Phase 4 N=93 Randomized Treatment

The SIM-SOF Trial for Hepatitis C

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT02168361 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Mar 2016

Primary outcome: Primary: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) — 54; 18 participants — p=.02

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pegylated Interferon alfa-2b (Drug); Simeprevir (Drug); Ribavirin (Drug); Sofosbuvir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Center For Hepatitis C, Atlanta, GA
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Sustained Virologic Response 12 (SVR-12)	54; 18	.02 sig
SECONDARY Serum HCV RNA Level	154; 880; 31; 740	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02168361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.