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Also known as Taribavirin, RNA003142-204
Viramidine · 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...
Viramidine is an investigational small molecule being studied for the treatment of chronic Hepatitis C. It is a nucleoside analogue that was evaluated in Phase 3 clinical trials as a potential alternative to ribavirin in patients with chronic Hepatitis C who are treatment naive.
Viramidine is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC on the stock market. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis C.
Viramidine is in Phase 3 clinical development. It has completed two Phase 3 trials, but it is not yet approved by regulatory authorities. The drug remains investigational and is not available for commercial use.
Viramidine has been studied in two completed Phase 3 clinical trials. The first trial, NCT00093093, enrolled 900 treatment-naive patients with chronic Hepatitis C across multiple countries. The second trial, NCT00230958, also enrolled 900 treatment-naive patients with the same condition.
No, Viramidine is not the same as ribavirin, but it was studied as a comparison to ribavirin in clinical trials. Both are small molecules used for chronic Hepatitis C, but Viramidine is a distinct investigational compound being evaluated as a potential alternative.