People living with HIV/Aids in Kenya and South Africa will soon benefit from the first affordable, generic, single-pill HIV treatment regimen containing dolutegravir (DTG) at a cost of Sh7, 500 per person, per year.
This follows an agreement signed by the Governments of Kenya and South Africa as well as the Bill and Melinda Gates Foundation, the Global Fund, Unitaid and The Joint United Nations Programme on HIV/Aids (UNAIDS). Other key partners in the initiative are the Clinton Health Access Initiative (CHAI), the UK’s Department for International Development (DFID), the US President’s Emergency Plan for Aids Relief (PEPFAR) and USAID.
This one pill, once-a-day generic fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) was developed by Mylan Laboratories and Aurobindo Pharma under licensing agreements from ViiV Healthcare, the original developer of DTG. The two generic medicine manufacturers – Mylan Laboratories and Aurobindo Pharma – are both based in India.
DTG – the newest of the three drugs – is an integrase inhibitor that avoids the drug resistance that often develops with older treatments. DGT is widely used in developed countries and is recommended by the World Health Organisation (WHO) as an alternative first-line HIV regimen.
It also a preferred treatment by the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, among 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. The agreement is expected to accelerate treatment roll-out 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. The UNAIDS Executive Director Michel Sidibe says: “This agreement will improve the quality of life for millions of people living with HIV… “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 said they (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,” said Dr Tedros.
“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.” Mylan and Aurobindo both recently received tentative approval from the US 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. Kenya’s Cabinet Secretary for Health, Dr Cleopa Mailu said: “In the antiretroviral therapy guidelines launched in July 2016, the Ministry of Health made provisions for use of newer antiretroviral medicines such as dolutegravir…
“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 Programme.” His South African counterpart, Dr Aaron Motsoaledi noted: “I am excited about this innovative agreement which will allow the government of South Africa to accelerate the introduction of the dolutegravir-based fixeddose combination which will greatly benefit our patients due to its superior therapeutic qualities…
“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.” The interim Global Fund Executive Director Marijke Wijnroks observed: “The Global Fund is excited to be part of this great initiative that will help us save more lives…
“As we strive to end HIV as an epidemic, we are committed to supporting people affected by diseases to access better products.” According to the press release, 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.
Stated BMGF CEO Sue DesmondHellman: “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… “This unprecedented new partnership – the largest of its kind ever seen in global health – will transform millions of lives by making a highlyeffective drug more affordable to countries with the largest numbers of people living with HIV.
The Bill and 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 programme managers, the press release says, 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. The press release says that to build momentum for TLD and familiarise 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 Executive Director Lelio Marmora observes: “Unitaid’s investments have laid the foundation for the ground-breaking introduction of TLD at an affordable price…
“Through our catalytic work we are overcoming barriers, thereby enabling countries like Kenya to access the latest HIV treatments on the market.” The CHAI chief executive Ira Magaziner adds: “This ground-breaking 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…
“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.”