Efficacy and safety of famciclovir for treating mucocutaneous herpes simplex infection in HIV-infected individuals

Objective: To compare the efficacy and safety of 7 days' treatment with fam ciclovir 500 mg twice a day versus acyclovir 400 mg five times a day, for m ucocataneous herpes simplex virus (HSV) infection in HIV-infected individua ls. Design: Randomized, double-blind, parallel-group study to demonstrate equiv alence 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 with in 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 sym ptoms, number of withdrawals due to treatment failure (secondary outcome me asures). Results: Equivalence was defined prospectively and famciclovir was equivale nt to acyclovir in preventing new lesion formation: new lesions occurred in 16.7% and 13.3% of patients, respectively [difference, 3.4%; 95% confidenc e 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 sym ptoms (median 4 days; hazard ratio, 0.99; 95% CI, 0.751.30; P = 0.93). Simi lar 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 tolerat ed as high-dose acyclovir for mucocutaneous HSV infections in HIV-infected individuals, and has the convenience of less frequent dosing. (C) 2000 Lipp incott Williams & Wilkins.