This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
University Of Miami Schiff Center For Liver Diseases
Miami, Florida, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Baylor St. Luke'S Medical Center
Houston, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
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.
Time frame: Post-treatment follow-up Week 12
Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
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.
Time frame: Post-treatment follow-up Week 12
Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
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.
Time frame: Post-treatment follow-up Week 12
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
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Harborview Medical Center
Seattle, Washington, United States
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.
Time frame: Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.
Time frame: Week 1, 2, 4, 6, 8, 12, End of treatment
Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be \<lower limit of quantitation ie, 25 IU/mL or below 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.
Time frame: Post-treatment follow-up Week 12
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. 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 up to 7 days post last dose of study treatment (approximately 13 weeks)
Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or \< 6.5 g/dL for grade 4, Platelet count as 25\*10\^9-50\*10\^9 /L for grade 3 and/or \< 25.000\*10\^9 /L for grade 4, International normalized ratio as 2.1-3.0\*upper limit of normal (ULN) \> 3.0\*ULN for grade 3 and/or \> 3.0\*ULN for grade 4, Leukocytes as 1.0\*10\^9-1.5\*10\^9/L for grade 3 and/or \<1.0\*10\^9/L for grade 4, Lymphocytes (Absolute) as 0.350\*109-0.499\*10\^9 /L for grade 3 and/or \< 0.350\*10\^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Alkaline phosphatase as 5.1-10.0\*ULN for grade 3 and/or \> 10.0\*ULN for grade 4, Bilirubin (Total) as 2.6-5.0\*ULN for grade 3 and/or \> 5.0\*ULN for grade 4, Albumin as \< 20 g/L, Lipase (Total) as 3.1-5.0\*ULN for grade 3 and/or \> 5.0\*ULN for grade 4, and Creatinine as 1.9-3.4\*ULN for grade 3 and/or ≥ 3.5\*ULN for grade 4.
Time frame: From start of study treatment up to 7 days post last dose of study treatment