To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
558
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
Tablets, oral, 0 mg, once daily, 24 weeks
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as HCV RNA \<lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Time frame: Weeks 4 and 12
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
SVR24 was defined as HCV \<lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time frame: From start of study treatment (day 1) up to follow-up Week 48
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time frame: Week 4
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
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Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Cli
Los Angeles, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
University Of Florida Hepatology
Gainesville, Florida, United States
...and 54 more locations
Time frame: Week 12
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
SVR12 was defined as undetectable RNA (HCV RNA \< lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time frame: Follow-up Week 12
Percentage of Resistant Variants Associated With Virologic Failure
Virologic failure was defined as: 1. Virologic breakthrough: confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment 3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment 4. HCV RNA \< LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24 5. HCV RNA ≥LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation) 6. Relapse, defined as HCV RNA ≥LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \< LLOQ, TND at EOT. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time frame: Follow-up Week 48