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Abstract
Nevirapine is safe in HIV-infected pregnant women with a proportionally elevated CD4+ lymphocyte count
Manfredi R.1, Calza L.2
Objective: To report our experience on liver safety issues of HIV-infected pregnant women who underwent-continued a nevirapine-based therapy.
Methods: 27 pregnant women were enrolled with nevirapine started as the first antiretroviral regimen (4 cases), continued from a previous regimen (12 patients), or introduced after another regimen (11 cases). A chronic hepatitis C was present in 5 women (18.5%), and gallstones in another patient. Drug-methadone-alcohol abuse was excluded. When assessing the temporal trend of serum liver function, we always referred to baseline values instead of normal laboratory levels.
Results: At the time of pregnancy detection and nevirapine continuation-introduction, 25 women (92.6%) had a CD4+ count of 330-1095 cells/µL, while the two remaining patients had values rising up to 298-552 cells/µL during the subsequent 4-6 months. A serum transaminase rise >2-fold versus baseline was detected in only 7 cases (25.9%) (including all patients with known chronic hepatobiliary disorders), while no episode of transaminase increase >4 times, and/or grade 3-4 hepatotoxicity was registered. During the 27.2±1.1 week-long clinical-laboratory follow-up, the mean time-to-peak serum transaminases ranged 3-6 months after recognized pregnancy, while the observed, mild liver-associated alterations were maintained within 5-10% fluctuating levels until the delivery of healthy, HIV- and HCV-negative babies. A mild, self-limiting rash occurred in only three women, in absence of any relationship with hepatotoxicity.
Conclusions: Our survey of nevirapine-treated pregnant women revealed neither relevant hepatotoxicity, nor a relationship with rash, nor an elevated CD4+ count. A series of variables (patients’ age; prior AIDS diagnosis or low CD4+ count; HIV virology status; number-type-length of previous antiretroviral lines; condition of nevirapine-naïve versus nevirapine-continuation), did not show any relationship with the rare occurrence of mild hepatotoxicity. Although the benefits of nevirapine administration seem to outweigh the low risk of hepatotoxicity, safety profiles remain an important component in the debate over antiretroviral options during pregnancy.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
CDB475
Suggested Citation
"ManfrediR., et al.
Nevirapine is safe in HIV-infected pregnant women with a proportionally elevated CD4+ lymphocyte count.
:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
CDB475"
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