Use of antiretroviral therapy in pregnant HIV-infected women and the risk of premature delivery: a meta-analysis.

BACKGROUND: The use of antiretroviral agents in pregnant HIV-infected women has been reported to increase the risk of premature delivery in some studies. We performed a meta-analysis on relevant studies to address this question.

METHODS: We searched Medline, Embase and the Cochrane Controlled Clinical Trials Register for English language articles. Studies that reported premature delivery for HIV-infected women treated with antiretroviral regimens during pregnancy were selected. Meta-analyses were performed using a random effects model.

RESULTS: Thirteen prospective cohorts and one retrospective study met the inclusion criteria. Antiretroviral therapy during pregnancy did not increase the risk of premature delivery overall [odds ratio (OR) 1.01, 95% confidence interval (CI) 0.76-1.34]. In subgroup analyses, compared with no therapy, monotherapy (mostly zidovudine) conferred an OR of 0.86 (95% CI 0.73-1.01), whereas combination therapy conferred an OR of 1.13 (95% CI 0.79-1.63). The use of protease inhibitor (PI)-containing combinations resulted in an OR for premature delivery of 1.24 (95% CI 0.76-2.02), compared with combinations without PI. The initiation of combination therapy before pregnancy or in the first trimester resulted in an OR of 1.71 (95% CI 1.09-2.67) compared with therapy initiation in the second trimester and beyond. There was a large degree of heterogeneity between studies.

CONCLUSION: Evidence indicates that antiretroviral therapy during pregnancy is not associated with an overall increased risk of premature delivery. The use of combination regimens before or early in pregnancy may slightly increase the risk of prematurity. Continued surveillance will be necessary to quantify such a risk accurately.