Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taribavirin · 1 trial · 1 indication
The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \<100 copies/mL serum HCV RNA. A PR is defined as \< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.
| Arm | Type | Description |
|---|---|---|
| Group 1: Drug | EXPERIMENTAL | Oral taribavirin tablet 20 mg/kg/day (Actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) |
| Group 2: Drug | EXPERIMENTAL | Oral taribavirin tablet 25 mg/kg/day (Actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) |
| Group 3: Drug | EXPERIMENTAL | Oral taribavirin 30 mg/kg/day (Actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) |
| Group 4: Drug | ACTIVE_COMPARATOR | Oral ribavirin 800 mg/day (body weight \<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) |
| Name | Type | Description |
|---|---|---|
| Taribavirin | DRUG | Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period. |
| Ribavirin | DRUG | Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period. |
Subject Inclusion Criteria To be eligible for enrollment, patients must meet all of the following criteria: 1. At least 18 years of age 2. Diagnosed with compensated chronic HCV genotype 1 infection that has not been treated with interferon, peginterferon, ribavirin or any experimental therapy for...
Taribavirin is an investigational small molecule being studied for the treatment of chronic Hepatitis C, an infectious disease of the liver. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Taribavirin is being developed by Bausch Health Companies Inc., a company publicly traded under the ticker symbol BHC. The drug is currently in Phase 2 clinical development for chronic Hepatitis C.
Taribavirin is in Phase 2 clinical development. It is an investigational drug for chronic Hepatitis C and has not been approved for marketing. One Phase 2 trial has been completed, and no trials are currently active.
Taribavirin has been studied in one completed Phase 2 clinical trial, identified as NCT00446134. This trial was a dose-finding study for the treatment of Hepatitis C virus (HCV) in the United States, enrolling 278 participants with chronic Hepatitis C.
Taribavirin is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for chronic Hepatitis C. The completed Phase 2 trial, NCT00446134, was a dose-finding study, but the drug has not received regulatory approval.