A once-weekly oral regimen holds HIV suppression as well as daily therapy

Design

Phase 3, double-blind, randomised, active-controlled non-inferiority trial (ISLEND-1)

Population

607 adults with HIV-1 suppressed ≥6 months on daily B/F/TAF

Primary outcome

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

Effect

Suppression 93.4% vs 92.4%; difference 1.0 point (95% CI −3.2 to 5.2)

ISLEND-1 randomised 607 adults with HIV-1 virologically suppressed for at least six months on daily bictegravir-emtricitabine-tenofovir alafenamide to switch to once-weekly oral islatravir-lenacapavir or continue the daily tablet, each with matching placebo, over 96 weeks.

At 48 weeks the weekly regimen was non-inferior: 93.4% kept HIV-1 RNA under 50 copies/mL versus 92.4% on daily therapy (difference 1.0 percentage point, 95% CI −3.2 to 5.2), and virological failure was rare in both arms. CD4 counts were stable and discontinuation for adverse events was similar (2.0% vs 1.7%).

A once-weekly oral option would ease the daily-pill burden that undermines adherence, the main reason suppression is lost. The evidence is for switching already-suppressed patients, not for starting treatment, and in India availability and cost will decide whether it reaches patients — but the direction is a real simplification of therapy.

• Once-weekly oral islatravir-lenacapavir kept suppression as well as the daily single tablet at 48 weeks.
• Viral suppression was 93.4% versus 92.4%, meeting non-inferiority.
• CD4 counts were stable and discontinuations for adverse events were similar between regimens.
• The evidence is for switching suppressed patients, not for initial therapy.

Why it matters

It offers a weekly alternative to daily dosing for the first time, targeting the adherence burden that drives loss of suppression.

Don't overread it

This tested a switch in already-suppressed patients over 48 weeks; it does not show the regimen works as initial therapy or in viraemic patients.

The statistics, in plain English

The difference of 1.0 percentage point with a confidence interval from −3.2 to 5.2 stays within the 4-point non-inferiority margin, meaning the weekly regimen is no worse — not that it is better.

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