Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

NCT02113631 | Completed DMC

• 1 other identifier: IRB #: 11064-H40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The primary objective is to study the comparative effectiveness and tolerability of boceprevir vs. telaprevir in HCV treatment, within the VA population.
2. 2.The secondary objective:
3. 3.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.

Conditions

Hepatitis C, Chronic; Cirrhosis

Keywords

Hepatitis C treatment,; Boceprevir,; Telaprevir,; Safety; Effectiveness; Head-to-head trial

Outcome Measures

Primary Outcomes (1)

• Safety/Adverse Event Outcome Measure

  Number of Participants with Serious and Non-Serious Adverse Events

  Up to 3 weeks

Study Arms (2)

Telaprevir

ACTIVE COMPARATOR

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

Drug: Telaprevir; Drug: Peg-IFN; Drug: Ribavirin

Boceprevir

ACTIVE COMPARATOR

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; Drug: Peg-IFN; Drug: Ribavirin

Interventions

Telaprevir DRUG

Also known as: INCIVEK

Telaprevir

Boceprevir DRUG

Also known as: Victrelis

Boceprevir

Peg-IFN DRUG

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

Also known as: Peg-Interferon alfa-2a, Pegasys

Boceprevir; Telaprevir

Ribavirin DRUG

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

Also known as: Copegus

Boceprevir; Telaprevir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

Louis Stokes Cleveland VA medical center

Cleveland, Ohio, 44106, United States

Location

Related Publications (8)

• Flamm SL, Lawitz E, Jacobson I, Bourliere M, Hezode C, Vierling JM, Bacon BR, Niederau C, Sherman M, Goteti V, Sings HL, Barnard RO, Howe JA, Pedicone LD, Burroughs MH, Brass CA, Albrecht JK, Poordad F. Boceprevir with peginterferon alfa-2a-ribavirin is effective for previously treated chronic hepatitis C genotype 1 infection. Clin Gastroenterol Hepatol. 2013 Jan;11(1):81-87.e4; quiz e5. doi: 10.1016/j.cgh.2012.10.006. Epub 2012 Oct 10.

  PMID: 23064222 BACKGROUND

• Vierling JM, Davis M, Flamm S, Gordon SC, Lawitz E, Yoshida EM, Galati J, Luketic V, McCone J, Jacobson I, Marcellin P, Muir AJ, Poordad F, Pedicone LD, Albrecht J, Brass C, Howe AY, Colvard LY, Helmond FA, Deng W, Treitel M, Wahl J, Bronowicki JP. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol. 2014 Apr;60(4):748-56. doi: 10.1016/j.jhep.2013.12.013. Epub 2013 Dec 19.

  PMID: 24362076 BACKGROUND

• Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482.

  PMID: 21449784 BACKGROUND

• Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.

  PMID: 21449783 BACKGROUND

• Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.

  PMID: 21696307 BACKGROUND

• Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

  PMID: 21696308 BACKGROUND

• Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, Fried MW, Adler M, Reesink HW, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S, Wright CI, Poordad F; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011 Sep 15;365(11):1014-24. doi: 10.1056/NEJMoa1014463.

  PMID: 21916639 BACKGROUND

• Davitkov P, Chandar AK, Hirsch A, Compan A, Silveira MG, Anthony DD, Smith S, Gideon C, Bonomo RA, Falck-Ytter Y. Treatment Selection Choices Should Not Be Based on Benefits or Costs Alone: A Head-to-Head Randomized Controlled Trial of Antiviral Drugs for Hepatitis C. PLoS One. 2016 Oct 14;11(10):e0163945. doi: 10.1371/journal.pone.0163945. eCollection 2016.

  PMID: 27741230 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis

Interventions

telaprevir; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yngve Falck-Ytter, MD

  Louis Stokes Cleveland VA medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 14, 2014
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)