Project Inform - September, 1998

A small study looking at the safety of anti-HIV therapy use in pregnant women and their newborn children revealed an unexpectedly high number of premature births as well as side effects in pregnant women using anti-HIV therapy with or without a protease inhibitor. Because of these concerns, the Pediatric AIDS Clinical Trials Groups (PACTG) temporarily stopped enrollment into studies which include protease inhibitor regimens for the prevention of mother-to-child HIV transmission. However, review of all the data show that the incidence of premature births was higher in women on no anti-HIV therapy than women on 2- or 3-drug combinations, which include a protease inhibitor. As a result, all protease inhibitor studies for prevention mother-to-child transmission have been re-opened.

The 37 women in this study tended to have low CD4+ cell counts and generally more advanced HIV disease. Their treatments included either two nucleoside analogue reverse transcriptase inhibitors (NARTIs) (21 women) or two NARTIs plus one or two protease inhibitors (16 women, 9 of whom used indinavir) and all were receiving anti-HIV treatment at the time of delivery.

The most common side effect was anemia, or low red blood cell counts (low grade in 9 women, higher grade in 6). Other side effects, seen in only one or two women, included low white blood cell counts, low platelets (cells involved in blood clotting), high amylase levels (related to possible pancreas problems), diabetes, kidney stones, high blood pressure and blood sugar problems. High liver function tests and persisting nausea were each reported in 3 women.

The most common side effects in newborn children were anemia (4), possibly related to AZT which is known to suppress the bone marrow, and high bilirubin levels which can indicate liver problems (4). High bilirubin levels in children are much more serious than high bilirubin levels in adults. Children do not have a fully developed "blood brain barrier" and therefore bilirubin can have potential toxic effects on the brain in children. Eleven children were born prematurely at 37 weeks, considered mildly premature. One child had a severe malformation (exposed to AZT + 3TC + indinavir) and two had non-life-threatening bleeding in the brain (exposed to either AZT + 3TC + indinavir or d4T + 3TC + indinavir). It is not clear if these severe side effects are specifically associated with indinavir use or just a result of the high proportion of women in the group taking the drug.

In all, 21 of 37 women and 17 of 30 babies experienced at least one side effect possibly related to anti-HIV therapy, primarily prematurity in children. It is possible that the increased events in the mothers and children may have been related to weaker health status of the mothers in this group. While it is not clear how many events are related to the drug side effects, HIV or to pregnancy itself, women with HIV who are pregnant and taking or considering anti-HIV therapies should be aware of the potential risks to their newborn children and seek prenatal care to monitor their health status as well as their child's health.

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The original of this article can be found at http://www.projinf.org/pub/25/antiviral.html