Last reviewed 2026-05-14 · How we verify

Vitekta (ELVITEGRAVIR)

Vitekta blocks the integrase enzyme, preventing HIV from replicating.

Vitekta (Elvitegravir) is a small molecule drug developed by Gilead Sciences Inc, classified as a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. It is used to treat Human Immunodeficiency Virus (HIV) infection. Vitekta works by blocking the integrase enzyme, which is essential for the replication of HIV. It is patented and has not yet gone off-patent. Key safety considerations include monitoring for liver function and potential interactions with other medications.

At a glance

Mechanism of action

GENVOYA is fixed-dose combination of antiretroviral drugs elvitegravir (plus the CYP3A inhibitor cobicistat), emtricitabine, and tenofovir alafenamide [see Microbiology (12.4)].

Approved indications

• Treatment of HIV-1 Infection
• Replacement of Current Antiretroviral Regimen

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 GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. 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 in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )

Common side effects

• Diarrhea
• Nausea
• Rash
• Jaundice
• Headache
• Fatigue
• Abnormal dreams
• Insomnia
• Somnolence
• Dizziness
• Increased lipase
• Creatine Kinase (>= 10.0 ULN)

Drug interactions

• algeldrate
• aluminium phosphate
• aluminum carbonate
• amprenavir
• atazanavir
• boceprevir
• darunavir
• delavirdine
• etravirine
• fosamprenavir
• indinavir
• nelfinavir

Key clinical trials

• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2,PHASE3)
• 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)
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
• Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
• Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
• Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Vitekta CI brief — competitive landscape report
• Vitekta updates RSS · CI watch RSS
• Gilead Sciences portfolio CI