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Also known as Ribavirin (RBV), Ribavirin (SCH 18908), RBV, Rebetol (Ribavirin), SCH 18908, Rebetol
Ribavirin · 1 trial · 1 indication
SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.
| Arm | Type | Description |
|---|---|---|
| Arm 1: peg-IFN + RBV | ACTIVE_COMPARATOR | Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) \[Arm 1a\]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV \[Arm 1b\]. |
| Arm 2: BOC + peg-IFN + RBV | EXPERIMENTAL | Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) \[Arm 2a\]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV \[Arm 2b\]. |
| Name | Type | Description |
|---|---|---|
| peg-Interferon alfa-2a | BIOLOGICAL | peg-IFN (180 ug) was taken once weekly via subcutaneous injection. |
| Ribavirin | DRUG | RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight \<75 kilograms \[kg\]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings. |
| Boceprevir | DRUG | Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg. |
Inclusion Criteria: * Is ≥ 40 kg and ≤ 125 kg. * Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL * Has IL-28B CC allele gene * Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for stag...
Ribavirin is used in the treatment of chronic hepatitis C, an infectious disease of the liver. In the Phase 3 trial listed here, it was given as part of a combination regimen with boceprevir and peginterferon alfa-2a in adults with chronic hepatitis C virus genotype 1. Ribavirin is a small molecule antiviral agent.
Ribavirin is an inhibitor of IMPDH1, inosine monophosphate dehydrogenase 1. By inhibiting this enzyme, the drug interferes with guanine nucleotide synthesis, which affects viral RNA replication. This mechanism underlies its antiviral activity against hepatitis C virus when used in combination with other antiviral agents.
Ribavirin is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 3 study of ribavirin in combination with boceprevir and peginterferon alfa-2a for chronic hepatitis C genotype 1. Ribavirin is also known by the abbreviation RBV and the code SCH 18908.
Ribavirin is in Phase 3 development for chronic hepatitis C. The listed Phase 3 trial, NCT01544920, has been completed. Ribavirin is an investigational agent in this program and is being studied as part of a combination regimen rather than as a standalone therapy.
Ribavirin has been studied in the Phase 3 trial NCT01544920, titled Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants. That trial enrolled 737 participants, was randomized and active controlled, and has been completed.
Yes. Ribavirin is also known as RBV, and it carries the development code SCH 18908. These names refer to the same small molecule IMPDH1 inhibitor studied in chronic hepatitis C. Searches for RBV or SCH 18908 refer to the same compound as ribavirin.