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Published on: March 24, 2017
Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis
Susan E Dorman1, Payam Nahid1, Ekaterina V Kurbatova1
1From the Medical University of South Carolina, Charleston (S.E.D.); the UCSF Center for Tuberculosis, University of California, San Francisco, San Francisco (P.N., P.P.J.P., R.M.S.); the Vietnam National Tuberculosis Program-University of California, San Francisco Research Collaboration Unit (P.N., P.P.J.P., H.T.T.P., N.V.N., T.H.P., R.M.S.) and the National Lung Hospital (N.V.N., T.H.P.) - both in Hanoi; the Centers for Disease Control and Prevention, Atlanta (E.V.K., K.B., S.V.G., A.E.P., N.A.S., E.S., A.V.); the University of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System, San Antonio (M.E., M.W.); the University of Zimbabwe College of Health Sciences, Harare (J.H., W.S.); Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland (J.L.J.); the Uganda-Case Western Reserve University Research Collaboration, Kampala (J.L.J., G.M.); TASK (M.L.), the University of Cape Town Lung Institute (K.N.), and the South African Tuberculosis Vaccine Initiative (J.S.), Cape Town, the Perinatal HIV Research Unit, University of the Witwatersrand (N.A.M., Z.W.), and the Wits Health Consortium (I.S.), Johannesburg - all in South Africa; Johns Hopkins University School of Medicine, Baltimore (K.E.D., N.A.M., R.E.C.), and the U.S. Public Health Service Commissioned Corps, Rockville (A.E.P.) - both in Maryland; the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince (S.N., S.P.); and the University of Nebraska Medical Center, Omaha (S.S.).
A 4-month rifapentine and moxifloxacin tuberculosis treatment regimen proved noninferior to the standard 6-month therapy. This shorter regimen offers a promising alternative for drug-susceptible pulmonary tuberculosis.
Area of Science:
- Infectious Diseases
- Microbiology
- Clinical Trials
Background:
- Rifapentine-based regimens demonstrate potent antimycobacterial activity.
- Shorter treatment durations are desirable for drug-susceptible pulmonary tuberculosis.
Purpose of the Study:
- To evaluate the noninferiority of two 4-month rifapentine-based regimens compared to a standard 6-month regimen for treating pulmonary tuberculosis.
Main Methods:
- An open-label, phase 3, randomized controlled trial compared two 4-month rifapentine regimens against a 6-month standard regimen (rifampin, isoniazid, pyrazinamide, ethambutol).
- The primary efficacy outcome was survival free of tuberculosis at 12 months.
- Participants were from 13 countries, including those with HIV coinfection and pulmonary cavitation.
Main Results:
- The 4-month rifapentine-moxifloxacin regimen was noninferior to the 6-month control regimen (unfavorable outcome rates: 15.5% vs. 14.6% in microbiologically eligible population; 11.6% vs. 9.6% in assessable population).
- The 4-month rifapentine-only regimen was not shown to be noninferior to the control.
- Adverse events of grade 3 or higher were comparable across groups, with the rifapentine-only group having fewer events.
Conclusions:
- A 4-month rifapentine-based regimen including moxifloxacin is a viable, noninferior alternative to the standard 6-month tuberculosis treatment.
- This shorter regimen could improve patient adherence and reduce treatment burden for pulmonary tuberculosis.
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