Antiretrovirals and Pregnancy Risk
Don’t drink when you are pregnant, we all know that you aren’t supposed to do that. We also know you shouldn’t smoke, use drugs, and should talk to your Doctor about what medications you are taking while pregnant. So then what about when your husband is HIV positive and you want to get pregnant, are antiretrovirals safe to be using while a woman is pregnant? As it turns out, there is no real research on it, and the answer might be a little harder to get at.
Among heterosexual African couples in which the male was HIV positive and the female was not, receipt of antiretroviral pre-exposure preventive [PrEP] therapy did not result in significant differences in pregnancy incidence, birth outcomes, and infant growth compared to females who received placebo, according to a study. That was the general consensus based on the data, but as you will see later on, it is not that simple. The authors note that these findings do not provide a definitive conclusion regarding the safety of PrEP therapy prior to pregnancy.
Antiretroviral pre-exposure prophylaxis as daily oral tenofovir disoproxil fumarate [TDF] and co-formulated emtricitabine/tenofovir disoproxil fumarate [Which is infact it’s own drug, this is not redundant, it is a fixed amount of FTC+TDF] has been demonstrated to be efficacious for the prevention of human immunodeficiency virus [otherwise known as HIV] acquisition in diverse populations. PrEP could be an important component of safer conception strategies for women at risk for HIV infection, including those in HIV-serodiscordant couples [ in other words when only one member is HIV infected], but the effect on pregnancy outcomes is not well defined.
The researchers conducted further follow-up of the Partners PrEP Study, a randomized, placebo-controlled trial of PrEP for HIV prevention among HIV-serodiscordant couples. This study was conducted between July 2008 and June 2013. For this analysis, which included 1,785 couples in Kenya and Uganda, the researchers assessed pregnancy incidence and outcomes among women using PrEP during the periconception period. Females had been randomized to daily oral TDF (n = 598), combination FTC+TDF (n = 566), or placebo (n = 621) through July 2011, when PrEP demonstrated efficacy for HIV prevention. After that, participants continued receiving active PrEP without placebo.
During the research period a total of 431 pregnancies occurred. The team found that pregnancy incidence did not differ significantly by study group. They also found that there was no statistically significant association between women receiving PrEP and those receiving placebo and the occurrence of pregnancy losses, which was 42.5 percent for women receiving FTC+TDF, 32.3 percent for those receiving placebo, and 27.7 percent for those receiving TDF alone. After July 2011 [when the placebo group was discontinued], the frequency of pregnancy loss was 37.5 percent for FTC+TDF and 36.7 percent for TDF alone.
Another point of data to note, the occurrence of preterm birth, congenital anomalies, kidney function and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo.
The authors write that for some outcomes, including pregnancy loss, preterm birth, congenital anomalies, and infant mortality, confidence intervals were wide [ which means that there is uncertainty in the result and that more data should be collected], including both a null effect and potential harm, and thus definitive statements about safety of PrEP in the periconception period cannot be made.
The researchers also suggest that these results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant. Since there is little data to go off of other than this study it is hard to make claims like, yes, it is safe or no, it is not safe. Something to keep in mind is that the study is the only real one of it’s kind. The numbers from the control [placebo] group and the groups on FTC+TDF or TDF alone weren’t statistically significant enough to say with confidence the result.
In other words, hopefully this will not be the only study of it’s kind for long.
Want the full study? As always you can find that —here!
Mugo NR, Hong T, Celum C, Donnell D, Bukusi EA, John-Stewart G, Wangisi J, Were E, Heffron R, Matthews LT, Morrison S, Ngure K, Baeten JM, & for the Partners PrEP Study Team (2014). Pregnancy Incidence and Outcomes Among Women Receiving Preexposure Prophylaxis for HIV Prevention: A Randomized Clinical Trial. JAMA : the journal of the American Medical Association, 312 (4), 362-371 PMID: 25038355