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Twice-yearly lenacapavir prevented nearly all HIV infections in two phase 3 trials and became a WHO-recommended PrEP option

PURPOSE 1 recorded zero HIV infections among 2,134 participants assigned twice-yearly lenacapavir, compared with infections in both daily-oral-PrEP groups; PURPOSE 2 showed similarly high prevention efficacy in a broader gender population. The FDA approved injectable lenacapavir for prevention in June 2025, and WHO recommended it as an additional PrEP choice in July 2025.

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Stable ID
science-2025-lenacapavir-twice-yearly-hiv-prep
Revision
science-2025-lenacapavir-twice-yearly-hiv-prep.v1
Field
Medicine · HIV prevention
Evidence
Tier 1 · Peer reviewed: Yes
Record state
Current · FDA-approved and WHO-recommended
Last checked

AI role

No substantive AI role was reported.

Record details

Problem or result
Daily oral HIV pre-exposure prophylaxis is highly effective when taken consistently, but adherence and access barriers reduce its real-world impact.
Authors
Linda-Gail Bekker et al., PURPOSE 1 Study Team; Colleen F. Kelley et al., PURPOSE 2 Study Team
Institutions
Multicountry PURPOSE trial networks; Gilead Sciences
Result date
July 14, 2025

Why it matters

A six-month injection can remove much of the day-to-day adherence burden that limits oral PrEP.

Limits

Public-health impact depends on price, equitable access, clinic capacity and timely HIV testing. Injection-site reactions occur, infection during the long pharmacologic tail can select resistance, and both phase 3 trials were manufacturer-sponsored.

Sources

  1. Primary: PURPOSE 1 primary paper
  2. Primary: PURPOSE 2 primary paper
  3. Primary: WHO guideline
  4. Independent: Nature specialist reporting on PURPOSE 1

Correction and revision history

  1. 2024-07-24 — PURPOSE 1 efficacy result reported.
  2. 2024-11-27 — PURPOSE 2 result published.
  3. 2025-06-18 — FDA approval reported by WHO.
  4. 2025-07-14 — WHO recommended twice-yearly injectable lenacapavir as an additional PrEP choice.

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