Antiretroviral Therapy during Pregnancy and the Risk of an Adverse Outcome
Ruth E. Tuomala, M.D., David E. Shapiro, Ph.D., Lynne M. Mofenson, M.D., Yvonne Bryson, M.D., Mary Culnane, M.S., C.R.N.P., Michael D. Hughes, Ph.D., M.J. O'Sullivan, M.D., Gwendolyn Scott, M.D., Alice M. Stek, M.D., Diane Wara, M.D., and Marc Bulterys, M.D., Ph.D.
Background Some studies suggest that combination antiretroviraltherapy in pregnant women with human immunodeficiency virustype 1 (HIV-1) infection increases the risk of premature birthand other adverse outcomes of pregnancy.
Methods We studied pregnant women with HIV-1 infection who wereenrolled in seven clinical studies and delivered their infantsfrom 1990 through 1998. The cohort comprised 2123 women whoreceived antiretroviral therapy during pregnancy (monotherapyin 1590, combination therapy without protease inhibitors in396, and combination therapy with protease inhibitors in 137)and 1143 women who did not receive antiretroviral therapy.
Results After standardization for the CD4+ cell count and useor nonuse of tobacco, alcohol, and illicit drugs, the rate ofpremature delivery (<37 weeks of gestation) was similar amongthe women who received antiretroviral therapy and those whodid not (16 percent and 17 percent, respectively); the rateof low birth weight (<2500 g) was 16 percent among the infantsborn to both groups; and the rate of very low birth weight (<1500g) was 2 percent for the group that received antiretroviraltherapy and 1 percent for the group that did not. The ratesof low Apgar scores (<7) and stillbirth were also similaror the same in the two groups. After adjustment for multiplerisk factors, combination antiretroviral therapy was not associatedwith an increased risk of premature delivery as compared withmonotherapy (odds ratio, 1.08; 95 percent confidence interval,0.71 to 1.62) or delivery of an infant with low birth weight(odds ratio, 1.03; 95 percent confidence interval, 0.64 to 1.63).Seven of the women who received combination therapy with proteaseinhibitors (5 percent) had infants with very low birth weight,as compared with nine women who received combination therapywithout protease inhibitors (2 percent) (adjusted odds ratio,3.56; 95 percent confidence interval, 1.04 to 12.19).
Conclusions As compared with no antiretroviral therapy or monotherapy,combination therapy for HIV-1 infection in pregnant women isnot associated with increased rates of premature delivery orwith low birth weight, low Apgar scores, or stillbirth in theirinfants. The association between combination therapy with proteaseinhibitors and an increased risk of very low birth weight requiresconfirmation.
Source Information
From the Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, and the Women and Infants Transmission Study (R.E.T.); the Pediatric AIDS Clinical Trials Group Statistical and Data Management Center (D.E.S., M.D.H.), Pediatric AIDS Clinical Trials Group Study 076 (D.E.S.), and the Center for Biostatistics in AIDS Research, Harvard School of Public Health (D.E.S., M.D.H.), Boston; the Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, Rockville, Md., and Pediatric AIDS Clinical Trials Group Study 185 (L.M.M.); the Department of Pediatrics, UCLA School of Medicine, Los Angeles, and University of California at Los Angeles Maternal–Infant HIV Transmission Study (Y.B.); the Pediatric Medicine Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Md., and Pediatric AIDS Clinical Trials Group Study 076 (M.C.); the Departments of Obstetrics (M.J.O.) and Pediatrics (G.S.), University of Miami School of Medicine, Miami, and the University of Miami Infants of HIV-1 Seropositive Mothers Study, Miami; the Department of Obstetrics and Gynecology, University of Southern California School of Medicine, Los Angeles, and the Los Angeles County–University of Southern California Perinatal Transmission Study (A.M.S.); the Department of Pediatrics, University of San Francisco, San Francisco, and the Bay Area Pediatric AIDS Consortium (D.W.); and the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, and the Perinatal AIDS Collaborative Transmission Studies (M.B.).
Address reprint requests to Dr. Tuomala at the Department of Obstetrics and Gynecology, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at rtuomala{at}partners.org.
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