Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-650032 (NS3 Protease Inhibitor), BMS-650032 (Asunaprevir), Asunaprevir (ASV), Asunaprevir
BMS-650032 · 12 trials · 5 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 |
| Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg) | EXPERIMENTAL | BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks |
| Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg) | EXPERIMENTAL | BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks |
| Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks |
| Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks |
| Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks |
| Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg) | EXPERIMENTAL | \* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks |
| Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV | EXPERIMENTAL | \* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablets orally twice daily 12 weeks BMS-790052 30 mg tablets orally twice daily 12 weeks BMS-791325 75 mg tablets orally twice daily 12 weeks Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks \[if subject is \< 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM\] |
| Phase 2a: Arm 1 | EXPERIMENTAL | - |
| Phase 2a: Arm 2 | PLACEBO_COMPARATOR | - |
| Phase 2b: Arm 1 | EXPERIMENTAL | - |
| Phase 2b: Arm 2 | PLACEBO_COMPARATOR | - |
| BMS-650032 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| Arm A - Ortho Tri-Cyclen® | ACTIVE_COMPARATOR | 1 to 28 days |
| Arm B - Ortho Tri-Cyclen® | ACTIVE_COMPARATOR | 29 to 56 days |
| Arm C - Ortho Tri-Cyclen® + BMS-650032 | ACTIVE_COMPARATOR | Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days |
| BMS-650032 in Child-Pugh A | ACTIVE_COMPARATOR | - |
| BMS-650032 in Child-Pugh B | ACTIVE_COMPARATOR | - |
| BMS-650032 in Child-Pugh C | ACTIVE_COMPARATOR | - |
| BMS-650032 in Healthy Subjects | ACTIVE_COMPARATOR | - |
| Treatment Group A | EXPERIMENTAL | - |
| Treatment Group B | EXPERIMENTAL | - |
| Treatment Group C | EXPERIMENTAL | Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg) |
| or Placebo - Dose Panel 1 | EXPERIMENTAL | Oral Suspension, 10 mg |
| or Placebo - Dose Panel 2 | EXPERIMENTAL | Oral Suspension 50 mg |
| or Placebo - Dose Panel 3 | EXPERIMENTAL | Oral Suspension, 200 mg |
| or Placebo - Dose Panel 4 | EXPERIMENTAL | Oral Suspension or Solution, 2.5 to 600 mg |
| 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 |
| BMS-650032 | DRUG | - |
| BMS-790052 | DRUG | - |
| BMS-791325 | DRUG | - |
| Placebo | DRUG | Tablets, Oral, 0 mg, twice daily, 48 weeks |
| Peginterferon Alfa-2a | DRUG | Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks |
| Ortho Tri-Cyclen® | DRUG | Tablets, Oral, 1 Tablet, once daily |
| BMS-650032 or Placebo | DRUG | Oral, Once daily, Single Dose |
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...
BMS-650032 is an investigational small molecule antiviral developed by Bristol-Myers Squibb for chronic hepatitis C and hepatitis C virus infection. It has also been studied in patients with hepatic insufficiency. Development reached Phase 2, and the compound has been evaluated in completed clinical trials.
BMS-650032 was studied for the treatment of chronic hepatitis C and hepatitis C virus infection. Trials also examined its use in patients with hepatic insufficiency. It was tested both as part of combination antiviral regimens and with peginterferon alfa-2a plus ribavirin in patients with HCV.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-650032. The company sponsored the clinical program evaluating the compound in hepatitis C and hepatic insufficiency, including Phase 1 and Phase 2 studies conducted across the United States, Europe, and other regions.
BMS-650032 reached Phase 2 clinical development. It is an investigational agent and is not described as approved. The program includes completed Phase 1 and Phase 2 trials, with no active trials currently listed.
BMS-650032 has been evaluated in completed trials including NCT01455090, a Phase 2 study of a three drug antiviral combination in previously untreated HCV patients, NCT01030432, a Phase 2 study with peginterferon alfa-2a plus ribavirin, and NCT01063023 and NCT01019070, Phase 1 studies.
Yes. BMS-650032 is also known as asunaprevir, and it has been referred to as an NS3 protease inhibitor. These names identify the same investigational compound developed by Bristol-Myers Squibb for hepatitis C virus infection.