This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
HCV RNA will be measured 12 weeks post-treatment to evaluate SVR
Time frame: 12 weeks post-treatment
Sustained Virologic Response 4 and 24 Weeks after Treatment Completion
HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR
Time frame: 4 and 24 weeks post-treatment
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