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Lopinavir/Ritonavir in Pregnancy

Roberts, Susan S PhD*†; Martinez, Marisol MD; Covington, Deborah L Dr PH; Rode, Richard A PhD; Pasley, Mary V RNC-NP; Woodward, William C DO

JAIDS Journal of Acquired Immune Deficiency Syndromes: August 2009 - Volume 51 - Issue 4 - p 456-461
doi: 10.1097/QAI.0b013e3181a2813f
Epidemiology and Social Science

Objective: The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir.

Methods: The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures.

Results: Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen.

Conclusions: The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women.

From the *Clinical Research Department, University of North Carolina Wilmington, Wilmington, NC; †Registries and Epidemiology, Kendle International Inc, Wilmington, NC; and ‡Abbott Laboratories, Abbott Park, IL.

Received for publication October 23, 2008; accepted January 29, 2009.

Supported by an unrestricted grant from Abbott Laboratories to Kendle International Inc to develop, organize, and prepare information related to this publication. The research did not receive funding from any of the following organizations: National Institutes of Health, Wellcome Trust, Howard Hughes Medical Institute, or other(s).

Presented as a poster at the XVII International AIDS Conference (AIDS 2008). August 3-8, 2008, Mexico City, Mexico.

Correspondence to: Susan Sinclair Roberts, PhD, University of North Carolina Wilmington, 601 South College Road, Wilmington, NC 28403-5995 (e-mail:

© 2009 Lippincott Williams & Wilkins, Inc.