Epivir HBV: Potent Nucleoside Therapy for Chronic Hepatitis B
Epivir HBV
| Product dosage: 100mg | |||
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Synonyms | |||
Epivir HBV (lamivudine) is a prescription antiviral medication specifically formulated 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 and reducing HBV DNA levels. Clinical studies demonstrate its efficacy in achieving virological suppression, normalizing alanine aminotransferase (ALT) levels, and inducing histological improvement in liver tissue. Proper patient selection and adherence to treatment guidelines are critical for optimizing therapeutic outcomes and managing potential resistance.
Features
- Contains lamivudine 100 mg as the active pharmaceutical ingredient
- Available as film-coated tablets and oral solution (5 mg/mL)
- Specifically indicated for chronic hepatitis B virus (HBV) infection
- Demonstrated activity against HBV reverse transcriptase
- Requires prescription and medical supervision
- Manufactured under current Good Manufacturing Practices (cGMP)
Benefits
- Achieves significant reduction in HBV viral load
- Promotes normalization of serum ALT levels
- Demonstrates improvement in liver histology
- May reduce risk of disease progression to cirrhosis
- Offers oral administration convenience
- Established pediatric dosing for patients 2 years and older
Common use
Epivir HBV is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. It is prescribed for both treatment-naïve patients and those who have previously received interferon therapy. The medication is typically used in patients with compensated liver disease and may be considered as part of combination therapy in certain clinical scenarios. Regular monitoring of HBV DNA levels, liver function tests, and clinical status is essential throughout treatment.
Dosage and direction
The recommended oral dosage for adults with chronic hepatitis B is 100 mg once daily. For pediatric patients aged 2 to 17 years, the recommended dose is 3 mg per kg once daily, up to a maximum of 100 mg daily. Administration may occur with or without food. Tablets should be swallowed whole with water; the oral solution should be measured using the provided dosing syringe. Treatment duration is determined by the treating physician based on virological response, serological status, and liver histology. Do not crush or chew tablets.
Precautions
Regular monitoring of HBV DNA levels, liver function tests, and complete blood counts is mandatory during therapy. Patients should be advised that cessation of therapy may result in severe acute exacerbations of hepatitis B. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues. Use with caution in patients with renal impairment (dose adjustment required). Patients should be monitored for signs of pancreatitis, particularly pediatric patients. Epivir HBV is not recommended for use in patients co-infected with HIV unless they are receiving concomitant antiretroviral therapy.
Contraindications
Epivir HBV is contraindicated in patients with known hypersensitivity to lamivudine or any component of the formulation. The medication should not be used as monotherapy in patients with unrecognized or untreated HIV-1 co-infection, as this may lead to HIV-1 resistance. Concomitant administration with other medications containing lamivudine or emtricitabine is contraindicated. Use is contraindicated in patients with severe hepatic impairment or decompensated liver disease without careful benefit-risk assessment.
Possible side effect
Common adverse reactions (≥10%) include headache, fatigue, dizziness, nausea, diarrhea, and cough. Less frequent side effects may include neutropenia, anemia, thrombocytopenia, elevated liver enzymes, pancreatitis, peripheral neuropathy, and muscle disorders. Lactic acidosis and severe hepatomegaly with steatosis, though rare, represent serious potential complications. Hypersensitivity reactions including anaphylaxis and urticaria have been reported. Some patients may experience redistribution/accumulation of body fat and exacerbation of hepatitis upon discontinuation.
Drug interaction
Concomitant use with other nephrotoxic agents may increase the risk of renal impairment. Trimethoprim/sulfamethoxazole increases lamivudine exposure approximately 40%; consider dosage adjustment in patients with renal impairment. Drugs that inhibit organic cationic transporters may increase lamivudine concentrations. No clinically significant interactions have been observed with interferon alfa, adefovir dipivoxil, or most commonly prescribed medications. However, healthcare providers should review all concomitant medications, including over-the-counter products and herbal supplements.
Missed dose
If a dose is missed, patients should take it as soon as they remember, unless it is almost time for the next scheduled dose. In that case, patients should skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed administration. Consistent adherence to the prescribed dosing regimen is crucial for maintaining virological suppression and preventing the development of resistance. Patients should contact their healthcare provider if multiple doses are missed.
Overdose
There is limited experience with Epivir HBV overdose. Cases of overdose have been reported with higher doses of lamivudine; symptoms may include dizziness, headache, nausea, and other neurological or gastrointestinal manifestations. Hemodialysis removes lamivudine, and this may be considered in cases of significant overdose, particularly in patients with renal impairment. In case of suspected overdose, contact a poison control center immediately and provide supportive care with monitoring of vital signs and laboratory parameters.
Storage
Store tablets and oral solution at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the container tightly closed and protect from moisture. The oral solution should be stored in the original container and used within the expiration date. Do not freeze. Keep all medications out of reach of children and pets. Properly dispose of any unused medication according to local regulations.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Epivir HBV should be used only under the supervision of a qualified healthcare professional. Treatment decisions must be based on individual patient characteristics, including virological markers, liver histology, and comorbid conditions. The prescribing physician should be familiar with the complete prescribing information and current treatment guidelines for chronic hepatitis B. Patients should not adjust their dosage or discontinue therapy without medical consultation.
Reviews
Clinical trials have demonstrated that Epivir HBV produces virological response (HBV DNA loss) in approximately 40-50% of patients after one year of therapy, with histological improvement observed in 50-60% of treated patients. However, long-term use is associated with increasing rates of viral resistance due to YMDD motif mutations. Many hepatologists consider Epivir HBV as an option for short-term treatment or in specific patient populations, though newer agents with higher genetic barriers to resistance are often preferred for first-line therapy. Patient experiences vary, with some reporting significant improvement in liver enzymes and quality of life, while others may experience limited response or development of resistance over time.