Providing an antiretroviral regimen of dolutegravir, tenofovir and lamivudine to all adults living with HIV in sub-Saharan Africa, regardless of viral suppression or plans to have children, would prevent more ill health than policies which restricted use of the regimen in women of childbearing potential or people with suppressed viral load, a modelling study published in The Lancet HIV shows. Moreover, it would be cost saving.
Antiretroviral treatment based on the integrase inhibitor dolutegravir is recommended by the World Health Organization as the preferred option for first-line treatment of all adults in low- and middle-income countries. Dolutegravir is recommended because the drug has few side-effects, is highly potent and has a high barrier to the development of resistance mutations if viral load should rebound.
Another important reason for recommending dolutegravir is that the drug is available in a low-cost generic form in many lower-income countries as result of a licensing agreement between the Medicines Patent Pool and the drug’s developer ViiV Healthcare. The Medicines Patent Pool has licensed dolutegravir to several manufacturers of generic antiretroviral products for incorporation into fixed-dose combination tablets with tenofovir DF and lamivudine.
In September 2017 the Bill and Melinda Gates Foundation announced that it will guarantee minimum sales volumes to two Indian manufacturers, Aurobindo and Mylan Laboratories, for a combination of dolutegravir, tenofovir and lamivudine sold at a cost of $75 a year to ministries of health and public-sector purchasers. The combination is available at this price in 92 countries. Many countries in sub-Saharan Africa have been making plans to introduce dolutegravir and lamivudine as a universal first-line regimen, simplifying the delivery of treatment.
But despite the recommendations and the improved affordability of dolutegravir, there is still uncertainty over how best to make the drug available in some countries.