The present randomized, double-blind, placebo-controlled, multicenter clinical trial was designed to compare the efficacy and tolerability of
sorivudine [1-beta-D-arabinofuranosyl-E-(2-bromovinyl)
uracil] and
acyclovir for the treatment of dermatomal
herpes zoster in human immunodeficiency virus (HIV)-seropositive patients. A total of 170 HIV-seropositive adults presenting with
herpes zoster (confirmed by direct fluorescent-
antigen testing and/or viral culture) were enrolled and randomized to receive a 10-day course of orally administered
sorivudine (40 mg once daily plus
acyclovir placebos) or
acyclovir (800 mg five times daily plus
sorivudine placebo). Patients were monitored daily to document the events of cutaneous healing,
pain,
zoster-related complications, and
drug-related adverse events. Patients were reassessed on days 21 and 28 and then once monthly for 1 year. The primary efficacy endpoint was time to the cessation of new vesicle formation. Secondary efficacy endpoints included times to other events of cutaneous healing, resolution of
pain, and frequency of dissemination and
zoster recurrence. In a multivariate analysis,
sorivudine was superior to
acyclovir for reducing the times to the cessation of new vesicle formation (relative risk [RR] = 1.54, 95% confidence interval [CI] = 1.00 to 2.36; P = 0.049) and total lesion crusting (RR = 1.48, 95% CI = 1.07 to 2.04; P = 0.017). In a univariate analysis, there was a trend favoring
sorivudine for the cessation of new vesicle formation (median of 3 versus 4 days; P = 0.07) and a significant advantage for time to total lesion crusting (median of 7 versus 8 days; P = 0.02). The time to the resolution of
zoster-associated
pain, the frequency of dissemination, and the frequency of
zoster recurrence were not different between the two treatment groups. Both drugs were well tolerated.
Sorivudine is an effective
drug for the treatment of
herpes zoster in HIV-infected patients and results in accelerated cutaneous healing when compared with
acyclovir therapy.