An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys(RegisteredTM)), and Ribavirin (Copegus(RegisteredTM)) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy Vertex Study Number: VX11-950-116
This is a single-arm, open-label, multicenter study of treatment-experienced subjects with genotype 1 hepatitis C virus (HCV), who self-identify as Black/african american (Group a) and a subgroup of subjects who do not self-identify as Black/african american (Group B).
all patients taking part of this study will receive telaprevir in combination with PeG and RBV. They will receive the telaprevir for 12 weeks. The duration of the PeG and RBV will be determined by the following:
* For prior relapsers (whose virus count becomes undetectable) at week 4 and 12 will receive the PeG anD RBV for 24 weeks.
* all other subjects (all prior partial responders, all prior null responders, and prior relapsers with a detectable virus count at week either 4 and/or 12) will receive PeG and RBV for 48 weeks.
about 20 patients with Hepatitis C will be screened in this study at uT Southwestern Medical Center. This study also is taking place at a number of other medical facilities around the country. There will be a total of 220 people participating in this research study at approximately 30 centers in the united States and Canada. The maximum time that a subject is expected to be enrolled in the study will depend upon their response to treatment. Screening, treatment, and treatment follow-up will require a maximum of 76 weeks.
The following inclusion criteria must be met for a subject to be eligible for enrollment into the study:
1.Male and female subjects, 18 to 70 years of age, inclusive
2.Subjects self-identify as Black/African American (Group A) or do not self-identify as Black/African American (Group B)
3.Subjects have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months, defined by:
* documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or
* documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the Screening Visit, or
* documented histologic evidence of CHC demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the Screening Visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required.
4. Subjects have screening laboratory values within the following acceptable ranges:
* Hepatitis B surface antigen - seronegative
* HIV-1 and HIV-2 antibodies x seronegative
* Absolute neutrophil count >1000/mm3
* Platelet count >90000/mm3
* Hemoglobin >12 g/dL for female subjects; >13 g/dL for male subjects
* Uric acid- within normal range
* Thyroid-stimulating hormone and thyroxine x within normal range or adequately controlled thyroid function on treatment, or considered clinically insignificant
* All other hematology and clinical chemistry results x within normal limits or showing no clinically significant abnormalities
5. Subjects did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had the following viral response:
* Prior relapsers: Subject had a documented undetectable HCV RNA level at the planned end of treatment of at least 42 weeks duration [HCV RNA evaluated at any time between 3 weeks before or 6 weeks after the last dose of Peg-IFN or RBV].
* Prior null responders: Subject had a <2-log10 decrease in HCV RNA at 12 weeks of prior Peg-IFN/RBV treatment, but never achieved undetectable HCV RNA while on treatment; or
* Prior partial responders: Subject had a >=2-log10 decrease in HCV RNA at 12 weeks of prior Peg-IFN/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
The following information related to the virologic response to the prior course of Peg-IFN/RBV treatment (that qualifies as an adequate course, as defined above) must be available in the subject[Single Quote]s medical records:
* Start dates of treatment must be documented for all subjects.
* Stop dates of treatment must be documented for prior relapsers.
* HCV RNA results at start of treatment (all subjects), at 12 weeks after start of treatment (null and partial responders), at end of treatment (all subjects), and during follow-up (relapsers). Note: the following time window is allowed for the Week 12 assessment time point: Week 11 to Week 16.
* Both the HCV RNA assay used and the limit of detection if available
6.Subject must have received the last dose of Peg-IFN or RBV at least 12 weeks before
the Screening Visit.
7.Baseline evidence of the absence or presence of cirrhosis at the Screening Visit by FibroSure/FibroTest (cirrhosis cutoff greater than 0.74), FibroScan (cirrhosis cutoff by standard criteria or manufacturer[Single Quote]s instruction), or documented liver biopsy result within 3 years of Day 1 (Metavir F4; Ishak score >=5). If a previous liver biopsy result showed evidence of cirrhosis at any time in the past, then no current testing is required to show evidence of cirrhosis.
8.Female subjects of childbearing potential agree to use 2 effective methods of contraception from the Screening Visit through 6 months after the last dose of RBV, as described in Section 12.6.1. Male subjects who have a female partner of childbearing potential agree to use 2 effective methods of contraception from the Screening Visit through 7 months after the last dose of RBV, unless vasectomized and with documented sterility.
9.Willing and able to refrain from the concomitant use of any restricted medications, substances or foods as indicated in Section 11.11 from 14 days before Day 1 through the end of study drug treatment.
10. An informed consent document signed and dated by the subject or legally acceptable representative.
11.Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.