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Emtricitabine/tenofovir or abacavir/lamivudine
Emtricitabine/tenofovir or abacavir/lamivudine is a Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) Small molecule drug developed by Fundacion SEIMC-GESIDA. It is currently FDA-approved for HIV-1 infection (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) for emtricitabine/tenofovir. Also known as: Truvada or Kivexa.
These are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that block HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells.
These are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that block HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells. Used for HIV-1 infection (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) for emtricitabine/tenofovir.
At a glance
| Generic name | Emtricitabine/tenofovir or abacavir/lamivudine |
|---|---|
| Also known as | Truvada or Kivexa |
| Sponsor | Fundacion SEIMC-GESIDA |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Emtricitabine and tenofovir (or abacavir and lamivudine as an alternative backbone) are nucleoside analogs that compete with natural substrates for incorporation into the growing DNA chain during reverse transcription. Once incorporated, they cause chain termination, effectively halting viral replication. These agents are typically used as part of combination antiretroviral therapy (cART) in HIV-infected patients.
Approved indications
- HIV-1 infection (as part of combination antiretroviral therapy)
- HIV-1 pre-exposure prophylaxis (PrEP) for emtricitabine/tenofovir
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Renal impairment (tenofovir-associated)
- Bone density loss (tenofovir-associated)
- Hypersensitivity reaction (abacavir-associated)
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 of GS-3242 in Participants With HIV-1; Substudy-05 (PHASE1)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Study of GS-1219 in Participants With HIV-1 (PHASE1)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients (PHASE4)
- Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3TC Compared to Maintaining A Three-Drug REgimen With BIC/FTC/TAF or DTG/3TC/ABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up (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:
- Emtricitabine/tenofovir or abacavir/lamivudine CI brief — competitive landscape report
- Emtricitabine/tenofovir or abacavir/lamivudine updates RSS · CI watch RSS
- Fundacion SEIMC-GESIDA portfolio CI
Frequently asked questions about Emtricitabine/tenofovir or abacavir/lamivudine
What is Emtricitabine/tenofovir or abacavir/lamivudine?
How does Emtricitabine/tenofovir or abacavir/lamivudine work?
What is Emtricitabine/tenofovir or abacavir/lamivudine used for?
Who makes Emtricitabine/tenofovir or abacavir/lamivudine?
Is Emtricitabine/tenofovir or abacavir/lamivudine also known as anything else?
What drug class is Emtricitabine/tenofovir or abacavir/lamivudine in?
What development phase is Emtricitabine/tenofovir or abacavir/lamivudine in?
What are the side effects of Emtricitabine/tenofovir or abacavir/lamivudine?
What does Emtricitabine/tenofovir or abacavir/lamivudine target?
Related
- Drug class: All Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: Fundacion SEIMC-GESIDA — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-1 pre-exposure prophylaxis (PrEP) for emtricitabine/tenofovir
- Also known as: Truvada or Kivexa
- Compare: Emtricitabine/tenofovir or abacavir/lamivudine vs similar drugs
- Pricing: Emtricitabine/tenofovir or abacavir/lamivudine cost, discount & access