Valacyclovir for herpes in HIV

Nurse Practitioner, Aug 2003

GlaxoSmithKline's valacyclovir HCI (Valtrex) caplets have received FDA approval for the suppression of recurrent genital herpes in HIV-infected people. The drug is the first and only antiviral approved for this indication. Valacyclovir is also indicated for the initial and recurrent treatment and for the suppression of genital herpes outbreaks in immunocompetent individuals.

FDA approval was based on a randomized, double-blind, placebo-controlled study of 293 HIV-positive patients on antiretroviral therapy for at least 2 months prior to randomization. The study followed the patients, all of whom had a history of recurrent genital herpes. Patients received either valacyclovir 500 mg twice daily or placebo. The primary endpoint was the proportion of patients free of genital herpes recurrences for the duration of the study. After 6 months, the proportion of patients taking valacyclovir who were recurrence-free was 65%, compared with 26% of those receiving placebo. Median time to first recurrence was greater than 180 days for patients receiving valacyclovir compared with 59 days for those receiving placebo.

The most common adverse events in the study were headache, fatigue, and rash.

According to the medication's labeling, valacyclovir is intended for suppression of genital herpes in HIV-infected adults with CD4 counts above 100 cells/[mu]L. The safety and efficacy of the medication in HIV-infected adults with CD4 counts below 100 cells/[mu]L, have not been established.