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Pre-exposure prophylaxis: increasing evidence for effectiveness but should the perspective return to test and treat?
Over 18 months after the pre-exposure prophylaxis (PrEP) initiative study1 in MSM, two double-blind placebo controlled studies examining the effect of oral PrEP in heterosexuals—Partners PrEP study2 and TDF2 study3—have recently been published. In both studies, couples received HIV prevention services comprising individual risk-reduction counselling, screening/treatment for STI and free condoms. In the Partners PrEP study, additional components included couple risk-reduction counselling, referral for male circumcision and postexposure prophylaxis in line with local guidance.
Between July 2008 and November 2012, the Partners PrEP study randomised 4747 serodiscordant couples from Kenya and Uganda in a 1 : 1 : 1 ratio to receive: (1) once daily tenofovir 300 mg (TDF); (2) once daily combination of emtricitabine 200 mg–tenofovir 300 mg (FTC–TDF); or (3) placebo. Of all the seronegative partners, 62% were male. Among those who were HIV positive, the median CD4 count was 495 cells/mm3 (IQR: 375–662) with a median plasma viral load of 3.9 log10 copies/ml. For inclusion, the seronegative partners were required to have normal renal function, not to be infected with hepatitis B, not be pregnant or breastfeeding. The positive partner was required not to be on antiretroviral therapy (ART) and not to meet local guidance for ART initiation.
Seronegative partners had monthly follow-up involving: HIV rapid antibody testing, dispensation of 30 days of study medication, collection of previous month's unused tablets, individual adherence counselling, pregnancy test for women, assessment of risk behaviour and side effects. Biochemical and haematological tests were performed at 1 month and …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.