Universal access

HARARE/GENEVA, 30 November 2015—The Clinton Health Access Initiative, Inc. (CHAI), UNAIDS, and UNITAID announce today three new agreements that could increase access to more sustainable HIV drug regimens at reduced prices, pending stringent regulatory approval and/or World Health Organization (WHO) pre-qualification.

These agreements have the potential to increase access to state-of-the-art HIV treatment regimens for people living with HIV in low- and middle- income countries. The regimens are expected to be more durable and produce fewer side effects than existing drugs and are included in the revised 2015 WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection.

“Ensuring access to the most innovative and effective medicines for all people with HIV is essential in every country,” said Dr Margaret Chan, WHO Director-General. “I applaud CHAI and all the partners involved for these agreements, which move us one step closer to a world without AIDS.”

Under the first agreement, Aurobindo Pharma Limited has agreed to make generic dolutegravir (DTG) available for US$44 per patient per year, subject to regulatory approval. At this price, a DTG-containing regimen is comparable in price to the leading first-line regimen containing efavirenz (EFV). WHO now recommends DTG as an alternate first-line therapy in those intolerant of efavirenz. There are, as yet, insufficient data to recommend the use of DTG in women who are or wish to become pregnant or for people on treatment for tuberculosis; associated studies are currently underway.

The launch price agreement for DTG was made possible in part by the leadership of the Government of Kenya, which agreed to incorporate DTG into national treatment guidelines and begin providing DTG to suitable patients as soon as regulatory approval is received.

ViiV Healthcare licensed Aurobindo for generic DTG, enabling Aurobindo to file for tentative approval with the U.S. Food and Drug Administration (US FDA) for the single formulation in May 2015, making this the fastest filing for a generic antiretroviral following approval for the originator, which occurred in August 2013. As a part of today’s agreement, Aurobindo confirmed they will also file for a one-pill, once per day fixed-dose combination of DTG (combined with tenofovir disoproxyl fumarate and lamivudine) with the US FDA by Q3 2016. ViiV has also enabled other manufacturers to develop this fixed-dose combination through an earlier license provided to the Medicines Patent Pool.

"Bringing effective new HIV drugs to the millions of people who have still not initiated treatment is a big challenge in global health today," said UNITAID Executive Director Lelio Marmora. "The agreements announced between CHAI, UNAIDS and UNITAID with four manufacturing partners will be crucial to having game-changing medications included in WHO and national guidelines and brought to market more speedily."

Secondly, Mylan Laboratories Limited will file for US FDA tentative approval for an alternate first-line fixed-dose combination regimen in Q1 2016, and make it available for US$99 per patient per year, subject to regulatory approval. The new product, TLE400, contains tenofovir disoproxyl fumarate, lamivudine, and a reduced dose of efavirenz, and produced positive results in the ENCORE1 clinical study by the Kirby Institute at the University of New South Wales, Australia. Again, there are insufficient data to recommend this combination in TB patients or women who are pregnant, but related studies are either planned or underway. The new price marks an 8% decrease from current prices and could generate US$80-100 million in savings globally through 2020, if approved. To foster future competition and ensure supply security, the Kirby Institute and CHAI have agreed to make the study data available to companies seeking to develop other generic versions of TLE400.

“Ensuring access to high quality and affordable HIV drugs for all people living with the virus is a top priority for Zimbabwe,” said Honorable Dr. David Parirenyatwa, Minister of Health and Child Care in Zimbabwe. “We look forward to adopting TLE400 as our standard first-line treatment as soon as ongoing efficacy trials amongst pregnant women and TB patients are complete and it receives the appropriate regulatory approvals and is available. The clinical benefits and affordability make it the right choice for Zimbabwe, and we thank CHAI, UNAIDS, UNITAID and Mylan for helping to make this possible.”

Thirdly, a new partnership between Janssen: Pharmaceutical Companies of Johnson & Johnson and CHAI will facilitate the development and delivery of a heat-stable formulation of darunavir/ritonavir (DRV/r) to enhance its availability in resource-limited settings. For the first time, the revised 2015 WHO HIV treatment guidelines include DRV/r as an alternative component of second- or third-line HIV treatment regimens for adolescents and adults. DRV/r has a favorable resistance and tolerability profile compared to the current treatment options (lopinavir/ritonavir and atazanavir/ritonavir) and represents a once-daily regimen option for patients on second-line treatment. CHAI is also partnering with Hetero Drugs Limited to accelerate development of a generic version of DRV/r, and Hetero has committed to file for regulatory approval by Q3 2016. Together, these partnerships will aim to address development, manufacturing, and uptake barriers in order to expedite DRV/r availability in resource-limited settings. Janssen is the originator manufacturer for DRV; please see accompanying full Product Information for more details.

“As a global community, we need to ensure that the 15.8 million people currently on HIV treatment, and the millions more to be initiated on treatment over the next few years, have access to the best possible drugs to treat the disease and prevent further spread of the disease,” said Ira Magaziner, CEO of CHAI. “The agreements announced today are a great step forward in that effort, and CHAI is pleased that our continued collaboration with UNAIDS, UNITAID, WHO, the British Government, and industry partners has enabled this success.”

Together, these agreements have the potential to enhance access to optimal HIV treatment regimens and improve treatment outcomes for people in low-and middle-income countries. Increased access to treatment, retention in care, and improved treatment outcomes are critical to reaching the ambitious global 90-90-90 treatment targets, which aim to lay the foundation to end AIDS as a public health threat by 2030. The 90-90-90 targets require that by 2020, 90 percent of all people living with HIV will know their HIV status; 90 percent of all people with an HIV diagnosis will receive sustained antiretroviral therapy; and 90 percent of all people receiving antiretroviral therapy will achieve viral suppression.

“Access to life-changing HIV treatment should not be a lottery based on where you happen to live. To ensure equity and sustainability in the global AIDS response, continued collaboration with our industry and technical partners is essential to make optimal first-, second- and third-line HIV treatment regimens available and affordable for all people living with HIV,” said Michel Sidibé, UNAIDS Executive Director. “We welcome today’s agreements which we hope will improve treatment options available to all countries and help us to achieve our ambitious 90-90-90 treatment targets.”

CHAI and UNITAID are committed to an open, competitive marketplace for the products included in these agreements, and the suppliers included here are those that are closest to having product dossiers ready for stringent regulatory approval and/or WHO pre-qualification; any suppliers who are committed to developing these products to the same standards will also receive support.

CHAI’s contribution was made possible through the generous support of UNITAID and the UK Department for International Development.

Clinton Health Access Initiative, Inc.

The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to strengthening integrated health systems and expanding access to care and treatment in the developing world. CHAI’s solution-oriented approach focuses on improving market dynamics for medicines and diagnostics; lowering prices for treatment; accelerating access to life-saving technologies; and helping governments build the capacity required for high-quality care and treatment programs. For more information, please visit clintonhealthaccess.org and connect with us on Facebook and Twitter.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook and Twitter.

UNITAID

UNITAID is an international organization founded in 2006 that finds new ways with partners to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria more quickly, more cheaply and more effectively. Its investments help turn groundbreaking ideas into effective solutions that enable partners to achieve the highest impact for those in need. Learn more at www.unitaid.org

New guidelines are a major step towards achieving UNAIDS Fast-Track Targets

GENEVA, 30 November 2015—UNAIDS has welcomed the release by the World Health Organization (WHO) of new guidelines on the use of antiretroviral medicines as a significant step towards improving the lives of people living with HIV and reducing the transmission of the virus.

The guidelines recommend that antiretroviral medicines be prescribed to people as soon as possible after their HIV diagnosis regardless of their CD4 count (CD4 is a measure of immune system health).The guidelines also recommend that people at higher risk of HIV infection be given access to pre-exposure prophylaxis (PrEP) as part of a combined HIV prevention strategy.

“These new guidelines and recommendations are a highly significant moment in the AIDS response,” said Michel Sidibé, Executive Director of UNAIDS. “The medicines and scientific tools now at our disposal provide us with a real opportunity to save millions of lives over the coming years and to end the AIDS epidemic by 2030.”

The WHO guidelines, produced with the support of UNAIDS, are being released following the increased weight of research evidence that has emerged over the past 12 months. This included data from the international randomized clinical trials Temprano and START (Strategic Timing of Antiretroviral Treatment), which found compelling evidence of the benefits of immediately starting antiretroviral therapy. The data from Temprano and START followed a series of research findings over several years demonstrating the health benefits of starting HIV treatment earlier.

Several research studies among groups at higher risk of HIV infection have also indicated the significant efficacy of PrEP in reducing new HIV infections. The new guidelines recommend that PrEP be offered to anybody at substantial risk of HIV exposure.            

The guidelines will also help reinforce the UNAIDS Fast-Track approach, which encompasses a set of targets to be reached by 2020. The targets include 90% of all people living with HIV knowing their HIV status, 90% of people who know their HIV-positive status having access to treatment and 90% of people on treatment having suppressed viral loads. They also include reducing new HIV infections by 75% and achieving zero discrimination.

“We are at a crossroads in the response to AIDS,” said Mr Sidibé. “We know what works – now we need to put people first and fully respect their right to health.”

UNAIDS reaffirms the importance of respecting a person’s right to know their HIV status and to decide whether and when to begin antiretroviral therapy. HIV prevention and treatment decisions must be well-informed and voluntary. Wider and more equitable delivery of antiretroviral therapy and PrEP will require increased efforts to address the social and legal barriers that inhibit access to health services for people living with HIV and for key populations at higher risk of infection. 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

GENEVA/HARARE, 29 November 2015—At the opening of the 18th International Conference on AIDS and STIs in Africa (ICASA), taking place from 29 November to 4 December in Harare, Zimbabwe, UNAIDS has urged countries to further accelerate their response to HIV. The biennial conference is taking place at a defining moment in the response to the epidemic.

“Africa is on the brink of breaking the AIDS epidemic,” said UNAIDS Executive Director Michel Sidibé at the opening ceremony of the conference. “We have no time to lose. We have five years to Fast-Track the AIDS response so that the epidemic can’t rebound.”

UNAIDS is hosting several special sessions at ICASA, including one to discuss its new Fast-Track Strategy. Fast-Track involves front-loading investments in the AIDS response to reach an ambitious 90—90—90 treatment target by 2020. Reaching this target would see 90% of people living with HIV knowing their HIV status, 90% of people who know their HIV-positive status accessing treatment and 90% of people on treatment having suppressed viral loads. Reaching the Fast-Track Targets will also reduce new HIV infections by 75% and realize the vision of zero discrimination. The Fast-Track Strategy will see resources concentrated in locations with the greatest need and among populations at higher risk of HIV.

Other sessions organized by UNAIDS at ICASA include sessions on AIDS in emergency, conflict and humanitarian contexts and on optimizing the prevention of mother-to-child transmission of HIV through community engagement and mobilization.

The conference is taking place against a backdrop of great progress in the response to HIV, even though many challenges remain. Worldwide, 15.8 million people now have access to life-saving antiretroviral medicines, with more than 10 million people in sub-Saharan Africa accessing treatment. Based on the increased weight of scientific evidence concerning earlier treatment, the World Health Organization has released new guidance recommending that people be offered access to antiretroviral medicines as soon as possible after their HIV diagnosis regardless of their CD4 count.

In sub-Saharan Africa, the number of AIDS-related deaths in 2014 was 48% lower than in 2005, while new infections have declined by 41% since 2000. Scaled-up access to antiretroviral medicines in 21 high-priority countries has resulted in a fall of 48% between 2009 and 2014 in the number of children becoming infected with HIV. A number of countries including Ethiopia, Mozambique, Namibia, South Africa, Swaziland, Uganda and the United Republic of Tanzania have experienced declines of more than 60% in the number of children becoming infected with HIV.

However, major challenges still remain across the continent. The same progress is not being seen among young women and adolescent girls, for example, with young women aged 15-19 years old accounting for 71% of new HIV infections among this age group in sub-Saharan Africa.

In 2014, there were 36.9 million people living with HIV globally, 25.8 million of whom lived in sub-Saharan Africa. 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

During a high-level event on 30 October on the sidelines of the Third India-Africa Forum Summit 2015 in New Delhi, India, leaders from India, the African Union, several African nations and major Indian pharmaceutical companies pledged to address existing and emerging challenges to health commodity security in Africa.

The Indian pharmaceutical industry produces low-cost generic medicines that have been instrumental in scaling up access to HIV treatment in developing countries. The low price of generic first-line regimens is one of the factors that have contributed to the milestone achievement of providing access to life-saving antiretroviral therapy to more than 15 million people around the world.

Of the 36.9 million people living with HIV in 2014, around 25.8 million live in sub-Saharan Africa. By mid-2015, 11.4 million people living with HIV in sub-Saharan Africa had access to treatment. The achievement builds momentum for ending the AIDS epidemic as a public health threat by 2030.

However, despite the progress made so far, the price of second- and third-line medicines and diagnostics continues to be a barrier to HIV treatment access. One of the actions that will improve the situation is ensuring that pharmaceutical innovations are available, affordable and accessible to all.

As part of the Pharmaceutical Manufacturing Plan for Africa, African Union member states are taking steps to develop the local pharmaceutical sector on the African continent to enable Africa to manufacture a sustainable supply of high quality and affordable essential medicines. The development of the pharmaceutical industry will contribute to better public health outcomes and economic growth across the continent. An African and international consortium of partners that includes UNAIDS is supporting the local production of medicines.

Kenya, South Africa, Uganda and Zimbabwe are already producing World Health Organization pre-qualified antiretroviral medicines, with other countries planning to start production. 

NEW YORK/GENEVA, 24 September 2015—As world leaders gather in New York to commit to the Sustainable Development Goals, including ambitious public health targets, UNAIDS has called on governments and the pharmaceutical industry to ensure that medicines remain accessible to all.

Dramatic increases in the prices of some medicines are raising concerns about their continued availability to patients as well as about the wider effects on public health.

“As world leaders commit to new public health targets as part of the Sustainable Development Goals, governments and the private sector have a responsibility to ensure that medicines remain accessible to everybody,” said UNAIDS Executive Director Michel Sidibé. “The AIDS response is proof that access to affordable and effective medicines can halt and reverse an epidemic.” 

Generic competition in the pharmaceutical industry, fostered by the use of intellectual property flexibilities, has helped make prices for life-saving medicines much more affordable over the past 15 years and allowed the massive scale-up of HIV treatment programmes. More than 15 million people are today accessing life-saving antiretroviral medicines, compared with fewer than 700 000 people in 2000.

UNAIDS has set a new 90–90–90 treatment target for 2020 with the aim of ending AIDS as a public health threat by 2030. Countries around the world are adopting the 90–90–90 treatment target, whereby 90% of people living with HIV know their HIV status, 90% of people who know their HIV status are accessing treatment and 90% of people on treatment have suppressed viral loads.

“Everyone has the right to health, no matter where they are born or who they are,” added Mr Sidibé. 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

Leading HIV researchers describing results from multiple clinical trials in sub-Saharan Africa report that innovative service delivery models are achieving results across the HIV treatment cascade that approach or exceed the 90–90–90 target.

Study results were presented at an all-day workshop hosted by the British Columbia Centre for Excellence in HIV/AIDS and the Division of AIDS at the University of British Columbia, prior to the opening of the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, Canada. The studies are being undertaken in a number of high-burden countries in sub-Saharan Africa, including Botswana, Kenya, Malawi, South Africa, Swaziland, Uganda and Zambia.

“These exceptional clinical trial results show yet again how innovation is driving progress in the AIDS response,” said UNAIDS Executive Director Michel Sidibé. “The results demonstrate that the 90–90–90 target is more than a dream. It is entirely feasible.”

Diane Havlir, of the University of California, San Francisco, presented interim results from the Sustainable East Africa Research for Community Health (SEARCH) trial in more than 30 rural communities in Kenya and Uganda. Having enrolled more than 334 000 people, the SEARCH trial is evaluating a multicomponent programme, including use of community-centred, multidisease campaigns to provide HIV testing and link HIV-positive individuals to immediate initiation of antiretroviral therapy.

At a population level, the SEARCH programme has achieved 90% knowledge of HIV status. Among participants living with HIV, more than 90% of people in Uganda and 83% in Kenya are receiving antiretroviral therapy. At 24 weeks, 92% of trial participants who have initiated antiretroviral therapy have achieved viral suppression.

Similarly encouraging, although preliminary, results were reported from the PopART trial by Richard Hayes of the London School of Hygiene and Tropical Medicine. Working in 21 communities, the trial is evaluating a combination HIV prevention package that includes repeated rounds of community-level HIV testing and immediate initiation of antiretroviral therapy for all people who are diagnosed HIV-positive. Among more than 115 000 community members enumerated in the trial, 90% of all men living with HIV and 92% of all women living with HIV were aware of their HIV status following the PopART programme. Among people with an HIV diagnosis, 62% of men and 65% of women were receiving antiretroviral therapy, highlighting the need to further strengthen linkage to care for people living with HIV. Data on rates of viral suppression among PopART participations will be available next year.

Max Essex, of the Harvard University School of Public Health, presented baseline findings for the Botswana Combination Prevention Protocol. Mr Essex and his colleagues have found that 79% of all people living with HIV in Botswana knew their HIV status as of mid-2015, 86% of adults who have been diagnosed with HIV were receiving antiretroviral therapy and 96% of people receiving antiretroviral therapy had achieved viral suppression.

Comparably impressive results have been achieved by a Médicins Sans Frontières (MSF) programme in the District of Chiradzulu in Malawi, according to David Maman of MSF. In Chiradzulu, 77% of all people living with HIV know their HIV status, 84% of people with an HIV diagnosis are receiving antiretroviral therapy and 91% of people receiving antiretroviral therapy have achieved viral suppression.

François Dabis, of the Bordeaux School of Public Health, described preliminary results from a separate trial in the Hlabisa district in KwaZulu-Natal, South Africa, of a test-and-treat initiative that includes six-month rounds of community-level testing and establishment of antiretroviral treatment sites in all communities in the study. Among more than 26 000 people in the study communities, 85% know their HIV status. Among HIV-diagnosed people reached by the programme, 86% are receiving antiretroviral therapy. Study results indicate that linkage to care remains suboptimal and an important focus of further work and innovation.

Several important themes emerged from these study findings. Researchers emphasized the importance and value of engaging and collaborating with local communities in developing programme approaches tailored to local needs and circumstances. Most of the studies have also taken multidisciplinary approaches to the development, monitoring and evaluation of programmes, involving social scientists, economists and community representatives as well as clinicians and biostatisticians.