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Also known as Viramidine, RNA003142-204
Taribavirin · 3 trials · 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 |
|---|---|---|
| Viramidine | DRUG | - |
| Ribavirin | DRUG | - |
| pegylated interferon alfa-2a | DRUG | - |
| pegylated interferon alfa-2b | DRUG | - |
| 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. |
Inclusion Criteria: * Treatment-naive patients with compensated chronic hepatitis C. * HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: * Severe neuropsychiatric diso...
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.