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Outcomes Following Pregnancy Conception on Antiretroviral Therapy: A Call for More Data.

Any discussion of the safety of maternal antiretroviral treatment (ART) in pregnancy must emphasize the remarkable benefits of ART for maternal health and for reducing mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV). As an increasing number of women of childbearing potential conceive on a wide array of antiretroviral regimens in the universal treatment era, however, researchers have appropriately moved their focus from MTCT prevention to evaluating the impact of the timing and type of antiretroviral regimen on pregnancy outcomes (which include spontaneous abortion, stillbirth, preterm delivery, or low birth weight/small for gestational age). Many studies have evaluated the association between ART initiation (and regimen) in pregnancy, and adverse pregnancy outcomes. Several studies have described pregnancy outcomes such as preterm delivery and low birth weight (or small for gestational age) among mothers who took ART from conception [1–7]. However, there is little published information regarding spontaneous abortion (pregnancy loss prior to 20 weeks’ gestation) with ART from conception [5]. This situation has arisen in part because it is challenging to collect accurate information on early pregnancy events such as spontaneous abortion in women conceiving on ART. We therefore commend Risa Hoffman and her colleagues for evaluating the combined rate of spontaneous abortion or stillbirth among women who became pregnant during follow-up in the Promoting Maternal and Infant Survival Everywhere (PROMISE) study, and describing these results in this issue of Clinical Infectious Diseases. Using prospectively collected data from the “HAART [highly active ART] Standard” component of PROMISE, the authors made inference regarding risk of pregnancy loss based on (1) whether women took ART during conception, and (2) whether women received protease inhibitor (PI)– or nonnucleoside reverse transcriptase inhibitor (NNRTI)–based regimens at conception. They found that women who had previously been randomized to continue (vs discontinue) ART postpartum had higher rates of the combined adverse pregnancy endpoint. In an “as-treated” analysis (which categorized women according to whether or not they actually received a 3-drug ART at the time of conception), the association trended in the same direction, but was not statistically significant. In women who had been previously randomized to continue ART, conceiving while taking an NNRTI (either efavirenz or rilpivirine) was associated with occurrence of spontaneous abortion or stillbirth compared with taking PI-based ART at the time of conception; this finding was not replicated among women in the other randomized arm, nor in both groups (all women) combined. An association between NNRTIs and spontaneous abortion has not been previously described, to our knowledge. A recently published study showed similar rates of spontaneous abortion or stillbirth in women conceiving on NNRTIvs PI-based ART in a secondary analysis of pooled data from several AIDS Clinical Trials Group trials [5]. Hoffman et al conducted several additional analyses (modified intent-to-treat; crossovers removed; as-treated; and time-updated), to account for changes in ART use in the periconception period. These analyses were intended to address “crossover” of women between arms (ie, stopping ART in the continued ART arm and starting ART in the stop ART arm), as well as the initiation of ART after conception. As the authors acknowledge, these analyses have several inherent limitations. Although these data derived from follow-up of subjects who participated in a randomized study, they might be considered more observational in nature in that issues of selection bias, confounding, and nonadherence to the originally randomized treatment strategy arise in analysis. The second pregnancy experienced by women in the study occurred following randomization, and may have depended on behavior altered by randomization. Women crossed over from one study arm to another for different reasons: women who were randomized E D I T O R I A L C O M M E N T A R Y