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E/C/F/TAF;

Phase 3

Human Immunodeficiency Virus | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Nov 14, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
PRIORITY_REVIEWACCELERATED_APPROVAL
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02660905HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-InfectionPHASE3 COMPLETED 25 — — Apr 1, 2016Jun 1, 2018Nov 14, 20222 Canada
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Study Endpoints
Primary Endpoints
Proportion of approached patients who agreed to switch from their current Antiretroviral (ARV) regimen and be screened for this study
52 weeks

Number of patients

Secondary Endpoints
Proportion of subjects achieving SVR12
24 weeks
Proportion of subjects maintaining undetectable HIV RNA levels
32 weeks
Proportion of subjects initiating HCV antiviral therapy
4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active TreatmentEXPERIMENTALE/C/F/TAF Ledipasvir-Sofosbuvir/TAF
Interventions
NameTypeDescription
E/C/F/TAF;DRUGEvaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
Ledipasvir-SofosbuvirDRUGEvaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * HIV infected (ELISA with western blot confirmation) * HCV RNA positive for minimum of 6 months / Genotype 1 * Prescribed cART that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers, is app...

Countries:Canada
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