EPIVIR (lamivudine)
Epivir is an antiretroviral medication that treats human immunodeficiency virus type 1 (HIV-1) infection. It helps patients with HIV-1 when used in combination with other antiretroviral agents. While the drug belongs to a class of nucleoside analogues, this specific product is used for HIV-1 and is not intended for hepatitis B virus (HBV) at this dosage.
How EPIVIR Works
Epivir works as a nucleoside analogue reverse transcriptase inhibitor. This antiretroviral agent interferes with viral replication to help control the HIV-1 infection.
Details
- Status
- Prescription
- First Approved
- 1995-11-17
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET
EPIVIR Approval History
What EPIVIR Treats
1 indicationsEPIVIR is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Infection
EPIVIR Boxed Warning
EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF EPIVIR Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPIVIR and are co-infected with HIV-1 and HBV. If appropriate, init...
WARNING: EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF EPIVIR Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )]. Important Differences among Lamivudine-Containing Products EPIVIR tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions ( 5.1 )]. WARNING: EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF EPIVIR See full prescribing information for complete boxed warning • Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1 ) • Patients with HIV-1 infection should receive only dosage forms of EPIVIR appropriate for treatment of HIV-1. ( 5.1 )
EPIVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EPIVIR
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT06494579 | STUDY-24-00614 | Ph 1, Ph 2 | active not recruiting | Lamivudine for Solid Tumors |
| NCT04696575 | I 691720 NCI-2020-13169, I 691720 | Ph 2 | recruiting | Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer |
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT07058974 | STUDY-24-01678 | Ph 1 | recruiting | A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation |
| NCT02470650 | Cost-Effect-Clinic 2014-004820-24 | Ph 4 | withdrawn | Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive |
| NCT03311945 results posted | RALAM-Roll Over 2017-000986-60 | Ph 3 | completed | Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM |
| NCT06428045 STARLITE | 20231163 | Ph 1 | recruiting | STARLITE for Unresectable High-Grade Gliomas |
| NCT03333083 | RALAM-II 2017-000985-31 | Ph 3 | terminated | Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen |
| NCT06503796 | KY-2023-12-85-1 | Ph 4 | not yet recruiting | Antiviral Therapy in Infants With HBV Infection |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT03144804 results posted | 17-044 | Ph 2 | completed | A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer |
| NCT01620944 results posted | AI424-494 2011-006187-47 | Ph 3 | terminated | Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC |
| NCT03272347 results posted | 8591-011 2017-000437-32 | Ph 2 | completed | Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) |
| NCT02712801 | 2015ZX10001001 | Ph 4 | completed | Antiretroviral Regime for Viral Eradication in Newborns |
| NCT00672412 | P1069 10620, IMPAACT P1069 | Ph 1, Ph 2 | completed | Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand |
| NCT02369965 TALENT | FB-ABWT-Ⅲ-301 ChiCTR-TRC-14004276 | Ph 3 | completed | Test Albuvirtide in Experienced Patients |
| NCT01352715 SELECT results posted | ACTG A5273 1U01AI068636, 5UM1AI068634 | Ph 3 | completed | Study of Options for Second-Line Effective Combination Therapy (SELECT) |
| NCT02566707 PRADAII | UMCN-AKF 14.08 | Ph 2 | terminated | Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen |
| NCT02263079 results posted | NV25361 2006-000977-31 | Ph 3 | completed | A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase |
| NCT02431975 LEOPARD | AAAO5011 U01HD080441 | Ph 4 | completed | Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial |
| NCT02945163 | 2016-M-2 | Ph 4 | completed | Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy |
| NCT02935075 OAT | 2016-M-1 | Ph 4 | completed | Optimization of Antiretroviral Therapy |
| NCT02263326 ASPIRE results posted | ASPIRE | Ph 3 | completed | Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure |
| NCT00993031 PROMOTE-PIs results posted | H5741-34342 P01HD059454, 2009-141 | Ph 3 | completed | Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT03078556 results posted | 204994 | Ph 1 | completed | Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine |
| NCT02770508 ANDES | FH-15 | Ph 4 | completed | Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects |
| NCT02582684 results posted | ACTG A5353 2UM1AI068636 | Ph 2 | completed | Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients |
| NCT01353742 | 114957 | Ph 1 | completed | Lamivudine and Adefovir Dipivoxil Fixed Dose Combination |
| NCT01580202 | AI463-246 | Ph 3 | completed | Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine |
| NCT02634073 results posted | 204857 | Ph 4 | completed | A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers |
| NCT02159599 DUAL | GESIDA 8014 2014-000515-14 | Ph 4 | completed | Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject |
| NCT01627223 NUC115132 | NUC115132 | Ph 4 | terminated | Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation |
| NCT02894554 | 201310070MINA | Ph 4 | terminated | Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment. |
| NCT01489046 | AI467-003 2011-003329-89 | Ph 2 | terminated | Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive |
| NCT01528865 | UMCC 2010 097 HUM 33361 | Ph 1, Ph 2 | withdrawn | Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma |
| NCT00986778 | AI463-195 | Ph 4 | withdrawn | Entecavir Plus Adefovir in Lamivudine-Resistant Patients |
| NCT01005238 SASL28 | SASL28 | Ph 4 | terminated | Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine |
| NCT00637663 | 0740-67-5 | Ph 4 | completed | Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA |
| NCT01023217 CAESAR results posted | AMC-2009-0536 | Ph 4 | completed | Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir |
| NCT00410202 DEFINE results posted | AI463-111 | Ph 3 | completed | Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus |
| NCT01088009 EXPLORE | MOH-02 | Ph 4 | completed | Efficacy Optimizing Research of Lamivudine Therapy |
| NCT01743079 | 20080810 | Ph 4 | completed | Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B |
| NCT01788371 | 2011.6 | Ph 4 | completed | Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus |
| NCT00915655 DIONE results posted | CR016312 TMC114-TiDP29-C230, 2008-004631-37 | Ph 2 | completed | A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents |
| NCT00625339 | 4-2007-0367 | Ph 4 | completed | Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA |
| NCT00625560 | 4-2007-0351 | Ph 4 | completed | Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA |
| NCT00612898 | AVX-301 | Ph 2, Ph 3 | terminated | Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection |
| NCT00798460 | IB-0809-055 | Ph 4 | terminated | Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPIVIR FDA Label Details
Indications & Usage
FDA Label (PDF)EPIVIR is indicated for the treatment of Human Immunodeficiency Virus Infection.
WARNING: EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF EPIVIR Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Hep...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.