ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Simeprevir; Sofosbuvir

Criteria

Inclusion Criteria:

• Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]

• Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)

• Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)

Exclusion Criteria:

• HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• had any liver disease other than chronic HCV GT4 infection.

• had a history of liver decompensation

• serum a-fetoprotein (AFP) > 100 ng/ml

• evidence of hepatocellular carcinoma

• major severe illness such as respiratory, renal, heart failure or autoimmune disease

• non-compliance with treatment.