How can we achieve universal access to low-cost treatment for HIV?

Mass production of low-cost antiretrovirals (ARVs) has already allowed over 17 million individuals to access treatment for HIV infection, mainly in low-income countries. It is possible to manufacture combination ARVs for $110 per person-year, using tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV). New combinations of ARVs costing as little as $60 per person-year will be available in the near future. Pre-exposure prophylaxis using TDF in combination with either 3TC or emtricitabine (FTC) could also be provided for less than $90 per person-year. Voluntary licensing allows people in the poorest countries to access new ARVs at prices close to manufacturing costs. Patents on several key ARVs will expire by 2018 and should allow worldwide access to high-quality, low-cost triple combination therapy, such as TDF/3TC/EFV. Several protease inhibitors will also become available as generics by 2018. However, ongoing patent restrictions will lead to sustained high prices for the most recently developed ARVs in most middle- and high-income countries. These include the nucleotide tenofovir alafenamide, the integrase strand inhibitor dolutegravir and several single combination tablet regimens. We suggest that as patents for ARVs expire, health authorities first need to rapidly import and introduce generic versions of drugs such as abacavir, 3TC, EFV and TDF. Once these low prices have been established for these generics, cost-effectiveness of patented ARVs needs to be re-evaluated. It may no longer be justified to pay high prices for these drugs. A strategy of low-cost generic ARVs for most people, with higher-cost patented alternatives used as switch options, could allow for an increased number of people to receive ARVs in the context of fixed health budgets.