Multicenter review of protease inhibitors in 89 pregnancies

Context: Despite the success of highly active antiretroviral therapy, the o ptimal approach for preventing perinatal HIV-1 transmission is not known. Objective: A retrospective survey was conducted at six centers in the Unite d States and Puerto Rico from January 1997 to October 1998 to evaluate the effects of protease inhibitor use during pregnancy on maternal and infant s afety, prematurity rate, and frequency of perinatal HIV-1 transmission. Results: In the study, 91 live infants, including 3 sets of twins, and 1 ne onate who died shortly after birth were born to 89 women. HIV perinatal tra nsmission rate in this series was 0 (95% confidence interval [CI], 0%-3%). Prematurity rate was 19.1%, comparable to rates in earlier reports of HIV-1 -infected women. In multiple regression analysis, only cocaine use and prem ature rupture of membranes were associated with prematurity (p =.03 and .00 8, respectively). The gestational week during which the protease inhibitors were initiated was not found to be significantly associated with prematuri ty, Adverse maternal, obstetric, and infant events possibly related to prot ease inhibitors were uncommon. Conclusions: Protease inhibitors appeared generally safe in mothers and inf ants in this series. No perinatal HIV-1 transmission occurred. Further pros pective, controlled studies are needed to define the optimal management of HIV-1 in pregnancy.