A new, daily oral tablet that combines two current HIV treatment medications, bictegravir and lenacapavir (BIC/LEN), may be able to effectively replace more complicated HIV treatment regimens used by people living with HIV who are long-term survivors, according to the results of a new phase 3 clinical trial published in The Lancet.
The trial, which included more than 550 people living with HIV across 15 countries, showed that the new single-pill treatment was highly effective in maintaining HIV suppression (HIV virus levels below 50 copies/mL). Nearly 96% of participants who switched to this simplified regimen maintained viral suppression with no new drug resistance reported. In comparison, participants who continued their existing complex, multi-pill treatments showed similar results, also maintaining viral suppression at a rate of about 94-96%.
Participants’ median age was 60 years (age ranges were between 22 and 84), which is considerably older than people who are usually included in HIV medication trials. Most trial participants had been taking between two and 11 pills per day for their HIV treatment, with approximately 40% of participants taking antiretrovirals more than once a day. Many participants also reported other health conditions, such as cardiovascular or kidney disease, and most had resistance to prior HIV therapy.
In the study, no significant or novel safety concerns were identified, and most participants experienced fewer lipid-related side effects, such as increased cholesterol levels, suggesting an additional potential benefit for those at risk of heart disease.
Participants reported that the new treatment option was easier and more convenient to take, which can help support consistent adherence to daily medication. The authors say this is especially important for older adults living with HIV, people with a previous history of developing resistance to HIV treatments, or those who are taking additional medications to help manage age-related health conditions along with HIV medication.
Additional clinical trials are underway to confirm the long-term safety and effectiveness of the BIC/LEN combination tablet.
This study will be presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026, taking place in Denver, Colorado, USA on Wednesday 25th February 2026.
Post-embargo URL: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00307-7/fulltext
The Lancet
Randomized controlled/clinical trial
People
Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial
25-Feb-2026
CO received grants (paid to her institution) from Gilead Sciences, MSD, and ViiV Healthcare; received consulting fees for advisory boards and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Bavarian Nordic, Gilead Sciences, GSK, MSD, and ViiV Healthcare; received support for attending meetings and/or travel from Bavarian Nordic, Gilead Sciences, and ViiV Healthcare; and is a governing council member of the International AIDS Society (unpaid). PJR received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences and ViiV Healthcare. MH received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events, and support for attending meetings and/or travel from, and participated on advisory boards for, Gilead Sciences, Merck, and ViiV Healthcare. CG received consulting fees from Gilead Sciences, Merck, and ViiV Healthcare; and received payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events from Gilead Sciences and ViiV Healthcare. MHL received research grants (paid to his institution) from Gilead Sciences, and participated on advisory boards for Gilead Sciences and ViiV Healthcare. BT received consulting fees, payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events, and support for attending meetings and/or travel, from Gilead Sciences and ViiV Healthcare. TL received grants or contracts from AbbVie, Charité Berlin, Deutsche Leberstiftung, Gilead Sciences, GSK/ViiV Healthcare, Immuno Therapeutics Heidelberg, Janssen, Moderna, and MSD. MO received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences; received support for attending meetings and/or travel from Gilead Sciences, Janssen, and ViiV Healthcare; participated on a data safety monitoring or advisory board for Gilead Sciences; and is an unpaid member of ASHM Board and Australian ARV Guidelines Committee. MB received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences, GSK, and ViiV Healthcare; received support for attending meetings and/or travel from Gilead Sciences and ViiV Healthcare; and participated on data safety monitoring or advisory boards for Gilead Sciences, GSK, and ViiV Healthcare. JS received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Gilead Sciences, Merck, Thera, and ViiV Healthcare. MRa received consulting fees from Gilead Sciences, Shionogi, and ViiV Healthcare; and received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AbbVie, Gilead Sciences, and ViiV Healthcare. SS received research grants and support for clinical trials (paid to her institution) from Janssen, Merck, and the South African Medical Research Council; received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from ViiV Healthcare; received support for attending meetings and/or travel from Merck; received a drug donation to her institution from ViiV Healthcare; and participated on an advisory board for AbbVie. KM received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from, and served on an advisory board for, Epividian, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. H-CT received honoraria for a lecture at an international congress, and travel and registration support for attending an international meeting, from Gilead Sciences. JSB received research grants or contracts from Chem Bio Diagnostics, Gilead Sciences, and Moderna; and consulting fees and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AbbVie. XZ, KA, KP, NM, JMM-R, PS, and MRh are employees of Gilead Sciences and own employee stock grants. PC received research grants and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from ViiV Healthcare; and consulting fees from Gilead Sciences, Merck, and ViiV Healthcare.