Epivir HBV: Potent Nucleoside Therapy for Chronic Hepatitis B
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Synonyms | |||
Epivir HBV (lamivudine) is a prescription antiviral medication specifically indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients. As a nucleoside reverse transcriptase inhibitor (NRTI), it works by inhibiting the reverse transcriptase enzyme, thereby suppressing viral replication. This action helps reduce viral load, lower liver inflammation, and decrease the risk of long-term hepatic complications, including cirrhosis and hepatocellular carcinoma. Clinical use requires careful patient selection and monitoring under the supervision of a hepatologist or infectious disease specialist.
Features
- Active pharmaceutical ingredient: Lamivudine 100 mg
- Formulation: Film-coated oral tablets
- Pharmacologic class: Nucleoside reverse transcriptase inhibitor (NRTI)
- Mechanism: Competitive inhibition of HBV reverse transcriptase and incorporation into viral DNA leading to chain termination
- Bioavailability: Approximately 86% following oral administration
- Half-life: 5–7 hours in adults with normal renal function
- Metabolism: Minimal hepatic metabolism; primarily excreted unchanged renally
- FDA-approved for treatment of chronic hepatitis B in adults and children aged 2 years and older
Benefits
- Significant viral suppression: Demonstrated efficacy in reducing HBV DNA to undetectable levels in a substantial proportion of patients
- Histological improvement: Proven to reduce necroinflammatory activity and fibrosis progression in liver biopsies
- Seroconversion promotion: Facilitates HBeAg seroconversion, indicating improved immune control of infection
- Favorable safety profile: Generally well-tolerated with a low incidence of serious adverse events in appropriate patient populations
- Pediatric formulation availability: Oral solution allows for weight-based dosing in children aged 2 years and older
- Convenient dosing: Once-daily administration supports treatment adherence
Common use
Epivir HBV is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of active viral replication, persistently elevated serum aminotransferases (ALT or AST), or histological evidence of active liver disease. It is typically prescribed for patients with compensated liver disease who meet treatment criteria based on international guidelines. The medication may be used as monotherapy or in combination regimens depending on viral characteristics, treatment history, and resistance patterns. Treatment decisions should incorporate assessment of HBeAg status, HBV DNA levels, liver function tests, and histological findings when available.
Dosage and direction
Adults: The recommended oral dosage is 100 mg once daily, with or without food. Tablets should be swallowed whole with water.
Pediatric patients (aged 2-17 years): The recommended dosage is 3 mg per kg of body weight once daily, up to a maximum of 100 mg daily. The oral solution (5 mg per mL) is available for precise weight-based dosing.
Renal impairment dosing: Requires adjustment based on creatinine clearance:
- CrCl ≥50 mL/min: 100 mg daily
- CrCl 30-49 mL/min: 100 mg first dose then 50 mg daily
- CrCl 15-29 mL/min: 100 mg first dose then 25 mg daily
- CrCl 5-14 mL/min: 35 mg first dose then 15 mg daily
- CrCl <5 mL/min: 35 mg first dose then 10 mg daily
Treatment duration should be individualized based on virological response, HBeAg status, and treatment goals. Most patients require long-term therapy, with regular monitoring to assess efficacy and detect potential resistance.
Precautions
Hepatitis exacerbation: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Epivir HBV. Monitor hepatic function closely for several months after discontinuation.
Lactic acidosis and severe hepatomegaly: Rare but serious complications, sometimes fatal, have been reported with nucleoside analogue use. Suspect these conditions in patients with unexplained metabolic acidosis, elevated lactate levels, or progressive hepatomegaly.
Pancreatitis: Use with caution in patients with history of pancreatitis or risk factors for pancreatitis; discontinue if clinical signs develop.
HIV co-infection: Lamivudine has activity against HIV-1 at higher doses. Untreated HIV/HBV co-infected patients may develop HIV resistance if receiving only the hepatitis B treatment dose.
Renal impairment: Requires dosage adjustment as lamivudine is primarily eliminated renally.
Pediatric use: Safety and effectiveness established in children aged 2 years and older; insufficient data for children under 2 years.
Elderly patients: Exercise caution due to increased likelihood of decreased renal function and concomitant disease.
Contraindications
- Hypersensitivity to lamivudine or any component of the formulation
- Use as monotherapy in HIV/HBV co-infected patients (due to risk of HIV resistance development)
- Concurrent administration with other medications containing lamivudine or emtricitabine
Possible side effect
Common (≥10%):
- Headache (35%)
- Fatigue (27%)
- Nausea (18%)
- Diarrhea (14%)
- Nasopharyngitis (12%)
- Cough (11%)
Less common (1-10%):
- Abdominal pain/discomfort
- Insomnia
- Dizziness
- Rash
- Elevated creatine kinase
- Transient elevations in liver enzymes
Rare (<1%):
- Lactic acidosis
- Severe hepatomegaly with steatosis
- Pancreatitis
- Peripheral neuropathy
- Myopathy
- Neutropenia
- Thrombocytopenia
Drug interaction
Zidovudine: Increased zidovudine exposure; monitor for increased toxicity Trimethoprim/sulfamethoxazole: Increases lamivudine exposure approximately 40%; consider dosage adjustment in renal impairment Other nephrotoxic drugs: May affect lamivudine clearance; monitor renal function Interferon alfa: No significant pharmacokinetic interaction observed Ribavirin: Concomitant use may increase risk of lactic acidosis; monitor closely Medications eliminated by active renal secretion: Potential for interaction; monitor appropriately
Missed dose
If a dose is missed, it should be taken as soon as possible unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed dose. Maintaining consistent dosing intervals is important for maintaining effective drug concentrations and suppressing viral replication. If multiple doses are missed, consult healthcare provider for guidance.
Overdose
Limited experience with overdose. There is no known specific antidote for lamivudine overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. Since lamivudine is dialyzable (approximately 30% removed during 4-hour hemodialysis session), hemodialysis may be considered in cases of significant overdose, particularly in patients with renal impairment. Continuous hemodialysis may be more effective. Contact poison control center for latest recommendations.
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed. Protect from moisture. Keep out of reach of children. Do not use after expiration date printed on packaging. Oral solution: Store at 2-8°C (36-46°F); do not freeze. May be stored at room temperature (up to 25°C/77°F) for up to 28 days.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Epivir HBV is available by prescription only and should be used under the supervision of a qualified healthcare professional. Treatment decisions should be based on individual patient characteristics, including viral load, liver function, treatment history, and potential for resistance. Always consult with a healthcare provider before starting or changing any medication regimen. Full prescribing information should be reviewed before administration.
Reviews
Clinical trial data demonstrate that lamivudine 100 mg daily produces HBV DNA suppression in approximately 40-45% of HBeAg-positive patients and 60-70% of HBeAg-negative patients after one year of treatment. HBeAg seroconversion occurs in 16-21% of patients annually. Histological improvement has been observed in 49-56% of treated patients versus 23-25% of placebo recipients. Long-term studies show maintained virological suppression in adherent patients, though resistance development increases over time, reaching approximately 70% after 4 years of monotherapy. Most clinical experts consider lamivudine an option for initial therapy in certain patient populations, particularly where cost is a consideration or for short-duration treatment in specific scenarios, though newer agents with higher genetic barriers to resistance are often preferred for first-line treatment.