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Hepatotoxicity and gastrointestinal intolerance when healthy volunteers taking rifampin add twice-daily atazanavir and ritonavir.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Haas, David W. Koletar, Susan L. Laughlin, Laura Kendall, Michelle A. Suckow, Carol Gerber, John G. Zolopa, Andrew R. Bertz, Richard Child, Michael J. Hosey, Lara Alston-Smith, Beverly Acosta, Edward P.
Description	Country affiliation: United States Author Affiliation: Haas DW ( Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN 37203, USA. david.w.haas@vanderbilt.edu)
Abstract	BACKGROUND: Rifampin is the cornerstone of antituberculosis therapy, but induction of hepatic cytochrome P4503A by rifampin markedly lowers HIV protease inhibitor plasma concentrations. METHODS: This phase 1, open-label, one-arm study was designed to assess pharmacokinetic interactions and safety of atazanavir, ritonavir, and rifampin among 14 evaluable HIV-seronegative volunteers. The study included 3 sequential periods of study drug dosing, with plasma sampling for pharmacokinetic analyses to occur on the last day of each period. During period 1, participants received rifampin 600 mg every 24 hours for 8 days. During period 2, participants continued rifampin 600 mg every 24 hours, and added atazanavir 300 mg and ritonavir 100 mg every 12 hours, to continue for at least 11 days. During period 3, atazanavir was to be increased to 400 mg every 12 hours. RESULTS: Upon adding atazanavir and ritonavir, the first 3 subjects developed vomiting and transaminase elevations resulting in study drug discontinuation. The study was therefore terminated. CONCLUSIONS: Coadministration of rifampin with HIV protease inhibitors may not be a viable treatment option if rifampin administration precedes protease inhibitor initiation. Future studies, which explore concomitant HIV protease inhibitors with rifampin must carefully consider the sequence in which drugs are initiated.
File Format	HTM / HTML
ISSN	15254135
e-ISSN	10779450
DOI	10.1097/QAI.0b013e318189a7df
Journal	JAIDS Journal of Acquired Immune Deficiency Syndromes
Issue Number	3
Volume Number	50
Language	English
Publisher	Lippincott Williams & Wilkins
Publisher Date	2009-03-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline AIDS Antitubercular Agents Adverse Effects Gastrointestinal Tract Drug Effects Hiv Protease Inhibitors Liver Oligopeptides Pyridines Rifampin Ritonavir Administration & Dosage Atazanavir Sulfate Clinical Trial, Phase I Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Pharmacology (medical)

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Hepatotoxicity and Gastrointestinal Intolerance when Healthy Volunteers taking Rifampin add Twice-Daily Atazanavir and Ritonavir

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Hepatotoxicity and gastrointestinal intolerance when healthy volunteers taking rifampin add twice-daily atazanavir and ritonavir.