Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2013-12-31
2015-04-30
Brief Summary
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Detailed Description
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Must have Child's Class A cirrhosis/compensated and no history of decompensation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard
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
Pegylated Interferon alfa-2b
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
Ribavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Simeprevir + Sofosbuvir
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Simeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Interventions
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Pegylated Interferon alfa-2b
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
Simeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
Ribavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Center For Hepatitis C, Atlanta, GA
OTHER
Responsible Party
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Principal Investigators
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Brian L Pearlman, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Hepatitis C
Locations
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Center for Hepatitis C
Atlanta, Georgia, United States
Countries
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References
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Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.
Other Identifiers
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CHC-21
Identifier Type: -
Identifier Source: org_study_id
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