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Forty patients presenting with first episode genital herpes were randomly allocated to seven day treatment with oral acyclovir alone, placebo alone, oral acyclovir plus co-trimoxazole, or placebo plus co-trimoxazole. Patients receiving acyclovir had significantly shorter periods of viral shedding (p less than 0.001), pain (p = 0.03), and times to lesion healing (p less than 0.05). Averaged over all patients there was no evidence that co-trimoxazole affected any of the variables, though in women cotrimoxazole was associated with a shorter time to lesion healing (p less than 0.01). Furthermore, the combination treatment gave significantly shorter times to lesion healing than acyclovir alone, placebo alone, or placebo and co-trimoxazole (p = 0.01) and good trends elsewhere (external lesions and duration of pain). Neither drug was associated with any adverse events or toxicity or influenced the subsequent recurrence rate.

Fifty-three patients with first episodes and 60 patients with prior culture proven recurrent genital herpes were enrolled in a single centre, double-blind, placebo-controlled trial of 5% acyclovir in an aqueous cream base versus matching placebo. For first episodes treated with topical acyclovir the median duration of pain (4 vs. 8 days, P less than 0.05), time to healing of all lesions (8 vs. 14 days, P less than 0.001), duration of viral shedding (4 vs. 11 days, P = 0.001) and duration of new lesion formation (0 vs. 2.5 days, P less than 0.001) were reduced compared with placebo recipients. In patients with recurrent episodes who completed the study topical acyclovir significantly reduced the median duration of all symptoms (3 vs. 6 days, P less than 0.001), the time to healing of all lesions (4 vs. 6 days, P less than 0.01), and the formation of new lesions (5 vs. 29%, P less than 0.01) compared with the controls. Greater clinical benefits were demonstrated in females than in males, particularly for first episodes, but the number of males was small. Topical acyclovir cream is well tolerated and an effective treatment for first and recurrent episodes of genital herpes.

Virus isolates from 55 patients with recurrent or first-episode genital herpes, treated with various formulation of acyclovir, were tested for their susceptibility to the drug. In all but one of these patients pre-treatment isolates were available for comparison with later isolates. In none of patients, even those receiving long-term prophylaxis, was the susceptibility of the post-treatment isolates significantly reduced.

77 patients with a first attack of genital herpes were entered into a double-blind trial to compare the efficacy of acyclovir with that of inosine pranobex. 24 patients received acyclovir with that of inosine pranobex, and 28 both drugs. Patients treated with acyclovir or both drugs healed more quickly and had a shorter duration of viral shedding than those treated with inosine pranobex. The time to first recurrence and frequency of subsequent recurrences were similar in the three treatment groups. Acyclovir is the treatment of choice for patients with a first attack of genital herpes.

Fifty patients presenting with first episode genital herpes were randomly allocated to seven day treatment with either oral acyclovir plus 5% acyclovir cream or oral acyclovir plus matching placebo cream. Combined treatment with oral and topical acyclovir was associated with a shorter duration of itching in women alone (p = 0.04) but gave no clinical relief of other symptoms, the time to healing of lesions, or the subsequent recurrence rate. Concomitant topical treatment with 5% acyclovir cream confers no advantages on patients who receive oral acyclovir.

The effect of topical acyclovir treatment of first episode genital herpes on the time to first recurrence in a group of 42 patients receiving either acyclovir or placebo was investigated. Topical acyclovir treatment had no effect on time to first recurrence in patients with either first episode HSV-1 or HSV-2 infections. There was no significant difference in the time to first recurrence in patients with either true primary or initial genital infections. However, the time to first recurrence in patients with first episode HSV-2 was significantly shorter than in patients with first episode HSV-1. Acyclovir treatment appeared to have no effect on the development of neutralising antibody in patients with either virus type.

Forty patients were entered into a randomised placebo controlled crossover study to assess the efficacy and safety of oral acyclovir 200 mg four times a day in the prophylaxis of recurrent genital herpes. Each treatment began during a recurrence and continued for a maximum of 84 days or until the onset of the next recurrence, when the alternate medication was started. Of 28 patients who completed both treatment courses, only three developed a recurrence while taking acyclovir compared with 26 while taking placebo. The mean time to first recurrence was more than 84 days in patients receiving acyclovir and 24 days in patients receiving placebo (p less than 0.001). The mean time to first recurrence after treatment with acyclovir ceased was 16 days. Adverse events, though thought unlikely to be related to treatment, necessitated the withdrawal from the study of two patients while taking acyclovir and one patient while taking placebo. No clinically important effects on haematological or biochemical variables occurred during the acyclovir treatment. All viral isolates tested after treatment remained sensitive to acyclovir. Acyclovir prophylaxis of recurrent genital herpes is effective and safe but does not appear to influence the natural history of the disease after cessation of 84 days' continuous treatment.