Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Copegus · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | EXPERIMENTAL | 24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period. |
| Treatment Arm B | EXPERIMENTAL | 24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
| Treatment Arm C (Control) | ACTIVE_COMPARATOR | 4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
| Previous null responders (Cohort B): Group 4 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous null responders (Cohort B): Group 5 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous null responders (Cohort B): Group 6 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment. |
| Previous partial responders (Cohort A): Group 1 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous partial responders (Cohort A): Group 2 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous partial responders (Cohort A): Group 3 | EXPERIMENTAL | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Group A | EXPERIMENTAL | Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
| Group B | EXPERIMENTAL | Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
| Group C | EXPERIMENTAL | Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
| Group D | EXPERIMENTAL | Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks |
| Group E | ACTIVE_COMPARATOR | Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks |
| Part 1: Placebo | PLACEBO_COMPARATOR | Placebo in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 300mg po | EXPERIMENTAL | RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 600mg po | EXPERIMENTAL | RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 900mg po | EXPERIMENTAL | RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
| Part 2: Placebo | PLACEBO_COMPARATOR | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus. |
| Part 2: RO5190591 300mg po | EXPERIMENTAL | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
| Group 1 | EXPERIMENTAL | Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Group 2 | EXPERIMENTAL | Group 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Group 3 | EXPERIMENTAL | Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. |
| Group 4 | EXPERIMENTAL | Group 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Group 5 | EXPERIMENTAL | Group 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Group 6 | EXPERIMENTAL | Group 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Group 7 | ACTIVE_COMPARATOR | Standard of care (SOC) |
| PEGASYS with COPEGUS | ACTIVE_COMPARATOR | - |
| RO5024048 1500mg in combination with PEGASYS | EXPERIMENTAL | - |
| RO5024048 3000mg in combination with PEGASYS | EXPERIMENTAL | - |
| RO5024048 in combination with PEGASYS and COPEGUS | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Copegus | DRUG | total daily dose of 1000 mg or 1200 mg for 24 weeks |
| Pegasys | DRUG | 180 microgram subcutaneous once a week for 24 weeks |
| boceprevir | DRUG | 800 mg three times a day for 24 weeks |
| mericitabine | DRUG | 1000 mg twice daily for 24 weeks |
| mericitabine placebo | DRUG | mericitabine placebo |
| boceprevir placebo | DRUG | boceprevir placebo |
| RO5024048 | DRUG | 1000 mg oral doses twice a day for 24 weeks |
| danoprevir | DRUG | 100 mg oral doses twice a day for 24 weeks |
| ritonavir | DRUG | 100 mg oral doses twice a day for 24 weeks |
| Placebo | DRUG | po for 12 weeks |
| RO5190591 (Danoprevir) | DRUG | 300mg po q8h for 12 weeks |
| RO4588161 | DRUG | 1000mg po bid for 24 weeks |
| RO5024048 1500mg | DRUG | 1500mg po bid for 4 weeks |
| RO5024048 3000mg | DRUG | 3000mg po bid for 4 weeks |
Inclusion Criteria: * Adult patients, \>/=18 years of age * Chronic hepatitis C infection for at least 6 months duration * Hepatitis C genotype 1a or 1b * Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study * Patient showed a previous null...
Copegus is a small molecule used for the treatment of chronic hepatitis C. It is developed by Roche Holding AG and is typically studied in combination with other antiviral agents, such as PEGASYS, to address chronic hepatitis C virus infection.
Copegus is a small molecule antiviral, but its specific molecular target is not disclosed in the available information. It is used in combination regimens for chronic hepatitis C, but the precise mechanism of action is not detailed.
Copegus is developed by Roche Holding AG, a pharmaceutical company. The company's stock is traded under the ticker RHHBY.
Copegus is in Phase 2 clinical development for chronic hepatitis C. It is an investigational drug and has not been approved by regulatory authorities. All seven clinical trials listed for Copegus are completed, with no active trials currently ongoing.
Copegus has been studied in seven completed Phase 2 clinical trials, including NCT00377182, NCT00517439, NCT01220947, and NCT01482403. These trials evaluated Copegus in combination with other agents like PEGASYS and danoprevir in patients with chronic hepatitis C.
Copegus is a brand name for ribavirin, an antiviral medication. It is used in combination with other drugs for chronic hepatitis C. The generic name is ribavirin, and Copegus is one of its trade names.