Interrupting the transmission of genital herpes with antivirals

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Interrupting the transmission of genital herpes with antivirals

Presented by L Corey, University of Washington, USA

Transmission of genital herpes to a sexual partner is a major concern to patients and acquiring genital herpes is a great concern to susceptible partners. Sexual transmission of genital herpes has been shown to result from both symptomatic and asymptomatic shedding of herpes simplex virus (HSV) from genital mucosa. Daily suppressive therapy with antivirals not only reduces the frequency of clinical recurrences, but also significantly reduces clinical and subclinical HSV shedding. This reduction in shedding provided the rationale for undertaking an international, randomized placebo-controlled trial to determine if daily valaciclovir suppressive therapy in the source partner could reduce genital herpes transmission to the susceptible partner in heterosexual, monogamous, HSV-2 discordant couples.

In a randomized double-blind study, HSV-2 seropositive source partners with a history of <10 episodes per year received valaciclovir 500 mg once daily or placebo for 8 months. HSV-2 seronegative susceptible partners were monitored monthly for acquisition of genital herpes. Couples were offered condoms and counselled on safer sexual behaviour at all visits. The primary endpoint was the proportion of susceptible partners with a first episode of symptomatic genital herpes (confirmed by HSV culture, PCR or seroconversion). All endpoints were ratified by an endpoints committee prior to unblinding the study.

One thousand four hundred and eighty four couples participated in the study. Seven hundred and forty one source partners received placebo and 743 received valaciclovir. 488 susceptible partners were women and 996 were men. Sixteen (2.2%) subjects in the placebo group, versus four (0.5%) in the valaciclovir group acquired symptomatic genital herpes (RR=0.25, 95% CI, 0.8, 0.74, P=0.011), a 75% reduction in risk. Twenty-seven (3.6%) of placebo- versus 14 (1.9%) of valaciclovir-treated partners transmitted genital HSV-2 infection (measured by laboratory-confirmed symptoms or seroconversion). At any time, the risk of transmitting HSV-2 infection was reduced by 48% (HR=0.52, 95% CI, 0.27, 0.99, P=0.039). Adverse events were similar in nature and frequency between treatment groups.

Once-daily valaciclovir suppressive therapy reduces the transmission of genital herpes among heterosexual HSV-2 discordant couples. This is the first randomized, controlled trial of an antiviral demonstrating a reduction in sexual transmission of an infection.

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