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

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Simeprevir; Drug: Sofosbuvir

• Registration Number: NCT02253550
• Lead Sponsor: Peter J. Ruane, M.D.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-27
• Study Start: 2014-10
• Study First Posted: 2014-10-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Cirrhotic	Sofosbuvir	Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
Cirrhosis	Simeprevir	Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
Cirrhosis	Sofosbuvir	Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
Non-Cirrhotic	Simeprevir	Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)	12 weeks post-treatment	HCV RNA will be measured 12 weeks post-treatment to evaluate SVR

Secondary Outcome Measures

Name	Time	Method
Sustained Virologic Response 4 and 24 Weeks after Treatment Completion	4 and 24 weeks post-treatment	HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR

Trial Locations

Locations (1)

Peter J. Ruane, MD, Inc.; 🇺🇸 Los Angeles, California, United States