Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy

Anouk M Kesselring, Ferdinand W Wit, Caroline A Sabin, Jens D Lundgren, M John Gill, Jose M Gatell, Andri Rauch, Julio S Montaner, Frank de Wolf, Peter Reiss, Amanda Mocroft, NN NN

71 Citations (Scopus)

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.
Original languageEnglish
JournalAIDS
Volume23
Issue number13
Pages (from-to)1689-99
Number of pages10
ISSN0269-9370
DOIs
Publication statusPublished - 2009

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

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