Geneva / Johannesburg – A highly effective oral medication to prevent HIV will be provided to young women in South Africa at high risk of getting the virus, as part of a sexual and reproductive health access project launched today by the Wits Reproductive Health and HIV Institute (Wits RHI) and Unitaid.
Working closely with the South African Department of Health, the US$10.6 million project will deliver comprehensive services, including medication known as pre-exposure prophylaxis (PrEP) to 6,640 adolescent girls and young women aged 15 to 24 in priority areas of South Africa.
PrEP is a one-pill-daily antiretroviral treatment that can reduce the risk of HIV infection from sex more than 90 percent, according to the US Centers for Disease Control and Prevention.
While South Africa has the world’s largest HIV treatment programme, it has not been as successful in preventing new infections.
Professor Helen Rees, Executive Director of Wits RHI said: “New HIV prevention technologies could make a major difference to the trajectory of the HIV epidemic. If we have new tools, even if they are partially effective, we must consider introducing them into the public sector if we want to stop new infections.”
“This project will help to fill a gap in the global evidence base for how real-life PrEP delivery can be carried out in the context of comprehensive health services for adolescent girls and young women,” said Dr Saiqa Mullick, Director of Implementation Science at Wits RHI, who will lead the project in close collaboration with the Department of Health.
In South Africa approximately 1,745 new HIV infections occur in young women in their early 20s every week, and they have a four-fold increased risk of contracting HIV compared with their male peers. One third of South African teenage girls become pregnant before the age of 20.Starting January 2018, the three-year project will be integrated into the National Department of Health’s She Conquers campaign, which works with adolescent women and young girls to reduce HIV incidence, gender-based violence, teenage pregnancy, school drop-out rates and youth unemployment, with a focus on prioritized districts.
The project will develop, implement and test various strategies to reach the adolescent girls and women who are at high risk of contracting HIV, create demand for and improve linkages to services; and support retention in care and adherence.
“Unitaid’s longer-term objective is to lay the groundwork for wider adoption of PrEP in high-risk groups,” said Lelio Marmora, Unitaid’s Executive Director. “At scale, this project is expected to avert 3,000 HIV infections a year and save nearly US$ 20 million, the difference between the cost of PrEP and that of adhering to HIV treatment for a lifetime.”
Adolescent girls and young women are a priority, high-risk population, particularly in East and Southern Africa, but few programmes have been implemented for them on a large scale, and many questions remain about how to reach young women to initiate and sustain HIV prevention options.
Unitaid seeks information on health products to tackle opportunistic infections in people living with HIV
Unitaid today issued a call to manufacturers and suppliers worldwide to provide information on health products to tackle opportunistic infections in people living with HIV.
The announcement follows the decision by Unitaid’s Executive Board this past June to support improved access to health products for people with advanced HIV disease, those co-infected with HIV and hepatitis, as well as people co-infected with HIV and the human papillomavirus (HPV), the most common sexually transmitted infection and cause of cervical cancer in women.
Opportunistic infections are infections that occur more frequently and are more severe in individuals with weakened immune systems, including people living with HIV. The most frequent ones are tuberculosis, pneumonia, severe bacterial infection, toxoplasmosis, and cryptococcal meningitis.
Unitaid is considering investing in ways to overcome market barriers that limit access to the best tools for effectively managing opportunistic infections among people with advanced HIV disease.
“Unitaid is essentially exploring ways to unlock access to important health products in low- and middle-income countries to protect people living with HIV from opportunistic infections,” said Dr Philippe Duneton, Unitaid Deputy Executive Director, speaking on the opening day of the 19th International Conference on AIDS and STIs in Africa (ICASA) in Abidjan.
The Request for Information (RFI) issued today calls on interested manufacturers and suppliers to submit information on their diagnosis, prevention and treatment products that are either commercially available or in the pipeline.
Download Request for Information forms: [PDF, 50 KB]
Contact
For more information on the RFI, please contact Ademola Osigbesan at Unitaid, osigbesana@unitaid.who.int
Preventing HIV infections in high-risk groups
CHAI seeks generic manufacturer for paediatric HIV drug dolutegravir
The Clinton Health Access Initiative (CHAI) today announced a request for proposals to select a generic manufacturer that could develop a paediatric version of the antiretroviral drug dolutegravir (DTG).
CHAI is working under the Unitaid-funded project “Accelerating patient access to optimal antiretrovirals” to make optimal antiretroviral (ARV) therapies more affordable and more accessible in low- and middle-income countries. In 2015, the World Health Organization recommended dolutegravir as an alternative first-line treatment for adults and adolescents. It has become the drug of choice for people living with HIV in high-income countries.
Dolutegravir has significant benefits compared to other anti-HIV medications currently available. It has few side effects and is taken just once daily, so patients are likely to stick with their regimens. The drug is effective against HIV even when the virus mutates, so the virus is unlikely to develop to develop resistance.
These attributes make DTG an optimal ARV that can significantly improve treatment for a large number of children in poorer countries. ViiV Healthcare, the originator company for DTG, is collaborating in the project to speed the development of DTG for paediatric populations in low- and middle-income countries. Children living with HIV in such countries currently have very limited optimal treatment options, and the highly effective DTG can offer a significant improvement for children over current options.
To start the paediatric DTG development programme, CHAI will undergo a competitive selection process to identify a partner or partners that manufacture generics. The Request for Proposals (RfP) is open to those companies that have either a direct license from ViiV Healthcare or have a license for paediatric DTG from the Medicines Patent Pool (MPP).
Increasing access and scale up of quality assured health products
New high-quality antiretroviral therapy to be launched in South Africa, Kenya and over 90 low- and middle-income countries at reduced price
Negotiated pricing agreements have lowered costs and will improve access to quality treatment for people living with HIV
New York – A breakthrough pricing agreement has been announced which will accelerate the availability of the first affordable, generic, single-pill HIV treatment regimen containing dolutegravir (DTG) to public sector purchasers in low- and middle-income countries (LMICs) at around US$75 per person, per year. The agreement is expected to accelerate treatment rollout as part of global efforts to reach all 36.7 million people living with HIV with high-quality antiretroviral therapy. UNAIDS estimates that in 2016, just over half (19.5 million) of all people living with HIV had access to the lifesaving medicines.
DTG, a best-in-class integrase inhibitor, is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line HIV regimen, as well as a preferred treatment by the U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescentsamong many others. In addition to improving treatment quality and retention, widespread use of DTG is expected to lower the cost of first-line HIV treatment regimens while also reducing the need for more expensive second- and third-line regimens. In July 2017, WHO issued guidance to countries on how to safely and rapidly transition to DTG-based antiretroviral treatment.
This agreement, announced by the governments of South Africa and Kenya, together with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the Bill & Melinda Gates Foundation (BMGF), Unitaid, the United Kingdom’s Department for International Development (DFID), the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, with Mylan Laboratories Limited and Aurobindo Pharma, takes an important step toward ensuring the availability of worldwide high-quality treatment for HIV.
“This agreement will improve the quality of life for millions of people living with HIV,” said UNAIDS Executive Director Michel Sidibé. “To achieve the 90-90-90 treatment targets, newer, affordable and effective treatment options must be made available—from Baltimore to Bamako—without any delay.”
WHO Director-General, Dr. Tedros Adhanom stated, “WHO welcomes this agreement which will make it possible to reach millions of people with better, more affordable and durable HIV drugs. This will save lives for the most vulnerable, bringing the world closer to the elimination of HIV. We congratulate South Africa, Kenya, CHAI and others on this landmark agreement. WHO will support countries in the safe introduction and a swift transition to this game-changing new treatment.”
This one pill, once-a-day generic fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) was developed by Mylan and Aurobindo under licensing agreements from ViiV Healthcare, the original developer of DTG. Mylan and Aurobindo both recently received tentative approval from the U.S. Food and Drug Administration (FDA) for their products under the United States PEPFAR program. Clinical studies demonstrated that treatment regimens that use DTG result in more rapid suppression of viral load, fewer side effects, and greater potency against drug resistance than current regimens used in LMICs.
“I am excited about this innovative agreement which will allow the government of South Africa to accelerate the introduction of the dolutegravir-based fixed-dose combination which will greatly benefit our patients due to its superior therapeutic qualities,” said Minister of Health of South Africa Dr. Aaron Motsoaledi. “The considerable price reductions could yield savings of up to US$900 million over the next six years for us, which means that we can initiate additional patients on treatment with the same amount of resources. Ramping up treatment with good viral suppression will enable us to reach HIV epidemic control more quickly. We are aiming at launching the new tender in April 2018.”
“In the antiretroviral therapy guidelines launched in July 2016, the Ministry of Health made provisions for use of newer antiretroviral medicines such as dolutegravir,” said Dr. Cleopa Mailu, Cabinet Secretary of Health in Kenya. “Research has shown that dolutegravir offers better tolerability, fewer adverse drug reactions, fewer drug interactions, and higher genetic barrier to resistance. It is with this in mind that, in July this year, Kenya approved its inclusion in the National ART Program.”
“The Global Fund is excited to be part of this great initiative that will help us save more lives,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “As we strive to end HIV as an epidemic, we are committed to supporting people affected by diseases to access better products.”
The BMGF, with the support of CHAI, recently completed ceiling price agreements with Mylan and Aurobindo with the goal of accelerating the availability of the new fixed-dose combination to the public sector in over 90 LMICs at reduced pricing. The agreements, which set an upper price limit for TLD, are by some estimates expected to save public sector purchasers over US$1 billion over the next six years.
“As a doctor with deep, personal experience of the heartache and despair caused by HIV and AIDS, I’m excited by the prospect of bringing better treatment to more people than ever before,” stated BMGF CEO Sue Desmond-Hellmann. “This unprecedented new partnership – the largest of its kind ever seen in
global health – will transform millions of lives by making a highly-effective drug more affordable to countries with the largest numbers of people living with HIV. The Bill & Melinda Gates Foundation is uniquely placed to help in this endeavor – and I’m delighted that our investment will give millions more people a shot at leading a healthy, productive life.”
Ministries of Health and program managers should anticipate being able to order TLD in 2018 at around a projected average price of US$75 per patient, per year. Further pricing details are available upon request to Mylan or Aurobindo. The ceiling price agreements apply to purchases for public sector use in all 92 countries covered under ViiV Healthcare’s dolutegravir licensing agreement, representing over 90 percent of people in LMICs currently living with HIV.
To build momentum for TLD and familiarize healthcare workers with the drug in resource-limited settings, Unitaid partnered with CHAI beginning in late 2016 to make generic DTG single tablets available in three early adopter countries: Kenya, Nigeria, and Uganda. Partnering with WHO, USAID, and the Ministries of Health, this innovative initiative is giving countries an opportunity to improve treatment offerings for their patients while also generating critical evidence on the use of DTG in certain populations, including pregnant women and tuberculosis (TB) co-infected patients.
“Unitaid’s investments have laid the foundation for the ground-breaking introduction of TLD at an affordable price,” said Lelio Marmora, Unitaid’s Executive Director. “Through our catalytic work we are overcoming barriers, thereby enabling countries like Kenya to access the latest HIV treatments on the market.”
“This groundbreaking agreement will help improve the lives of millions of patients by reducing costs and increasing availability of a one pill, once daily fixed-dose-combination including dolutegravir,” stated Ira Magaziner, CEO of CHAI. “This drug combination is better tolerated and more effective and will lead to improved health outcomes by ensuring that fewer HIV patients develop drug resistance and that more remain on treatment.”
In June the Government of Kenya and Unitaid announced the introduction of a new first-line drug for people living with HIV, making Kenya the first African country to introduce the generic version of this new drug for routine use. Read more
About 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.
About the Clinton Health Access Initiative
Founded in 2002, by President William J. Clinton and Ira C. Magaziner, the Clinton Health Access Initiative, Inc. (“CHAI”) is a global health organization committed to saving lives, reducing the burden of disease and strengthening integrated health systems in the developing world. Learn more at www.clintonhealthaccess.org
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
About Unitaid
Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps set the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund.
About the Global Fund
The Global Fund is a 21st-century partnership designed to accelerate the end of AIDS, tuberculosis and malaria as epidemics. As a partnership between governments, civil society, the private sector and people affected by the diseases, the Global Fund mobilizes and invests nearly US$4 billion a year to support programs run by local experts in more than 100 countries. The Global Fund’s operating costs are approximately 2 percent of grants under management, reflecting an exceptionally high degree of efficiency. By challenging barriers and embracing innovative approaches, we are working together to better serve people affected by the diseases.
About USAID
USAID is a key implementing agency of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and is responsible for over half of all PEPFAR programs with activities focused in 35 priority countries and regions, mainly in sub-Saharan Africa and Asia. For more information, please visit: www.usaid.gov
Leaders say action targeting women, children and adolescents key to meeting health SDG
New York – Over the next twelve years, the world will face an enormous challenge to ensure health for women, children and adolescents while seeking to achieve the Sustainable Development Goals (SDGs).
We therefore call on Heads of State and Government to put reproductive, maternal, newborn, child and adolescent health at the core of efforts to accelerate the global response against HIV/AIDS, tuberculosis, and malaria and to reach ambitious global health goals by 2030.
Based on successful strategies and experiences, we invite countries to attain our shared commitments by:
Reducing inequities among populations and promoting health as a fundamental human right;
Increasing investments in innovative approaches to achieve SDG 3, and its associated targets, that help to ensure healthy lives and promote well-being for everyone at all ages;
Creating and improving innovative financing mechanisms for health;
Accelerating access to innovative health products, quality health services and adequate support for most vulnerable populations, particularly women, children and adolescents.
Strengthening the coordination of the global health response and the collaboration between health stakeholders at global, regional and country level;
Ensuring predictable and sustainable global and domestic funding to intensify the global response by aiming to meet a target of committing 0.7% of developed countries’ gross national income to official development assistance.
Meeting the challenge of achieving the SDGs and ensuring the health of women, children and adolescents is a crucial step towards bringing about healthy and robust economies, politically stable societies and resilient communities. The health of women, children and adolescents is critically important to virtually every area of human development and progress, and directly affects the success of the international community in accordance with global commitments.
H.E. Ms Michelle Bachelet H.E. Mr Celso Amorim
President of Chile Chair of the Executive Board of Unitaid
Signed on the occasion of the High-level Breakfast held on 21 September 2017 during 72nd session of the United Nations General Assembly in New York
These tools were developed in line with the World Health Organization’s 2016 guidelines, which include a number of ARV medications that are more effective, tolerable and affordable than standard regimens. They are expected to help accelerate access to the best available treatment options for those who need them most and support significant scale-up of treatment, thereby saving money, and achieving public health goals.
The toolkit and guide include a wide range of information, tools, and resources about introducing new products. Topics include product adoption, forecasting, procurement, facility phase-in, and supply planning and monitoring. Together, these guides provide a comprehensive overview of key considerations for adopting and rolling out new HIV products. They also provide resources to support implementation.
The toolkit and guide are made available at a pivotal time for introducing optimal ARVs to millions of patients around the world.
Accelerating access to new, optimal, and cost-effective antiretroviral drugs is central to Unitaid’s strategy in reaching the fast-track “90-90-90” targets by 2020.
