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Paritaprevir/ritonavir/ombitasvir

Phase 3

Hepatitis C, Acute | Small molecule | Infectious Disease |AbbVie Inc.|Last Updated: Aug 22, 2022

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02634008Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/PPHASE3 COMPLETED 83 — — Jun 1, 2016Apr 30, 2021Aug 22, 202211 Australia, New Zealand +1
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Study Endpoints
Primary Endpoints
Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12).
12 weeks post treatment
Secondary Endpoints
The proportion of treated subjects overall with ETR, SVR4 and SVR24 defined as undetectable HCV RNA at end of therapy, 4 weeks and 24 weeks post therapy, respectively.
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 24 weeks post treatment
Comparison of ETR, SVR4, SVR12 and SVR24 between those receiving 8 weeks treatment and those receiving 6 weeks treatment.
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 12 weeks post treatment; 24 weeks post treatment
Comparison of adherence between those receiving 8 weeks treatment and those receiving 6 weeks treatment
Baseline to week 6 or week 8 treatment duration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALParitaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks.
Cohort 2EXPERIMENTALThree tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks
Cohort 3EXPERIMENTALThree tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks
Interventions
NameTypeDescription
Paritaprevir/ritonavir/ombitasvirDRUG -
DasabuvirDRUG -
RibavirinDRUG -
Glecaprevir/pibrentasvirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Provision of written informed consent; * Male and female patients aged 18 years and over; * For Cohort One: willing to use two effective methods of contraception during the treatment period and 24 weeks post; * For Cohort Two and Three: If female and of childbearing potential,...

Countries:AustraliaNew ZealandUnited Kingdom
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