Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asunaprevir · 5 trials · 3 indications
SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \< lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.
HCV RNA measured 12 weeks after the end of the HCV treatment (Week 36)
Area under the concentration-time curve in one dosing interval \[AUC(TAU)\] will be calculated from the blood drug concentration versus time curve
| Arm | Type | Description |
|---|---|---|
| Asunaprevir + Daclatasvir | EXPERIMENTAL | Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and Daclatasvir 60mg tablet by mouth once daily for 24 weeks |
| QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin | EXPERIMENTAL | Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks |
| Arm 1: Null or Partial Responder to P/R (ASV + DCV) | EXPERIMENTAL | Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks |
| Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) | EXPERIMENTAL | Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks |
| Arm 3: Treatment naive (ASV + DCV) | EXPERIMENTAL | \[Subjects will receive ASV + DCV for 24 weeks\] followed by ASV + DCV for 24 weeks in protocol AI444026\] Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks |
| Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week | EXPERIMENTAL | Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks |
| Asunaprevir, Daclatasvir, Ribavirin, Peg-Interferon alpha-2a | EXPERIMENTAL | Quadritherapy from Day 0 to Week 24 |
| Arm A: Subjects with normal renal function | EXPERIMENTAL | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm B: Subjects with end stage renal disease | EXPERIMENTAL | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm C: Subjects with mild renal impairment | EXPERIMENTAL | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm D: Subjects with moderate renal impairment | EXPERIMENTAL | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Arm E: Subjects with severe renal impairment | EXPERIMENTAL | Asunaprevir 100 mg tablet by mouth twice daily for 7 days |
| Name | Type | Description |
|---|---|---|
| Asunaprevir | DRUG | - |
| Daclatasvir | DRUG | - |
| Peg-interferon Alfa-2a | DRUG | - |
| Ribavirin | DRUG | - |
| Asunaprevir (ASV) | DRUG | - |
| Daclatasvir (DCV) | DRUG | - |
| Pegylated-interferon alfa 2a (PegIFN) | DRUG | - |
| Ribavirin (RBV) | DRUG | - |
| Pegylated Interferon alpha-2a | DRUG | Pegylated Interferon alpha-2a, by subcutaneous injection 180µg / week, from Day 0 to Week 24 |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and females, ≥ 18 years of age * Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Asunaprevir is an investigational small molecule being developed for the treatment of Hepatitis C Virus (HCV) infection, including Hepatitis C Virus Genotype 4 Infection. It is intended for use in patients with chronic HCV infection.
Asunaprevir is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has conducted clinical trials of Asunaprevir in multiple countries for the treatment of Hepatitis C Virus infection.
Asunaprevir has completed Phase 3 clinical trials for the treatment of Hepatitis C Virus infection. It is an investigational drug and has not been reported as approved by regulatory authorities. The Phase 3 trials were part of the Hallmark program.
Asunaprevir has completed two Phase 3 trials: NCT01573351 (Hallmark QUAD, combining Asunaprevir with daclatasvir, peginterferon, and ribavirin) and NCT01581203 (Hallmark DUAL, combining Asunaprevir with daclatasvir). Both trials enrolled patients with Hepatitis C Virus who were null or partial responders, or intolerant/ineligible to prior therapy.
Asunaprevir is a small molecule that targets the Hepatitis C Virus. It is designed to inhibit viral replication by interfering with the NS3/4A protease enzyme, which is essential for the virus to replicate. This mechanism helps reduce the viral load in infected patients.
No, Asunaprevir is not the same as daclatasvir. Asunaprevir is an NS3/4A protease inhibitor, while daclatasvir is an NS5A inhibitor. In clinical trials, they have been studied in combination for the treatment of Hepatitis C Virus infection.