| Antiretroviral therapy during pregnancy and the risk of an adverse outcome. | |
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MedLine Citation:
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PMID: 12063370 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy. METHODS: We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, 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 use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (<37 weeks of gestation) was similar among the women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (<2500 g) was 16 percent among the infants born to both groups; and the rate of very low birth weight (<1500 g) was 2 percent for the group that received antiretroviral therapy and 1 percent for the group that did not. The rates of low Apgar scores (<7) and stillbirth were also similar or the same in the two groups. After adjustment for multiple risk factors, combination antiretroviral therapy was not associated with an increased risk of premature delivery as compared with monotherapy (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 protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without 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 is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation. |
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Authors:
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Ruth E Tuomala; David E Shapiro; Lynne M Mofenson; Yvonne Bryson; Mary Culnane; Michael D Hughes; M J O'Sullivan; Gwendolyn Scott; Alice M Stek; Diane Wara; Marc Bulterys |
Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: The New England journal of medicine Volume: 346 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2002 Jun |
Date Detail:
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Created Date: 2002-06-13 Completed Date: 2002-06-18 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1863-70 Citation Subset: AIM; IM |
Affiliation:
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Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston 02115, USA. rtuomala@partners.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Anti-HIV Agents / adverse effects*, therapeutic use Apgar Score Drug Therapy, Combination Female Fetal Death HIV Infections / drug therapy* HIV Protease Inhibitors / adverse effects, therapeutic use Humans Infant, Low Birth Weight Infant, Newborn Infant, Premature Male Multivariate Analysis Pregnancy Pregnancy Complications, Infectious / drug therapy* Pregnancy Outcome* |
| Grant Support | |
ID/Acronym/Agency:
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AI-27541/AI/NIAID NIH HHS; AI-27550/AI/NIAID NIH HHS; AI-27560/AI/NIAID NIH HHS; AI-34840/AI/NIAID NIH HHS; AI-34841/AI/NIAID NIH HHS; AI-34842/AI/NIAID NIH HHS; AI-34858/AI/NIAID NIH HHS; AI-41110/AI/NIAID NIH HHS; DA-15054/DA/NIDA NIH HHS; HD-2-5714/HD/NICHD NIH HHS; HD-33162/HD/NICHD NIH HHS; HD-36117/HD/NICHD NIH HHS; HD-82913/HD/NICHD NIH HHS; M01 RR-43/RR/NCRR NIH HHS; M015501271//PHS HHS; R01 A123524//PHS HHS; R01 HD 30629/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anti-HIV Agents; 0/HIV Protease Inhibitors |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2003 Jan 30;348(5):471-2; author reply 471-2
[PMID:
12556551
]
N Engl J Med. 2002 Jun 13;346(24):1842-3 [PMID: 12063367 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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