@article{7462282072d311df928f000ea68e967b,
title = "Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy",
abstract = "BACKGROUND: This collaboration of seven observational clinical cohorts investigated risk factors for treatment-limiting toxicities in both antiretroviral-naive and experienced patients starting nevirapine-based combination antiretroviral therapy (NVPc). METHODS: Patients starting NVPc after 1 January 1998 were included. CD4 cell count at starting NVPc was classified as high (>400/microl/>250/microl for men/women, respectively) or low. Cox models were used to investigate risk factors for discontinuations due to hypersensitivity reactions (HSR, n = 6547) and discontinuation of NVPc due to treatment-limiting toxicities and/or patient/physician choice (TOXPC, n = 10,186). Patients were classified according to prior antiretroviral treatment experience and CD4 cell count/viral load at start NVPc. Models were stratified by cohort and adjusted for age, sex, nadir CD4 cell count, calendar year of starting NVPc and mode of transmission. RESULTS: Median time from starting NVPc to TOXPC and HSR were 162 days [interquartile range (IQR) 31-737] and 30 days (IQR 17-60), respectively. In adjusted Cox analyses, compared to naive patients with a low CD4 cell count, treatment-experienced patients with high CD4 cell count and viral load more than 400 had a significantly increased risk for HSR [hazard ratio 1.45, confidence interval (CI) 1.03-2.03] and TOXPC within 18 weeks (hazard ratio 1.34, CI 1.08-1.67). In contrast, treatment-experienced patients with high CD4 cell count and viral load less than 400 had no increased risk for HSR 1.10 (0.82-1.46) or TOXPC within 18 weeks (hazard ratio 0.94, CI 0.78-1.13). CONCLUSION: Our results suggest it may be relatively well tolerated to initiate NVPc in antiretroviral-experienced patients with high CD4 cell counts provided there is no detectable viremia.",
author = "Kesselring, {Anouk M} and Wit, {Ferdinand W} and Sabin, {Caroline A} and Lundgren, {Jens D} and Gill, {M John} and Gatell, {Jose M} and Andri Rauch and Montaner, {Julio S} and {de Wolf}, Frank and Peter Reiss and Amanda Mocroft and NN NN",
note = "Keywords: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Drug Hypersensitivity; Female; HIV Infections; Humans; Male; Middle Aged; Nevirapine; Retrospective Studies; Risk Factors; Treatment Outcome; Viral Load",
year = "2009",
doi = "10.1097/QAD.0b013e32832d3b54",
language = "English",
volume = "23",
pages = "1689--99",
journal = "AIDS, Supplement",
issn = "1350-2840",
publisher = "Lippincott Williams & Wilkins",
number = "13",
}