Safety and Efficacy of Once-Daily Nevirapine Dosing: A Multicohort Study

Antiviral Therapy - Tập 14 Số 7 - Trang 931-938 - 2009
Alexandra Calmy1, N Vallier1, Alain Nguyen1, Joep MA Lange2, Manuel Battegay3, Frank de Wolf4, Peter Reiss2, Viviane D. Lima5, Bernard Hirschel1, Robert S. Hogg6,5, Benita Yip5, Julio Montaner7,5, Ferdinand W.N.M. Wit2
1Division of Infectious Disease/HIV unit, University Hospital Geneva, Geneva, Switzerland
2Department of Infectious Diseases, Tropical Medicine and AIDS, Center for Poverty-Related Communicable Diseases, Amsterdam Institute of Global Health and Development (AIGHD), Academic Medical Center, Amsterdam, the Netherlands
3Division of Infectious Diseases, University Hospital Basel, Basel, Switzerland
4HIV Monitoring Foundation, Amsterdam, the Netherlands
5Population Health Program, British Columbia Centre for Excellence in HIV/AIDS, St Paul's Hospital, Vancouver, BC, Canada
6Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada
7Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada

Tóm tắt

Background Nevirapine (NVP) is often prescribed once daily in clinical practice in combination with a once daily nucleoside backbone. We investigated the relationship of NVP dosing with safety and efficacy. Methods Patients from the Dutch AIDS Therapy Evaluation in the Netherlands (ATHENA) cohort study, Canadian HAART Observational Medical Evaluation and Research (HOMER) cohort and Swiss HIV Cohort Study (SHCS) using NVP-based combination therapy either once daily or twice daily were included. Risk factors for discontinuing NVP because of hypersensitivity reactions (HSRs) were investigated using multivariate logistic regression. Risk factors for virological failure 96 weeks after NVP initiation were identified using logistic regression and Cox models. Results Of 5,636 patients (774 once daily and 4,862 twice daily), 268 (4.8%) discontinued NVP because of HSR between 2 and 18 weeks. Logistic regression showed that, compared with patients with detectable HIV type-1 (HIV-1) RNA starting twice-daily NVP, there was a significantly higher risk of discontinuation of once-daily NVP because of HSR in patients with detectable HIV-1 RNA at the start of NVP (odds ratio [OR] 1.52; P=0.04), whereas the risk was actually significantly lower in patients starting once-daily NVP with undetectable HIV-1 RNA (OR 0.44; P=0.04). Cox models showed that risk of virological failure was not different for twice- versus once-daily NVP in treatment-naive patients (twice-daily versus once-daily hazard ratio [HR] 1.01; P=0.95), treatment- experienced patients experiencing treatment failure (twice-daily versus once-daily HR 1.22; P=0.30) or patients with undetectable HIV-1 RNA simplifying treatment with NVP (twice-daily versus once-daily HR 1.29; P=0.30). Conclusions Initiation of a once-daily NVP-based regimen in patients with suppressed viraemia carries a low risk of treatment-limiting HSR. Once- or twice-daily NVP-based regimens appear to have similar antiretroviral efficacy.

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