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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety of efavirenz in first-trimester of pregnancy: A systematic review and meta-analysis of outcomes from observational cohorts
AIDS, Volume 24, No. 10, Year 2010
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Description
Introduction: Data on efavirenz safety in first trimester pregnancy are conflicting. We conducted a systematic review and meta-analysis of the available evidence from observational cohorts. Methods: We ran duplicate searches of databases (up to 02 January, 2010) and searchable websites of major HIV conferences (up to February, 2010) to identify observational cohorts reporting birth outcomes among women exposed to efavirenz during the first trimester of pregnancy. Our primary endpoint was birth defects of any kind; secondary outcomes were spontaneous abortions, termination of pregnancy, stillbirths, and preterm delivery. Results: Sixteen studies met our inclusion criteria, comprising 11 prospective cohorts and five retrospective reviews. Nine prospective studies reported on rates for birth defects both among women exposed to efavirenz-containing regimens (1132 live births) and non-efavirenz- containing regimens (7163 live births) during first trimester, giving a pooled, nonsignificant relative risk of 0.87 [95% confidence interval (CI) 0.61-1.24%, P = 0.45]. Low heterogeneity was observed between studies (I = 0, 95% CI 0-56.3%, P = 0.85). Across all studies (1256 live births), one neural tube defect (meningomyelocele) was observed with first trimester efavirenz exposure, giving a prevalence of 0.08% (95% CI 0.002-0.44%). Conclusion: We found no increased risk of overall birth defects among women exposed to efavirenz during the first trimester of pregnancy compared with exposure to other antiretroviral drugs. Prevalence of overall birth defects with first trimester efavirenz exposure was similar to the ranges reported in the general population. However, the limited sample size for detection of rare outcomes such as neural tube defects prevents a definitive conclusion. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Ford, Nathan P.
Unknown Affiliation
Mofenson, Lynne M.
Unknown Affiliation
Kranzer, Katharina A.
Unknown Affiliation
Medu, Lanre
Unknown Affiliation
Frigati, Lisa Jane
Unknown Affiliation
Mills, Edward J.
Unknown Affiliation
Calmy, Alexandra L.
Unknown Affiliation
Statistics
Citations: 138
Authors: 7
Affiliations: 8
Identifiers
Doi:
10.1097/QAD.0b013e32833a2a14
e-ISSN:
14735571
Research Areas
Genetics And Genomics
Infectious Diseases
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Systematic review
Participants Gender
Female