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Tenofovir disoproxil/emtricitabine/efavirenz

Tenofovir disoproxil/emtricitabine/efavirenz is a Antiretroviral combination therapy (NRTI + NNRTI) Small molecule drug developed by Sheba Medical Center. It is currently FDA-approved for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 prevention (pre-exposure prophylaxis, PrEP). Also known as: Atripla.

This combination inhibits HIV reverse transcriptase and integrase through three antiretroviral agents working synergistically to block viral replication.

This combination inhibits HIV reverse transcriptase and integrase through three antiretroviral agents working synergistically to block viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 prevention (pre-exposure prophylaxis, PrEP).

At a glance

Mechanism of action

Tenofovir disoproxil and emtricitabine are nucleoside reverse transcriptase inhibitors (NRTIs) that compete with natural nucleotides to terminate viral DNA chain elongation. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to reverse transcriptase and blocks its catalytic activity. Together, these three agents suppress HIV replication by targeting the same enzyme through complementary mechanisms.

Approved indications

• HIV-1 infection in treatment-naïve and treatment-experienced patients
• HIV-1 prevention (pre-exposure prophylaxis, PrEP)

Common side effects

• Dizziness and CNS effects
• Rash
• Nausea
• Headache
• Elevated liver enzymes
• Renal dysfunction (tenofovir-related)
• Bone density loss

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)
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
• Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection (PHASE1)
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
• Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
• Research on the Psychological Status of Patients With HIV-1 Infection
• Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (PHASE4)

Primary sources

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Competitive intelligence

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

• Tenofovir disoproxil/emtricitabine/efavirenz CI brief — competitive landscape report
• Tenofovir disoproxil/emtricitabine/efavirenz updates RSS · CI watch RSS
• Sheba Medical Center portfolio CI

Frequently asked questions about Tenofovir disoproxil/emtricitabine/efavirenz

Related

• Drug class: All Antiretroviral combination therapy (NRTI + NNRTI) drugs
• Target: All drugs targeting HIV reverse transcriptase
• Manufacturer: Sheba Medical Center — full pipeline
• Therapeutic area: All drugs in Infectious Disease / Virology
• Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced patients
• Indication: Drugs for HIV-1 prevention (pre-exposure prophylaxis, PrEP)
• Also known as: Atripla
• Compare: Tenofovir disoproxil/emtricitabine/efavirenz vs similar drugs
• Pricing: Tenofovir disoproxil/emtricitabine/efavirenz cost, discount & access