The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
Key objectives of this study include: 1. To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy. 2. To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Stanford University Medical Center
Palo Alto, California, United States
Yale University Medical Center
New Haven, Connecticut, United States
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment
Time frame: 12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment
Serious adverse events, adverse events grade 3 and above
Time frame: 24 weeks while on treatment and 24 weeks after end of treatment
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