3rd Conference on Retroviruses and Opportunistic Infections Washington, DC - January 28-February 1, 1996

Conf Retroviruses Opportunistic Infect 1996 Jan 28-Feb 1; 3rd:55 (abstract no. 13)

Schacker T, Shaughessy M, Barnum G, Selke S, Zeh J, Corey L
University of Washington Seattle, WA.

To determine the efficacy of Famciclovir for suppression of anogenital HSV-2 reactivation in HIV infected persons, we enrolled 42 HIV+/HSV2+ persons (40 males and 2 females), followed ≥14d into a double-blind placebo-controlled crossover study of Famciclovir (500 mg twice daily) vs. placebo for 8 weeks followed by a 7 day washout period and 8 weeks of the alternate substance. Subjects performed daily home cultures of the oropharynx, genitals, and rectum every day for 17 weeks and recorded presence or absence of lesions and drug compliance in a daily diary. There was no difference in demographic back-ground stage of HIV disease,CD4 cell count at entry, or compliance record between persons initially randomized to the Famciclovir/placebo (group 1) vs. those initially randomized to the Placebo/Famciclovir (group 2). In the initial phase of the trial the median days of follow-up was 56 (range 18-64) and HSV cultures were performed from all 3 sites a median of 55 days (range 18-61). Results were similar during phase 2. In the intent to treat analysis of time prior to crossover, 4/21 (19%) on Famciclovir vs 13/21 (62%) on placebo reactivated HSV (p<.02), the overall shedding rate was 8/1035 (0.8%) days vs. 98/1090 (9.0%) days, respectively (p<.01). Among the 29 patients who participated in the crossover design the overall HSV shed rate (total culture positive days/total culture days) was 8.5% (134/1570) on placebo vs. 1.2% (18/1554) on Famciclovir. The subclinical anogenital HSV shed rate (days of positive culture/days of culture with no lesions) was 5.5% (76/1379) on placebo vs. 1.0% (16/1489) on Famciclovir. Among these 29 subjects, Famciclovir therapy was associated with significantly less overall HSV shedding, subclinical HSV shedding, and days of reported lesions. Suppressive therapy with Famciclovir at 500 mg PO BID x 8 weeks is safe, well tolerated and effective in significantly reducing clinical and subclinical HSV reactivation in HIV infected persons.

960128
13

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