Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
peg-Interferon alfa-2a · 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...
Peg-Interferon alfa-2a is used for the treatment of chronic hepatitis C. It is being developed by Merck & Company, Inc. for this infectious disease indication. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.
Peg-Interferon alfa-2a is a monoclonal antibody. Its specific molecular target is not disclosed in the available information. The drug is being studied for its effects in patients with chronic hepatitis C virus infection.
Peg-Interferon alfa-2a is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in chronic hepatitis C.
Peg-Interferon alfa-2a is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in any active trials.
Peg-Interferon alfa-2a has been studied in one completed Phase 3 clinical trial, identified as NCT01544920. This trial evaluated the safety and efficacy of boceprevir, peginterferon alfa-2a, and ribavirin in 737 participants with chronic hepatitis C virus genotype 1 who were positive for the interleukin-28B CC allele.
Peg-Interferon alfa-2a is the same as peginterferon alfa-2a, as the name is written with and without a hyphen. In clinical trial records, it is referred to as peginterferon alfa-2a. This drug is being studied in combination with other antiviral agents for chronic hepatitis C.