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Genvoya

Phase 4FDA approved 2015

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

Genvoya development status

FDA approval Nov 5, 2015
Approval holderGilead Sciences Inc
ApplicationNDA207561
Highest phase Phase 4 (NCT03549312)
Phase scored for GILDPhase 3
Registered trials 3 across 3 sponsors since Jun 2018

Label indication GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known… FDA label

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Genvoya clinical trials

Genvoya · 1 trial · 1 indication

Phase 3 1
NCT02998320Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure ProphylaxisHIV Risk
COMPLETED101 Analytics
PHASE3COMPLETED
Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
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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 to 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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Frequently asked questions about Genvoya

What is Genvoya?

Genvoya is a small molecule medicine developed by Gilead Sciences, Inc. (ticker GILD) for HIV risk. It has been studied in a Phase 3 clinical trial in France evaluating compliance with treatment when used as HIV post-exposure prophylaxis in adults aged 18 years and older.

What is Genvoya used for in HIV risk?

Genvoya was studied for HIV post-exposure prophylaxis, a preventive use in people at risk of HIV exposure. The Phase 3 trial NCT02998320 evaluated how well participants complied with treatment when Genvoya was given in this setting. The study enrolled 101 adults in France.

Who makes Genvoya?

Genvoya is made by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the developer associated with the clinical program for Genvoya in HIV risk.

What phase is Genvoya in?

Genvoya has been evaluated in a Phase 3 clinical trial for HIV risk. The trial, NCT02998320, is listed as completed. Genvoya is an investigational use in this prevention setting and is not described as approved for this indication.

What clinical trials is Genvoya in?

Genvoya has been studied in the Phase 3 trial NCT02998320, titled Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis. The trial was completed, enrolled 101 participants, was conducted in France, and included adults aged 18 years and older.

How was the Genvoya HIV risk trial designed?

The Phase 3 trial NCT02998320 was an uncontrolled study, meaning it did not use a randomized or double-blind design. It enrolled 101 adults aged 18 years and older in France and assessed compliance with Genvoya treatment when used as HIV post-exposure prophylaxis.