Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02496078 | A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection | PHASE3 | COMPLETED | 207 | — | — | Aug 1, 2015 | Feb 1, 2017 | Apr 19, 2017 | 29 | China, Russia +1 |
| NCT02319031 | Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis | PHASE3 | COMPLETED | 53 | — | — | Feb 1, 2015 | Dec 1, 2015 | Jan 27, 2017 | 10 | Australia, France |
| NCT02032875 | Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant | PHASE3 | COMPLETED | 116 | — | — | Mar 1, 2014 | Jan 1, 2016 | Feb 9, 2017 | 5 | United States |
| NCT02032888 | A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection. | PHASE3 | COMPLETED | 238 | — | — | Feb 1, 2014 | Jan 1, 2015 | Oct 27, 2015 | 37 | United States |
| NCT02032901 | Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV | PHASE3 | COMPLETED | 173 | — | — | Jan 1, 2014 | Dec 1, 2014 | Oct 1, 2015 | 31 | United States, Puerto Rico |
| NCT01973049 | UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis | PHASE3 | COMPLETED | 202 | — | — | Dec 1, 2013 | Nov 1, 2014 | Oct 9, 2015 | 49 | United States, Australia +2 |
| NCT01492426 | Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection | PHASE3 | COMPLETED | 605 | — | — | Jan 1, 2012 | Mar 1, 2014 | Jun 3, 2016 | 91 | United States, Argentina +14 |
| NCT01389323 | BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C | PHASE3 | COMPLETED | 448 | — | — | Sep 1, 2011 | Jan 1, 2014 | Oct 12, 2015 | 36 | United States, Puerto Rico |
| NCT02159352 | Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants | PHASE1 | COMPLETED | 49 | — | — | Jun 1, 2014 | Jul 1, 2014 | Nov 30, 2015 | 1 | United States |
| NCT02103569 | Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2014 | Jul 1, 2014 | Aug 15, 2014 | - | — |
| NCT02104843 | Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin | PHASE1 | COMPLETED | 18 | — | — | Apr 1, 2014 | May 1, 2014 | Jul 18, 2014 | - | — |
| NCT01830205 | Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment | PHASE1 | COMPLETED | 58 | — | — | Sep 1, 2012 | Jun 1, 2013 | Nov 16, 2015 | 2 | United States |
HCV RNA \< Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
SVR12 was defined as HCV RNA \<lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.
AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.
AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.
| Arm | Type | Description |
|---|---|---|
| Active dual arm | ACTIVE_COMPARATOR | Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48 |
| Placebo arm | PLACEBO_COMPARATOR | Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60 |
| Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) | ACTIVE_COMPARATOR | Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing |
| Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) | ACTIVE_COMPARATOR | Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing |
| Post-liver Transplant Cohort | EXPERIMENTAL | Participants with liver transplant received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets daily for 12 weeks and were followed for 24 weeks post treatment. |
| Cirrhotic Cohort | EXPERIMENTAL | Cirrhotic participants received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets orally for 12 weeks and were followed for 24 weeks post-treatment. Cirrhotic participants who received a liver transplant while on study treatment were eligible (\>3 months post transplant) for a treatment extension of daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (dose based on hemoglobin level) tablets orally for an additional 12 weeks |
| Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks | EXPERIMENTAL | Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks |
| Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks | EXPERIMENTAL | Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks |
| Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks | EXPERIMENTAL | Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks |
| A1:Daclatasvir + Sofosbuvir in treatment-naive subjects | EXPERIMENTAL | Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks |
| A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects | EXPERIMENTAL | Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks |
| A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) | EXPERIMENTAL | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks |
| A2: DCV/ASV/BMS-791325 + RBV (naive) | EXPERIMENTAL | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks |
| A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) | EXPERIMENTAL | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks |
| A4: DCV/ASV/BMS-791325 + RBV (experienced) | EXPERIMENTAL | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If \< 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening |
| Daclatasvir + Peginterferon alfa-2a + Ribavirin | EXPERIMENTAL | - |
| Telaprevir + Peginterferon alfa-2a + Ribavirin | EXPERIMENTAL | - |
| Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin | EXPERIMENTAL | - |
| Group 1: Daclatasvir and Darunavir/Ritonavir | EXPERIMENTAL | Treatment A: Daclatasvir oral tablet on specific days Treatment B: Daclatasvir tablet and Darunavir Tablet/Ritonavir capsule orally on specific days |
| Group 2: Daclatasvir and Lopinavir/Ritonavir | EXPERIMENTAL | Treatment C: Daclatasvir oral tablet on specific days Treatment D: Daclatasvir tablet and Lopinavir/Ritonavir tablet orally on specific days |
| Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325 | EXPERIMENTAL | Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days |
| Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin | EXPERIMENTAL | Treatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days |
| Group A (Normal renal function): Daclatasvir | EXPERIMENTAL | Daclatasvir 60 mg tablet by mouth single dose on Day 1 |
| Group B (End Stage Renal Disease): Daclatasvir | EXPERIMENTAL | Daclatasvir 60 mg tablet by mouth single dose on Day 1 |
| Group C (Moderate renal impairment): Daclatasvir | EXPERIMENTAL | Daclatasvir 60 mg tablet by mouth single dose on Day 1 |
| Group D (Severe renal impairment): Daclatasvir | EXPERIMENTAL | Daclatasvir 60 mg tablet by mouth single dose on Day 1 |
| Name | Type | Description |
|---|---|---|
| Daclatasvir | DRUG | Daclatasvir tablet 60mg |
| Asunaprevir | DRUG | Asunaprevir soft capsule 100 mg |
| Sofosbuvir | DRUG | - |
| Ribavirin | DRUG | - |
| BMS-791325 | DRUG | - |
| Placebo matching Ribavirin | DRUG | - |
| Telaprevir | DRUG | Film-coated tablet, oral, 750 mg, 3 times daily |
| Peginterferon alfa-2a | DRUG | Solution for injection, subcutaneous injection, 180 μg, weekly |
| Peg-Interferon Alfa-2a | DRUG | Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response |
| Darunavir | DRUG | - |
| Ritonavir | DRUG | - |
| Lopinavir/Ritonavir | DRUG | - |
| FDC of Daclatasvir, Asunaprevir and BMS-791325 | DRUG | - |
| FDC of Norethindrone and Ethinyl Estradiol | DRUG | - |
| Daclatasvir, Asunaprevir and BMS-791325 FDC | DRUG | - |
| Rosuvastatin | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients chronically infected with HCV Genotype 1b * No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent * HCV RNA vira...
| 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 |