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Antiretroviral therapy. (Drugs, Pregnancy, and Lactation).
When considering treatment of HIV infection during pregnancy the risk-benefit equation for the fetus clearly favors treatment. Even if there are remote, undefined side effects of therapy due to prenatal exposure, the risk of vertical transmission is markedly reduced when the woman takes antiretroviral therapy during pregnancy.
In the National Institutes of Health 076 protocol, the vertical transmission rate among pregnant women treated with the nucleoside reverse-transcriptase inhibitor zidovudine was 8% vs. 26% among those who were not treated. With the addition of other drugs to this regimen, transmission rates have been reported to be as low as 0%-1%.
Most of the available data on the effects of prenatal exposure to zidovudine monotherapy come from large studies that compared women who were treated during pregnancy with untreated women. The results with zidovudine have not shown differences in malformation rates, neurobehavioral development, or IQ in children who have been followed through early childhood. Thus, nothing suggests that prenatal exposure to this nucleoside affects brain development. Much less information exists about newer antiretrovirals; however, the prevailing data do not suggest that these medications pose a major teratogenic risk.
There have been some case reports that infants exposed prenatally to zidovudine developed what appeared to be very serious mitochondrial diseases that were fatal in some cases. This has biologic plausibility, because mitochondrial toxicities have been described in adults receiving zidovudine and other HIV drugs. These findings have not been confirmed in analyses of prospectively collected data in large U.S. databases. This does not rule out an association between prenatal exposure and mitochondrial toxicity, but if such an association exists, it is very rare.
Other drugs are now combined with zidovudine to increase efficacy reduce the risk of antiretroviral resistance in the mother, and further reduce vertical transmission. These drugs are other nucleoside reverse transcriptase inhibitors such as lamivudine, and nonnucleoside reverse transcriptase inhibitors such as nevirapine, and protease inhibitors such as indinavir and ritonavir. Only limited data are available on the fetal safety of such combination therapy which may involve a combination of two or more reverse transcriptase inhibitors or a combination of reverse transcriptase inhibitors and protease inhibitors. There is no evidence of ...
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