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Gilead, Merck's Long-Acting HIV Regimen Hits Week-48 Endpoint

6/11/2026

Summary

Gilead/Merck Regimen Success

Gilead and Merck reported the islatravir/lenacapavir regimen met its endpoint in ISLEND-1 and ISLEND-2.
The regimen was non-inferior to daily Biktarvy in ISLEND-1 and to daily therapy in ISLEND-2, maintaining suppression through Week 48.
Safety matched comparators no new signals, and the combination remains investigational.
Gilead will file the data, present at a congress, and lifted its 2026 sales guidance to $1 billion; shares closed at $125.18, while Merck’s closed at $120.07.

Summary

Gilead Halts Trial

Gilead and Merck halted a trial of Trodelvy with Keytruda in metastatic non-small cell lung cancer after data showed no survival benefit.
Gilead said its islatravir/lenacapavir pill, oral HIV regimen, eliminates dosing and injections and boosts adherence versus pills or twice-yearly injectable Yeztugo.
Both companies will present the full HIV data at upcoming medical meetings while reallocating resources after the lung-cancer trial termination.

History

Historical Context

The first FDA-approved HIV protease inhibitor, saquinavir, launched HAART in the 1990s, cutting AIDS mortality and prompting a wave of oral combos. A decade later, the FDA approved darunavir in June 2006, a more mutation-resistant PI. Today Gilead and Merck’s islatravir/lenacapavir pill follows that legacy, aiming to reshape HIV treatment with a once-daily oral option.

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Gilead/Merck Regimen Success

Gilead and Merck reported the islatravir/lenacapavir regimen met its endpoint in ISLEND-1 and ISLEND-2.
The regimen was non-inferior to daily Biktarvy in ISLEND-1 and to daily therapy in ISLEND-2, maintaining suppression through Week 48.
Safety matched comparators no new signals, and the combination remains investigational.
Gilead will file the data, present at a congress, and lifted its 2026 sales guidance to $1 billion; shares closed at $125.18, while Merck’s closed at $120.07.

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