Oral acyclovir in the treatment of genital herpes. Preliminary report of a multicenter trial.

Ninety patients with genital herpes (29 initial and 61 recurrent episodes) were entered into a double-blind randomized trial of oral acyclovir and placebo. Treatment consisted of 200 mg acyclovir five times a day for five days or matching placebo. Therapy was initiated a mean of 2.8 days and 1.0 days after onset of lesions in initial and recurrent infections respectively. The 13 culture-positive patients with initial disease who received acyclovir had a shorter median duration in days of viral shedding (1.0), pain (3.5), combined symptoms (3.5), time to crusting (3.5), and time to complete healing (5.5) than the 11 culture-positive placebo recipients whose scores were 8.0, 4.5, 4.5, 9.0, and 11.0 respectively (p less than 0.05 for all comparisons). Patients with recurrent disease receiving acyclovir also experienced a reduction in the median duration in days of viral shedding (0.5), time to crusting (men only) (3.0), and time to complete healing (5.0), compared with 2.5, 4.0, and 7.0 days, respectively, for control patients (p less than 0.01 for each variable). New lesion formation was effectively prevented by acyclovir in patients with both initial and recurrent infections (p less than 0.05). Oral acyclovir therapy was well-tolerated and shortened the course of both initial and recurrent genital herpes.