Repeated administration of high-dose intermittent rifapentine reduces rifapentine and moxifloxacin plasma concentrations

Antimicrobial Agents and Chemotherapy

Volumn 52, Issue 11, 2008, Pages 4037-4042

  Dooley, Kelly ^a   Flexner, Charles ^a   Hackman, Judith ^a   Peloquin, Charles A ^b   Nuermberger, Eric ^a   Chaisson, Richard E ^a   Dorman, Susan E ^a,c  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATIONAL JEWISH MEDICAL AND RESEARCH CENTER   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; MOXIFLOXACIN; RIFAPENTINE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; DISTRIBUTION VOLUME; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HEADACHE; HEPATITIS; HUMAN; HUMAN EXPERIMENT; MALAISE; MALE; NAUSEA; NORMAL HUMAN; PRIORITY JOURNAL; RASH; SIDE EFFECT; URTICARIA;

ADULT; ANTITUBERCULAR AGENTS; AZA COMPOUNDS; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; DRUG TOLERANCE; FEMALE; HUMANS; MALE; MIDDLE AGED; QUINOLINES; RIFAMPIN; SAFETY; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

EID: 55849088724     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00554-08     Document Type: Article

References (32)

1. Acocella, G., A. Nonis, G. Perna, E. Patane, G. Gialdroni-Grassi, and C. Grassi. 1988. Comparative bioavailability of isoniazid, rifampin, and pyrazinamide administered in free combination and in a fixed triple formulation designed for daily use in antituberculosis chemotherapy. II. Two-month, daily administration study. Am. Rev. Respir. Dis. 138:886-890.
2. Ambrose, P. G., D. M. Grasela, T. H. Grasela, J. Passarell, H. B. Mayer, and P. F. Pierce. 2001. Pharmacodynamics of fluoroquinolones against Streptococcus pneumoniae in patients with community-acquired respiratory tract infections. Antimicrob. Agents Chemother. 45:2793-2797.
3. Benator, D., M. Bhattacharya, L. Bozeman, W. Burman, A. Cantazaro, R. Chaisson, F. Gordin, C. R. Horsburgh, J. Horton, A. Khan, C. Lahart, B. Metchock, C. Pachucki, L. Stanton, A. Vernon, M. E. Villarino, Y. C. Wang, M. Weiner, and S. Weis for the Tuberculosis Trials Consortium. 2002. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet 360:528-534.
4. Boman, G., and V. A. Ringberger. 1974. Binding of rifampicin by human plasma proteins. Eur. J. Clin. Pharmacol. 7:369-373.
5. Burman, W. J., K. Gallicano, and C. Peloquin. 2001. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin. Pharmacokinet. 40:327-341.
6. Drusano, G. L., S. L. Preston, C. Fowler, M. Corrado, B. Weisinger, and J. Kahn. 2004. Relationship between fluoroquinolone area under the curve: minimum inhibitory concentration ratio and the probability of eradication of the infecting pathogen, in patients with nosocomial pneumonia. J. Infect. Dis. 189:1590-1597.
7. Frieden, T. R., T. R. Sterling, S. S. Munsiff, C. J. Watt, and C. Dye. 2003. Tuberculosis. Lancet 362:887-899.
8. Grosset, J., and S. Leventis. 1983. Adverse effects of rifampin. Rev. Infect. Dis. 5(Suppl. 3):S440-S450.
9. Gumbo, T., A. Louie, M. R. Deziel, W. Liu, L. M. Parsons, M. Salfinger, and G. L. Drusano. 2007. Concentration-dependent Mycobacterium tuberculosis killing and prevention of resistance by rifampin. Antimicrob. Agents Chemother. 51:3781-3788.
10. Gumbo, T., A. Louie, M. R. Deziel, L. M. Parsons, M. Salfinger, and G. L. Drusano. 2004. Selection of a moxifloxacin dose that suppresses drug resistance in Mycobacterium tuberculosis, by use of an in vitro pharmacodynamic infection model and mathematical modeling. J. Infect. Dis. 190:1642-1651.
11. Heifets, L. B., P. J. Lindholm-Levy, and M. A. Flory. 1990. Bactericidal activity in vitro of various rifamycins against Mycobacterium avium and Mycobacterium tuberculosis. Am. Rev. Respir. Dis. 141:626-630.
12. Jayaram, R., S. Gaonkar, P. Kaur, B. L. Suresh, B. N. Mahesh, R. Jayashree, V. Nandi, S. Bharat, R. K. Shandil, E. Kantharaj, and V. Balasubramanian. 2003. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob. Agents Chemother. 47:2118-2124.
13. Ji, B., N. Lounis, C. Maslo, C. Truffot-Pernot, P. Bonnafous, and J. Grosset. 1998. In vitro and in vivo activities of moxifloxacin and clinafloxacin against Mycobacterium tuberculosis. Antimicrob. Agents Chemother. 42:2066-2069.
14. Keung, A., K. Reith, M. G. Eller, K. A. McKenzie, L. Cheng, and S. J. Weir. 1999. Enzyme induction observed in healthy volunteers after repeated administration of rifapentine and its lack of effect on steady-state rifapentine pharmacokinetics: part I. Int. J. Tuberc. Lung Dis. 3:426-436.
15. Langdon, G., J. J. Wilkins, P. J. Smith, and H. McIlleron. 2004. Consecutive-dose pharmacokinetics of rifapentine in patients diagnosed with pulmonary tuberculosis. Int. J. Tuberc. Lung Dis. 8:862-867.
16. Long, M. W., D. E. Snider, Jr., and L. S. Farer. 1979. U.S. Public Health Service Cooperative trial of three rifampin-isoniazid regimens in treatment of pulmonary tuberculosis. Am. Rev. Respir. Dis. 119:879-894.
17. Loos, U., E. Musch, J. C. Jensen, G. Mikus, H. K. Schwabe, and M. Eichelbaum. 1985. Pharmacokinetics of oral and intravenous rifampicin during chronic administration. Klin. Wochenschr. 63:1205-1211.
18. Martinez, E., J. Collazos, and J. Mayo. 1999. Hypersensitivity reactions to rifampin. Pathogenetic mechanisms, clinical manifestations, management strategies, and review of the anaphylactic-like reactions. Medicine (Baltimore) 78:361-369.
19. Nijland, H. M., R. Ruslami, A. J. Suroto, D. M. Burger, B. Alisjahbana, R. van Crevel, and R. E. Aarnoutse. 2007. Rifampicin reduces plasma concentrations of moxifloxacin in patients with tuberculosis. Clin. Infect. Dis. 45:1001-1007.
20. Nuermberger, E. L., T. Yoshimatsu, S. Tyagi, R. J. O'Brien, A. N. Vernon, R. E. Chaisson, W. R. Bishai, and J. H. Grosset. 2004. Moxifloxacin-containing regimen greatly reduces time to culture conversion in murine tuberculosis. Am. J. Respir. Crit. Care Med. 169:421-426.
21. Nuermberger, E. L., T. Yoshimatsu, S. Tyagi, K. Williams, I. Rosenthal, R. J. O'Brien, A. A. Vernon, R. E. Chaisson, W. R. Bishai, and J. H. Grosset. 2004. Moxifloxacin-containing regimens of reduced duration produce a stable cure in murine tuberculosis. Am. J. Respir. Crit. Care Med. 170:1131-1134.
22. Reith, K., A. Keung, P. C. Toren, L. Cheng, M. G. Eller, and S. J. Weir. 1998. Disposition and metabolism of 14C-rifapentine in healthy volunteers. Drug Metab. Dispos. 26:732-738.
23. Rosenthal, I. M., K. Williams, S. Tyagi, C. A. Peloquin, A. A. Vernon, W. R. Bishai, J. H. Grosset, and E. L. Nuermberger. 2006. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am. J. Respir. Crit. Care Med. 174:94-101.
24. Rosenthal, I. M., K. Williams, S. Tyagi, A. A. Vernon, C. A. Peloquin, W. R. Bishai, J. H. Grosset, and E. L. Nuermberger. 2005. Weekly moxifloxacin and rifapentine is more active than the Denver regimen in murine tuberculosis. Am. J. Respir. Crit. Care Med. 172:1457-1462.
25. Rosenthal, I. M., M. Zhang, K. N. Williams, C. A. Peloquin, S. Tyagi, A. A. Vernon, W. R. Bishai, R. E. Chaisson, J. H. Grosset, and E. L. Nuermberger. 2007. Daily dosing of rifapentine cures tuberculosis in three months or less in the murine model. PLoS Med. 4:E344.
26. Schentag, J. J., A. K. Meagher, and A. Forrest. 2003. Fluoroquinolone AUIC break points and the link to bacterial killing rates. Part 2: human trials. Ann. Pharmacother. 37:1478-1488.
27. Shandil, R. K., R. Jayaram, P. Kaur, S. Gaonkar, B. L. Suresh, B. N. Mahesh, R. Jayashree, V. Nandi, S. Bharath, and V. Balasubramanian. 2007. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamic indices that best predict in vivo efficacy. Antimicrob. Agents Chemother. 51:576-582.
28. Soto, S., L. Lopez-Roses, S. Avila, A. Lancho, A. Gonzalez, E. Santos, and B. Urraca. 2002. Moxifloxacin-induced acute liver injury. Am. J. Gastroenterol. 97:1853-1854.
29. Strolin Benedetti, M., and P. Dostert. 1994. Induction and autoinduction properties of rifamycin derivatives: a review of animal and human studies. Environ. Health Perspect. 102(Suppl. 9):101-105.
30. U.S. Department of Health and Human Services, Food and Drug Administration. 2003. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations. U.S. Department of Health and Human Services, Food and Drug Administration, Washington, DC.
31. Vernon, A., W. Burman, D. Benator, A. Khan, and L. Bozeman for the Tuberculosis Trials Consortium. 1999. Acquired rifamycin monoresistance in patients with HIV-related tuberculosis treated with once-weekly rifapentine and isoniazid. Lancet 353:1843-1847.
32. Weiner, M., W. Burman, C.-C. Luo, C. A. Peloquin, M. Engle, S. Goldberg, V. Agarwal, and A. Vernon. 2007. Effects of rifampin and multidrug resistance gene polymorphism on concentrations of moxifloxacin. Antimicrob. Agents Chemother. 51:2861-2866.