1. Incidence and risk factors of severe adverse events with nevirapine-based antiretroviral therapy in HIV-infected women. MTCT-Plus program, Abidjan, Côte d'Ivoire
- Author
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Didier K. Ekouevi, Patrick A. Coffie, Aristophane Tanon, Clarisse Amani-Bosse, Elaine J. Abrams, François Dabis, Besigin Tonwe-Gold, Gédéon Bedikou, Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, MTCT-Plus programme (ACONDA), MTCT-Plus programme, Service des maladies infectieuses et tropicales, CHU Treichville, MTCT-Plus Initiative, Columbia University [New York]-International Center for AIDS Care and Treatment Programs-Columbia Mailman School of Public Health, Mouillet, Evelyne, and Columbia University [New York]
- Subjects
MESH: Exanthema ,Prevalence ,HIV Infections ,Severity of Illness Index ,MESH: Antiretroviral Therapy, Highly Active ,0302 clinical medicine ,Risk Factors ,MESH: Risk Factors ,Antiretroviral Therapy, Highly Active ,030212 general & internal medicine ,MESH: Incidence ,MESH: Anti-HIV Agents ,MESH: Nevirapine ,0303 health sciences ,Incidence ,Incidence (epidemiology) ,MESH: HIV Infections ,Rash ,3. Good health ,Infectious Diseases ,Female ,Chemical and Drug Induced Liver Injury ,medicine.symptom ,Research Article ,medicine.drug ,Adult ,medicine.medical_specialty ,MESH: Drug-Induced Liver Injury ,Nevirapine ,Anti-HIV Agents ,MESH: Cote d'Ivoire ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,Internal medicine ,MESH: Severity of Illness Index ,parasitic diseases ,medicine ,Humans ,lcsh:RC109-216 ,Adverse effect ,Pregnancy ,MESH: Humans ,030306 microbiology ,business.industry ,Proportional hazards model ,MESH: Adult ,Exanthema ,medicine.disease ,Regimen ,Cote d'Ivoire ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Immunology ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,MESH: Female - Abstract
Background In resource-limited settings where nevirapine-containing regimen is the preferred regimen in women, data on severe adverse events (SAEs) according to CD4 cell count are limited. We estimated the incidence of SAEs according to CD4 cell count and identify their risk factors in nevirapine-treated women. Methods All HIV-infected women who initiated nevirapine-containing regimen in the MTCT-Plus operational program in Abidjan, Côte d'Ivoire, were eligible for this study. Laboratory and clinical (rash) SAEs were classified as grade 3 and 4. Cox models were used to identify factors associated with the occurrence of SAEs. Results From August 2003 to October 2006, 290 women initiated a nevirapine-containing regimen at a median CD4 cell count of 186 cells/mm3 (IQR 124-266). During a median follow-up on treatment of 25 months, the incidence of all SAEs was 19.5/100 patient-years. The 24-month probability of occurrence of hepatotoxicity or rash was not different between women with a CD4 cell count >250 cells/mm3 and women with a CD4 cell count ≤250 cells/mm3 (8.3% vs. 9.9%, Log-rank test: p = 0.75). In a multivariate proportional hazard model, neither CD4 cell count >250 cells/mm3 at treatment initiation nor initiation NVP-based regimen initiated during pregnancy were associated with the occurrence of SAEs. Conclusion CD4 cell count >250 cells/mm3 was not associated with a higher risk of severe hepatotoxicity and/or rash, as well as initiation of ART during pregnancy. Pharmacovogilance data as well as meta-analysis on women receiving NVP in these settings are needed for better information about NVP toxicity.
- Published
- 2010
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