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Maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy
Presented by Oriol Coll, Spain.
Coll O.1, Lonca M.2, Ocaña I.3, Lopez M.1, Diaz M.4, Montero M.4, Hernandez S.1, Figueras F.1, Suy A.5, Guelar A.4
1Hospital Clinic, Maternal Fetal Medicine, Barcelona, Spain, 2Hospital Clinic, Infectious Diseases, Barcelona, Spain, 3Hospital Vall d' Hebron, Infectious Diseases, Barcelona, Spain, 4Hospital del Mar, Infectious Diseases, Barcelona, Spain, 5Hospital Vall d' Hebron, Obstetrics, Barcelona, Spain
Objectives: To establish maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy
Methods: A retrospective multicenter study including three university hospitals was carried out to evaluate the risk of maternal toxicity and adverse perinatal outcome associated to HAART containing nevirapine (NVP) during pregnancy. All women who received HAART during pregnancy for at least 2 weeks and who delivered beyond 22 weeks of gestation between 1997 and 2005 were included. Toxic events were defined as skin rash, hepatotoxicity or fever, according standard criteria. An adverse perinatal outcome was considered if preterm delivery, small for gestational age, preeclampsia or intrauterine fetal demise.
Results: A total of 311 women were identified as receiving HAART during pregnancy of which 61.4% (191/311) with NVP-containing regimens. Whereas a total of 21 toxic events (hepatotoxicity=9, skin rash=10 and fever=2) occurred in 17 pregnant women on NVP-containing regimens, no events were observed in women without NVP (p <0.001). Thus, the incidence of toxicity in women on NVP-containing regimens was 8.9% (17/191). All but one cases occurred in women who initiated NVP during pregnancy. The median interval between initiation of NVP and the toxic event was 4 weeks (range 1-12). No association was found between pregnancy trimester of initiation of nevirapine therapy and toxicity. A similar incidence of toxic events was observed in women with CD4+ T cell counts of >250 cells/mm3 (13/162, 8%) when compared to women with <250 cells/mm3 (4/28 14,3%) (Chi2 p 0.65). Adverse perinatal outcome was less frequent in women on NVP-containing regimens (30.9 vs. 40.8%; OR 0.65 (0.4-1.04)), albeit without reaching statistical significance.
Conclusions: Almost all toxic events occurred in women on NVP-containing regimens, but the incidence was similar than the one described in non-pregnant women. In addition, a lower incidence of adverse perinatal outcome among these women may justify the use of nevirapine-containing regimens during pregnancy.
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