What Happened to Antiretroviral Therapy (ART)?
Antiretroviral Therapy (ART) has revolutionized the management of HIV, transforming it from a rapidly fatal disease into a chronic, manageable condition. Initially involving complex daily pill regimens, ART has evolved significantly, with 2026 seeing major advancements in long-acting injectable and once-weekly oral formulations, alongside ongoing research into HIV cure strategies and expanded access to prevention methods like PrEP.
Quick Answer
Antiretroviral Therapy (ART) has dramatically improved the lives of people with HIV, allowing them to live long, healthy lives by suppressing the virus to undetectable levels. As of 2026, the field is rapidly advancing towards less frequent dosing, with once-weekly oral regimens and twice-yearly injectable treatments showing promising results in clinical trials. Global efforts are also focused on expanding access to these innovative therapies and to pre-exposure prophylaxis (PrEP), though challenges in funding and equitable distribution persist, particularly in low- and middle-income countries.
📊Key Facts
📅Complete Timeline14 events
First cases of severe immunodeficiencies reported
The first cases of severe immunodeficiencies, later identified as AIDS, were reported to the CDC.
FDA approves AZT, the first antiretroviral drug
The U.S. FDA approved zidovudine (AZT) as the first antiretroviral drug for the treatment of HIV/AIDS, marking the beginning of ART.
Merck and NIAID begin three-drug combination trial
Scientists recognized the need for combination therapy, leading Merck and the National Institute of Allergy and Infectious Diseases to begin trials of a three-drug combination.
Introduction of Highly Active Antiretroviral Therapy (HAART)
The success of three-drug combinations, including protease inhibitors, was announced, ushering in the era of Highly Active Antiretroviral Therapy (HAART), which dramatically improved treatment outcomes.
Launch of PEPFAR and Global Fund
The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria played crucial roles in expanding ART access in low- and middle-income countries.
First integrase inhibitor approved
The first integrase inhibitor, a new class of antiretroviral drugs, was introduced, further diversifying treatment options.
START study confirms benefits of early ART
The Strategic Timing of AntiRetroviral Treatment (START) study demonstrated that starting ART early in HIV-infected individuals significantly prevents serious AIDS-related and non-AIDS-related diseases.
First long-acting injectable ART approved
Long-acting injectable cabotegravir/rilpivirine (Vocabria and Rekambys) was approved, offering a less frequent dosing option (once-monthly or every other month).
US guidelines endorse individualized long-acting ART
US treatment guidelines from HSS and IAS-USA began endorsing the option to individualize the use of long-acting cabotegravir/rilpivirine in people who still have detectable viral load, expanding its application.
Twice-yearly injectable regimen shows strong efficacy in Phase 2
A new study published in The Lancet Microbe reported that the first twice-yearly injectable HIV treatment regimen (lenacapavir, teropavimab, zinlirvimab) achieved high rates of viral suppression and a favorable safety profile in Phase 2 trials.
New long-acting drugs for potential twice-yearly injection presented at CROI
Experimental injectable antiretrovirals, including a novel capsid inhibitor (VH-499) and next-generation integrase inhibitors (VH-184, GS-3242), were presented at CROI 2026 as potential components of future twice-yearly HIV treatment regimens.
AIDS 2026 Conference highlights advancements
The 26th International AIDS Conference in Rio de Janeiro highlighted significant progress in long-acting prevention and treatment, including once-weekly oral ART and continued efficacy of twice-yearly lenacapavir for PrEP.
Once-weekly oral ART (islatravir/lenacapavir) Phase 3 results presented
Detailed results from the ISLEND-1 and ISLEND-2 Phase 3 trials of oral islatravir/lenacapavir were presented at AIDS 2026, showing it to be efficacious and well tolerated as a potential first complete once-weekly oral treatment for HIV.
Antibody studies point to new cure pathways
Studies on broadly neutralizing antibodies (bnAbs) presented at AIDS 2026 revealed new insights into achieving prolonged HIV remission without ART, offering hope for less drastic cure strategies.
Follow this story
Get an email when this timeline gets a major update.
🔍Deep Dive Analysis
Antiretroviral Therapy (ART) represents one of the most significant medical advancements of the late 20th and early 21st centuries. Its journey began in 1987 with the approval of azidothymidine (AZT), the first antiretroviral drug, which offered limited benefits and severe side effects. The true turning point came in 1996 with the introduction of Highly Active Antiretroviral Therapy (HAART), a combination of multiple drugs that proved far more effective in suppressing the Human Immunodeficiency Virus (HIV) and preventing the progression to AIDS. This innovation transformed HIV from a death sentence into a chronic, manageable condition, compatible with a near-normal life expectancy for many.
The evolution of ART has been marked by a continuous drive to simplify regimens, reduce side effects, and improve adherence. Early HAART regimens often involved a high pill burden and complex dosing schedules, but by the 2010s, many patients could manage their condition with a single pill taken once a day. This simplification has been crucial in improving the quality of life for people living with HIV and in facilitating wider global access to treatment. The benefits have been profound, with ART averting millions of deaths and generating trillions in economic benefits worldwide.
Current Status as of 2026-09-13:
As of 2026, the landscape of ART continues to evolve rapidly, with a strong focus on long-acting formulations and less frequent dosing. The 26th International AIDS Conference (AIDS 2026), held in Rio de Janeiro in July 2026, highlighted significant progress. Once-weekly oral HIV treatment is now 'within sight,' with detailed results from Phase 3 ISLEND-1 and ISLEND-2 trials of oral islatravir/lenacapavir demonstrating efficacy and good tolerability in virologically suppressed individuals. Furthermore, twice-yearly injectable HIV treatment regimens, combining drugs like lenacapavir, teropavimab, and zinlirvimab, have shown strong efficacy and a favorable safety profile in Phase 2 studies, marking a major step towards ultra-long-acting therapy.
Long-acting injectable options, such as cabotegravir/rilpivirine (approved in 2021), are increasingly popular, and US treatment guidelines since 2024 endorse their individualized use even for people with detectable viral loads, expanding their utility beyond initial switch options. New drugs in the pipeline, including novel capsid inhibitors (e.g., ViiV Healthcare's VH-499) and next-generation integrase inhibitors (e.g., ViiV's VH-184 and Gilead's GS-3242), are being developed for potential twice-yearly administration. For adolescents, a long-acting injectable regimen given every eight weeks has proven superior to daily oral treatment in African trials, addressing adherence challenges in this population.
Pre-Exposure Prophylaxis (PrEP), which uses antiretroviral medicines to prevent HIV infection, has also seen significant advancements. Twice-yearly injectable lenacapavir for PrEP continues to demonstrate sustained high efficacy in prevention trials, with updated findings from PURPOSE 1 and PURPOSE 2 trials presented at AIDS 2026. Despite these scientific breakthroughs, a critical challenge remains: equitable global access. Monica Gandhi noted at AIDS 2026 that long-acting HIV drugs are still largely confined to wealthy countries, paralleling historical inequities in oral ART availability and threatening progress in low- and middle-income settings due to funding cuts and cost barriers.
Beyond treatment, HIV cure research continues to advance. AIDS 2026 reported on the 12th and 13th individuals to achieve sustained HIV remission after stem-cell transplants, known as the 'Kansas City patient' and a patient in Essen, Germany. Studies on broadly neutralizing antibodies (bnAbs) are also showing promise in enabling prolonged remission off ART for a significant proportion of participants, offering hope for less drastic and more accessible cure strategies.
What If...?
Explore alternate histories. What if Antiretroviral Therapy (ART) made different choices?