Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
peginterferon alfa 2a · 5 trials · 1 indication
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (\<) 50 international units per millilitre (IU/mL) measured \>=140 days after treatment end (i.e., \>= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
| Arm | Type | Description |
|---|---|---|
| PEG-IFN alfa-2a + Ribavirin for 24 weeks | EXPERIMENTAL | After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. |
| PEG-IFN alfa-2a + Ribavirin for 48 weeks | ACTIVE_COMPARATOR | After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. |
| Peginterferon alfa-2a 135 microgram (mcg) | EXPERIMENTAL | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. |
| Peginterferon alfa-2a 90 mcg | EXPERIMENTAL | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. |
| Peginterferon alfa-2a monotherapy or combined with ribavirin | EXPERIMENTAL | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. |
| Active Comparator | ACTIVE_COMPARATOR | Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) |
| Setrobuvir | EXPERIMENTAL | Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) |
| A/B | EXPERIMENTAL | - |
| C/D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| peginterferon alfa-2a | DRUG | - |
| Ribavirin | DRUG | - |
| peginterferon alfa-2a [Pegasys] | DRUG | 180 mcg sc weekly |
| placebo | DRUG | Orally b.i.d. |
| ribavirin [Copegus] | DRUG | 1000 mg or 1200 mg orally daily |
| setrobuvir | DRUG | Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks |
| peginterferon alfa 2a [Pegasys] | DRUG | sc weekly |
Inclusion Criteria: * adult patients, \>=18 years of age; * serological evidence of chronic hepatitis C (CHC); * CHC genotype 2 or 3; * receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR); * compensated liver disease. Exclusion Criteria: * pegylated i...
Peginterferon Alfa-2A is used for chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, chronic myelogenous leukemia, and hepatocellular carcinoma. It is being studied in clinical trials for these conditions, with completed trials focusing on chronic hepatitis B and chronic myelogenous leukemia.
Peginterferon Alfa-2A is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's efficacy in various chronic viral hepatitis and leukemia indications.
Peginterferon Alfa-2A is in Phase 2 clinical development. It has completed five trials, including Phase 1 and Phase 3 studies, but the current development stage is Phase 2. It remains investigational and is not yet approved for any indication.
Peginterferon Alfa-2A has completed five clinical trials, including NCT00962871 and NCT00962975 for chronic hepatitis B, NCT02736721 for chronic myelogenous leukemia, and NCT02992704 for inactive chronic hepatitis B carriers. All trials are completed with no active trials ongoing.
Yes, Peginterferon Alfa-2A is also known as Pegasys. Clinical trials reference Pegasys in their titles, such as NCT00962871 and NCT00962975, confirming that Peginterferon Alfa-2A and Pegasys refer to the same drug.