Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis

Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

Study Overview

• Status: Completed
• Conditions: HIV Risk
• Intervention / Treatment: Drug: Genvoya

Detailed Description

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.

Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Hopital Jean Minjoz
  • Bordeaux, France, 33075
    • Hôpital Saint-André
  • Boulogne-Billancourt, France, 92100
    • CHU Ambroise Pare
  • Charleville-Mézières, France, 08011
    • Hôpital Manchester
  • Dijon, France, 77908
    • CHU Dijon
  • Lyon, France, 69317
    • Hopital Croix Rousse
  • Metz, France, 57050
    • CHR de Metz
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75571
    • Hopital Saint-Antoine
  • Paris, France, 75018
    • CHU Bichat
  • Paris, France, 75651
    • GH Pitié Salpêtrière
  • Reims, France, 51092
    • CHU de Reims
  • Rennes, France, 35033
    • CHU
  • Strasbourg, France, 67091
    • Hopitaux Universitaires
  • Suresnes, France, 92150
    • Hôpital FOCH
  • Tourcoing, France, 59208
    • Hôpital de Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 consent form to participate in the study

Exclusion Criteria:

• person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
• contraindications to the prescription of Genvoy
• other medical contraindications
• person infected by hepatitis B virus
• pregnant or lactating woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genvoya; Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days	Drug: Genvoya; Oral use (one tablet each day); 150/150/200/10 mg; 28 days; Other Names: (E/C/F/TAF) ATC Code: J05AR18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks	Day 28

Collaborators and Investigators

• Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: David REY, Hôpitaux Universitaires de Strasbourg

Publications and helpful links

General Publications

• Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GEFR1044015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No