Integration with TB care. In Lesotho and policies allowing nurses to prescribe and Similarly to policies that allow the task- South Africa, integrating HIV and TB at the provide TB treatment. shifting of treatment initiation, policies that primary health care level has shown improved Integration with prenatal and infant care. allow lay workers to dispense antiretroviral case-finding and better outcomes17 as well as New WHO guidance on option B+ for drugs support scale-out by easing the strain reducing half the delay in starting antiretroviral services for preventing mother-to-child on the health system. A study in western therapy for people newly diagnosed with transmission of HIV – in which all pregnant Kenya showed that lay workers living TB.18 Despite growing recognition that HIV women living with HIV are to be offered with HIV successfully provided adherence and TB integration is the preferred approach continuous antiretroviral therapy, instead of screening and antiretroviral drug refills to tackling the twin epidemics in settings starting and stopping antiretroviral therapy to people in the community, and the with a high burden of HIV infection and TB with each pregnancy – can greatly simplify government is considering replicating disease, and despite resulting policy changes, the provision of prenatal and infant care. This this strategy throughout the country.16 integration is lagging in practice across many applies especially to regions with high fertility, A randomized trial, also done in Kenya, of the countries surveyed, and full one-stop since it should reduce attrition between showed that outcomes were equivalent care remains rare. pregnancies. An MSF study from Thyolo, under lay worker surveillance and clinic- Malawi showed that, during the expansion In several of the countries surveyed, the and integration of HIV services with prenatal based care but required half the number policies that establish where antiretroviral of clinic visits, easing the burden on both and infant care, the use of reproductive therapy and TB treatment can be provided health services increased, and the outcomes the people living with HIV and the system. and by whom make decentralization and of infants born to mothers living with HIV In many countries, however, policies still integration difficult. Of the 16 countries in improved. Of the countries surveyed, only do not support lay workers providing which MSF provides HIV treatment, only six Malawi and Uganda have option B+ as basic HIV-related tasks: only 14 of the 23 were free from policy barriers that prevent policy, and Uganda only plans to implement countries allow lay workers to provide HIV the same primary health care worker the policy if it is successful in securing testing and antiretroviral therapy adherence from providing HIV and TB treatment. In additional funds from international sources. counselling. Seven of the 23 do not allow Cameroon, for example, nurses can initiate Other countries such as Mozambique are lay workers to provide HIV testing. TB treatment but not antiretroviral therapy. also considering switching to this protocol.

Strategies to address the HIV care cascade

HIV Testing Pre-ART • Improved HIV rapid regular Early ART tests (e.g. oral tests) clinic care retention Long-term • Home and in care ART and • Strong referral and community-based undetectable linkage to care counseling and testing • Timely and / or earlier viral load ART initiation • HIV testing by • Free HIV care community and lay & treatment • Adapted adherence • Simplified clinical and refill schedules health workers • Point of care CD4 support • Provider-initiated HIV count testing • Decentralization, • Community-based, primary care integration testing and counseling • Rapid diagnosis peer-supported ART and integration with and treatment of TB • Task-shifting • Viral load-triggered primary care • Regular visits, TB • Non-toxic robust drugs; adherence support • Targeted mobile and PCP prophylaxis once-daily fixed-dose • Reliable drug supply, testing for hard to combinations reach groups at • Support tools (mobile multiple month refills messages, patient held • Viral load monitoring schools, taxi ranks, • Defaulter tracing farms, workplaces appointment cards) • Out of clinic care

8 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner 3) Managing treatment at the HIV treatment in conflict settings and among mobile populations community level Access to treatment has increased in Providing antiretroviral therapy for With the continuing shift away from stable environments but is less available mobile populations requires adapted specialised clinic HIV care, antiretroviral in conflict or post-conflict settings.26 operational strategies to deliver therapy programmes are increasingly Given competing medical priorities, treatment. Migrants (especially those looking towards newer models for chronic severe human resource and funding who are undocumented) can be disease management, whereby the constraints and a lack of priority given reluctant to seek care for fear of community manages people living with HIV to HIV-related health needs in countries deportation, and likewise, clinics can with a stable condition and interventions to in conflict, the international community be reluctant to deliver care for migrants support treatment adherence. This further has been reluctant to engage. One out of fear that they will not adhere to decentralization and task-shifting involves major concern is that treatment treatment or be able to access refills. strategies such as peer antiretroviral therapy will be interrupted in an unstable Through a weekly mobile HIV and TB groups, which can boost adherence and environment, leading to possible drug clinic service, MSF provides HIV care relieve the burden on people living with HIV resistance. In these contexts, simplified to Zimbabwean migrant farm workers and health systems. Other policies can help recommendations and implementation in South Africa in Musina. They receive reduce the number of required clinic visits, procedures that anticipate the possibility a three-month supply of antiretroviral simplify clinical appointments and/or reduce of sudden population movements are drugs if they plan to return home for burdens by providing people with several essential, as is the integration of HIV with a period, as well as a health “passport” months of medicines in one refill visit.19, 20 other health services. MSF’s experience in that serves as a record of their care if they treating HIV in post-conflict settings, such need to transfer to another antiretroviral In the Democratic Republic of the Congo, as in Bukavu, Democratic Republic of the therapy provider. Models that account community organizations of people living Congo, has shown results comparable to for population mobility could benefit with HIV run antiretroviral drug distribution those in stable settings, with programmes other HIV treatment programmes.27 points throughout Kinshasa, providing refills, rarely disrupted by conflict.26 adherence counselling and basic health follow-up. People spent an average of 12 minutes to pick up their refills at these points, out in 20 health facilities in Tete Province, project. A similar strategy in Khayelitsha, compared with 85 minutes at the hospital.21 and only 0.1% of the 4,410 people enrolled South Africa offers streamlined health visits MSF has piloted community-based in 1,023 groups between February 2008 and for people in stable condition in adherence programmes in several high-prevalence December 2011 have been lost to follow-up. groups, who receive check-ups as a group and settings. For example, in Tete, Mozambique, get refills within two hours. A lay adherence community antiretroviral therapy groups of In response to this success, the Government counsellor leads the group, providing six people on antiretroviral therapy take turns of Mozambique is scaling up the strategy support to long-term service users who going to the clinic every month to pick up nationwide, and health ministry delegations sometimes experience adherence fatigue. medicine refills for the whole group. This peer from Malawi, Swaziland and Zimbabwe Retention in care was significantly higher for management also helps people to motivate have visited the project to assess whether the group members compared with people not one another to adhere to treatment and helps model could be replicated in their contexts. in groups (97% versus 85%).23 Among the prevent loss to follow-up.22 This was rolled Malawi’s health ministry has started a pilot 23 countries surveyed, only Mozambique has an explicit policy allowing antiretroviral drugs to be dispensed outside facilities and “I’ve found so many advantages to mobile clinics. belonging to the community group. Firstly we all support one another Routine multiple-month refills and simplified like a family and if someone in clinical appointments have been implemented the group is sick we help them – in many programmes and settings. Such maybe we fetch water or we clean practices are showing good outcomes for or cook for them. Then another people in their first year of antiretroviral therapy good thing is that we only need to in Zimbabwe.24 In Chiradzulu, Malawi, 97% send one person in the group each of those in a programme offering clinician month to the clinic to collect the appointments every six months for people in medicine refills for everyone else in stable condition, and antiretroviral drug refills the group. Now we only have to go every three months from health surveillance individually to the clinic once every assistants, remained in care after one year.25 six months. That means for me that Of the 23 countries surveyed, eight explicitly I can stay home, getting essential allow in the treatment guidelines for multiple things done around the house (two or three) month refills for people in and my shop.” stable condition, a policy that is also accepted standard practice, although not reflected in Carmen Jose-Panti, 32 years old, the guidelines, in three additional countries. HIV positive, Tete, Mozambique Drug supply problems, however, can be a © Brendan Bannon barrier to implementing such strategies.

July 2012 msfaccess.org 9 Tools: improving quality of care 5 Getting the best possible treatment to the most people possible – and retaining them in care – requires securing access to the best medicines and tools needed to monitor HIV treatment and properly and timely diagnose TB. These must be affordable. But limited budgets should not stand in the way of ensuring the best possible treatment and monitoring options are available.

Better drugs In 2006, WHO recommended a shift away from stavudine; WHO’s 2010 “To make sure my treatment is effective, the clinic takes a blood guidelines recommended that it be sample to check my CD4 count and viral load. My latest viral phased out entirely and be replaced in load count, taken in June 2011, was undetectable. Antiretroviral first-line treatment by either treatment is life-long so it’s encouraging to be told that the or tenofovir. The current best option for treatment is working well for me. first-line therapy is the combination of tenofovir + lamivudine + efavirenz, which It helps to know that whatever the difficulties, I am controlling the is available as an adherence-friendly one- virus. I am proud that my viral load is undetectable, and I tell others pill-once-a-day formulation. about it. It helps me plan for tomorrow and I am confident I will live a normal life in the future.” Of the countries surveyed, all had adopted alternatives to stavudine into Fanelwa Gwashu, 40, HIV positive, Khayelitsha, South Africa policy, be it tenofovir (eleven countries) or zidovudine (seven countries) or either Given the development of new drug classes five years on antiretroviral therapy30. This of the two options (five countries). compromises people’s care and reduces However, in several countries, funding and new generations of well-tolerated and constraints have resulted in decisions to easy-to-use drugs, first-line regimens are the impact of antiretroviral therapy at the delay the implementation of improved expected to improve further. Second-line community level because of increased treatment whether for people initiating regimens should also be revised to include illness and transmission. more powerful protease inhibitors and therapy, or people already receiving Viral load monitoring can improve integrase inhibitors. antiretroviral therapy, or to roll it out on a treatment by indicating when a person partial basis only. may need to switch regimens. Viral Viral load As more people are placed on treatment, load monitoring also helps preventively, providing robust and potent antiretroviral monitoring as it can identify people who need drugs with as few side effects as possible Treatment failure, where HIV develops drug targeted adherence support to stave off will help long-term adherence, which resistance, goes mostly underdetected and the emergence of drug resistance and delays the need to switch to more costly underdiagnosed in low- and middle-income treatment failure, so that they can continue second-line regimens. New treatments countries; according to WHO,28 only 3% of on the same regimen. In Khayelitsha, will need to be easy to take and should the people receiving antiretroviral therapy South Africa, where routine viral load be offered in fixed-dose, once-daily are receiving second-line treatment, testing identified detectable viral load in combinations. They also must not be although the need is greater given the clinic attendees, all were given targeted counterindicated with other medicines rate of failure:29 one study of almost adherence support. Of that group, 71% routinely taken for coinfections and 20,000 people in South Africa found that had an undetectable viral load at the next should be safe for use in pregnancy. 10% needed second-line treatment after check three months later.31

10 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner Nevertheless, most programmes in TB diagnostics Africa do not have access to viral load TB continues to be the main killer of people testing – primarily because of its high living with HIV,36 with at least 350,000 cost and because the complexity of people dying from HIV-associated TB each “When my TB treatment the technologies make them ill-suited year. A key factor behind this persistently was completed, I felt as if for resource-limited settings. At best, high death rate is the difficulty of I had got a new life. I could viral load monitoring is reserved for accurately diagnosing TB among people now live for my children confirming treatment failure once people living with HIV. The most commonly used and do some work. Now already show clinical or immunological test, sputum smear microscopy, detects I stitch blouses, dresses, signs of failure – not to guide targeted only half of all TB cases among people alteration work. People of adherence counselling that can prevent living with HIV.37 my neighbourhood support the emergence of resistance in the first me a lot. They give me place. Of the 23 countries surveyed, There is still an urgent need for affordable work and I am able to earn and easy-to-use tests that can detect nearly all recommend using viral load good money from my work.” TB without referral for more specialized testing to confirm treatment failure. testing. Many people living with HIV are Veena Panchal, HIV positive Six of the countries’ guidelines require harder to diagnose with the usual sputum and previously co-infected viral load testing before switching test. Developing a new test or technology with MDR TB, Mumbai regimens, and routine monitoring of to diagnose TB that does not rely on viral load is recommended in some sputum but on other samples such as countries and required in four of them. urine or blood offers the best solution. Nevertheless, of the countries surveyed, the tools necessary for viral load are only widely available in four countries. New TB molecular testing There is an urgent need for simple A new rapid molecular test, Xpert smear microscopy, but of the remaining and affordable viral load technologies MTB/RIF, represents an important that are adapted to resource-limited negative 1,488 samples, Xpert MTB/ advance. Not only does it speed up settings and that could be used in RIF detected TB in a further 116, which diagnosis (giving results in two hours district laboratories, clinics and at the had been missed by microscopy. After versus up to two months with other community level.32,33 A number of point- implementing Xpert MTB/RIF, the methods) and therefore significantly of-care tests are expected to become median time from diagnosis of smear- shortens the time from TB test to available starting in 2013,34 and several negative TB among people living with initiating TB treatment, improving laboratory-based tests in the pipeline HIV who have TB to the initiation of chances of survival for people living could also be simple enough for use at the treatment was reduced from 18.5 days with HIV who have TB, it also screens district level.35 Although cost currently to seven days38. for drug-resistant TB and improves limits the use of viral load testing, TB detection among people who Although Xpert offers new potential donors and national governments should have falsely tested negative through in TB diagnosis, it has a number of support its implementation, since this will sputum smear (prominent among drawbacks including its relatively high draw multiple producers to the market, people living with HIV who have TB). price (120 countries will be soon eligible fostering price-reducing competition. A study by MSF in Zimbabwe38 showed for a new price of US$ 9.98 per cartridge) Similarly, additional simplified tools that, of 1,672 sputum samples, 184 and its reliance on a stable electricity could help in overcoming existing human were positive for TB using sputum supply and controlled temperature. resource constraints towards greater implementation of viral load monitoring.

July 2012 msfaccess.org 11 Policies: enabling affordable 6 and rapid scale-up Bringing to scale the strategies outlined in this report could help dramatically accelerate the scaling up of antiretroviral therapy. Countries hard hit by the epidemic have a responsibility to implement health policies that serve the needs of people living with HIV, even in an environment of tight budgets. But these efforts must be backed up by sustained international donor commitment and policies that promote access to affordable antiretroviral drugs.

Donors must 17% of the HIV funding gap.41 Further, However, patent barriers and restrictive re-engage extra revenue should not come at the licensing agreements often prevent many expense of people: although Zimbabwe is low- and middle-income countries from Funding for global HIV treatment has raising an AIDS levy, it is still considering accessing the most affordable prices for been lagging during the past several a change to its policy of providing medicines (see box, page 14). years. Although there has been some HIV treatment free of charge and may Competition among multiple generic renewed political commitment to support introduce user fees. the scaling up of HIV treatment and care, pharmaceutical manufacturers in countries such as the AIDS-free generation policy Nevertheless, innovative funding in which medicines were not patented, mechanisms, if applied in multiple of the United States Government, many especially India, is what has reduced the countries, could add up to a substantial international donors continue to leave cost of HIV treatment by 99% since 2000. amount to supplement national and their financial commitments unfulfilled. The lack of pharmaceutical patents in India donor governments’ contributions. An estimated US$ 22 – 24 billion will until 2005 additionally allowed for the UNITAID, an international organization be needed each year to reach the goal production of fixed-dose combinations, that generates funds for HIV, TB and of reaching 15 million people with which both support adherence and are malaria through an airline tax, is an antiretroviral therapy by 2015, but donors crucial to the simplification of treatment important example of how a small tax can are falling short of this, by half.3 that has been central to the global scaling have an ongoing and important impact up of treatment. India has thus been called One consequence of reduced global on health. Mechanisms able to generate the pharmacy of the developing world: donor funding was the unprecedented long-term, predictable revenue, such as more than 80% of donor-funded purchases cancellation of a funding round in late through a financial transaction tax, could of antiretroviral drugs for use in low- and 2011 by the Global Fund to Fight AIDS, raise substantial revenue and should be middle-income countries from 2003 to Tuberculosis and Malaria.39 Some donor implemented. Although the feasibility of 2008 were manufactured in India, and countries’ bilateral programmes have a financial transaction tax is now largely more than 80% of the antiretroviral drugs also reduced funding. Both of these accepted in many government circles, MSF uses are sourced from India.43 leave countries more vulnerable and especially in Europe, whether or to what When India did introduce pharmaceutical less equipped to scale up antiretroviral extent the revenue raised from such a tax patents, it designed a patent law that therapy. will be dedicated to global health remains an unanswered question. is strict about what merits a patent, Although low- and middle-income reserving these only for medicines that countries cannot pay for the response Antiretrovirals show therapeutic benefit over products on their own,40 national governments that already exist. India has also put in do need to increase domestic HIV must be place a system that allows patents to and health funding. Some countries affordable be opposed before and after they are are considering innovative strategies Sustained access to the best treatment granted. This measure has led to several to identify new revenue streams. But options at affordable prices is essential antiretroviral drug patents being rejected these have limitations: an assessment in so that money goes as far as possible. in India, keeping the door open for price- Malawi concluded that a combination The most powerful tool to bring reducing generic competition. Other of new strategies such as an airline and medicine prices down is market countries should consider designing telecommunication levy would cover only competition among multiple producers.42 patent laws that have similar clauses.

12 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner But increased drug patenting in key arrangements that respond to public priced out of reach. Low- and middle- production countries, especially India, is health needs. income countries should ensure that they starting to block price-reducing generic have the ability to issue such licences in When drugs are patented, generic competition for newer antiretroviral their legislation. competition can only happen through drugs. If increased patenting and other compulsory licences or voluntary licences. In issuing a voluntary licence, a patent intellectual property measures mean Compulsory licences can open up the holder authorizes a generic manufacturer that generic competition cannot catalyse market to competition by overriding to produce and export a generic version reductions in the prices of medicines, patents to lower prices and increase access. of a medicine, often in exchange for tomorrow’s battle for access to affordable Several countries have issued compulsory royalty payments. Several antiretroviral antiretroviral drugs will require more licences for antiretroviral drugs, which drugs are now being produced under systematic use of compulsory licences have led to significant cost savings and different forms of licensing agreements and other policies to bring prices have set an important precedent for between originator and generic down or through voluntary licensing access to medicines that have been producers. However, the terms of these licences are critical: they often exclude many low- and middle-income countries “Affordable ARVs made in India have played a vital role in scaling with sizeable burdens of HIV; they often up ART to eight million people in developing countries over the last contain clauses that limit competition decade. But this ‘safe haven’ for the production of low-cost, quality by restricting where licensees can generic medicines is under threat: local generic production of a produce and the sources of the active number of newer antiretroviral medicines is being blocked because pharmaceutical ingredient; and they of patents and new threats are emerging. often are a de facto way of preventing If we want to scale up treatment to those in need, we must keep these compulsory licences by preventing sources of affordable medicines open.” licensees from supplying a country if it issues a compulsory licence. Further, Leena Menghaney, MSF Access Campaign, Delhi the terms and conditions of voluntary licences are not publicly available, meaning that their potential contribution or threat to public health benefit cannot be scrutinized. Mechanisms that encourage transparent licensing, such as the , should be supported. The Medicines Patent Pool manages intellectual property collectively in the interest of public health rather than through secret bilateral agreements between companies.

Other policies also threaten affordable medicines. Bilateral free-trade agreements and poorly drafted anti-counterfeiting legislation often seek levels of intellectual property protection that exceed requirements in international trade rules.43 Examples include the European Union–India free-trade agreement © Mudit Mathur currently being negotiated, the Anti- Demonstrators against the India-EU FTA on the streets of New Delhi. Counterfeiting Trade Agreement and

Continued overleaf

July 2012 msfaccess.org 13 Antiretrovirals must be affordable continued

the Trans-Pacific Partnership Agreement that the United States is negotiating Antiretroviral drug prices and the 23 countries with Pacific Rim countries. The leaked Trans-Pacific Partnership Agreement text Annex 2 illustrates how quality- market within the next 12 months, has shown that the United States is seeking assured generic manufacturers charge which should lower the generic to impose intellectual property provisions significantly less for the key fixed-dose price even further. at levels yet unseen that would restrict combination (tenofovir + lamivudine Annex 2 also shows that certain access to life-saving medicines. + efavirenz) recommended for first- per person per year countries are line treatment in comparison with Ensuring that more affordable generic excluded from originators’ discount the price charged by the originator. versions of newer-generation antiretroviral pricing schemes and/or are unable to drugs can be produced and accessed Matrix/Mylan sells tenofovir + lamivudine access medicines manufactured under is therefore critical. Low- and middle- + efavirenz for US$ 172 per person per voluntary licence because of territorial income countries should enact and use year. In contrast, Merck charges certain restrictions. India, for example, is not all the public health flexibilities allowed low- and middle-income countries eligible for Merck’s discounted price, in international trade rules. Ensuring that US$ 613 per person per year for the although it may purchase from both excessive intellectual property provisions therapeutically equivalent regimen current generic suppliers. In contrast, are kept out of both free-trade agreements tenofovir + lamivudine + efavirenz and Brazil and China are excluded from and anti-counterfeiting agreements will US$ 1033 per person per year in other both the discount prices offered also be essential to sustaining long-term low- and middle-income countries. by Merck and from purchase access.44 Low- and middle-income countries Two additional generic sources of from Mylan because of voluntary should refrain from pushing measures quality-assured tenofovir + lamivudine licence restrictions. that impose even greater intellectual + efavirenz are expected to reach the property protection than international trade rules require.

Spotlight: low HIV Treatment coverage

Democratic Republic their child; the country’s Global Fund the country has a fully comprehensive of the Congo Round 11 proposal aimed to increase health care system. A total of 40,000 The vast majority of people living the coverage of services for preventing people receive antiretroviral therapy, less with HIV in the Democratic Republic mother-to-child transmission of HIV, but than a quarter of the estimated 125,000 45 of the Congo do not have access to the funding round was subsequently who urgently need it. Between 15,000 antiretroviral therapy. This is because cancelled. In 2013, the Global Fund and 20,000 people living with HIV die of a lack of political commitment will be, again, the main ARV purchaser every year in Myanmar because of the on the part of the government, in the country. The PMTCT program lack of access to life-saving antiretroviral compounded by the withdrawal of supported by PEPFAR purchases ARV therapy. Despite 9,300 new cases international donors. An estimated one treatment for mothers that are eligible of drug-resistant TB every year, by million people are living with HIV and for lifelong treatment, up to 18 months the end of 2011, only 300 people 435,000 need antiretroviral therapy, only. By 2015 the ART coverage is had been started on treatment.46 with only 12% of those in need forecast to be 22%, a best-case scenario. Life-saving treatment for both HIV and receiving treatment. In 2011 funding drug-resistant TB urgently needs to shortfalls led to a cap on the number Myanmar be scaled up. Political reform in the of new treatment slots. Nationally, Myanmar is the least developed country country has led to greater international only 6% of mothers living with HIV in South-East Asia. Although there are engagement, providing an opportunity have access to antiretroviral therapy expectations of an increase to the to give priority to access to treatment to prevent transmission of HIV to health budget, it will be years before for people living with HIV and TB.

14 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner Conclusion Recent research results along with novel treatment models provide a genuine possibility to both reduce the number of people acquiring HIV infection and ensure long-term survival for people already living with HIV. National governments, donors, and other key actors must seize this opportunity to turn around the epidemic.

Research results presented in this report treatment further into the community, Nevertheless, the right policies must be show that critical progress has been offer integrated HIV at the lowest-level in place. Policies should be promoted made in ensuring policies are put in place facilities and offer simplified treatment that support the production of affordable that allow more people to be reached outside of facilities. It is crucial to move medicines and the development of medical with treatment. Antiretroviral therapy is treatment to the community level to tools that enable massive scale-up and sustainable long-term treatment provision. getting decentralized further and further reduce the burden of multiple clinic visits into communities, people are being Further, international donors must on people with HIV and decrease the reached with treatment earlier in their re-engage and recommit to HIV globally. workload at over-stretched health facilities. disease progression, and more individuals If they continue to withdraw support, the This approach also allows people with HIV are being provided with better-tolerated progress achieved over the last decade greater autonomy and responsibility for drugs that allow them to stay on their of investing in global HIV treatment risks managing their own care. regimens longer. being unravelled.

At the same time, much more needs to The experience of the past decade has Governments and donors: 47 be done to reach even more people with shown that treatment costs can and “Pay now, or pay forever.” treatment and care: several countries will decrease when tools are simplified, are still resisting policies to allow the treatment is decentralized and measures task-shifting necessary to decentralize are supported to reduce medicine prices.

“When I first found out I was HIV positive, I didn’t believe for a minute that I would be here today. Everyone in my family was upset and crying. But now I am on treatment and working again. In the future I would like to have a sewing machine to make clothes for my husband, my kids and my neighbours.”

Ivone Culimbica, HIV positive, Mozambique © Brendan Bannon

July 2012 msfaccess.org 15 Annex 1. Survey results: strategies, tools and policies supporting the scaling up of treatment in 23 countries MSF field teams provided data for the first 16 countries shown here where MSF has HIV projects. Data for the remaining seven countries were collected from national and international sources with the support of UNAIDS.

Cameroon CAR† DRC‡ Ethiopia Guinea India Kenya Lesotho Malawi Mozambique Myanmar South Africa Swaziland Uganda Zambia Zimbabwe Botswana Brazil China Namibia Nigeria Tanzania Ukraine

Population (millions) 20.1 5.10 73.6 93.8 10.9 1,210.2 43 1.9 16.3 23.5 54.6 48.8 1.4 35.9 14.3 12.6 2.9 205.7 1,343.2 2.2 170.1 43.6 44.9

Prevalence of HIV infection among adults (%) 4.3 4.9* 2.6 1.5 1.5 0.3** 6.2 23** 10.6* 11.5** 0.5 16.6 26◊ 6.7 14.6** 13.1 25 0.6 05-0.07 13.5 3.4* 5.6** 1

Antiretroviral therapy coverage and availability % of pregnant women living with HIV receiving services for preventing 53* a 24* a 5.6 b 24 b 40.5 c 27.8 d 69.2 b 78 c 48 b, e 52* c 54.3* c 87.1 c 87.5 c 46.1 b 84.5 b 84* b 93.98 c 50.23 c N/A f 89.5 c 15.9 c 71.53 b 68 g mother-to-child transmission % of people in need who receive antiretroviral therapy 46.4 26.1 12.3 86 h 59.9 N/A i 72.1◊ 61 57.7 45.5 33.4 52 80 54.3 77.6 79.7 96.1 h 71.9 46.8% j 74 29.8 76.2 13.4* k

Number (%) of public-sector facilities offering antiretroviral therapy 108 76 222 l 743 41 1,297 1,242 197 487 261 100 2,552 110 1,424 n 1784 590 (32.2%) 737 3.142 181 (2.9%)* (17.4%)* 127 (4.4%) (9%) (3%) (34.8%) (94%)* (80.4%) m (22%) (3.4%)* (68%) (42%) (25.4%)* (36%) o (0.3%) (0.3%) (52.8%) (16.7%) Children (<15 years) as a % of people receiving antiretroviral therapy 4.2 5.4* 11.6 6 4.8 5.8◊ 9◊ 7.3 8.9 8.4 7.5 8.5 9.1 7.9 7.3 8.4 6.2* 2.7 1.84 10.2 5.7* 7.7* 8.5

Best practices and WHO protocols as national policies Provider-initiated testing and counselling is national policy Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Antiretroviral therapy offerred free of charge in outpatient Yes, but Yes, but Yes, but Yes Yes Yes Yes, but Yes Yes Yes, with Antiretroviral Yes Yes Yes Yes Yes, not in Yes, with Yes Yes, but not Yes Yes, with Yes Yes public facilities not labs not in not in not some restrictions q drugs, not practice restrictions s opportunistic restrictions t practice practice opportunistic opportunistic consistently infections infections p infections/labs r WHO-recommended protocol for services for preventing mother-to-child A A A A B B A, B, or B+ A B+ A A or B A A B+ u A A B B B A A or B v A B transmission is national policy WHO-recommended protocol for initiating ART is national policy Yes Yes Yes No w Yes Yes Yes Yes Yes Yes Yes x Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

TDF or AZT is part of the preferred adult first-line regimen AZT or TDF AZT AZT AZT or TDF AZT AZT TDF TDF TDF y AZT AZT or TDF TDF TDF TDF TDF TDF TDF AZT TDF TDF AZT or TDF AZT TDF

% of people on ART on a d4t-containing regimen 0◊ N/A N/A 59* N/A t 24.9◊ N/A 81 7* N/A z 40* 0◊ 2 N/A 75.8◊ N/A N/A 36.3 N/A N/A 63* aa 4.6

% of pregnant women receiving single-dose NVP 13.4 N/A 43.4 N/A N/A 27.8 4.2 0* 14 b b 28 0 0* 0* 7.3 11.4 8.6 0* N/A N/A 3.7 24.8* 18.2 4.3

Protocol includes third-line antiretroviral therapy or salvage treatment Yes No No No Yes No Yes Yes No No Yes Yes No No Yes No Yes Yes No Yes Yes No Yes

TB prophylaxis (isoniazid preventive therapy) for all people living with Yes (LTD) No No Yes No No Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) ee Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) Yes (LTD) Yes No Yes Yes (LTD) Yes (LTD) Yes HIV is national policy Viral load (VL) testing in national protocols VL testing to confirm treatment failure Optional Optional Optional No Optional Required Optional Optional Required Optional Optional Required Optional Optional Optional Optional Required Required Optional Optional Optional Optional Required

Routine VL testing of people on antiretroviral therapy Optional No No No No No No No No cc Required dd No Required No Optional Optional No Required Required Optional Optional Optional Optional Optional

VL testing is available for this purpose LTD LTD LTD LTD LTD LTD Yes LTD LTD No LTD Yes LTD LTD LTD LTD Yes Yes LTD LTD LTD LTD LTD

Task-shifting allowed as national policy Nurses can initiate antiretroviral therapy Follow-up Yes No Yes Yes ff No Yes Yes Yes No gg No Yes Yes Follow-up Yes Yes ii Yes jj No No Follow-up No No No only only hh only Nurses can initiate TB treatment (drug-sensitive) Yes No kk Yes ll No No No Yes Yes Yes No No Yes Yes Yes Yes Yes ll Yes No No Yes Yes No No

Same health worker can provide TB and HIV treatment at PHC level No mm N/A No ll No mm No nn No nn No oo Yes pp Yes No qq No rr Yes Yes No ss Yes Yes No No N/A N/A No No No

Lay workers can provide HIV testing and antiretroviral therapy Adherence Adherence Yes No HIV Yes Yes Yes Yes HIV No Yes Yes Yes Yes Yes Yes Adherence Yes Yes Adherence Yes Adherence adherence counselling Simplified antiretroviral drug dispensing allowed as national policy 2- to 3-month routine antiretroviral drug refills for people in stable condition No No No 2 No 2 2-3 No 2-3 No No 3 3 No (Yes in 3 No (Yes in No No (Yes in No (Yes in No No 2 or more No (Yes in practice) practice) practice) practice) practice) Antiretroviral drug refill dispensing at the community level No No No No No No No No No Yes tt No No uu No No Yes vv No No No No No No No No

FUNDING FOR HIV & HEALTH

% of government expenditure on health as % of general 8.5* 8.5* 9.1* 13.5* 1.8* 3.6* 7.3* 13.4* 14.2* 12.2* 1* 11.9* 10.1* 12.1* 15.6* N/A ww 17* 7.1* 12.1* 12.1* 4.4* 13.8* 9.4* government expenditure

16 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner Annex 1. Survey results: strategies, tools and policies supporting the scaling up of treatment in 23 countries MSF field teams provided data for the first 16 countries shown here where MSF has HIV projects. Data for the remaining seven countries were collected from national and international sources with the support of UNAIDS.

Cameroon CAR† DRC‡ Ethiopia Guinea India Kenya Lesotho Malawi Mozambique Myanmar South Africa Swaziland Uganda Zambia Zimbabwe Botswana Brazil China Namibia Nigeria Tanzania Ukraine

Population (millions) 20.1 5.10 73.6 93.8 10.9 1,210.2 43 1.9 16.3 23.5 54.6 48.8 1.4 35.9 14.3 12.6 2.9 205.7 1,343.2 2.2 170.1 43.6 44.9

Prevalence of HIV infection among adults (%) 4.3 4.9* 2.6 1.5 1.5 0.3** 6.2 23** 10.6* 11.5** 0.5 16.6 26◊ 6.7 14.6** 13.1 25 0.6 05-0.07 13.5 3.4* 5.6** 1

Antiretroviral therapy coverage and availability % of pregnant women living with HIV receiving services for preventing 53* a 24* a 5.6 b 24 b 40.5 c 27.8 d 69.2 b 78 c 48 b, e 52* c 54.3* c 87.1 c 87.5 c 46.1 b 84.5 b 84* b 93.98 c 50.23 c N/A f 89.5 c 15.9 c 71.53 b 68 g mother-to-child transmission % of people in need who receive antiretroviral therapy 46.4 26.1 12.3 86 h 59.9 N/A i 72.1◊ 61 57.7 45.5 33.4 52 80 54.3 77.6 79.7 96.1 h 71.9 46.8% j 74 29.8 76.2 13.4* k

Number (%) of public-sector facilities offering antiretroviral therapy 108 76 222 l 743 41 1,297 1,242 197 487 261 100 2,552 110 1,424 n 1784 590 (32.2%) 737 3.142 181 (2.9%)* (17.4%)* 127 (4.4%) (9%) (3%) (34.8%) (94%)* (80.4%) m (22%) (3.4%)* (68%) (42%) (25.4%)* (36%) o (0.3%) (0.3%) (52.8%) (16.7%) Children (<15 years) as a % of people receiving antiretroviral therapy 4.2 5.4* 11.6 6 4.8 5.8◊ 9◊ 7.3 8.9 8.4 7.5 8.5 9.1 7.9 7.3 8.4 6.2* 2.7 1.84 10.2 5.7* 7.7* 8.5

Best practices and WHO protocols as national policies Provider-initiated testing and counselling is national policy Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Antiretroviral therapy offerred free of charge in outpatient Yes, but Yes, but Yes, but Yes Yes Yes Yes, but Yes Yes Yes, with Antiretroviral Yes Yes Yes Yes Yes, not in Yes, with Yes Yes, but not Yes Yes, with Yes Yes public facilities not labs not in not in not some restrictions q drugs, not practice restrictions s opportunistic restrictions t practice practice opportunistic opportunistic consistently infections infections p infections/labs r WHO-recommended protocol for services for preventing mother-to-child A A A A B B A, B, or B+ A B+ A A or B A A B+ u A A B B B A A or B v A B transmission is national policy WHO-recommended protocol for initiating ART is national policy Yes Yes Yes No w Yes Yes Yes Yes Yes Yes Yes x Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

TDF or AZT is part of the preferred adult first-line regimen AZT or TDF AZT AZT AZT or TDF AZT AZT TDF TDF TDF y AZT AZT or TDF TDF TDF TDF TDF TDF TDF AZT TDF TDF AZT or TDF AZT TDF

% of people on ART on a d4t-containing regimen 0◊ N/A N/A 59* N/A t 24.9◊ N/A 81 7* N/A z 40* 0◊ 2 N/A 75.8◊ N/A N/A 36.3 N/A N/A 63* aa 4.6

% of pregnant women receiving single-dose NVP 13.4 N/A 43.4 N/A N/A 27.8 4.2 0* 14 b b 28 0 0* 0* 7.3 11.4 8.6 0* N/A N/A 3.7 24.8* 18.2 4.3

Protocol includes third-line antiretroviral therapy or salvage treatment Yes No No No Yes No Yes Yes No No Yes Yes No No Yes No Yes Yes No Yes Yes No Yes

TB prophylaxis (isoniazid preventive therapy) for all people living with Yes (LTD) No No Yes No No Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) ee Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) Yes (LTD) Yes No Yes Yes (LTD) Yes (LTD) Yes HIV is national policy Viral load (VL) testing in national protocols VL testing to confirm treatment failure Optional Optional Optional No Optional Required Optional Optional Required Optional Optional Required Optional Optional Optional Optional Required Required Optional Optional Optional Optional Required

Routine VL testing of people on antiretroviral therapy Optional No No No No No No No No cc Required dd No Required No Optional Optional No Required Required Optional Optional Optional Optional Optional

VL testing is available for this purpose LTD LTD LTD LTD LTD LTD Yes LTD LTD No LTD Yes LTD LTD LTD LTD Yes Yes LTD LTD LTD LTD LTD

Task-shifting allowed as national policy Nurses can initiate antiretroviral therapy Follow-up Yes No Yes Yes ff No Yes Yes Yes No gg No Yes Yes Follow-up Yes Yes ii Yes jj No No Follow-up No No No only only hh only Nurses can initiate TB treatment (drug-sensitive) Yes No kk Yes ll No No No Yes Yes Yes No No Yes Yes Yes Yes Yes ll Yes No No Yes Yes No No

Same health worker can provide TB and HIV treatment at PHC level No mm N/A No ll No mm No nn No nn No oo Yes pp Yes No qq No rr Yes Yes No ss Yes Yes No No N/A N/A No No No

Lay workers can provide HIV testing and antiretroviral therapy Adherence Adherence Yes No HIV Yes Yes Yes Yes HIV No Yes Yes Yes Yes Yes Yes Adherence Yes Yes Adherence Yes Adherence adherence counselling Simplified antiretroviral drug dispensing allowed as national policy 2- to 3-month routine antiretroviral drug refills for people in stable condition No No No 2 No 2 2-3 No 2-3 No No 3 3 No (Yes in 3 No (Yes in No No (Yes in No (Yes in No No 2 or more No (Yes in practice) practice) practice) practice) practice) Antiretroviral drug refill dispensing at the community level No No No No No No No No No Yes tt No No uu No No Yes vv No No No No No No No No

FUNDING FOR HIV & HEALTH

% of government expenditure on health as % of general 8.5* 8.5* 9.1* 13.5* 1.8* 3.6* 7.3* 13.4* 14.2* 12.2* 1* 11.9* 10.1* 12.1* 15.6* N/A ww 17* 7.1* 12.1* 12.1* 4.4* 13.8* 9.4* government expenditure

July 2012 msfaccess.org 17 Cameroon CAR† DRC‡ Ethiopia Guinea India Kenya Lesotho Malawi Mozambique Myanmar South Africa Swaziland Uganda Zambia Zimbabwe Botswana Brazil China Namibia Nigeria Tanzania Ukraine

Population (millions) 20.1 5.10 73.6 93.8 10.9 1,210.2 43 1.9 16.3 23.5 54.6 48.8 1.4 35.9 14.3 12.6 2.9 205.7 1,343.2 2.2 170.1 43.6 44.9

Prevalence of HIV infection among adults (%) 4.3 4.9* 2.6 1.5 1.5 0.3** 6.2 23** 10.6* 11.5** 0.5 16.6 26◊ 6.7 14.6** 13.1 25 0.6 05-0.07 13.5 3.4* 5.6** 1

Antiretroviral therapy coverage and availability % of pregnant women living with HIV receiving services for preventing 53* a 24* a 5.6 b 24 b 40.5 c 27.8 d 69.2 b 78 c 48 b, e 52* c 54.3* c 87.1 c 87.5 c 46.1 b 84.5 b 84* b 93.98 c 50.23 c N/A f 89.5 c 15.9 c 71.53 b 68 g mother-to-child transmission % of people in need who receive antiretroviral therapy 46.4 26.1 12.3 86 h 59.9 N/A i 72.1◊ 61 57.7 45.5 33.4 52 80 54.3 77.6 79.7 96.1 h 71.9 46.8% j 74 29.8 76.2 13.4* k

Number (%) of public-sector facilities offering antiretroviral therapy 108 76 222 l 743 41 1,297 1,242 197 487 261 100 2,552 110 1,424 n 1784 590 (32.2%) 737 3.142 181 (2.9%)* (17.4%)* 127 (4.4%) (9%) (3%) (34.8%) (94%)* (80.4%) m (22%) (3.4%)* (68%) (42%) (25.4%)* (36%) o (0.3%) (0.3%) (52.8%) (16.7%) Children (<15 years) as a % of people receiving antiretroviral therapy 4.2 5.4* 11.6 6 4.8 5.8◊ 9◊ 7.3 8.9 8.4 7.5 8.5 9.1 7.9 7.3 8.4 6.2* 2.7 1.84 10.2 5.7* 7.7* 8.5

Best practices and WHO protocols as national policies Provider-initiated testing and counselling is national policy Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Antiretroviral therapy offerred free of charge in outpatient Yes, but Yes, but Yes, but Yes Yes Yes Yes, but Yes Yes Yes, with Antiretroviral Yes Yes Yes Yes Yes, not in Yes, with Yes Yes, but not Yes Yes, with Yes Yes public facilities not labs not in not in not some restrictions q drugs, not practice restrictions s opportunistic restrictions t practice practice opportunistic opportunistic consistently infections infections p infections/labs r WHO-recommended protocol for services for preventing mother-to-child A A A A B B A, B, or B+ A B+ A A or B A A B+ u A A B B B A A or B v A B transmission is national policy WHO-recommended protocol for initiating ART is national policy Yes Yes Yes No w Yes Yes Yes Yes Yes Yes Yes x Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

TDF or AZT is part of the preferred adult first-line regimen AZT or TDF AZT AZT AZT or TDF AZT AZT TDF TDF TDF y AZT AZT or TDF TDF TDF TDF TDF TDF TDF AZT TDF TDF AZT or TDF AZT TDF

% of people on ART on a d4t-containing regimen 0◊ N/A N/A 59* N/A t 24.9◊ N/A 81 7* N/A z 40* 0◊ 2 N/A 75.8◊ N/A N/A 36.3 N/A N/A 63* aa 4.6

% of pregnant women receiving single-dose NVP 13.4 N/A 43.4 N/A N/A 27.8 4.2 0* 14 b b 28 0 0* 0* 7.3 11.4 8.6 0* N/A N/A 3.7 24.8* 18.2 4.3

Protocol includes third-line antiretroviral therapy or salvage treatment Yes No No No Yes No Yes Yes No No Yes Yes No No Yes No Yes Yes No Yes Yes No Yes

TB prophylaxis (isoniazid preventive therapy) for all people living with Yes (LTD) No No Yes No No Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) ee Yes (LTD) Yes Yes (LTD) Yes (LTD) Yes (LTD) Yes (LTD) Yes No Yes Yes (LTD) Yes (LTD) Yes HIV is national policy Viral load (VL) testing in national protocols VL testing to confirm treatment failure Optional Optional Optional No Optional Required Optional Optional Required Optional Optional Required Optional Optional Optional Optional Required Required Optional Optional Optional Optional Required

Routine VL testing of people on antiretroviral therapy Optional No No No No No No No No cc Required dd No Required No Optional Optional No Required Required Optional Optional Optional Optional Optional

VL testing is available for this purpose LTD LTD LTD LTD LTD LTD Yes LTD LTD No LTD Yes LTD LTD LTD LTD Yes Yes LTD LTD LTD LTD LTD

Task-shifting allowed as national policy Nurses can initiate antiretroviral therapy Follow-up Yes No Yes Yes ff No Yes Yes Yes No gg No Yes Yes Follow-up Yes Yes ii Yes jj No No Follow-up No No No only only hh only Nurses can initiate TB treatment (drug-sensitive) Yes No kk Yes ll No No No Yes Yes Yes No No Yes Yes Yes Yes Yes ll Yes No No Yes Yes No No

Same health worker can provide TB and HIV treatment at PHC level No mm N/A No ll No mm No nn No nn No oo Yes pp Yes No qq No rr Yes Yes No ss Yes Yes No No N/A N/A No No No

Lay workers can provide HIV testing and antiretroviral therapy Adherence Adherence Yes No HIV Yes Yes Yes Yes HIV No Yes Yes Yes Yes Yes Yes Adherence Yes Yes Adherence Yes Adherence adherence counselling Simplified antiretroviral drug dispensing allowed as national policy 2- to 3-month routine antiretroviral drug refills for people in stable condition No No No 2 No 2 2-3 No 2-3 No No 3 3 No (Yes in 3 No (Yes in No No (Yes in No (Yes in No No 2 or more No (Yes in practice) practice) practice) practice) practice) Antiretroviral drug refill dispensing at the community level No No No No No No No No No Yes tt No No uu No No Yes vv No No No No No No No No

FUNDING FOR HIV & HEALTH

% of government expenditure on health as % of general 8.5* 8.5* 9.1* 13.5* 1.8* 3.6* 7.3* 13.4* 14.2* 12.2* 1* 11.9* 10.1* 12.1* 15.6* N/A ww 17* 7.1* 12.1* 12.1* 4.4* 13.8* 9.4* government expenditure

Legend and Footnotes continued overleaf

17 Annex 1: Legend and Footnotes

LEGEND j. Based on 2010 WHO estimates of national ART dd. National protocol requires VL testing at need. The government-reported coverage figure six months on ART, but this testing is not HIV programme and policy data are from (76.1%) is based on the actual reported number generally available. 2011 except where indicated: of people in need of ART (such as those registered ee. Policy is in place, but implementation is **2009 data; *2010 data, ◊2012 data. in the HIV program) at the end of 2011. still at pilot stage. †Central African Republic. ‡Democratic Republic k. MOH reports 53% coverage, which is of Congo Adult population means 15 – 49 years ff. Only under doctor’s supervision. based on the total number of people needing old. TDF: tenofovir. AZT: zidovudine. NVP: gg. Only medical technicians (Tecnicos de nevirapine. NA: not available. LTD: limited ART and registered and enrolled in the MOH medicina) can initiate and manage ART. A 2011 availability or implementation. Adherence: health care system. pilot program to train agents of medicine Antiretroviral treatment adherence counseling. l. Government target is for 4,017 public and (agentes de medicina), general nurses (Nurses PMTCT and ART coverage: As reported private ART facilities. In 2011, 444 public and Geral Medio) and general and PMTCT middle by governments or sources such as WHO, private sites were operational, so current coverage nurses (Nurses Medio) to initiate and manage these figures are based on the numbers of based on the government target is 11%. ART is undergoing an evaluation by the MOH. Basic nurses, who represent more than half the pregnant women living with HIV receiving m. Includes some Christian Health Association health workforce are not being considered to intervention for PMTCT out of national of Malawi facilities, partly supported by the estimates of need. initiate ART or provide follow-up. MOH to provide ART. PMTCT protocols include: option A hh. Nurses can start ART for HIV+ positive n. Includes non-MOH facilities. (zidovudine from week 14, single-dose pregnant women and provide ART follow-up. nevirapine at birth, zidovudine + lamivudine o. Number of facilities offering ART follow-up. ii. Registered General Nurses who received during labour and delivery and zidovudine Initiation is provided at 141 facilities. training and mentorship can initiate ART + lamivudine one week postpartum); option with verbal authorization from district health p. Free ART policy includes diagnostics and B (triple-course antiretroviral therapy from officials, although formal policies not yet treatment only for certain OI’s. week 14 of pregnancy through to one week adopted. Primary Care Nurses cannot initiate after breastfeeding); and option B+ (lifelong q. Patients pay a nominal fee for prescriptions but can provide follow-up. antiretroviral therapy for all pregnant women (not including TB treatment and ART) and living with HIV). jj. Nurses can start ART for asymptomatic adults consultations. with CD4>150 and not yet exposed to ARVs. WHO recommended ART initiation protocol r. Patients pay under a cost-sharing model 3 kk. No official policy adopted, but in practice includes CD4<350 per mm , HIV/TB coinfection for labs and OI treatment. TB diagnosis and and/or Stage 3 or 4. nurses can prescribe TB treatment. treatment is free. ll. Nurses can start TB treatment only for Footnotes s. For citizens only. smear-positive patients. a. Based on women receiving ARV drugs, t. Includes CD4 monitoring but not other lab tests mm. Nurses cannot initiate ART, but they can excluding single-dose NVP. and also not consistently offered free in practice. start patients on TB treatment. b. Includes pregnant HIV-positive women u. Option B+ adopted as national policy, nn. HIV and TB treatment provided in separate who received a partial PMTCT protocol but roll-out deferred until early 2013 due to facilities or at different levels of care. (e.g. single-dose NVP). funding shortfalls. oo. TB treatment initiated at lower-level c. Does not delineate specific protocols for v. MOH recommends Option B for “facilities health centers (II and III) than ART (mainly preventing mother-to-child transmission with capacity to provide and monitor triple level IV and above), although the latter is delivered. ARV medication” and Option A for “facilities changing. Thus, TB and ART may soon be with limited capacity (on–site or by referral) to initiated by the same PHC health worker. d. Based on percentage of estimated 43,000 provide and monitor triple ARV medication.” HIV poslitive pregnant women in 2010–2011, pp. Policy supports task-shifting of ART and of whom 11,962 mother-baby pairs received w. Pregnant women or people at clinical Stage TB treatment to nurses, but ART is being intervention for preventing mother-to-child 3 can start ART with a CD4<350. Otherwise, more rapidly decentralized to PHC. Most transmission. ART initiation threshold for adults is CD4<200. health centers still lack drugs and/or capacity to initiate TB treatment. e. Data from last quarter of 2011 only, x. Latest guidelines include CD4<350 but haven’t following change in PMTCT eligibility been implemented in parts of the country. qq. Nurses cannot initiate ART and TB protocol in mid-2011. treatment but are the only medical staff y. Full implementation delayed due to funding present in many PHC clinics. Cadres allowed f. National estimate for the number of HIV shortfalls. The first phase of implementation to initiate both treatments are not widely positive pregnant women not available. prioritizes HIV positive pregnant women, available at PHC level. Government-reported PMTCT coverage figure people with TB/HIV co-infections, and rr. ART not available at MOH-supported PHC (74.1%) is based instead on the number of patients with severe d4T side effects (e.g., facilities but new HIV/TB policies in development pregnant women who tested positive for advanced lipodystrophy). Other adults start are expected to support integrated HIV/TB care. HIV at ANC clinics received intervention for on a d4t-containing regimen. preventing mother-to-child transmission. ss. TB treatment is decentralized further than ART. z. The majority of people on ART in Myanmar Nurses can initiate ART only in pregnant women. g. Ministry of Health reports 95.5% coverage, are on d4t as the new guidelines stipulating based on the number of pregnant women TDF-containing regimens for preferred first-line tt. Peers in community ART groups (CAGs) who tested positive rather than on national treatment for adults are not in full effect yet. can deliver ARV refills to other CAG members. estimates of HIV positive pregnant women. aa. Estimates of people on ART are on a uu. MSF is piloting pre-packed ARVs dispensed h. Based on CD4<200. d4t-containing regimen in 2011 are between by lay counselors to CAGs in Khayelitsha. i. National estimate for the number of HIV+ 10-20%. vv. Mobile ART clinics are part of national people in need of ART is not available. The bb. For the last quarter of 2011. HIV strategy. government-reported ART coverage figure (33.8%) is based on the number of people cc. VL monitoring for patients on ART is ww. The Government of Zimbabwe allocated registered to be in need, a subset of the included in Malawi’s ART guidelines, but 9.3% of its 2011 budget to health. Health overall population in need. rollout deferred due to funding shortfalls. expenditure data is not available. Annex 2. TDF-containing first-line regimen: pricing eligibility in 23 countries

First-line treatment option of TDF/3TC/EFV 300/300/600 mg COUNTRY or TDF/FTC/EFV 300/200/600 mg

Quality-assured* generic Quality-assured* generic options for Quality-assured* originator options for TDF/3TC/EFV TDF/FTC/EFV 300/200/600 mg option for TDF/FTC/EFV 300/300/600 mg 300/200/600 mg

Merck

Matrix (Mylan) Matrix (Mylan) Cipla Category 1 Category 2 US$ 172 US$ 197 US$ 207 a countries countries US$ 613 b US$ 1033 c

Botswana Eligible Eligible d Eligible for supply if patent Eligible d N/A barriers overcome** d

Brazil e Not eligible f Not eligible f Eligible for supply but Not eligible Not eligible price unknown

Cameroon Eligible Eligible Eligible for supply but Eligible N/A patent status unknown***

CAR, DRC, Ethiopia, Eligible Eligible Eligible Eligible N/A Guinea, Lesotho, Malawi, Mozambique, Myanmar, Tanzania, Uganda, Zambia g

China Not eligible f Not eligible f Eligible for supply if patent Not eligible Not eligible barriers overcome

India Eligible Eligible Eligible Not eligible Not eligible

Kenya Eligible Eligible Eligible for supply if patent Eligible d N/A barriers overcome d

Namibia Eligible Eligible d Eligible for supply if patent Eligible d N/A barriers overcome d

Nigeria Eligible Eligible Eligible for supply but Eligible N/A patent status unknown

South Africa Eligible Eligible Eligible for supply if patent Eligible N/A barriers overcome

Swaziland Eligible Eligible d Eligible for supply if patent Eligible d N/A barriers overcome d

Ukraine Not eligible f Not eligible f Eligible for supply if patent Eligible N/A barriers overcome

Zimbabwe Eligible Eligible d Eligible for supply if patent Eligible d N/A barriers overcome d

20 Médecins Sans Frontières Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner © Brendan Bannon

LEGEND b. The following list of category 1 countries e. There are several combination patents on TDF was provided by Merck for TDF/FTC/EFV filed in Brazil, but none are currently granted. All prices displayed in US$ per patient per 300/200/600mg: Afghanistan; Angola; Source: http://www.medicinespatentpool. year, as quoted by companies. Antigua and Barbuda; Bangladesh; Belize; org/table/. Last updated January 2012. *Quality-assured: The term quality assured Benin; Bhutan; Botswana; Burkina Faso; [Last accessed 18/06/12]. is used here to refer to products assured Burundi; Cambodia; Cameroon; Cape Verde; f. Matrix manufactures TDF under voluntary by US FDA or WHO prequalification (as Central African Republic; Chad; Comoros; licence from Gilead. Those countries marked of June 2012). Currently Mylan is the only Congo; Congo (DRC); Côte d’Ivoire; Djibouti; as ‘non eligible’ are countries not included in quality assured source of this combination, Dominica; Dominican Rep.; Equatorial Guinea; Eritrea; Ethiopia; Gabon; Gambia; Ghana; the geographic scope for sale. but additional manufacturers in India are Grenada; Guatemala; Guinea-Bissau; Guinea; in the process of submitting their products g. The World Trade Organization (WTO) Doha Guyana; Haiti; Honduras; Jamaica; Kenya; for quality assurance. Prices should decrease Declaration, paragraph 7 states that least- Kiribati; Laos; Lesotho; Liberia; Madagascar; further as this competition is introduced. developed members do not have to implement Malawi; Maldives; Mali; Mauritania; Moldova; or enforce pharmaceutical patent protection Mozambique; Myanmar; Namibia; Nepal; **Eligible for supply if patent barriers overcome: until January 1, 2016. List of 48 LDCs Niger; Nigeria; Pakistan; Panama; Papua New Countries identified as ‘eligible for supply if Source: http://www.unohrlls.org/en/ldc/25/. Guinea; Rwanda; São Tomé and Principe; patent barriers overcome’ are those territories [Last accessed 18/06/12]. where a patent on one of the drugs or drug Senegal; Sierra Leone; Solomon Islands; combinations has been granted. Patent status Somalia; South Africa; St Kitts and Nevis; St Lucia; St Vincent and the Grenadines; METHODOLOGY information taken from the Medicines Patent Samoa; Sudan; Suriname; Swaziland; Pool Patent Status database available at The latest pricing data supplied by ARV Tanzania; Timor-Leste; Togo; Trinidad and http://www.medicinespatentpool.org/table/. producers to MSF for the 15th edition of Tobago; Tuvalu; Uganda; Ukraine; Vanuatu; [Last accessed 18/06/12]. ‘Untangling the web of antiretroviral price Yemen; Zambia; Zimbabwe. reductions’ utw.msfaccess.org was cross ***Eligible for supply but patent status is checked with the stated eligibility criteria c. The following list of category 2 countries unknown: The patent status for TDF and was provided by Merck for TDF/FTC/ of these companies in order to determine TDF combinations is unknown. Source: EFV 300/200/600mg: Bolivia; Indonesia; which of the 23 countries were eligible for http://www.medicinespatentpool.org/table/. Kyrgyzstan; Mauritius; Mongolia; Nicaragua; supply from each producer. Where generic [Last accessed 18/06/12]. Seychelles; Syria; Tajikistan; Uzbekistan; companies had not included their own Vietnam. eligibility restrictions through, for example, FOOTNOTES specifying a list of eligible countries under d. The Medicines Patent Pool patent status the terms of a voluntary licence, we used the a. Cipla does not manufacture TDF under database shows that a TDF combination Medicines Patent Pool Patent Status database voluntary licence from Gilead, and are with FTC patent was granted (AP2089) http://www.medicinespatentpool.org/ therefore free to sell in any territory. However, in the ARIPO region. Non LDC ARIPO patent-data/patent-status-of-arvs/ to identify where patents on TDF or TDF combinations countries could technically see combination where patents on these ARVs had been filed with FTC or EFV have been granted, patents on TDF with FTC enforced. Source: or granted. Where we identified patent importation barriers may occur. Cipla has http://www.medicinespatentpool.org/table/. barriers we noted them. Such barriers may negotiated higher prices separately for Last updated November 2011. [Last accessed be overcome, but the importing country 10 Latin American countries. 18/06/12]. will need to take specific action in this case.

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