Gilead’s Bictegravir/Lenacapavir Shows Promise in HIV Treatment Switch Studies
Foster City, California – – Gilead Sciences, Inc. (Nasdaq: GILD) announced promising Phase 3 trial results for a novel, single-tablet combination of bictegravir and lenacapavir (BIC/LEN) for the treatment of HIV. The data, presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, suggest the regimen offers a viable alternative to both complex multi-tablet regimens and existing single-tablet options like BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets).
The ARTISTRY-1 and ARTISTRY-2 trials, pivotal to these findings, assessed the efficacy and safety of switching virologically suppressed HIV patients to the BIC/LEN combination. ARTISTRY-1 focused on individuals currently on complex, multi-tablet regimens, while ARTISTRY-2 evaluated a switch from BIKTARVY, a widely prescribed single-tablet regimen. Both trials demonstrated non-inferiority to their respective control arms in maintaining viral suppression – defined as HIV-1 RNA levels below 50 copies/mL – at .
Specifically, ARTISTRY-1 showed that 0.8% of participants receiving BIC/LEN experienced virologic failure, compared to 1.1% in the group continuing their complex regimens. ARTISTRY-2 reported a failure rate of 1.3% for those switched to BIC/LEN versus 1.0% for those remaining on BIKTARVY. These results support the potential of BIC/LEN to simplify treatment for a broad range of patients, including those with pre-existing drug resistance or other factors preventing them from utilizing standard single-tablet therapies.
The significance of this development extends beyond simply offering another treatment option. Many individuals living with HIV, particularly long-term survivors, face challenges with adherence due to the pill burden associated with their regimens. According to trial data, approximately 40% of participants were taking antiretroviral therapy more than once a day and a substantial portion were on between two and eleven pills daily. Simplifying this regimen to a single daily pill could significantly improve adherence and, treatment outcomes.
the trials revealed potential benefits beyond viral suppression. Participants switching to BIC/LEN from complex regimens experienced a statistically significant improvement in fasting lipid parameters, with a median decrease in total cholesterol of 15 mg/dL compared to a 2 mg/dL increase in the control group. This is particularly relevant given the increased risk of cardiovascular disease among people living with HIV, and the potential for some antiretroviral therapies to negatively impact lipid profiles.
Patient-reported outcomes also indicated a positive impact on quality of life. Those switched to BIC/LEN reported a mean increase of 7 points on the HIV Treatment Satisfaction Questionnaire (HIVTSQs) score, suggesting improved convenience and satisfaction with their treatment.
Lenacapavir, a key component of the BIC/LEN combination, is a first-in-class capsid inhibitor with a unique mechanism of action. Unlike many existing antiretrovirals, lenacapavir targets the viral capsid, a protein shell that protects the virus’s genetic material. This novel approach offers a distinct advantage, as it exhibits no overlapping resistance to other drug classes currently available. Bictegravir, an integrase strand transfer inhibitor, is a well-established component of several existing HIV treatment regimens and is known for its high barrier to resistance.
“The ARTISTRY trials represent the latest example of Gilead’s commitment to advancing HIV treatment through continuous scientific innovation,” said Jared Baeten, M.D., Ph.D., Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “This once-daily single-tablet regimen combines the durability of bictegravir with lenacapavir, a first‑in‑class capsid inhibitor. The novel treatment combination is designed to sustain virologic suppression for those seeking new options.”
The safety profile of BIC/LEN appears favorable. Drug-related adverse events were reported in 14.3% of participants who switched to BIC/LEN in ARTISTRY-1, compared to 1.6% of those continuing their complex regimens. Serious drug-related adverse events were rare, occurring in 0.3% and 0% of the respective groups. ARTISTRY-2 showed similar rates of drug-related adverse events (10.4% vs. 12.0% for BIC/LEN and BIKTARVY, respectively) with no serious events reported.
Gilead plans to submit the Phase 3 results from the ARTISTRY trials to regulatory authorities, paving the way for potential approval and market availability. The company also intends to present the detailed findings at a future scientific congress. The publication of the primary outcome results of the ARTISTRY-1 trial in on , further validates the significance of these findings.
While there is currently no cure for HIV/AIDS, the development of BIC/LEN represents a significant step forward in simplifying treatment, improving patient adherence, and potentially reducing the long-term health complications associated with the virus. The combination offers a promising new option for a diverse population of individuals living with HIV, including those with complex treatment histories and those seeking a more convenient and tolerable regimen.