EPIVIR
LOE ApproachingNDAORALTABLETPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
6/8 — Strong
Priority Review
EPIVIR by GSK is [see microbiology ()]. Approved for combination with other antiretroviral agents for the treatment of hiv‑1 infection. First approved in 1995.
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIVIR (lamivudine) is an oral nucleoside reverse transcriptase inhibitor (NRTI) approved in 1995 for treatment of hepatitis B virus and HIV infection. It works by inhibiting viral reverse transcriptase, preventing viral replication in infected cells. The drug is now primarily used as a component of combination antiretroviral regimens rather than as monotherapy.
$0.103MPart D
LOE ApproachingDeclining
Minimal commercial momentum with only 281 Part D claims in 2023; EPIVIR monotherapy team is likely small and focused on managed decline or transition to combination formulations.
Mechanism of Action
[see Microbiology ()].
Clinical Trials (4)
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
Started Sep 2015
110 enrolled
HIV-1 Infection
SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
Started Aug 2006
HIV InfectionsLipodystrophy
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
Started May 2004
866 enrolled
HIV InfectionInfection, Human Immunodeficiency Virus
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
200 enrolled
HIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.