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Once-weekly treatment effective as daily treatment in TB continuation phase
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ATLANTA — A 6-month tuberculosis treatment regimen with once-weekly rifapentine and moxifloxacin in the 4-month continuation phase was noninferior to the standard treatment, Amina Jindani, MD, of St. George’s, University of London, reported here.
“The WHO recommended treatment regimen is very effective,” Jindani said during a presentation at the 2013 Conference on Retroviruses and Opportunistic Infections. “But effectiveness depends on adherence. We show that giving two drugs once a week in the 4-month continuation phase is as effective as giving two different drugs daily.”
Jindani and colleagues conducted the RIFAQUIN study, in which patients with smear-positive pulmonary TB were randomly assigned to three treatment arms: control, which included 2 months of daily ethambutol, isoniazid, rifampin and pyrazinamide (intensive phase), followed by a 4-month continuation phase of daily isoniazid and rifampin; a 4-month regimen in which moxifloxacin replaced isoniazid in the intensive phase and a 2-month continuation phase included twice-weekly moxifloxacin and 900 mg rifapentine (Priftin, Sanofi-Aventis); and a 6-month regimen in which moxifloxacin replaced isoniazid in the intensive phase and a 4-month continuation phase included once-weekly moxifloxacin and 1,200 mg rifapentine.
The study included 827 patients. In an intention-to-treat analysis, the difference in proportion unfavorable between the 4-month regimen and control was 11.9% (95% CI, 3.7-20), and in a per protocol analysis, the difference in proportion unfavorable was 13.2% (95% CI, 6.4-20). The difference between the 6-month regimen and control was –2% (95% CI, –8.9 to 4.9) in an intention-to-treat analysis, and –1.5% (95% CI, –5.7 to 2.8) in a per protocol analysis.
“The 6-month regimen with once-weekly 1,200 mg rifapentine and moxifloxacin in the continuation phase was noninferior to control, even at the 95% level, and was safe and well tolerated,” Jindani said.
For more information:
Jindani A. #147LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta
Disclosure: Jindani reports no relevant financial disclosures.
Perspective
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Richard Chaisson, MD
In the United States, 10 years ago, we completed a study of once-weekly rifapentine. It was approved by the FDA, but most clinicians felt that it wasn’t as good as the standard regimen. These new data show that a weekly regimen of a higher dose of rifapentine and moxifloxacin is certainly as good as the standard regimen. We were prepared to go to the once-weekly regimen 10 years ago, but since the study was not as successful as we had hoped, many of us gave up hope on a once-weekly regimen. I think that hope has been rekindled because of this study.
Perspective
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David Cohn, MD
We have been waiting for these results for quite some time. It is one of the first randomized trials to see if we can shorten treatment of TB from 6 months to 4 months. The other purpose was to use high-dose rifapentine in the continuation phase of TB treatment, in combination with moxifloxacin. This regimen appears as good as the traditional TB treatment. I wouldn’t call it a break through, but it’s an important finding. The nice thing is that this treatment is that it facilitates giving directly observed therapy once a week in the continuation phase of therapy. It’s also proof of concept to show that rifapentine used with moxifloxacin has potent activity. However, the 4-month regimen wasn’t effective, which is unfortunate, but doesn’t come as a complete surprise. We all want to reach the goal of shorter treatment time for TB, but it’s going to take more work.
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