A new once‑daily pill that combines bictegravir and lenacapavir could offer a simpler treatment option for older people who have lived with HIV for decades and remain on complex multi‑pill regimens, according to results from a clinical trial. Lenacapavir is already approved as an injectable; this study tested an oral formulation combining it with bictegravir (BIC/LEN).
The trial, led by Professor Chloe Orkin of Queen Mary University of London, enrolled the oldest cohort yet in an HIV drug study: participants averaged 60 years of age, with some in their eighties. Over nine months, participants were either switched to the once‑daily BIC/LEN pill or continued their existing complex daily regimens tailored because of past drug resistance.
Viral suppression was similar in both groups, achieved in roughly 96% of participants. Those taking the single pill also showed improved cholesterol measures and reported higher satisfaction compared with people remaining on multi‑pill therapy—findings that could matter as cardiovascular risk rises with age. The investigators emphasized that BIC/LEN is aimed at people whose earlier treatments produced resistance and who have not benefited from recent advances in HIV therapy; simplifying dosing may lower the risk of missed doses that could compromise treatment.
HIV advocates welcomed the results. Mitchell Warren, executive director of the prevention group AVAC, called treatment simplification an “incredible opportunity” to boost adherence and sustain viral suppression, which also prevents transmission.
BIC/LEN is undergoing two follow‑up assessments and the developers plan regulatory submissions to agencies including the U.S. Food and Drug Administration and the European Medicines Agency. The combination is also being tested against a gold‑standard regimen in people without complex resistance, where it has performed well as a potential broader advance in HIV care.
The trial data were published in The Lancet on February 25, 2026.