Infectious Disease
RCT
● RCT
Can a single daily pill control HIV as well as complex multi-pill regimens?
Lancet (London, England)
Published March 30, 2026
Orkin Chloe, Ruane Peter J, Hedgcock Malcolm, Gaultier Cyril, Losso Marcelo H, Trottier Benoit, Lutz…
Imagine taking multiple pills every day for decades to keep a chronic condition in check. For many people with HIV, that's been the reality. A new study asked if a simpler, single daily pill could work just as well for those who have already achieved viral suppression on more complex regimens.
The trial involved 557 adults, mostly in their 60s who had been on HIV treatment for a median of 28 years. They were either switched to a new single-tablet regimen called bictegravir-lenacapavir or stayed on their current multi-pill treatment. After 48 weeks, both groups had the same result: only 1% of people in each group saw their viral load rise above a detectable level. The new pill was just as effective at keeping the virus suppressed. Rates of side effects were similar between the two groups.
It's important to note that the study was open-label, meaning both participants and doctors knew which treatment they were on, which can sometimes influence how people report their experiences. While the results are promising for simplifying treatment, the study only followed people for 48 weeks. We don't yet know the long-term safety profile of this new combination. Five people in the single-pill group died during the study, though none of the deaths were judged to be related to the study drug.
View Original Abstract ↓
BACKGROUND: Single-tablet regimens (STRs) revolutionised HIV-1 treatment, improving adherence and clinical outcomes; however, many people cannot take these due to resistance, contraindications, or drug-drug interactions, instead relying on complex multi-tablet regimens. Novel STRs are therefore needed. We aimed to evaluate the efficacy and safety of a novel STR, bictegravir-lenacapavir, in people with HIV-1.
METHODS: ARTISTRY-1 was a randomised, open-label, active-controlled, non-inferiority phase 3 trial conducted at hospitals and clinics across 15 countries that enrolled people with HIV-1 with virological suppression on complex regimens. Participants were randomly assigned (using interactive technology, 2:1, stratified by geographical region) to switch to once-daily oral bictegravir-lenacapavir 75 mg/50 mg STR or continued complex regimen. The primary outcome was the proportion of participants with an HIV-1 RNA viral load of 50 copies per mL or higher at week 48 (US Food and Drug Administration Snapshot algorithm), assessed in all randomly assigned participants who received any dose of assigned treatment. This trial (active; enrolment complete) was registered with ClinicalTrials.gov (NCT05502341).
FINDINGS: Between Jan 29 and Sept 26, 2024, 729 participants were screened; 557 were randomly assigned and treated (bictegravir-lenacapavir n=371; complex regimen n=186). At baseline, median age was 60 years (range 22-84), HIV treatment duration was 28 years (IQR 22-32); participants were taking a median of three antiretroviral pills per day (range 2-11). At week 48, an HIV-1 RNA viral load of 50 copies per mL or higher was observed in three (1%) participants receiving bictegravir-lenacapavir and two (1%) receiving a complex regimen (difference -0·3%; 95·002% CI -2·3 to 1·8), meeting the non-inferiority margin of 4%. No resistance emerged. Adverse event rates were similar between groups. Six (2%) participants discontinued bictegravir-lenacapavir and one (1%) discontinued their complex regimen due to adverse events. There were five deaths in the bictegravir-lenacapavir group, none of which were deemed related to study drug. Participants reported increased treatment satisfaction after switching to bictegravir-lenacapavir.
INTERPRETATION: Bictegravir-lenacapavir STR demonstrated non-inferior efficacy to complex regimens, with a similar safety profile and increased treatment satisfaction. Bictegravir-lenacapavir offers new opportunities for HIV-1 treatment optimisation for people taking complex regimens.
FUNDING: Gilead Sciences.
