A new multi-institutional study has examined the cost-effectiveness of the pre-exposure prophylaxis (PrEP) combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and assisted reproductive options for serodiscordant couples with an HIV-infected male and HIV-uninfected female looking to conceive. The study focused on examining scenarios in which ‘Undetectable=Untransmittable’ (’U=U’) infection, achieved with combination antiretroviral therapy, (cART) is not sufficient for conception.
Combination antiretroviral therapy and PrEP make it possible for serodiscordant couples to reduce the risk of spreading HIV infection through sexual transmission and to a child they conceive together. Investigators on the new recent study, published in the journal AIDS and led by a Vanderbilt University School of Medicine investigator, aimed to assess the value of interventions such as PrEP to reduce perinatal HIV transmission based on the effect on cumulative risks of HIV transmission to women and babies, maternal life expectancy, discounted quality-adjusted life years (QALYs), discounted lifetime medical costs, and incremental cost-effectiveness ratios (ICERs).
The investigators developed a Markov cohort simulation model to estimate the incremental benefits and cost-effectiveness of PrEP compared with alternative safer conception strategies, including combination antiretroviral therapy alone for the partner who is HIV infected, and assisted reproductive technologies including sperm wash with intrauterine insemination (SW-IUI) and in-vitro fertilization (IVF).
The study team modeled a total of 6 strategies: combination antiretroviral therapy alone with intercourse not limited to ovulation, combination antiretroviral therapy alone with intercourse limited to ovulation, combination antiretroviral therapy and generic TDF/FTC for PrEP with intercourse not limited to ovulation, combination antiretroviral therapy and generic TDF/FTC for PrEP with intercourse limited to ovulation, combination antiretroviral therapy and SW-IUI, and combination antiretroviral therapy and IVF.
The investigators used a base case analysis to develop the models, assuming the most optimal scenario of HIV suppression in the male partner. They then relaxed the assumption, varying the probability that the male partner was HIV suppressed to 75%, 50%, 25%, and 9%.
Overall, the strategies that limited unprotected intercourse to the ovulatory period provided better outcomes at a lower cost-per-QALY gained than the strategies that did not.
In cases where the male was consistently on suppressive combination antiretroviral therapy, PrEP marginally reduced the risk of sexual HIV transmission and was not economically attractive, even when assuming generic pricing. In a scenario where the male partner was not reliably HIV-suppressed and assuming generic PrEP pricing, PrEP became economically attractive and with lower cART adherence, the value of PrEP increased. In addition, PrEP was a favorable strategy even at higher than generic pricing when the male partner was not HIV suppressed.
While SW-IUI and IVF had better protective effects against HIV transmission than PrEP strategies, both were expensive and had an unappealing ICER compared to the next best strategy.
“With the availability of PrEP, the reproductive landscape has changed and priorities have shifted for serodiscordant couples seeking conception,” the study’s authors wrote. “Although PrEP is not a high-value intervention for all women seeking to conceive a baby with an HIV-infected male partner, it is a cost-effective, and potentially cost-saving, option in scenarios in which partners are not reliably on combination antiretroviral therapy.”