Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir
Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Response Guided Therapy (RGT) for Boceprevir Combined With Peginterferon Alpha-2b Plus Ribavirin in Naïve Hispanic Patients With Genotype 1 Hepatitis C Infection|
- SVR based on intention to treat analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Patients who have detectable HCV RNA at week 24 must have study treatment discontinued.
- Tolerance [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
All patients who have study treatment discontinued should have the assessments scheduled for the end of anti HCV treatment (Week 48) performed at the time of premature discontinuation and the follow-up assessments required 12 weeks after the end of anti HCV therapy.
If a discontinued patient received greater than or equal to 12 weeks of anti HCV therapy, an HCV test should be performed 24 weeks after the last dose of anti HCV treatment.
- BDI II score 31 or above [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Any patient who has a BDI II score greater than or equal to 31 at any time during the study should have study treatment discontinued.
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Hispanic, HCV genotype 1
Historical group will be a continuous group of Hispanic patients with genotype 1 who were naive to treatment and completed or initiated 48 weeks of pegylated interferon and ribavirin. Patients, who discontinued the treatment due to side effects, adherence issues, or treatment failure, will be included and analyzed based on intention to treat analysis. All patients will be stratified according to their SVR, relapse and no response rate. RVR, EVR, and ETR will be also collated and compared to the study group.
Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin).
Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results
Other Name: Victrelis
STUDY DESIGN AND ENROLLMENT Open label single arm pilot study enrolling Hispanic patients with HCV genotype 1 and naive to pegylated interferon and BOC treatment.
Definition of BOC RGT:
All patients will receive 4 weeks of PR (lead-in), and BOC will be added at the beginning of week 5. Patients who have an undetectable HCV RNA at week 8 and week 24 will receive 24 weeks of PR and BOC (28 weeks total treatment); patients who have a detectable HCV RNA at week 8, but an undetectable HCV RNA at week 24, will receive an additional 32 weeks of PR and BOC, followed by 12 weeks of PR (48 weeks total treatment).
Patients with cirrhosis or bridging fibrosis (Stage 4 fibrosis) will receive 4 weeks of lead in followed by 44 weeks of BOC and PR (total 48 weeks).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465516
|United States, California|
|Southern California Transplantation Institute Research Foundation|
|Riverside, California, United States, 92501|
|Principal Investigator:||Zeid Kayali, MD||Southern California Transplantation Institute Research Foundation|