Last reviewed · How we verify
Genvoya
At a glance
| Generic name | Genvoya |
|---|---|
| Also known as | (E/C/F/TAF) ATC Code: J05AR18, Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide, Cobicistat/Elvitegravir/Emtricitabine/Tenofovir alafenamide, elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide, TAF/FTC/EVG-cb |
| Sponsor | Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue G
Common side effects
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (PHASE2, PHASE3)
- Early ART to Limit Infection and Establishment of Reservoir (PHASE2)
- Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection
- B-free Multistage Trial (PHASE4)
- Bictegravir in the Elderly Living With HIV (BICEP)
- Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE) (PHASE3)
- Analysis of Crushed and Whole Tablet Genvoya (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Genvoya CI brief — competitive landscape report
- Genvoya updates RSS · CI watch RSS
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux portfolio CI