Abstract

The toxic potential of nevirapine in pregnant women with CD4 count over 250 cells mm−3 and the unsatisfactory efficacy of nelfinavir in patients with baseline Viral Load (VL) over 100,000 copies mL−1 has prompted the use of Lopinavir/ritonavir (LPV/r) in selected situations. This study aims to assess safety of LPV/r in pregnancy. Medical records from pregnant women receiving LPV/r were retrospectively reviewed. Charts corresponding to twin pregnancy, hypertension and having a lack of data supporting a reliable estimate of Gestational Age (GA) at delivery were excluded. Low Birth Weight (LBW) was defined as less than 2500 g. Pre-Term Delivery (PD), defined as GA at delivery less than 259 days, was estimated using date of Last Menstruation Period (LMP) and obstetrical ultrasound. A total of 64 women were analyzed. LPV/r was used in 46.9% due to virologic failure with other Protease Inhibitors (PIs). LPV/r was used for a mean of 108.8 days. Baseline median CD4+ cell count and HIV-1 RNA were 287 mm−3 and 31,100 copies mL−1, respectively and 345 mm−3 and less than 400 copies mL−1 at delivery. HIV-1 was not transmitted to any newborn. LBW was observed in 13 (20.3%) and PD in 16 (25%) newborns. Time on LPV/r during pregnancy, maternal age, baseline CD4+ cell count and HIV-1 RNA, GA at initiation of LPV/r, reason for prescribing LPV/r and type of delivery were not associated with PD. Frequencies of LBW and PD were, respectively, 20.3 and 25%. Neither the magnitude nor the timing in pregnancy of LPV/r use was associated with PD.

Highlights

  • In countries where antiretrovirals (ARVs) are widely available, the optimal ARV regimen for prevention of mother-to-child transmission during pregnancy is currently under debate

  • The objective of this study was to assess the impact of LPV/r, as part of combination therapy prescribed to treat HIV-infected pregnant women, on the rates of infant Low Birth Weight (LBW) and Pre-Term Delivery (PD), HIV RNA load reduction and mother-to-child HIV transmission

  • Ten women were excluded from the analysis: one refused to take any drug during gestation, three had twins and six could not be given an accurate Gestational Age (GA) estimation because they began care late in pregnancy and were not able to recall the Last Menstruation Period (LMP) reliably

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Summary

Introduction

In countries where antiretrovirals (ARVs) are widely available, the optimal ARV regimen for prevention of mother-to-child transmission during pregnancy is currently under debate. Most guidelines recommended either nevirapine or nelfinavir in combination with two nucleoside reverse transcriptase inhibitors (NRTIs), usually zidovudine (AZT)+lamivudine (3TC) in HIV-infected pregnant women who do not have evidence of drugresistant virus. The use of both nevirapine and nelfinavir has been questioned because of either an increased risk for toxicity or subtherapeutic plasma levels, respectively[1,2]. The development of severe nevirapine-associated skin rash has been reported to be 5.5-7.3 times more common in women than men and has been reported in pregnant women[3,4,5]. The degree of risk for hepatic toxicity varies with CD4+ cell count. Women with CD4+ cell counts greater than 250 cells mm−3 who initiate nevirapine including pregnant women receiving

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