1980s: The first antiretroviral
The first medical report on AIDS was published in June 1981, and researchers discovered that HIV was the cause of AIDS in 1983. It would be four more years before the Food and Drug Administration (FDA) approved the first antiretroviral drug, the nucleoside reverse transcriptase inhibitor Retrovir (AZT, or zidovudine), in 1987.
1990s: Mixed cocktails
The FDA implemented an accelerated approval process for experimental drugs in 1992. In the early 1990s, three more nucleoside reverse transcriptase inhibitors were approved, but it became clear that using drugs one at a time led to resistance. The FDA approved the first protease inhibitor, Invirase (saquinavir), in 1995, and the first nucleoside/nucleotide reverse transcriptase inhibitor (NNRTI), Viramune (nelfinavir), in 1996, ushering in the era of effective combination therapy.
2000s: Refined Regimes
Early HIV medications were difficult to take, often involving multiple pills and unexpected side effects, which spurred efforts to develop more convenient and better-tolerated regimens. In 2001, the FDA approved Viread (tenofovir disoproxil fumarate, or TDF), the first nucleotide reverse transcriptase inhibitor. The first single-tablet regimen, Atripla (efavirenz/TDF/emtricitabine), received approval in 2006, allowing many people to take a single pill once a day. And in 2007, the FDA approved the first integrase inhibitor, Isentress (raltegravir).
2010s: More options and the dawn of PrEP
A growing body of evidence showed that effective antiretroviral therapy could not only halt the progression of the disease but also prevent HIV transmission. In 2012, federal guidelines recommended HIV treatment for all people diagnosed with HIV, regardless of their CD4 count. In July of that year, the FDA approved Truvada (TDF/emtricitabine) for pre-exposure prophylaxis (PrEP).
2020s: New Innovations
In 2020, the FDA approved the first HIV adherence inhibitor, Rukobia (fostemsavir). In 2021, the agency approved the first complete long-acting injectable treatment regimen, Cabenuva (cabotegravir and rilpivirine), followed later that year by Apretude long-acting injections (cabotegravir alone) for PrEP. More recently, in late 2022, the FDA approved the first HIV capsid inhibitor, Sunlenca (lenacapavir), an injection given once every six months to people with multidrug-resistant HIV.