Single-Pill HIV Treatment Shows Promise in Major Clinical Trial | Lancet Study

A once-daily single-tablet regimen combining bictegravir and lenacapavir has demonstrated high efficacy in maintaining viral suppression among adults with HIV who are switching from complex antiretroviral therapy (ART), according to results from the Phase 3 ARTISTRY-1 trial published in The Lancet.

The open-label, randomized trial, conducted across 90 hospitals and clinics in 15 countries including Australia, Canada, the United States, and the United Kingdom, involved 557 participants. The study evaluated the effectiveness of switching to the investigational single-tablet regimen compared to continuing existing multi-tablet ART regimens. Participants had a median age of 60, ranging from 22 to 84 years, and were taking an average of three antiretroviral pills daily, with approximately 40% taking medication more than once a day.

The data showed that 95.9% of the 371 participants who switched to bictegravir 75mg/lenacapavir 50mg (BIC/LEN) maintained viral suppression, with no new instances of drug resistance reported. This was comparable to the 94% to 96% viral suppression rate observed in the 186 participants who continued their existing multi-tablet regimens. The primary efficacy endpoint, defined by the FDA snapshot algorithm, was met, demonstrating non-inferiority to baseline therapy.

Many participants in the trial also had co-existing health conditions, such as cardiovascular or kidney disease, and a majority had prior resistance to HIV treatments. Researchers noted that the BIC/LEN regimen was generally well-tolerated, with no significant or previously unidentified safety concerns. Participants reported fewer lipid-related side effects, such as increased cholesterol levels, potentially offering an additional benefit for those at risk of heart disease.

Participants also reported that the single-tablet regimen was easier and more convenient to take, which researchers believe could improve adherence to daily medication. The study authors highlighted the importance of this simplification for older adults living with HIV, individuals with a history of treatment resistance, and those managing multiple medications for age-related health conditions.

Gilead Sciences, the manufacturer of both bictegravir and lenacapavir, announced the positive topline results in November 2025 and plans to submit the Phase 3 data to regulatory authorities. Additional clinical trials are underway to confirm the long-term safety and efficacy of the combined pill. The findings were also presented at the Conference on Retroviruses and Opportunistic Infections in Denver, Colorado.