Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment

University of Calgary11 enrolled

Overview

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response. ii) Evaluate adverse events. iii) Evaluate viral resistance.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

BoceprevirDRUG

All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will be eligible for the study if they meet the following inclusion criteria: 1. 18 years of age or older 2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted) 3. Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin 4. Detectable serum HCV-RNA 5. No significant co-morbid conditions 6. Liver biopsy is not necessary 7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects) Exclusion Criteria: * Subjects will be excluded from participation in this study if the following conditions are present: 1. Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma. 2. Active substance abuse within the past 12 months 3. Co-infection with hepatitis B or HIV 4. Decompensated cirrhosis (Child-Pugh class B or C) 5. Significant cytopenia - any of the following: platelets \<80 x 109/L, neutropenia \<1.2 x 103/L, Hb \<120 g/l for men or 110 g/l for women 6. Lack of informed consent 7. Previous null-responders (\<2 log10 decrease at week 12 with previous PR therapy)

Locations (1)

University of Calgary Liver Unit

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Sustained Virologic Response (SVR) at 24 Weeks Post Treatment

Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.

Time frame: 24 weeks after treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.