Once-weekly oral islatravir–lenacapavir held viral suppression as well as daily therapy

Design

Phase 3, randomised, double-blind, active-controlled non-inferiority trial, 12 countries

Population

607 adults with HIV-1 suppressed on daily B/F/TAF for at least 6 months

Primary outcome

HIV-1 RNA ≥50 copies/mL at week 48 (snapshot)

Effect

0% vs 0.3%; difference −0.3 points (CI −1.4 to 0.8), margin 4 points

ISLEND-1 randomised 607 adults in 12 countries whose HIV had been suppressed on daily bictegravir–emtricitabine–tenofovir alafenamide for at least six months, either to switch to once-weekly oral islatravir 2 mg with lenacapavir 300 mg or to stay on daily therapy, double-blind with matched placebos. It was published on 29 July.

At 48 weeks, no participant on the weekly regimen had HIV RNA of 50 copies/mL or more, against one (0.3%) on daily therapy (difference −0.3 points, CI −1.4 to 0.8), well inside the 4-point non-inferiority margin. CD4 counts were stable in both groups, and discontinuation for adverse events was similar (2.0% vs 1.7%).

A weekly pill could help people for whom daily dosing is the barrier, without the clinic visits that injectable regimens need. Islatravir's earlier development was paused over falls in lymphocyte counts at higher doses; this lower dose did not show a CD4 problem at 48 weeks, but longer follow-up matters. The combination is not approved by FDA, EMA or CDSCO, and the trial enrolled people already suppressed, not those starting treatment.

• Tell suppressed patients who ask that a weekly oral option is in development but not yet approved.
• Consider which patients struggle with daily adherence and may benefit when weekly options arrive.
• Do not apply these results to treatment-naive patients or those with resistance; they were not studied.
• Watch for 96-week data on lymphocyte and CD4 counts before routine adoption.

Why it matters

Weekly dosing could suit patients who need neither injections nor a daily reminder.

Don't overread it

Results apply to people already suppressed on a single regimen, not to anyone starting treatment.

The statistics, in plain English

Non-inferiority means the new regimen was shown to be no more than 4 percentage points worse than the standard. The upper confidence limit of 0.8 points is far inside that margin, so the trial is convincing on that question.

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