A new HIV program was recently signed to provide access to affordable HIV medication in low-income regions, but budget cuts by the Trump administration could delay implementation.
The pricing arrangement gives hope to millions of people around the world living with HIV in low-income countries.
Through the use of sales-volume guarantees, the partners of the agreement have managed to negotiate a production and sales package that will see the price tag of the treatment capped at around USD75 per patient per year, a massive cut down from what is today an average of over USD1,000.
The agreement is signed by the governments of South Africa and Kenya, 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 US President’s Emergency Plan for AIDS Relief (PEPFAR), the US Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as drug developers Mylan Laboratories Limited and Aurobindo Pharma.
According to the South African government, the lower costs will save around USD900 million over the next six years, which will allow to extend assistance to many more people.
The treatment consists of a one pill, once-a-day generic fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir, (TLD) a state-of-the-art treatment widely used in western countries, which is considered more effective and tolerable than conventional antiretroviral drugs.
Mylan and Aurobindo produce the drug under licensing agreements from ViiV Healthcare, the patent holder and developer of DTG.
The agreement was reached with the producers, both based in India, after the BMGF and the CHAI agreed on a multimillion-dollar guarantee of sales volume.
This allowed for a massive reduction in price, although no other financial details were made available.
It applies to any public sector purchases within the 92 countries covered by ViiV Healthcare’s dolutegravir licensing agreement, where over 90% of the people suffering with HIV in low and middle income countries reside.
The roll-out will begin in Africa.
In 2016, BMGF and CHAI started a pilot project using the TLD drug in Kenya, Nigeria, and Uganda to familiarize healthcare professionals with the drug and try out the plan on a smaller scale.
One of the challenges of rolling out such a program involving a new drug is the possibility of resistance developing among patients.
The roll-out of such a wide-reaching program involving a new drug is particularly relevant in the context of preventing the building up of drug resistance among patients.
There are, however, fears that the viability of the program might be threatened due to possible budget cuts for PEPFAR by US president Donald Trump.
As with many other international cooperative efforts, the US administration sees their contributions as disproportionately high.
A proposal to slash 17% of the program’s budget, from USD4.6 billion to USD3.8 billion, has been rejected by both the House and the Senate Appropriations Committees, but it is possible that new attempts at budget cuts be made in the future.
Coincidentally, the announcement of the program comes only weeks after HIV lost the first place in the list of Africa’s biggest killers. Between 2012 and 2015, African people being killed by HIV-related complications decreased from 1.1 million to 760,000 per year, mostly due to aid programs and extensive awareness and prevention packages.
Today, lower respiratory tract infections, such as bronchitis and pneumonia, have taken the first place in this grim ranking, responsible for the loss of the lives of around 1 million Africans every year.
While some of this makes for hopeful reading, around 37 million people are still infected with the HIV virus around the world, with only about half having access to anti-retroviral treatments.
