The above

position statement by BHIVA and EAGA summarizes extensive discussion about various aspects of the scientific data and it was felt that some explanatory notes would be helpful, particularly where there are areas of controversy. The mechanisms by which Ipilimumab manufacturer condoms and ART prevent HIV transmission are fundamentally different. Condoms prevent contact with genital fluids and their efficacy is reduced by factors that compromise the integrity of the physical barrier, such as non-use, slippage and breakage. ART prevents HIV transmission by stopping viral replication and lowering the amount of virus within the genital compartment; its value will be reduced by nonadherence, poor absorption and the presence of other STIs. The observed reduction in HIV transmission between couples (assumed to be having vaginal sex) in the HIV prevention trials network (HPTN) 052 trial [1] was 96%, when the HIV-positive partner took ART. We do not yet know, however, how ART use affects HIV transmission between couples in ‘real-world’ Alectinib concentration settings outside a clinical trial. Conversely, there has never been a randomized controlled trial of the efficacy of condom use vs. no use. However, several meta-analyses of observational

and cohort studies of HIV infection in couples who maintained 100% condom use have found that this strategy is about 80% (79–93%) effective in reducing HIV infections [2]. It must be noted, though, that it is not possible to make a direct comparison of these two strategies: HPTN 052 was a prospective randomized controlled trial enrolling HIV-serodiscordant couples where

HIV transmission was the primary outcome, whereas the condom evaluation was a meta-analysis of multiple observational studies, and as such may underestimate the (-)-p-Bromotetramisole Oxalate effect of condoms. BHIVA and EAGA believe that giving an actual figure for the risk of transmission for one episode of sex in a serodiscordant couple is not currently meaningful for an individual and that any figure proposed would be misleading, for the reasons outlined below. In the absence of such a figure, BHIVA and EAGA have therefore adopted the term ‘extremely low’ whilst recognizing the difficulty inherent in the imprecise nature of such a term. The studies conducted to date in heterosexual serodiscordant couples indicate that there have been no confirmed transmissions from people whose HIV infection is virologically undetectable (< 50 copies/mL). The small number of documented HIV transmissions in these studies occurred from HIV-positive individuals who had only recently started therapy and in whom, therefore, it is unlikely that an undetectable HIV viral load had been achieved or sustained for the 6-month time period recommended by this statement. However, to be certain that the risk of transmission approaches zero in defined circumstances, a much larger number than the 1763 serodiscordant couples enrolled in HPTN 052 would have to be studied.