Phase 4
Completed N=93
The SIM-SOF Trial for Hepatitis C
Source: ClinicalTrials.gov NCT02168361 ↗Enrolled (actual)
93
Serious AEs
1.2%
Results posted
Mar 2016
Primary outcomePrimary: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) — 54; 18 participants — p=.02
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.
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 | — |
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
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. Informational only — not medical advice.