Two-stage activity-safety study of daily rifapentine during intensive phase treatment of pulmonary tuberculosis.
Int J Tuberc Lung Dis
; 19(7): 780-6, 2015 Jul.
Article
em En
| MEDLINE
| ID: mdl-26056101
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 RPT regimens 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.
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Base de dados:
MEDLINE
Assunto principal:
Rifampina
/
Escarro
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Tuberculose Pulmonar
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Mycobacterium tuberculosis
/
Antituberculosos
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article