1980s: The First Antiretroviral
The first medical report of 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 medication, the nucleoside reverse transcriptase inhibitor Retrovir (AZT, or zidovudine), in 1987.
1990s: Combination Cocktails
The FDA implemented an accelerated approval process for experimental drugs in 1992. Three more nucleoside reverse transcriptase inhibitors were approved in the early 1990s, 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 Regimens
Early HIV meds were difficult to take—often involving multiple pills and unexpected side effects—spurring 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), got the nod in 2006, enabling many people to take just one pill once daily. 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 disease progression but also prevent HIV transmission. In 2012, federal guidelines recommended HIV treatment for everyone 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 attachment 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 long-acting Apretude injections (cabotegravir alone) for PrEP. Most recently, in late 2022, the FDA gave the green light to the first HIV capsid inhibitor, Sunlenca (lenacapavir), an injection administered once every six months for people with multidrug-resistant HIV.
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