Antiretroviral therapies in pregnancy: maternal, fetal and neonatal effects

Background: Therapies containing two reverse transcriptase inhibitors (RTI) with or without protease inhibitors are used with increasing frequency in pregnant HIV-infected women. Objective: To assess the safety of antiretroviral therapy in pregnant women and their newborns. Methods: All clinical events and laboratory abnormalities in pregnant women on RTI with or without protease inhibitors and in their newborns were coll ected through an observational study. Results: A total of 37 HIV-infected pregnant women have given birth to 30 c hildren (by 30 April 1998). All received RTI, which were combined with prot ease inhibitors in 16 cases. Twelve women became pregnant while on treatmen t. Drugs used were as follows: zidovudine (n = 33), lamivudine (n = 33), st avudine (n = 4), indinavir (n = 9), ritonavir (n = 4), nelfinavir (n = 2) a nd saquinavir (n = 2). Adverse events during pregnancy were anaemia (n = 15 ), elevation of transaminases (n = 4), nausea/vomiting (n = 4), glucose int olerance (n = 2), nephrolithiasis (n = 2), diarrhoea (n = 2), hypertension (n = 1), insulin-requiring diabetes (n = 1). Adverse events in neonates wer e prematurity (n = 10), anaemia (n = 8), cutaneous angioma (n = 2), cryptor chidism (n = 2), transient hepatitis (n = 1). Non-life-threatening intracer ebral haemorrhage occurred in a premature baby (33 weeks gestation) exposed during fetal life to zidovudine-lamivudine-indinavir, and in a term baby e xposed to stavudine-lamivudine-indinavir. Extrahepatic biliary atresia occu rred in one newborn exposed to zidovudine-lamivudine-indinavir. Maternal Vi ral load was below 400 copies/ml in 18 out of 30 patients who delivered. On e case of mother-to-child HIV transmission was identified. Conclusions: In HIV-infected pregnant women treated with two RTI with or wi thout protease inhibitors, one or more adverse events occurred in 29 out of 37 women and in 14 out of 30 babies. In newborns, frequent prematurity, on e case of biliary malformation and one intracerebral haemorrhage in a term baby are of concern. These observations do not preclude combination therapi es during pregnancy but emphasize the necessity to maintain updated registe rs on their safety. (C) 1998 Lippincott Williams & Wilkins.