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peginterferon alfa-2a

Phase 2

Hepatitis C | Monoclonal antibody | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Mar 10, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00983853Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIVPHASE2 COMPLETED 62 — — Oct 1, 2009 -Oct 10, 201316 United States, France +2
NCT00911963Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C InfectionPHASE1 COMPLETED 49 — — Apr 1, 2009Sep 1, 2012Mar 10, 201410 United States, Argentina +2
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Study Endpoints
Primary Endpoints
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
12 weeks after first dose of study drug
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Study visits throughout part B
Secondary Endpoints
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
4 and 12 weeks after the first dose of study drug
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
12 weeks after last dose of study drug
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
through 12 weeks after first dose of study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part AEXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent
Part BEXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent
Interventions
NameTypeDescription
telaprevir or matching placeboDRUGTablet, Oral, 750 mg, q8h, 12 weeks
peginterferon alfa-2aBIOLOGICALSubcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)DRUGTablet, Oral, 800 mg, b.i.d., 48 weeks
ribavirin (weight-based dose)DRUGTablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
VCH-222 or matching placeboDRUGcapsule, oral, 4 doses once daily or twice daily, 3 days
ribavirinDRUGtablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Chronic, genotype 1, hepatitis C with detectable HCV RNA * HIV-1 infection for \>6 months * Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis) Exclusion Criteria: * Previous tr...

Countries:United StatesFranceGermanySpainArgentinaCanadaPuerto Rico
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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