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Birth Defect Rate Low and Similar With
Darunavir and Other Antiretroviral Regimens
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15th European AIDS Conference, October 21-24, 2015, Barcelona
Mark Mascolini
Birth defect rates proved low and nearly identical in women taking a darunavir regimen and in those taking other antiretrovirals in pregnancy, according to analysis of the Antiretroviral Pregnancy Registry [1]. Rates of spontaneous loss and low birth weight were significantly greater with darunavir than with other regimens.
Department of Health and Human Services antiretroviral guidelines list the protease inhibitor darunavir as a preferred agent for treatment-naive women during pregnancy. Animal studies found no signals of embryotoxicity or teratogenicity with darunavir. Researchers from the University of Pennsylvania, Janssen (darunavir's maker), and other institutions conducted this analysis to assess birth outcomes and prevalence of birth defects in women taking darunavir versus nondarunavir regimens during pregnancy.
The researchers probed the Antiretroviral Pregnancy Registry (APR), a voluntary database that includes about 1300 antiretroviral-exposed pregnant US women yearly, representing about 15% of HIV-positive women who give birth in the United States every year. The registry also includes data from about 200 non-US women every year. The investigators combed APR reports accumulated from January 1989 to January 2015 and compared APR results with findings in 2 large population-based birth-defect databases, the Metropolitan Atlanta Congenital Defects Program (MACDP) and the Texas Birth Defects Registry (TBDR).
The analysis focused on 535 women who took darunavir during pregnancy and 16,797 taking regimens that did not contain darunavir. Respective total numbers of birth outcomes were 542 and 17,088. Median ages of the darunavir and nondarunavir group were 29 and 28, proportions of blacks 49.9% and 57.5%, proportions of whites 13.6% and 14.8%, and proportions of Hispanics 16.3% and 18.1%. Similar proportions of women taking or not taking darunavir had a CD4 count at or above 500 (28% and 30%), between 200 and 499 (36.6% and 41.6%), and below 200 (18.9% and 14.8%).
Among all birth outcomes reported, proportions of live births were 91.9% with darunavir and 93.2% with nondarunavir regimens. Prevalence of spontaneous loss was significantly higher in women taking darunavir (4.49% versus 2.85%, P = 0.0348), as was low birth weight prevalence (20.63% versus 15.77%, P = 0.008). Rates of stillbirth, induced abortion, and premature birth did not differ between the darunavir group and the nondarunavir group.
Prevalence of birth defects stood at 2.81% with darunavir (14 of 498 live births) and 2.86% with nondarunavir regimens (456 of 15,930 live births), a nonsignificant difference (relative risk 0.98, 95% confidence interval [CI] 0.57 to 1.68). When women took darunavir during the first trimester, birth defect prevalence stood at 2.87% (9 of 314 live births). That rate did not differ significantly from the 1.66% birth defect rate among women first exposed to darunavir in the second or third trimester (relative risk 1.75, 95% CI 0.47 to 6.55).
The overall 2.81% birth defect rate with darunavir did not differ significantly from rates in the MACDP database (2.72%) or the TBDR database (4.17%).
Reference
1. Short WR, Albano JD, Cook TS, et al. Darunavir-containing antiretroviral regimens in pregnancy: findings from the Antiretroviral Pregnancy Registry. 15th European AIDS Conference, October 21-24, 2015, Barcelona. Abstract PE8/11.
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