Single-Day, Patient-Initiated Famciclovir Therapy for Recurrent Genital Herpes: A Randomized, Double-Blind, Placebo-Controlled Trial
January 11, 2006
Orally administered antiviral therapy for recurrent genital herpes outbreaks has traditionally consisted of twice-daily dosing for five days, the authors noted. However, recent studies have shown the effectiveness of shorter courses. The current study assessed the safety and efficacy of a patient-initiated, single-day regimen of famciclovir (1000 mg twice-daily) in comparison with placebo among immunocompetent adult patients with recurrent genital herpes.
The parallel-group trial was placebo-controlled, multicenter, multinational, randomized and double-blind. Patients were instructed to initiate therapy within six hours after onset of prodromal symptoms or genital herpes lesions.
Participants taking famciclovir reduced (P<0.001) the time for healing nonaborted lesions (i.e., those that did not progress beyond papule stage) to a median 4.3 days, compared to 6.1 days among the control group. Healing time was also reduced to a median 3.5 days for all aborted and nonaborted lesions, compared to a median 5 days for the placebo group. Moreover, the proportion of famciclovir patients with aborted lesions was larger than the proportion among the placebo group (23.3 percent vs. 12.7 percent; P = 0.003). Adverse events among the famciclovir group were infrequent, most of mild-to-moderate severity, and events were similar to those observed in the control group.
"A single-day regimen of patient-initiated famciclovir treatment was well tolerated and safe, and the healing of recurrent genital herpes lesions occurred on average two days faster than with placebo," researchers concluded. "Moreover, single-day famciclovir treatment stopped the development or progression of lesions beyond the papule stage. This convenient single-day regiment has the potential for improving patient compliance and satisfaction with therapy."
Clinical Infectious Diseases
01.01.06; Vol. 42; No. 1: P. 8-13; Fred Y. Aoki; Stephen Tyring; Francisco Diaz-Mitoma; Gerd Gross; Joseph Gao; Kamal Hamed
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