Hepatitis C
Conditions
Keywords
Boceprevir, Hepatitis C Genotype 3
Brief summary
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).
Detailed description
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.
Interventions
DRUGBoceprevir
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).
Sponsors
Merck Sharp & Dohme LLC
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response (SVR) at 24 Weeks Post Treatment | 24 weeks after 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. |
Countries
Canada
Participant flow
Recruitment details
It was hoped that 21 patients with chronic HCV genotype 3 who had failed to achieve an SVR with a standard course of treatment with Peginterferon α + ribavirin (PR) would be selected from the University of Calgary Liver Unit (UCLU) database. 11 patients were able to be enrolled in the study.The last patient completed the study in December 2014.
Pre-assignment details
Of the 11 patients who were enrolled in the study, 1 patient was a screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Victrelis Triple All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple) | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Victrelis Triple |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 53.3 years STANDARD_DEVIATION 6.945 |
| Region of Enrollment Canada | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
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
Population: Patients who completed full course of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Victrelis Triple | Sustained Virologic Response (SVR) at 24 Weeks Post Treatment | Subjects who completed treatment | 6 participants |
| Victrelis Triple | Sustained Virologic Response (SVR) at 24 Weeks Post Treatment | Subjects who obtained SVR 24 | 3 participants |