Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DCV
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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
DCV/ASV/BMS-791325 is an investigational fixed dose combination of three direct acting antivirals developed by Bristol-Myers Squibb for the treatment of chronic hepatitis C virus infection. It combines daclatasvir, asunaprevir, and BMS-791325 into a single regimen studied in Phase 3 trials.
DCV/ASV/BMS-791325 is being studied for the treatment of chronic hepatitis C virus infection, including genotype 1 and genotype 3 hepatitis C. Clinical trials have evaluated it in both non-cirrhotic and cirrhotic patients, sometimes in combination with sofosbuvir and ribavirin.
Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of DCV/ASV/BMS-791325. The company sponsored the Phase 2 and Phase 3 studies of the fixed dose combination regimen in chronic hepatitis C.
DCV/ASV/BMS-791325 has been studied in Phase 3 clinical development. All three registered trials of the regimen are completed, including two Phase 3 studies and one Phase 2 study, with no trials currently active.
Registered trials include the Phase 3 UNITY 1 study (NCT01979939) in non-cirrhotic genotype 1 patients, the Phase 3 fixed dose combination study NCT02170727 in genotype 1 patients, and the Phase 2 FOURward study (NCT02175966). A related Phase 3 study, NCT02673489, evaluated daclatasvir and sofosbuvir with ribavirin in genotype 3 cirrhosis.
DCV is shorthand for daclatasvir, one of the three components of the DCV/ASV/BMS-791325 fixed dose combination. The full regimen also contains asunaprevir (ASV) and BMS-791325, so DCV alone refers only to the daclatasvir portion rather than the complete combination.