Weekly oral islatravir-lenacapavir was noninferior to daily bictegravir-based therapy in suppressed HIV

Design

Phase 3, randomised, double-blind, active-controlled noninferiority trial; 12 countries

Population

607 adults with HIV-1 suppressed for at least 6 months on bictegravir-emtricitabine-tenofovir alafenamide

Primary outcome

HIV-1 RNA of 50 copies/mL or higher at week 48 (FDA snapshot)

Effect

0 vs 1 (0.3%); difference -0.3 percentage points (95% CI -1.4 to 0.8)

ISLEND-1 was a phase 3, double-blind, active-controlled noninferiority trial in 12 countries. It enrolled 607 adults whose HIV-1 had been suppressed for at least 6 months on bictegravir-emtricitabine-tenofovir alafenamide, and randomised them 1:1 to switch to once-weekly oral islatravir 2 mg with lenacapavir 300 mg or to continue the daily tablet; each group received a matched placebo for the other regimen.

At week 48 no participant in the weekly group and one (0.3%) in the daily group had an HIV-1 RNA level of 50 copies/mL or higher (difference -0.3 percentage points, 95% CI -1.4 to 0.8; margin 4 points). HIV-1 RNA below 50 copies/mL was seen in 93.4% and 92.4%, and CD4 counts were similar. Treatment was stopped for adverse events in 2.0% and 1.7%; serious adverse events occurred in 5.3% and 4.6%.

This is a 48-week switch study in people who were already suppressed; it says nothing about starting treatment or about resistance in the long term. Participants were 21% women, and the trial was funded by the two manufacturers. Availability and cost in India are not established by the paper.

• This was a switch trial in people suppressed for at least 6 months; it does not cover treatment-naive patients.
• Virological failure was 0 vs 0.3% at 48 weeks, well within the 4-point margin.
• Adherence to a weekly dose still matters; the trial did not test missed-dose handling in routine care.
• Check regulatory status and access before discussing it with patients.

Why it matters

It tests whether a pill taken once a week can replace daily therapy without losing viral control.

Don't overread it

The result is at 48 weeks of a planned 96, in suppressed patients, with a manufacturer-funded design.

The statistics, in plain English

Noninferiority here means the weekly regimen was not worse than the daily one by more than 4 percentage points of failures. With so few failures, the interval is narrow in absolute terms but still based on very few events.

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