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Chronic in utero exposition to nevirapine does not cause hepatotoxicity in HIV-uninfected healthy infants

Abstract number: O213

Felipe A., Noguera A., Fortuny C., Sánchez E., Rovira N., Simó M.

Objective: Liver function abnormalities and clinical hepatitis have been associated with NVP use, also in the paediatric age. NVP crosses the placenta and achieves neonatal blood concentrations equivalent to that in the mother (cord-to-maternal blood ratio 0.90). NVP elimination is prolonged in infants. While single-dose NVP regimens at delivery have proved safe, little is known about chronic in utero exposure to NVP and hepatotoxicity in these otherwise healthy HIV-uninfected infants.

Methods: Prospective observational study on a cohort of HIV-uninfected healthy infants born to HIV-infected mothers and exposed in utero to either NVP-based or non-NVP-based HAART regimens. Infants perinatally infected with HIV and/or HCV, and those who received neonatal NVP were excluded. Plasmatic alanine aminotransferase (ALT, normal values up to 40 IU/l) levels obtained up to the age of 12wk were compared between groups; in Exposed, total time of in utero HAART exposure (12wk or less) was also taken into account. Student's t-test and other parametric tests were used.

Results: Overall, 170 infants (76 females, 44.7%) were included, 80 (47.1%) of them (33 females, 41.2%) exposed in utero to a NVP-based HAART regimen. ZDV+3TC (n = 100) and 3TC+d4T (n = 39) were the most commonly used nucleoside analogue backbones; mothers of the Non-exposed group mostly received a PI-based therapy during gestation (NFV, n = 57; LPV/r, n = 19). Mean duration of HAART during pregnancy was 28wk (range: 3–40wk). Mean gestational age and weight at birth were 37wk and 2767g, respectively. At delivery, 98.2% of the mothers received intravenous ZDV; all infants received a 4 to 6-wk course of oral ZDV.

None of the patients showed clinical symptoms consistent with hepatitis during follow-up, except for 8 patients (3 Exposed, 5 Non-exposed) who developed self-limited neonatal jaundice. ALT plasmatic levels were obtained at a median age of 26 days (range: 1–84 days). No differences are reported in ALT levels between Exposed (mean value: 19.8, range: 5–31 IU/l) and Non-exposed (mean value: 20.0, range: 1–79 IU/l); in the Non-exposed group, differences were neither observed when length of exposure (12 weeks or less) was considered. Three infants in the Non-exposed group developed non-symptomatic elevation of ALT values that had spontaneously normalised by the age of 6 months.

Conclusions: In this study, chronic in utero exposure to NVP did not cause elevation of ALT levels in HIV-uninfected infants.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Barcelona, Spain
Presentation type:
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