Nevirapine-induced side effects in pregnant women: experience of a Brazilian university hospital.

Nevirapine-based therapy is associated with increased frequency of adverse events among HIV-infected pregnant women. The aim of this article was to evaluate the incidence of adverse effects in HIV-infected women who started nevirapine during pregnancy. A retrospective study was performed in our center between January 2003 and December 2006 analyzing all women prescribed nevirapine during pregnancy. Women presenting any risk factor for hepatotoxicity were excluded from the analysis. Patients were divided into two groups according to the presence or absence of adverse effects, and a correlation to CD4 counts was performed. Liver function abnormality was graded according to the Division of AIDS toxicity guidelines. A total of 170 women initiated nevirapine during pregnancy, but only 133 were included in the study. Twenty-seven women (20.3%) presented adverse effects, skin rash accounting for 77.8% (21/27 women) and liver function abnormalities for 22.2% (6/27) of the cases. Baseline CD4 counts, viral loads and transaminases were similar in both groups. All nevirapine side effects were developed in less than seven weeks. Four of 31 women with CD4 counts <250 cells/microL (12.9%) and 23 of 102 women with CD4 counts > or = 250 cells/microL (22.5%) developed adverse events. All patients who experienced hepatotoxicity had pretreatment CD4 counts > or =250 cells/microL. The incidence of adverse events with nevirapine in our study was high, but most of them were cutaneous. There was no correlation between high CD4 counts and adverse events when analyzing both cutaneous and hepatic reactions; nevertheless, hepatotoxicity occurred only in pregnant women with CD4 counts > or =250 cells/microL.

[1]  P. Easterbrook,et al.  Experience of nevirapine use in a London cohort of HIV‐infected pregnant women , 2001, HIV medicine.

[2]  M. Deltenre,et al.  Fatal liver failure associated with Nevirapine in a pregnant HIV patient: The first reported case , 2000 .

[3]  W. Miller,et al.  Sex differences in nevirapine rash. , 2001, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  B. D. Saúde. Recomendações para profilaxia da transmissão vertical do HIV e terapia anti-retroviral em gestantes , 2007 .

[5]  J. Ena,et al.  Risk and determinants of developing severe liver toxicity during therapy with nevirapine-and efavirenz-containing regimens in HIV-infected patients , 2003, International journal of STD & AIDS.

[6]  P. Narciso,et al.  Safety of nevirapine‐containing antiretroviral triple therapy regimens to prevent vertical transmission in an African cohort of HIV‐1‐infected pregnant women , 2006, HIV medicine.

[7]  J. Anderson,et al.  Safety of nevirapine in pregnancy , 2007, HIV medicine.

[8]  Dorothy Bray,et al.  Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial , 1999, The Lancet.

[9]  F. Mulcahy,et al.  Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy , 2006, HIV medicine.

[10]  S. Koletar,et al.  Third-Trimester Maternal Toxicity With Nevirapine Use in Pregnancy , 2005, Obstetrics and gynecology.

[11]  J. Beijnen,et al.  Case series of acute hepatitis in a non-selected group of HIV-infected patients on nevirapine-containing antiretroviral treatment , 2003, AIDS.

[12]  V. Soriano,et al.  Liver toxicity caused by nevirapine. , 2002, AIDS.

[13]  J. Hitti,et al.  Antiretroviral-Associated Toxicity Among HIV-1-Seropositive Pregnant Women in Mozambique Receiving Nevirapine-Based Regimens , 2007, Journal of acquired immune deficiency syndromes.

[14]  V. Soriano,et al.  Incidence of Liver Injury After Beginning Antiretroviral Therapy with Efavirenz or Nevirapine , 2003, HIV clinical trials.

[15]  J. Sullivan,et al.  Nevirapine pharmacokinetics in pregnant women and in their infants after in utero exposure. , 2001, The Pediatric infectious disease journal.

[16]  Andrew Phillips,et al.  Hepatotoxicity in HIV-1-infected patients receiving nevirapine-containing antiretroviral therapy , 2001, AIDS.

[17]  Lee-Jen Wei,et al.  Maternal Toxicity With Continuous Nevirapine in Pregnancy: Results From PACTG 1022 , 2004, Journal of acquired immune deficiency syndromes.

[18]  R. Ditangco,et al.  Highly active antiretroviral treatment containing efavirenz or nevirapine and related toxicity in the TREAT Asia HIV Observational Database. , 2006, Journal of acquired immune deficiency syndromes.

[19]  Elliot Marseille,et al.  Cost effectiveness of single-dose nevirapine regimen for mothers and babies to decrease vertical HIV-1 transmission in sub-Saharan Africa , 1999, The Lancet.

[20]  D. Mayers,et al.  A Comprehensive Hepatic Safety Analysis of Nevirapine in Different Populations of HIV Infected Patients* , 2003, Journal of acquired immune deficiency syndromes.

[21]  J. Beijnen,et al.  Incidence and risk factors for nevirapine-associated rash , 2003, European Journal of Clinical Pharmacology.

[22]  V. Soriano,et al.  Risk Factors for Severe Hepatic Injury After Introduction of Highly Active Antiretroviral Therapy , 2001, Journal of acquired immune deficiency syndromes.

[23]  C. Moore,et al.  Predisposition to nevirapine hypersensitivity associated with HLA-DRB1*0101 and abrogated by low CD4 T-cell counts , 2005, AIDS.

[24]  S. Kukich Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000. , 2001, MMWR. Morbidity and mortality weekly report.

[25]  D. Dieterich,et al.  Drug-induced liver injury associated with the use of nonnucleoside reverse-transcriptase inhibitors. , 2004, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[26]  P. F. Kauff Group , 2000, Elegant Design.

[27]  L. Naldi,et al.  Nevirapine and the risk of Stevens–Johnson syndrome or toxic epidermal necrolysis , 2001, AIDS.

[28]  E. Joao,et al.  Nevirapine toxicity in a cohort of HIV-1-infected pregnant women. , 2006, American journal of obstetrics and gynecology.