The SIM-SOF Trial for Hepatitis C

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Pegylated Interferon alfa-2b; Drug: Simeprevir; Drug: Ribavirin; Drug: Sofosbuvir

• Registration Number: NCT02168361
• Lead Sponsor: Center For Hepatitis C, Atlanta, GA

Brief Summary

Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Detailed Description

Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-20
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Results First Submitted: 2016-02-05
• Results First Submitted QC: 2016-02-05
• Status Verified: 2016-03
• Results First Posted: 2016-03-04
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• chronic hepatitis c,
• cirrhosis biopsy-proven, or via fibrotest,
• CPT score less than 7,
• genotype 1a,
• INR 2.3 or less,
• serum albumin greater than 2.7 gm/dL,
• total bilirubin less than 3 gm/dL,
• platelet count 50,000 per cubic milliliter or more
• GFR >50 ml/min

Exclusion Criteria

• non genotype 1a,
• history of CPT class B or C or decompensation or history of same,
• HIV or HBV coinfection,
• prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
• uncontrolled psychiatric or cardiopulmonary disorders,
• planning pregnancy or unwilling/unable to practice contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Pegylated Interferon alfa-2b	Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
Standard	Ribavirin	Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
Standard	Sofosbuvir	Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
Simeprevir + Sofosbuvir	Simeprevir	(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Simeprevir + Sofosbuvir	Sofosbuvir	(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)	12 weeks post-therapy	Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy

Secondary Outcome Measures

Name	Time	Method
Serum HCV RNA Level	4 and 12 weeks into therapy

Trial Locations

Locations (1)

Center for Hepatitis C; 🇺🇸 Atlanta, Georgia, United States