Long-term impact of acyclovir suppressive therapy on genital and plasma HIV RNA in Tanzanian women: A randomized controlled trial

Clare Tanton, Helen A. Weiss, Mary Rusizoka, Jerome Legoff, John Changalucha, Kathy Baisley, Kokugonza Mugeye, Dean Everett, Laurent Belec, Tim C. Clayton, David A. Ross, Richard J. Hayes, Deborah Watson-Jones

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25 Scopus citations

Abstract

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 [41.3%] of 213 vs 84 [44.0%] 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 3≥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.

Original languageBritish English
Pages (from-to)1285-1297
Number of pages13
JournalJournal of Infectious Diseases
Volume201
Issue number9
DOIs
StatePublished - 1 May 2010

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