Antiretroviral therapy during pregnancy and the risk of an adverse outcome

Ruth E. Tuomala, David E. Shapiro, Lynne M. Mofenson, Yvonne Bryson, Mary Culnane, Michael D. Hughes, M. J. O'Sullivan, Gwendolyn B Scott, Alice M. Stek, Diane Wara, Marc Bulterys

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Abstract

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.

Original languageEnglish
Pages (from-to)1863-1870
Number of pages8
JournalNew England Journal of Medicine
Volume346
Issue number24
DOIs
StatePublished - Jun 13 2002

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Pregnancy
Protease Inhibitors
Very Low Birth Weight Infant
Therapeutics
Low Birth Weight Infant
Virus Diseases
HIV-1
Pregnant Women
Stillbirth
Apgar Score
Odds Ratio
Confidence Intervals
Premature Birth
Street Drugs
Pregnancy Outcome
CD4 Lymphocyte Count
Tobacco
Alcohols

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Tuomala, R. E., Shapiro, D. E., Mofenson, L. M., Bryson, Y., Culnane, M., Hughes, M. D., ... Bulterys, M. (2002). Antiretroviral therapy during pregnancy and the risk of an adverse outcome. New England Journal of Medicine, 346(24), 1863-1870. https://doi.org/10.1056/NEJMoa991159

Antiretroviral therapy during pregnancy and the risk of an adverse outcome. / Tuomala, Ruth E.; Shapiro, David E.; Mofenson, Lynne M.; Bryson, Yvonne; Culnane, Mary; Hughes, Michael D.; O'Sullivan, M. J.; Scott, Gwendolyn B; Stek, Alice M.; Wara, Diane; Bulterys, Marc.

In: New England Journal of Medicine, Vol. 346, No. 24, 13.06.2002, p. 1863-1870.

Research output: Contribution to journalArticle

Tuomala, RE, Shapiro, DE, Mofenson, LM, Bryson, Y, Culnane, M, Hughes, MD, O'Sullivan, MJ, Scott, GB, Stek, AM, Wara, D & Bulterys, M 2002, 'Antiretroviral therapy during pregnancy and the risk of an adverse outcome', New England Journal of Medicine, vol. 346, no. 24, pp. 1863-1870. https://doi.org/10.1056/NEJMoa991159
Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD et al. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. New England Journal of Medicine. 2002 Jun 13;346(24):1863-1870. https://doi.org/10.1056/NEJMoa991159
Tuomala, Ruth E. ; Shapiro, David E. ; Mofenson, Lynne M. ; Bryson, Yvonne ; Culnane, Mary ; Hughes, Michael D. ; O'Sullivan, M. J. ; Scott, Gwendolyn B ; Stek, Alice M. ; Wara, Diane ; Bulterys, Marc. / Antiretroviral therapy during pregnancy and the risk of an adverse outcome. In: New England Journal of Medicine. 2002 ; Vol. 346, No. 24. pp. 1863-1870.
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abstract = "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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AU - Culnane, Mary

AU - Hughes, Michael D.

AU - O'Sullivan, M. J.

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AU - Bulterys, Marc

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N2 - 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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