Data published in JAMA Network Open suggest that prescribing practices of antiretroviral therapy (ART) in pregnant women living with HIV in the United States do not align optimally with national guidelines. In this prospective cohort study including data from 1867 pregnancies in 1582 women living with HIV, 49.5% were associated with prescribed ART designated as preferred or alternative.
The cohort was drawn from women enrolled in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART Toxicities (SMARTT) study, which was conducted between January 1, 2008, and June 30, 2017.
According to investigators, 26.4% of pregnancies involved ART with insufficient evidence for use during pregnancy and another 7.3% that were not recommended during pregnancy. They also found that compared with women resuming ART or women treated with ART before conception, a higher percentage of pregnant women initiating ART for the first time were prescribed preferred or alternative ART (316 of 452 [69.9%] vs 325 of 625 [52.0%] vs 284 of 790 [35.9%]; P <.001). Of the women who initiated ART during pregnancy, 20.1% were prescribed ART with insufficient evidence for use during pregnancy or not recommended to receive ART during pregnancy. Of the women resuming ART, women with viral loads greater than 1000 copies/mL early in pregnancy had higher odds of being prescribed guideline-recommended ART (adjusted odds ratio, 2.03; 95% CI, 1.33-3.10) compared with women whose viral load was 400 copies/mL or less.
Despite the robust and detailed data provided by using women enrolled in the SMARTT study, the fact that SMARTT sites are based primarily at academic institutions limits the generalizability of the results. Also, investigators did not have access to data that would have prompted clinicians to prescribe non-preferred or alternative regimens. A 3-month lag time after the updated guidelines were released was assumed before clinician prescribing practices changed and investigators believe that academic institutions may disproportionately adopt revised guidelines more quickly. However, the 63 prescriptions for ART regimens categorized as insufficient evidence for use during pregnancy in treatment-naïve women occurred within 90 days of updated guidelines. Therefore, it was concluded that this reflects early adoption and suggests that “identified variances between prescribing practices and guidelines were not associated with the 3-month lag that we selected for analysis purposes.”
Investigators also excluded data from 433 pregnancies because data on the use of ART prior to the current pregnancy were not available. This precluded the differentiation between women resuming ART and women newly initiating treatment. Furthermore, they speculated that since 89.9% of these pregnancies occurred before 2010 and prior to the collection of information on the use of ART prior to the current pregnancy, “a higher percentage of these women were likely prescribed a preferred or alternative regimen because the earlier guideline periods were associated with prescribing patterns more closely aligned with guideline recommendations.”
The use of ART in pregnant women must balance efficacy of preventing perinatal transmission and safety of both the mother and fetus. Therefore, the US Perinatal Antiretroviral Medication Treatment guidelines need continual updating in response to new evidence based safety and efficacy outcomes. According to investigators, this study demonstrates a discordance between guideline recommendations and actual practices. While this may reflect the fact that pregnant women are excluded from clinical trials, the findings “highlight the importance of conducting quantitative and qualitative research to better understand the extent to which individual, social, institutional, and structural determinants are associated with prescribing practices that do not align with guideline recommendations.”
Powis KM, Huo Y, Williams PL, et al. Antiretroviral prescribing practices among pregnant women living with HIV in the United States, 2008-2017. JAMA Netw Open. 2019;2:e1917669.