Long‐Term Impact of Acyclovir Suppressive Therapy on Genital and Plasma HIV RNA in Tanzanian Women: A Randomized Controlled Trial

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Abstract
(See the editorial commentary by Baeten, on pages 1279–1281.) Background. Herpes simplex virus (HSV) suppressive therapy reduces genital and plasma human immunodeficiency virus type 1 (HIV-1) RNA over periods up to 3 months, but the long-term effect is unknown. Methods. A total of 484 HIV-1 and HSV type 2 seropositive Tanzanian women aged 16–35 years were enrolled in a randomized placebo-controlled trial of acyclovir administered at a dosage of 400 mg twice daily. Cervicovaginal lavage and blood samples were collected at 6 months, 12 months, and 24 months for quantification of genital and plasma HIV-1 RNA and genital HSV DNA. Primary outcomes were detection and quantity of cervicovaginal HIV-1 RNA at 6 months. Results. At 6 months, there was little difference between the acyclovir and placebo arms for cervico-vaginal HIV-1 RNA detection (88 [41%]of 213 vs 84 [44%] of 191; odds ratio [OR], 0.90; 95% confidence interval [CI], 0.60–1.33), HSV DNA detection (20 [9.4%] of 213 vs 22 [11.5%] of 191; OR, 0.80; 95% CI, 0.42–1.51), genital HIV or HSV loads, or plasma HIV-1 RNA load. Estimated median adherence was 91%. There was a suggestion of an impact on cervico-vaginal HIV-1 RNA detection among women with estimated adherence ⩾90% (OR, 0.74; 95% CI, 0.50–1.09) when data from all 3 visits were included. Conclusions. Acyclovir administered at a dosage of 400 mg twice daily is unlikely to be a useful long-term intervention to reduce HIV transmission. The lack of effect on HIV may be attributable to suboptimal adherence or treatment regimen. Clinical trial registration. Current Controlled Trials registration no.: ISRCTN35385041.

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