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Also known as Asunaprevir (ASV), BMS-650032
Asunaprevir · 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...
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| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
Asunaprevir is an investigational small molecule antiviral studied for the treatment of hepatitis C, including hepatitis C virus genotype 4 infection. It has been evaluated in clinical trials as part of combination regimens for patients with chronic hepatitis C, including those who had previously failed peg-interferon and ribavirin therapy.
Asunaprevir is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored the clinical trial program evaluating asunaprevir in hepatitis C, including Phase 3 studies such as the Hallmark DUAL trial.
Asunaprevir has been studied in Phase 3 clinical development. The program includes completed Phase 3 trials such as the Hallmark DUAL study and a Phase III China GT 1b trial, along with earlier-phase studies. Asunaprevir is investigational and has not been approved by the FDA.
Asunaprevir has been evaluated in completed trials including NCT01581203 (Phase 3 Hallmark DUAL), NCT01995266 (Phase III China GT 1b), NCT02107365 (Phase 2 ANRS HC32 QUATTRO in HCV genotype 4), and NCT01886599 (Phase 1 pharmacokinetics in kidney disease). These trials enrolled a combined total of 1,146 participants.
Yes, asunaprevir is also known as ASV. ASV is the abbreviated name used for asunaprevir in clinical trial titles and scientific literature, such as the Phase III Hallmark DUAL study listed as ASV+DCV.