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Tenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC is a Nucleoside/nucleotide reverse transcriptase inhibitor combination Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals.
Tenofovir and emtricitabine are nucleotide/nucleoside reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.
Tenofovir and emtricitabine are nucleotide/nucleoside reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA. Used for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals.
At a glance
| Generic name | Tenofovir/emtricitabine FDC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor combination |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Tenofovir (a nucleotide analog) and emtricitabine (a nucleoside analog) both target HIV reverse transcriptase, preventing the virus from synthesizing DNA copies of its genome. When combined in a fixed-dose combination, they provide complementary antiretroviral activity and are commonly used as backbone agents in HIV treatment regimens. This combination is also approved for HIV pre-exposure prophylaxis (PrEP).
Approved indications
- HIV-1 infection treatment (as part of combination antiretroviral therapy)
- HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Renal impairment (tenofovir-related)
- Bone density loss
Key clinical trials
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (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)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (PHASE2)
- Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV (PHASE2)
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (PHASE3)
- 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)
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:
- Tenofovir/emtricitabine FDC CI brief — competitive landscape report
- Tenofovir/emtricitabine FDC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Tenofovir/emtricitabine FDC
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Related
- Drug class: All Nucleoside/nucleotide reverse transcriptase inhibitor combination drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection treatment (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
- Compare: Tenofovir/emtricitabine FDC vs similar drugs
- Pricing: Tenofovir/emtricitabine FDC cost, discount & access