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Epivir (3TC)
Epivir (3TC) is a Nucleoside reverse transcriptase inhibitor (NRTI) Small molecule drug developed by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is currently in Phase 3 development for HIV-1 infection (in combination antiretroviral therapy), Chronic hepatitis B infection. Also known as: Lamivudine.
Epivir (lamivudine/3TC) is a nucleoside reverse transcriptase inhibitor that blocks HIV reverse transcriptase, preventing viral replication by terminating DNA chain elongation.
Epivir (3TC) is a small molecule used to treat various conditions, including Human Immunodeficiency Virus (HIV)-1 Infection and Hepatitis B. It is one of the interventions studied in clinical trials for conditions such as post-transplant Hepatitis B.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Epivir (3TC) |
|---|---|
| Also known as | Lamivudine |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | HIV reverse transcriptase; Hepatitis B virus polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology/Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
3TC is a cytidine analog that gets phosphorylated intracellularly and incorporated into the growing HIV DNA chain during reverse transcription. Once incorporated, it causes chain termination because it lacks a 3'-OH group, effectively halting viral genome synthesis. It is also active against hepatitis B virus through the same mechanism.
Approved indications
- HIV-1 infection (in combination antiretroviral therapy)
- Chronic hepatitis B infection
Common side effects
- Headache
- Nausea
- Fatigue
- Diarrhea
- Pancreatitis
- Peripheral neuropathy
- Lactic acidosis
Key clinical trials
- Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (NA)
- 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)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
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:
- Epivir (3TC) CI brief — competitive landscape report
- Epivir (3TC) updates RSS · CI watch RSS
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) portfolio CI
Frequently asked questions about Epivir (3TC)
What is Epivir (3TC)?
How does Epivir (3TC) work?
What is Epivir (3TC) used for?
Who makes Epivir (3TC)?
Is Epivir (3TC) also known as anything else?
What drug class is Epivir (3TC) in?
What development phase is Epivir (3TC) in?
What are the side effects of Epivir (3TC)?
What does Epivir (3TC) target?
Related
- Drug class: All Nucleoside reverse transcriptase inhibitor (NRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase; Hepatitis B virus polymerase
- Manufacturer: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) — full pipeline
- Therapeutic area: All drugs in Virology/Infectious Disease
- Indication: Drugs for HIV-1 infection (in combination antiretroviral therapy)
- Indication: Drugs for Chronic hepatitis B infection
- Also known as: Lamivudine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing