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Sofosbuvir

Phase 3

Chronic HCV Infection | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Feb 20, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment804
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02074514Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV InfectionPHASE3 COMPLETED 117 — — Mar 1, 2014Nov 1, 2015Oct 25, 201613 India
NCT02021643Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV InfectionPHASE3 COMPLETED 687 — — Dec 10, 2013Nov 3, 2016Feb 20, 201835 China, Hong Kong +3
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Study Endpoints
Primary Endpoints
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Endpoints
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure and Viral Relapse
Up to Posttreatment Week 24
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sofosbuvir+RBV 16 weeksEXPERIMENTALParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Sofosbuvir+RBV 24 weeksEXPERIMENTALParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
Sofosbuvir+RBV+PEG 12 weeksEXPERIMENTALParticipants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Sofosbuvir+RBV 12 weeksEXPERIMENTALParticipants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Interventions
NameTypeDescription
SofosbuvirDRUG400 mg tablet administered orally once daily
RBVDRUG200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEGDRUGPegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * HCV RNA ≥10\^4 IU/mL at screening * Confirmed chronic HCV genotype 1 or 3 infection * HCV treatment naive * Approximately 30% of individuals may have compensated cirrhosis at screening Exclusion Criteria: * Any other chronic liver disease * Infection with hepatitis B virus (...

Countries:IndiaChinaHong KongSouth KoreaTaiwanVietnam
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