A new once‑daily pill could be the first major advance for older people who have lived with HIV for decades but remain on complex, multi‑pill regimens, according to results from a clinical trial.
The pill, called BIC/LEN, combines the antiviral drugs bictegravir and lenacapavir. Lenacapavir was recently approved as an injectable HIV drug; this trial tested it combined with bictegravir in a single oral formulation. Researchers hope the pill will offer a simpler daily routine for older people whose early treatments led to drug resistance and now require highly specialized regimens.
The trial, led by Professor Chloe Orkin of Queen Mary University of London, assembled the oldest group ever for an HIV drug study. Participants had an average age of 60, with some in their eighties. Over nine months, they were either switched to BIC/LEN once a day or remained on their complex, daily multi‑pill regimens.
Both groups achieved viral suppression in about 96% of participants. In addition, those taking BIC/LEN showed improved cholesterol levels, a potential benefit for patients at higher risk of cardiovascular disease as they age. Participants using the single pill also reported higher satisfaction than those on complex regimens.
Orkin said the drug is intended for people with viral resistance who have not benefitted from recent advances in HIV therapy. Simplifying treatment could reduce the risk of poor adherence, where missed doses might jeopardize treatment gains.
HIV advocates welcomed the findings. Mitchell Warren, executive director of the prevention advocacy group AVAC, said simplifying drug taking is an “incredible opportunity” to improve adherence and maintain viral suppression, which also prevents transmission.
BIC/LEN is undergoing two follow‑up assessments and is set to be submitted for approval to regulators including the US Food and Drug Administration and the European Medicines Agency. Orkin added that the drug is also being tested against a gold‑standard therapy in people without complex regimens and has performed well in that context as a broader advance in HIV treatment.
The trial data were published February 25, 2026, in The Lancet.
Edited by: Zulfikar Abbany