Published ahead of print on February 12, 2004, doi:10.1164/rccm.200311-1612OC
Am. J. Respir. Crit. Care Med., Volume 169, Number 11, June 2004, 1191-1197
A more recent version of this article appeared on June 1, 2004
Submitted on November 26, 2003
Accepted on February 10, 2004
Pharmacokinetics of Rifapentine 600, 900 and 1,200 mg during Once-Weekly Tuberculosis Therapy
Marc Weiner1*, Naomi Bock2, Charles A Peloquin3, William J Burman4, Awal Khan2, Andrew Vernon2, Zhen Zhao2, Stephen Weis5, Timothy R Sterling6, Katherine Hayden7, Stefan Goldberg8, and Tuberculosis Trials Consortium9
1 South Texas Veterans Health Care System, San Antonio, TX, USA,
2 Division of TB Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA,
3 National Jewish Medical and Research Center, Denver, CO, USA,
4 Denver Public Health, Denver, CO, USA,
5 University of North Texas Health Sciences Center, Fort Worth, TX, USA,
6 Johns Hopkins University School of Medicine, Baltimore, MD, USA,
7 Arkansas Department of Health, Little Rock, AR, USA,
8 Seattle-King County Department of Public Health, Seattle, WA, USA,
9 Tuberculosis Trials Consortium, none
* To whom correspondence should be addressed. E-mail: weiner{at}uthscsa.edu.
The pharmacokinetics of rifapentine at 600, 900 and 1,200 mg were studied during once-weekly continuation phase therapy in 35 patients with tuberculosis. Mean area under the plasma concentration-versus-time curve (AUC 0-[infinity]) increased significantly with dose (rifapentine AUC 0-[infinity] 296, 410 and 477 mcg*hr/ml at 600, 900 and 1,200 mg respectively, P-value = 0.02 by linear regression). In multivariate stepwise regression analyses, AUC 0-[infinity] of rifapentine and of the active 25-desacetyl metabolite were associated with drug dose and plasma albumin concentration, and were lower among men and persons of white race. Fifty-four percent of patients had total (free and protein-bound) plasma concentrations of rifapentine and of desacetyl rifapentine detected for more than 36 hours after clearance of concurrently administered isoniazid. Serious adverse effects of therapy in these study patients were infrequent (one [3%] of 35 cases) and not linked with higher rifapentine drug exposure (AUC0-[infinity] or peak concentration). The present pharmacokinetic study supports further trials to determine an optimal rifapentine dose for treatment of tuberculosis.
Key words: tuberculosis, rifapentine, pharmacokinetics, treatment
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