Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ribavirin (RBV), Comparator: Ribavirin, Ribavirin (SCH 18908), ribavirin (SCH 18908)
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...