Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PSI-7977 · 1 trial · 1 indication
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
| Arm | Type | Description |
|---|---|---|
| Treatment A: PSI-7977 + Daclatasvir | EXPERIMENTAL | Genotype 1a or 1b |
| Treatment B: PSI-7977 + Daclatasvir | EXPERIMENTAL | Genotype 2 or 3 |
| Treatment C: PSI-7977 + Daclatasvir | EXPERIMENTAL | Genotype 1a or 1b |
| Treatment D: PSI-7977 + Daclatasvir | EXPERIMENTAL | Genotype 2 or 3 |
| Treatment E: PSI-7977 + Daclatasvir + Ribavirin | EXPERIMENTAL | Genotype 1a or 1b |
| Treatment F: PSI-7977 + Daclatasvir+ Ribavirin | EXPERIMENTAL | Genotype 2 or 3 |
| Treatment G: PSI-7977 + Daclatasvir | EXPERIMENTAL | Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b |
| Treatment H: PSI-7977 + BMS-790052 + Ribavirin | EXPERIMENTAL | Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b |
| Treatment I: PSI-7977 + Daclatasvir | EXPERIMENTAL | Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b |
| Treatment J: PSI-7977 + Daclatasvir + Ribavirin | EXPERIMENTAL | Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b |
| Name | Type | Description |
|---|---|---|
| PSI-7977 | DRUG | Tablets, oral, 400 mg, once daily |
| Daclatasvir | DRUG | Tablets, oral, 60 mg, once daily |
| Ribavirin | DRUG | Tablets, oral, 200 mg |
Inclusion Criteria: * Men and women, ages 18 to 70 years. * Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (inc...
PSI-7977 is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in patients who have not previously received the standard of care for Hepatitis C virus infection.
PSI-7977 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational drug for chronic Hepatitis C.
PSI-7977 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of chronic Hepatitis C in patients who have not previously received the standard of care.
PSI-7977 has been studied in one completed Phase 2 clinical trial, identified as NCT01359644. This trial enrolled 350 participants with chronic Hepatitis C in the United States and Puerto Rico. The study was a randomized, controlled trial that evaluated the safety and effectiveness of antiviral combination therapy in patients who had not previously received the standard of care.
PSI-7977 is an investigational drug being developed by Bristol-Myers Squibb for chronic Hepatitis C. It is currently in Phase 2 clinical trials. The drug is a small molecule being studied for its safety and effectiveness in patients who have not previously received the standard of care for Hepatitis C virus infection.