The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention.

OBJECTIVES To compare the potential impact of rectal (RMB), vaginal (VMB) and bi-compartment (RVMB) (applied vaginally and protective during vaginal and anal intercourse) microbicides to prevent HIV in various heterosexual populations. To understand when a RMB is as useful than a VMB for women practicing anal intercourse (AI). METHODS Mathematical model was used to assess the population-level impact (cumulative fraction of new HIV infections prevented (CFP)) of the three different microbicides in various intervention scenarios and prevalence settings. We derived the break-even RMB efficacy required to reduce a female's cumulative risk of HIV infection by the same amount than a VMB. RESULTS Under optimistic coverage (fast roll-out, 100% uptake), a 50% efficacious VMB used in 75% of sex acts in population without AI may prevent ∼33% (27, 42%) new total (men and women combined) HIV infections over 25 years. The 25-year CFP reduces to ∼25% (20, 32%) and 17% (13, 23%) if uptake decreases to 75% and 50%, respectively. Similar loss of impact (by 25%-50%) is observed if the same VMB is introduced in populations with 5%-10% AI and for RR(RAI)=4-20. A RMB is as useful as a VMB (ie, break-even) in populations with 5% AI if RR(RAI)=20 and in populations with 15%-20% AI if RR(RAI)=4, independently of adherence as long as it is the same with both products. The 10-year CFP with a RVMB is twofold larger than for a VMB or RMB when AI=10% and RR(RAI)=10. CONCLUSIONS Even low AI frequency can compromise the impact of VMB interventions. RMB and RVMB will be important prevention tools for heterosexual populations.