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Label indication PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) PRIFTIN is indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. FDA label
Also known as rifapentine (M000473), Priftin®, RPT (common abbreviation), Rifadin
rifapentine · 4 trials · 4 indications
Number of Participants with Grade 2 or higher adverse events over 26 days
To determine and compare the steady-state pharmacokinetics and dose linearity of escalating daily doses of rifapentine in dose cohorts of 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg in healthy volunteers after a single dose (Day 2) or multiple doses (Day 15)
Target AUC is no more than 25% lower than, and no more than 75% higher than, the target AUC of 522 mcg\*h/L. Data to be used for dose adjustments throughout the study and to create dosing algorithm for pediatric subgroups.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | rifampin, isoniazid, pyrazinamide, ethambutol |
| 2 | EXPERIMENTAL | rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol |
| 3 | EXPERIMENTAL | rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol |
| 4 | EXPERIMENTAL | rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol |
| Rifampin control | ACTIVE_COMPARATOR | Rifampin + midazolam |
| RPT 1 | EXPERIMENTAL | RPT Cohort 1 - 5 mg/kg |
| RPT 2 | EXPERIMENTAL | RPT Cohort 2 - 10 mg/kg |
| RPT 3 | EXPERIMENTAL | RPT Cohort 3 - 15 mg/kg |
| RPT 4 | EXPERIMENTAL | RPT Cohort 4 - 20 mg/kg |
| RPT 5 | EXPERIMENTAL | RPT Cohort 5 - Maximal tolerated dose, if dose limiting toxicities are observed |
| Single Arm Rifapentine and Isoniazid | EXPERIMENTAL | Single arm, open label and exposure-controlled. Intervention is rifapentine given in a new fixed dose combination once-weekly, in combination with isoniazid for 12 weeks, in HIV-infected and HIV-uninfected children aged 0-12 years in whom LTBI treatment is indicated. The protocol allows for parallel enrolment of children into cohorts 1 and 2, simultaneously, using a predetermined modeled initial dose for each cohort, separately. Similarly, cohorts 3 and 4 will be enrolled in parallel, using modeled doses for each cohort, based on data from cohorts 1 and 2 and historical data from TBTC trials. |
| cohort 1 | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1). |
| cohort 2 | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2). |
| cohort 3 (optional) | EXPERIMENTAL | Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3). |
| Name | Type | Description |
|---|---|---|
| rifampin | DRUG | tablet, 10 mg/kg, daily, 8 weeks |
| rifapentine | DRUG | tablet, 10 mg/kg, daily, 8 weeks |
| Rifampin & midazolam | DRUG | rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
| rifapentine & midazolam | DRUG | rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
| rifapentine and midazolam | DRUG | rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
| Isoniazid | DRUG | Isoniazid. 25mg/kg |
| rifapentine (M000473) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| EFZ EMT TDF | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion Criteria: 1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. 2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment. 3...
Rifapentine is studied for the treatment of tuberculosis, including latent tuberculosis, pulmonary tuberculosis, and tuberculosis in people living with HIV. It has been evaluated in Phase 1 and Phase 2 clinical trials, including a large Phase 2 study of rifapentine during the intensive phase of pulmonary tuberculosis treatment.
Rifapentine is developed by Sanofi, which trades under the ticker SNY. The company has sponsored clinical studies of the drug, including pharmacokinetic and drug interaction trials in tuberculosis and HIV patients.
Rifapentine is in Phase 1 clinical development. It has completed Phase 1 trials and a Phase 2 trial, but it is investigational and has not been approved by the FDA for the studied indications.
Rifapentine has been studied in several completed trials, including NCT03730181, a Phase 1 trial in latent tuberculosis in South Africa; NCT01690403, a Phase 1 drug interaction study in HIV patients; NCT01162486, a Phase 1 dose escalation study in healthy volunteers; and NCT00694629, a Phase 2 trial in pulmonary tuberculosis.