Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
danoprevir · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| with cirrhosis | EXPERIMENTAL | - |
| without cirrhosis | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| danoprevir + ritonavir | DRUG | 125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks |
| peginterferon alfa-2a [Pegasys] | DRUG | 180 mcg sc weekly, 12 weeks |
| ribavirin [Copegus] | DRUG | 1000-1200 mg orally daily in divided doses, 12 weeks |
| danoprevir | DRUG | oral doses |
| placebo | DRUG | oral doses |
| ribavirin | DRUG | 1000-1200mg/day po |
| ritonavir | DRUG | oral doses |
Inclusion Criteria: * Adult patients of East Asian or Southeast Asian origin, \>/= 18 years of age * Presence of chronic genotype 1 hepatitis C infection * Treatment-naïve Exclusion Criteria: * History or presence of decompensated liver disease * Presence or history of non-hepatitis C chronic liv...
Danoprevir is an investigational small molecule antiviral developed by Roche Holding AG (ticker RHHBY) for the treatment of chronic hepatitis C. It is given as danoprevir plus ritonavir, a ritonavir-boosted regimen, and has been studied in Phase 2 clinical development. It is not an approved medicine.
Danoprevir is being studied for the treatment of chronic hepatitis C, specifically genotype 1 infection, including patients with or without cirrhosis. Trials have evaluated it in combination with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus). It remains investigational and is not approved for treating hepatitis C.
Danoprevir is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trials of ritonavir-boosted danoprevir in chronic hepatitis C, including studies conducted in Asian and European patient populations.
Danoprevir is in Phase 2 development. It is investigational and has not been approved by the FDA or any other regulator for chronic hepatitis C. Two completed trials are registered, one Phase 2 and one Phase 1, with no active trials currently listed.
Two completed trials are registered for danoprevir. NCT01749150 was a Phase 2 study of ritonavir-boosted danoprevir with peginterferon alfa-2a and ribavirin in Asian patients with chronic hepatitis C genotype 1, enrolling 61 participants. NCT01185860 was a Phase 1 study of the same combination in 59 patients.