Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Sponsor

Louis Stokes VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02113631

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population.
The secondary objective:

Resource use: recording of differences in resource use, such as direct costs (e.g., drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as the study will not only derive data by comparing those two drugs but also study the effect on different treatment lengths.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic Cirrhosis	Drug: Telaprevir Drug: Boceprevir Drug: Peg-IFN Drug: Ribavirin	N/A

Detailed Description

This is a randomized clinical trial comparing the effectiveness and safety of boceprevir and telaprevir.

Recruitment of current eligible subjects will occur during their regular appointments at the Hepatitis C clinic. Eligible patients will have already been cleared for Hepatitis C treatment through their screening period which is including blood work, liver biopsy, urine collection/analysis, pregnancy screening and behavioral/mental health screening. On one of their standard visits to the Hepatitis C clinic, the health care provider(who is also research staff) or research staff will provide a consent form that the patient may take home and read more about the study.

On the day of enrollment, which will also be the first day of treatment, health care providers within the Hepatitis C clinic will describe the study to the patient or refer them to one of the research for completion of these tasks. The consent form will be explained in detail at this meeting, and the patient will have the opportunity to ask questions and make comments about the study.

Study subjects will initially be stratified into 6 groups (1a. treatment naives without cirrhosis and b. with compensated cirrhosis ; 2a. prior treatment experienced non-responders without cirrhosis and b. with cirrhosis; 3a. prior treatment experienced relapsers without cirrhosis and b. with cirrhosis). Patients in each of these groups will be randomized using random number table and allocation concealment will be achieved by using serially numbered, opaque, sealed envelopes into one of two study groups. The first group will receive boceprevir with Peg-IFN and ribavirin as indicated by package insert, and the second group will receive telaprevir with Peg-IFN and ribavirin as indicated by its package insert. All other stratified groups will receive protease inhibitor therapy as indicated by the FDA product labeling.

Safety and effectiveness assessments will be conducted at study entry, PI therapy week 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 42 and 48, if applicable. Those are SOC visits during the treatment period and they will include blood tests, complete review of systems, and physical exams. Patients in all groups will be assessed for sustained viral response (SVR) at 12 and 24 weeks after the last dose of the medication is administered.

Identical to SOC, safety and effectiveness assessments will be determine by health care providers and the adjudication committee, the latter of which will be unaware of the treatment arm of the patients. Members of the adjudication committee will be independent of the treating clinicians, and will be responsible for adjudicating the following outcomes:

Viral response
Adverse effects
Decision regarding treatment discontinuation, based on adverse effect or virological failure

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir and Re-assessment of Treatment Duration in Patients With Chronic Hepatitis C

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Telaprevir Telapravir was administer with Peg-IFN and Ribavirin as per package insert Dose Telaprevir : PO, tablet 1125 mg BID for 12 weeks	Drug: Telaprevir Other Names: INCIVEK Drug: Peg-IFN Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks Other Names: Peg-Interferon alfa-2a, Pegasys Drug: Ribavirin Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks Other Names: Copegus
Active Comparator: Boceprevir Boceprevir was administer with Peg-IFN and Ribavirin as per package insert Dose Boceprevir PO capsule, 800mg TID for up to 44 weeks	Drug: Boceprevir Other Names: Victrelis Drug: Peg-IFN Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks Other Names: Peg-Interferon alfa-2a, Pegasys Drug: Ribavirin Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks Other Names: Copegus

Arm

Intervention/Treatment

Active Comparator: Telaprevir

Telapravir was administer with Peg-IFN and Ribavirin as per package insert Dose Telaprevir : PO, tablet 1125 mg BID for 12 weeks

Drug: Telaprevir

Other Names:

INCIVEK

Drug: Peg-IFN

Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks

Other Names:

Peg-Interferon alfa-2a, Pegasys

Drug: Ribavirin

Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks

Other Names:

Copegus

Active Comparator: Boceprevir

Boceprevir was administer with Peg-IFN and Ribavirin as per package insert Dose Boceprevir PO capsule, 800mg TID for up to 44 weeks

Drug: Boceprevir

Other Names:

Victrelis

Drug: Peg-IFN

Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks

Other Names:

Peg-Interferon alfa-2a, Pegasys

Drug: Ribavirin

Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks

Other Names:

Copegus

Outcome Measures

Primary Outcome Measures

Safety/Adverse Event Outcome Measure [Up to 3 weeks]
Number of Participants with Serious and Non-Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age
Have HCV genotype 1 infection and evidence of chronic hepatitis, as confirmed by a liver biopsy completed within three years prior to enrollment in the study, patients with cirrhosis will not need to undergo biopsy. Patients with compensated liver cirrhosis will be eligible. Patients who have previously been treated under standard of care (Peg-IFN, Ribavrin) and were non-responders, partial responders, or relapsers will also be eligible.
Platelet count >60,000/mm3
Absolute neutrophil count > 1000/mm3
Hemoglobin >11.0 g/dL for females or >12.0 g/dL for males
Serum creatinine </=1.5 mg/dL
Adequately controlled DM
Normal or adequately controlled TSH on prescription medication
All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator
Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose
Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent

Exclusion Criteria:

Positive HIV or HbsAg serology
Severe psychiatric or neuropsychiatric disorders including, but not limited to uncontrolled severe depression, history of suicidal ideations or suicide attempt(s), as determinate by SOC psychological evaluation 3 History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease
Chronic hepatic diseases other than hepatitis C 5. Organ or bone marrow transplant 6. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study 7. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study 8. Males whose female partners are pregnant 9. Patients who have had a malignancy diagnosed and/or treated within the past 3 years, except for localized squamous or basal cell cancers treated by local excision 10. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening 11. Current alcoholism or drug addiction