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Merck’s Once-Monthly Oral PrEP Candidate MK-8527 Shows Early Promise in Study

The PLOS Biology paper details a next-generation NRTTI designed for extended oral dosing.

Blue pre-exposure prophylaxis (PrEP) pill to prevent HIV in palm of hand.
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Overview

  • Researchers engineered MK-8527 from islatravir as a nucleoside reverse transcriptase translocation inhibitor that targets HIV replication through multiple mechanisms.
  • In vitro testing found potent antiviral activity, with animal pharmacokinetics supporting potential for long-acting monthly dosing.
  • Early human studies are evaluating safety and tolerability in low-risk volunteers, with at least one completed study reporting promising results.
  • The candidate is not approved and will require efficacy trials and regulatory review before any clinical use.
  • A monthly pill could ease adherence, privacy and access challenges associated with daily regimens and provider-administered injectables, a priority given roughly 1.3 million new infections globally each year.