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

Beni-Suef University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Hepatitis C Virus Infection

Treatments

Drug: SOF/SMV/DCV/RBV

Study type

Interventional

Funder types

Other

Identifiers

NCT04387539

SOF/SMV/DCV/RBV

Details and patient eligibility

About

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

Full description

Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.

In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.

Enrollment

94 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.