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Human respiratory syncytial virus (RSV) is a widespread pathogen that primarily targets infants and young children but also poses a serious health risk to elderly and immunocompromised individuals. Belonging to the Pneumoviridae family, RSV is a negative-sense, single-stranded RNA virus within the Pneumovirus genus. Its global health burden is significant, with millions of cases annually resulting in hospitalizations and mortality, particularly in resource-limited settings. Although most...

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Weekly Oral Prophylaxis With MK-8527 Protects Rhesus Macaques From Intrarectal Challenge With Simian-Human

Tracy L Diamond1, Yash Kapoor1, Fangbiao Li1

  • 1MRL, Merck & Co., Inc., Rahway, New Jersey, USA.

The Journal of Infectious Diseases
|December 16, 2025
PubMed
Summary

MK-8527, a novel HIV-1 pre-exposure prophylaxis, completely protected macaques from simian-human immunodeficiency virus (SHIV) infection. This nucleoside reverse transcriptase inhibitor shows promise for preventing HIV-1 acquisition in further clinical development.

Keywords:
HIV-1 preventionMK-8527nonhuman primatepre-exposure prophylaxissimian–human immunodeficiency virus

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Area of Science:

  • Virology
  • Pharmacology
  • Infectious Diseases

Background:

  • MK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor.
  • It is phosphorylated to its active form, MK-8527-triphosphate, inhibiting HIV-1 replication.
  • The study evaluated MK-8527 efficacy for HIV-1 prevention.

Purpose of the Study:

  • To assess the efficacy of oral MK-8527 as pre-exposure prophylaxis (PrEP).
  • To evaluate protection against intrarectal simian-human immunodeficiency virus (SHIV) challenge in rhesus macaques.

Main Methods:

  • Rhesus macaques received weekly oral doses of MK-8527 for 12 weeks.
  • Animals were challenged intrarectally with SHIV162P3 weekly for 10 weeks.
  • Viral loads and drug concentrations were monitored; infection was confirmed by SHIV RNA levels.

Main Results:

  • Once-weekly MK-8527 at ≥0.1 mg/kg provided complete protection against SHIV acquisition.
  • Infection rates were significantly lower (≥11.1-fold) in treated macaques compared to controls.
  • MK-8527-triphosphate trough concentrations at 0.1 mg/kg achieved a mean inhibitory quotient of 2.2.

Conclusions:

  • MK-8527 prophylaxis demonstrated complete protection against SHIV infection in macaques.
  • These findings support the further clinical development of MK-8527 for HIV-1 prevention.
  • MK-8527 is a promising candidate for pre-exposure prophylaxis to prevent HIV-1 acquisition.