The CDC published a recommendation and interim guidance in MMWR for a 4-month regimen to treat patients aged 12 years or older with drug-susceptible pulmonary tuberculosis.
The regimen containing rifapentine, moxifloxacin, isoniazid and pyrazinamide was shown in a recent clinical trial to be noninferior to the standard 6-month regimen in curing drug-susceptible TB.
“Clinical practice guidelines for treatment of drug-susceptible tuberculosis (TB) in the U.S. were published in 2016,” Wendy Carr, PhD, and colleagues in the CDC’s Division of Tuberculosis Elimination, wrote. “This interim guidance updates 2016 guidelines by recommending and providing implementation considerations for a novel 4-month daily treatment regimen.”
The recommendation follows results of an open-label phase 3 randomized, controlled trial that compared 4-month rifapentine-based regimens with a 6-month regimen of rifampin, isoniazid, pyrazinamide, and ethambutol.
The trial assessed outcomes among participants with newly diagnosed pulmonary TB at 34 sites in 13 countries — Brazil, China (Hong Kong), Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, the United States, Vietnam, and Zimbabwe.
Overall, the researchers assessed 2,234 study participants 726 in the standard 6-month treatment control group, 756 in a group in which rifampin was replaced with rifapentine and ethambutol with moxifloxacin, and 752 in a group in which rifampin was replaced with rifapentine.
The study showed that rifapentine with moxifloxacin was noninferior to the control regimen (15.5% vs. 14.6% with an unfavorable outcome; 95% CI, 2.6 to 4.5) in the microbiologically eligible population and in the assessable population (11.6% vs. 9.6%; 95% CI, 1.1 to 5.1). Additionally, the study showed that rifapentine without moxifloxacin was not noninferior to the control in either the population (17.7% vs. 14.6 and 14.2% vs. 9.6%, respectively).
Based on these findings, the CDC recommended a 4-month regimen consisting of 8 weeks of daily treatment with rifapentine, isoniazid, pyrazinamide and moxifloxacin, followed by a continuation phase of 9 weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin in patients with drug-susceptible tuberculosis.
Carr and colleagues noted that the CDC does not recommend the regimen for people with body weight less than 40 kg; patients aged younger than 12 years; women who are pregnant or breastfeeding; patients with most types of suspected or documented extrapulmonary TB infection; people with known drug-drug interactions with any of the regimen medications; or patients infected with a baseline Mycobacterium tuberculosis isolate known or suspected to be resistant to isoniazid, pyrazinamide, rifampin or fluoroquinolones.
“Clinicians should carefully review a patient’s clinical history, concurrent medications, social determinants of health, and risk factors for adverse drug reactions when making the decision to use this regimen,” Carr and colleagues wrote.
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