Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

Peter J. Ruane, M.D.

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Sofosbuvir; Drug: Simeprevir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02253550

TMC435HPC2012

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCV genotype 4 infection
• HCV RNA >10,000 IU/mL at screening.

Exclusion criteria

• Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
• Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
• Infection/co-infection with HCV non-genotype 4.
• Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
• Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).
• Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
• Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cirrhosis

Experimental group

Description:

Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir

Treatment:

Drug: Simeprevir

Drug: Sofosbuvir

Non-Cirrhotic

Experimental group

Description:

Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir

Treatment:

Drug: Simeprevir

Drug: Sofosbuvir