Efficacy and safety of famciclovir for treating mucocutaneous herpes simplex infection in HIV-infected individuals. Collaborative Famciclovir HIV Study Group

AIDS. 2000 Jun 16;14(9):1211-7. doi: 10.1097/00002030-200006160-00019.


Objective: To compare the efficacy and safety of 7 days' treatment with famciclovir 500 mg twice a day versus acyclovir 400 mg five times a day, for mucocutaneous herpes simplex virus (HSV) infection in HIV-infected individuals.

Design: Randomized, double-blind, parallel-group study to demonstrate equivalence for the primary efficacy parameter.

Setting: Forty-eight hospital-based or specialist public-health clinics in 12 countries.

Patients: Two-hundred and ninety-three HIV-positive patients with recurrent HSV infection (orolabial or genital) starting treatment within 48 h of first appearance of herpetic lesions.

Main outcome measures: Proportion of patients developing new lesions during treatment (primary outcome measures); Time to complete healing of lesions, time to cessation of viral shedding, time to loss of lesion-associated symptoms, number of withdrawals due to treatment failure (secondary outcome measures).

Results: Equivalence was defined prospectively and famciclovir was equivalent to acyclovir in preventing new lesion formation: new lesions occurred in 16.7% and 13.3% of patients, respectively [difference, 3.4%; 95% confidence interval (CI), -4.8-11.5]. The groups were comparable in time to complete healing (median 7 days for both groups; hazard ratio, 1.01; 95% CI, 0.79-1.29; P = 0.95), cessation of viral shedding (median of 2 days [hazard ratio = 0.93; 95% C.I. 0.68, 1.27; p = 0.64]), and loss of lesion-associated symptoms (median 4 days; hazard ratio, 0.99; 95% CI, 0.75-1.30; P = 0.93). Similar numbers in each group withdrew because of treatment failure. There were no differences between groups in the incidence of adverse events.

Conclusions: Famciclovir given twice a day is as effective and well tolerated as high-dose acyclovir for mucocutaneous HSV infections in HIV-infected individuals, and has the convenience of less frequent dosing.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Aminopurine / adverse effects
  • 2-Aminopurine / analogs & derivatives*
  • 2-Aminopurine / therapeutic use
  • AIDS-Related Opportunistic Infections / drug therapy*
  • Acyclovir / therapeutic use*
  • Adult
  • Antiviral Agents / therapeutic use*
  • Double-Blind Method
  • Famciclovir
  • Female
  • HIV Infections*
  • HIV Seropositivity
  • Herpes Simplex / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Prodrugs / therapeutic use
  • Time Factors


  • Antiviral Agents
  • Prodrugs
  • 2-Aminopurine
  • Famciclovir
  • Acyclovir