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Orolabial and Genital Herpes Clinical Trials: A Meta-analysis of Endpoints

Abigail Sloan1, Mahta Mortezavi2, Jacqueline Gerhart1

  • 1Research and Development, Pfizer, New York City, New York, USA.

Open Forum Infectious Diseases
|January 9, 2026
PubMed

Insights

New antiviral therapies for herpes simplex virus (HSV) infections are needed. Clinical trials for HSV treatments have used varied endpoints, hindering consistent study design and evaluation of new agents.

Area of Science:

  • Virology
  • Clinical Trials
  • Pharmacology

Background:

  • Existing antiviral agents for orolabial and genital herpes simplex virus (HSV) infections require complementary therapies.
  • Evaluating new HSV treatments is challenging due to inconsistent clinical trial endpoint definitions.

Purpose of the Study:

  • To systematically review and meta-analyze randomized placebo-controlled trials (RCTs) of HSV treatments.
  • To assess the heterogeneity of endpoints used in HSV clinical trials over the past 30 years.

Main Methods:

  • Systematic review and meta-analysis of 22 RCTs published between 1995 and 2024.
  • Included immunocompetent, nonpregnant adults with established HSV infection.
  • Analyzed endpoints for episodic treatment (healing time, symptom cessation) and suppressive therapy (recurrence rates, shedding rates).

Main Results:

  • Significant heterogeneity in clinical trial endpoints and definitions for HSV infections was observed over the last three decades.
  • Commonly used endpoints included time to healing, symptom cessation, recurrence rates, and viral shedding rates.
  • No single endpoint was consistently applied across studies.

Conclusions:

  • The evaluation of novel antiviral agents for HSV infections is hampered by nonstandardized clinical trial endpoints.
  • Reassessing and standardizing trial endpoints, with regulatory guidance, is crucial for consistent study design.
  • Standardized endpoints will facilitate the effective evaluation of new therapeutic agents for herpes simplex virus.
Keywords:
HSVgenital herpesmeta-analysisorolabial herpessystematic review

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