The SIM-SOF Trial for Hepatitis C

Center For Hepatitis C, Atlanta, GA

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Pegylated Interferon alfa-2b; Drug: Simeprevir; Drug: Ribavirin; Drug: Sofosbuvir

Study type: Interventional

Funder types: Other

Identifiers

NCT02168361

CHC-21

Details and patient eligibility

About

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.

Full 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

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Standard

Active Comparator group

Description:

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

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: Pegylated Interferon alfa-2b

Simeprevir + Sofosbuvir

Experimental group

Description:

(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Simeprevir