Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCV/ASV/BMS-791325 · 4 trials · 2 indications
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
SVR12 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 12. Imputed SVR12 was based on Next Value Carried Backwards approach.
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.
| Arm | Type | Description |
|---|---|---|
| Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV) | EXPERIMENTAL | Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks. |
| Arm 1 : DCV/ASV/BMS-791325 | EXPERIMENTAL | DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks |
| A 1: DCV/ASV/BMS-791325 in treatment-naive subjects | EXPERIMENTAL | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks |
| A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects | EXPERIMENTAL | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks |
| Arm 1: DCV/ASV/BMS-791325+Sofosbuvir | EXPERIMENTAL | Initial Therapy: Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks Sofosbuvir 400 mg tablet once daily orally for 4 weeks |
| Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir | EXPERIMENTAL | Initial Therapy Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks Sofosbuvir 400 mg tablet once daily orally for 6 weeks |
| Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a | EXPERIMENTAL | Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks |
| Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a | OTHER | Sofosbuvir 400 mg tablet once daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks |
| Name | Type | Description |
|---|---|---|
| DCV | DRUG | - |
| SOF | DRUG | - |
| RBV | DRUG | - |
| DCV/ASV/BMS-791325 | DRUG | - |
| Ribavirin | DRUG | - |
| Sofosbuvir | DRUG | - |
| Peginterferon α-2a | DRUG | - |
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Genotype 3 HCV * HCV RNA ≥10000 IU (International Unit)/mL * Compensated Liver Cirrhosis * BMI 18-40 kg/m2 * Previously treated for HCV or never treate...
| 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 |
DCV/ASV/BMS-791325 is an investigational fixed-dose combination regimen being studied for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. It combines three direct-acting antiviral agents: daclatasvir, asunaprevir, and BMS-791325. The regimen is being evaluated in non-cirrhotic subjects and in broader genotype 1 populations.
DCV/ASV/BMS-791325 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has conducted clinical trials of this fixed-dose combination for chronic hepatitis C virus infection.
DCV/ASV/BMS-791325 is in Phase 3 clinical development for chronic hepatitis C virus infection. It is an investigational regimen and has not been approved by regulatory authorities. The Phase 3 trials have been completed, along with one Phase 2 study.
DCV/ASV/BMS-791325 has been studied in three completed trials. NCT01979939 (UNITY 1) enrolled 416 non-cirrhotic genotype 1 patients across the US, Australia, Canada, France, and Puerto Rico. NCT02170727 enrolled 199 genotype 1 patients in Russia, South Korea, and Taiwan. NCT02175966 (FOURward) was a Phase 2 study with 35 patients.
DCV/ASV/BMS-791325 is a fixed-dose combination of three individual drugs: daclatasvir (DCV), asunaprevir (ASV), and BMS-791325. The combination is being studied as a single regimen for chronic hepatitis C virus infection, with the components acting together as direct-acting antivirals.
DCV/ASV/BMS-791325 is a combination of direct-acting antiviral agents that target hepatitis C virus proteins. Daclatasvir inhibits the NS5A protein, asunaprevir inhibits the NS3/4A protease, and BMS-791325 inhibits the NS5B polymerase. Together they block multiple steps of the HCV replication cycle.