The SIM-SOF Trial for Hepatitis C

Center For Hepatitis C, Atlanta, GA93 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

Pegylated Interferon alfa-2bDRUG

1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total

SimeprevirDRUG

150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks

RibavirinDRUG

1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Hepatitis C

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Proportion of Participants With Sustained Virologic Response 12 (SVR-12)

Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy

Time frame: 12 weeks post-therapy

Secondary Outcomes

Serum HCV RNA Level

Time frame: 4 and 12 weeks into therapy

Data from ClinicalTrials.gov

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