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Genvoya

Phase 3

HIV Risk | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Feb 15, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02998320Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure ProphylaxisPHASE3 COMPLETED 101Mar 10, 2017Sep 30, 2018Feb 15, 201916 France
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Study Endpoints
Primary Endpoints
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GenvoyaEXPERIMENTALGenvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
Interventions
NameTypeDescription
GenvoyaDRUGOral use (one tablet each day); 150/150/200/10 mg; 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * an age above 18 years * consultation within 48 hours following a risk of HIV transmission (blood or sexual contact) * indication for HIV post-exposure prophylaxis (according to French guidelines) * person able to understand the nature of the study * person who signed his conse...

Countries:France
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