Two-stage activity-safety study of daily rifapentine during intensive phase treatment of pulmonary tuberculosis

R. Dawson, K. Narunsky, D. Carman, N. Gupte, A. Whitelaw, A. Efron, G. L. Barnes, J. Hoffman, R. E. Chaisson, H. McIlleron, S. E. Dorman

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Rifapentine (RPT) has potent activity against Mycobacterium tuberculosis; however, the optimal dose for anti-tuberculosis treatment is unknown. OBJECTIVE : To determine the antimicrobial activity, safety and tolerability of RPT 450 mg or 600 mg administered daily during the first 8 weeks of treatment for pulmonary tuberculosis (TB). DESIGN : In a two-stage, randomised open-label study, adults with sputum smear-positive TB were randomised to receive RPT 450 mg, RPT 600 mg or rifampicin (RMP) 600 mg daily for 8 weeks with isoniazid, pyrazinamide and ethambutol. The primary endpoint was sputum culture status on Löwenstein- Jensen (LJ) medium at completion of 8 weeks of treatment. RESULTS : A total of 153 participants were enrolled. Both RPTregimens met pre-specified criteria to advance to stage 2. At completion of 8 weeks of treatment, LJ culture conversion occurred in 85% (35/41), 96% (43/ 45) and 94% (34/36) of participants in the RPT 450 mg, RPT 600 mg and RMP groups, respectively. The proportions of participants discontinuing treatment were similar (respectively 1/54 [2.0%], 1/51 [2.0%] and 4/48 [8.3%] in the RPT 450 mg, RPT 600 mg and RMP groups), as were >grade 3 adverse events (0/54 [0%], 1/51 [2.0%] and 4/48 [8.3%]). CONCLUSIONS: There was a trend towards greater efficacy with RPT 600 mg than with RPT 450 mg. Daily RPT was safe and well-tolerated.

Original languageEnglish (US)
Pages (from-to)780-786
Number of pages7
JournalInternational Journal of Tuberculosis and Lung Disease
Volume19
Issue number7
DOIs
StatePublished - Jul 1 2015

Keywords

  • Mycobacterium
  • RPT
  • Rifampicin
  • Rifamycin
  • TB
  • Therapeutics

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

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