The Priority Review

Clinical trials

1.3 percent on BIC/LEN had HIV-1 RNA of 50 copies/mL or more at Week 48; 1.0 percent on B/F/TAF

In ARTISTRY-2, 1.3 percent of 383 participants switched to bictegravir/lenacapavir had HIV-1 RNA of 50 copies/mL or more at Week 48, versus 1.0 percent of 191 who stayed on Biktarvy. Gilead Sciences has posted the Phase 3 results for adults with HIV-1 who were virologically suppressed.

By The Priority Review desk

Machine-summarized from the primary sources listed below; not independently reported. How we use automation

In the Phase 3 ARTISTRY-2 study, 1.3 percent of participants who switched to bictegravir/lenacapavir (BIC/LEN) had HIV-1 RNA of 50 copies/mL or more at Week 48, compared with 1.0 percent of those who stayed on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), the study's registry record shows. Gilead Sciences ran the trial in 577 randomized adults with HIV-1 whose virus was already suppressed, so sites and sponsors now have posted Week 48 results for that switch.

Week 48 results by arm
ArmParticipantsHIV-1 RNA of 50 copies/mL or moreHIV-1 RNA below 50 copies/mLTreatment-emergent adverse events
BIC/LEN3831.3 percent93.5 percent72.8 percent
B/F/TAF1911.0 percent90.6 percent72.3 percent

From the trial registry record NCT06333808, results first posted November 5, 2026.

Why it matters

The DailyMed label for BIXLENVO SUNLENCA STARTER PACK, published November 02, 2026, says the product is indicated for the initiation of BIXLENVO, a complete regimen for the treatment of HIV-1 infection in adults. The label says it replaces the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO. The label also says safety and effectiveness have not been established in patients less than 18 years of age. The registry record's own summary says the study was designed to learn more about the effects of switching to BIC/LEN versus current therapy with B/F/TAF in people successfully treated with B/F/TAF.

Week 48 results

Results were first posted on November 5, 2026, according to the record. The record lists these measures at Week 48. The two HIV-1 RNA measures use the US FDA-defined snapshot algorithm; the CD4 measure comes from a separate model:

  • HIV-1 RNA of 50 copies/mL or more: 1.3 percent on BIC/LEN (383 participants) and 1.0 percent on B/F/TAF (191 participants). The difference in percentages was 0.3, with a two-sided 95.002% confidence interval of -1.9 to 2.4.
  • HIV-1 RNA below 50 copies/mL: 93.5 percent on BIC/LEN and 90.6 percent on B/F/TAF. The difference was 3.1, with a confidence interval of -1.8 to 8.0.
  • Change from baseline in CD4 cell count: baseline means were 755 cells/µL on BIC/LEN and 714 on B/F/TAF. The change at Week 48 was -20 cells/µL (standard deviation 192.5) on BIC/LEN and -6 (standard deviation 164.0) on B/F/TAF. The difference in least squares mean was -8.4, with a confidence interval of -39.8 to 22.9 and a P value of 0.5964.

The record reports the share of participants in each group and does not give a verdict in words on the comparison. The title of the linked Lancet HIV paper, listed in the record, calls the trial a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial.

Safety measures

The record reports adverse events through Week 48 for participants who took at least one dose:

  • Treatment-emergent adverse events: 72.8 percent on BIC/LEN and 72.3 percent on B/F/TAF.
  • Serious adverse events: 27 of 383 participants on BIC/LEN and 13 of 191 on B/F/TAF.
  • 0 of 384 participants randomized to BIC/LEN died, and 1 of 193 randomized to B/F/TAF died.

Trial design and participants

ARTISTRY-2 is a randomized, double-blind, active-controlled study. Participants were randomized in parallel to one of two treatment groups during the Blinded Phase. One group switched from B/F/TAF 50/200/25 mg to a BIC/LEN 75/50 mg tablet once daily, with a 2-day oral loading dose of LEN 600 mg and placebo-to-match B/F/TAF tablets. The other group stayed on B/F/TAF 50/200/25 mg and took placebo-to-match BIC/LEN tablets, for up to 48 weeks.

Participants in both groups were offered BIC/LEN in an Open-label Phase after the Blinded Phase. The record says 666 participants were screened and 577 were randomized. Sites were in Asia, Europe, North America, Oceania and South America.

Key inclusion criteria in the record include:

  • Receiving B/F/TAF for at least 6 months before screening.
  • HIV-1 RNA below 50 copies/mL at screening.
  • No documented or suspected resistance to bictegravir or tenofovir alafenamide.
  • Estimated glomerular filtration rate of 30 mL/min or more by the Cockcroft-Gault formula.

Key exclusion criteria include prior use of, or exposure to, LEN, and chronic hepatitis B virus infection as defined in the record.

What remains uncertain

The record lists the Week 96 and Week 144 measures as not posted. It says the data submitted are the primary analysis performed on data collected by the primary completion date, and that complete data are to be submitted within 1 year of the study completion date.

Sources