4th International AIDS Society Conference on HIV Pathogenesis and Treatment Sydney, Australia - July 22 - 25, 2007

IMPACT OF HSV-2 SUPPRESSIVE THERAPY ON HIV INCIDENCE IN HSV-2 SEROPOSITIVE WOMEN: A RANDOMISED CONTROLLED TRIAL IN TANZANIA

IAS Conf HIV Pathog Treat 2007 Jul 22-25;4th: Abstract No. MOAC104

Watson-Jones D.¹, Rusizoka M.¹, Weiss H.², Mugeye K.¹, Baisley K.³, Changalucha J.³, Everett D.³, Tanton C.², Clayton T.², Ross D.², Hayes R.^2
1African Medical & Research Foundation, Mwanza, Tanzania, United Republic of, ²London School of Hygiene & Tropical Medicine, London, United Kingdom, ³National Institute of Medical Research, Mwanza, Tanzania, United Republic of

OBJECTIVES: New strategies are needed for HIV prevention in Africa. Recent randomized controlled trials have shown an impact of Herpes simplex virus (HSV) suppressive therapy on HIV-1 genital and plasma viral load. The aim of our study was to determine the impact of suppressive therapy on HIV incidence among women at high risk of infection in northern Tanzania.

METHODS: We conducted a randomized, double-blind, placebo-controlled trial of acyclovir (ACV) suppressive treatment (400 mg BD) among initially HIV-seronegative, HSV-2 seropositive women in northern Tanzania. Women working in bars, guesthouses and similar facilities were followed through mobile clinics every 3 months for up to 30 months and provided with safe sex counseling, condoms, health checks, syndromic STI care and were offered VCT. The primary analysis is modified intention-to-treat, where women are withdrawn from treatment and censored at pregnancy diagnosis.

RESULTS: 820 HIV-seronegative women were enrolled in three phases and randomized to ACV or placebo. Follow-up will be completed in Apr 2007. By Jan 2007, attendance at 30 months was 76%. To date, 25% have been withdrawn from study tablets, mainly because of pregnancy. At the 6, 12, 24 and 30 month visits, 79%, 72%, 59% and 54% of women attended and were on study tablets, respectively. Of those, >75% of tablets had been taken in the preceding 3 months by 76%, 81%, 84% and 80% of women, respectively. To date there have been 47 seroconversions, corresponding to an overall HIV incidence rate of 3.8 per 100/py.

CONCLUSIONS: The impact of suppressive therapy on HIV incidence up to 30 months follow-up will be presented. Preliminary analysis suggests that adherence assessed by tablet counting improved and then fell with time. Pregnancy is the main reason for withdrawal from study tablets.

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2007-07-22
MOAC104
STI Treatment for HIV Prevention

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