A single daily pill combining two existing HIV medicines could replace complex multi-tablet treatment regimens, according to a phase 3 clinical trial published in The Lancet.
The findings were presented on February 25 at the Conference on Retroviruses and Opportunistic Infections 2026 in Denver, Colorado.
The new oral tablet combines Bictegravir and Lenacapavir, referred to as BIC/LEN.
The phase 3 ARTISTRY 1 trial, led by Professor Chloe Orkin of Queen Mary University of London, enrolled more than 550 people living with HIV across 15 countries. The study found that nearly 96% of participants who switched to the simplified regimen maintained viral suppression, defined as HIV levels below 50 copies per mL, with no new drug resistance reported. Among those who continued their existing multi-pill regimens, 94 to 96% maintained viral suppression.
Dr. I.S. Gilada, president emeritus of the AIDS Society of India, said the results were not unexpected since both Bictegravir and Lenacapavir have individually demonstrated safety in earlier studies. He noted that three two-drug combinations are already in global use, including Dolutegravir plus Lamivudine, Dolutegravir plus Rilpivirine, and Cabotegravir plus Rilpivirine, with the first available in India. When licensed, BIC/LEN would become the fourth such combination, offering another option rather than a distinct advantage.
Dr. Gilada added that new drugs must undergo phase 3 trials in India, which can cost about Rs 10 crore per trial. He said Indian generic manufacturers ultimately benefit from large-scale production, improving affordability for low and middle-income countries under approvals from the Central Drugs Standard Control Organisation.
India has an estimated 26 lakh people living with HIV, of whom 18 lakh are on treatment. The country follows a test and treat strategy, initiating therapy immediately after diagnosis, typically using a three-drug single tablet regimen known as TLD.