Epivir HBV: Potent Nucleoside Analog Therapy for Chronic Hepatitis B
| Product dosage: 100mg | |||
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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 analog reverse transcriptase inhibitor, it works by inhibiting the reverse transcriptase enzyme, thereby suppressing viral replication. This action helps reduce the viral load in the bloodstream, potentially leading to biochemical, virological, and histological improvement. Proper use under medical supervision can significantly alter the disease’s progression, decreasing the risk of complications such as cirrhosis and hepatocellular carcinoma.
Features
- Active ingredient: Lamivudine 100 mg
- Formulation: Oral tablets and an oral solution (5 mg/mL)
- Mechanism: Nucleoside analog reverse transcriptase inhibitor (NRTI)
- FDA-approved for treatment of chronic hepatitis B
- Bioavailability: Approximately 86% for tablets and 87% for oral solution
- Half-life: 5 to 7 hours in adults with normal renal function
- Excretion: Primarily renal, requiring dosage adjustment in impaired renal function
Benefits
- Effectively suppresses HBV DNA replication, leading to reduced viral load
- Can normalize serum ALT levels, indicating improved liver function
- May induce hepatitis B e antigen (HBeAg) seroconversion in a subset of patients
- Helps reduce liver inflammation and fibrosis progression
- Oral administration allows for convenient outpatient treatment
- Well-established safety profile with extensive clinical experience
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 used in both HBeAg-positive and HBeAg-negative patients. Treatment decisions should be based on appropriate virological, biochemical, and histological parameters. The medication is typically prescribed as part of a comprehensive management plan that may include regular monitoring of viral load, liver function tests, and assessment for potential complications.
Dosage and direction
The recommended oral dosage of Epivir HBV for adults is 100 mg once daily. For pediatric patients aged 2 to 17 years, the recommended dosage is 3 mg per kg once daily, up to a maximum of 100 mg daily. The oral solution should be used for patients with difficulty swallowing tablets or when weight-based dosing is required. Administration can occur with or without food. Dosage adjustment is necessary for patients with impaired renal function (creatinine clearance <50 mL/min). Treatment duration should be determined by the healthcare provider based on individual patient response and periodic assessment of treatment efficacy and safety.
Precautions
Regular monitoring of HBV DNA levels, liver function tests, and complete blood counts is essential 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 analogs. Use with caution in patients with risk factors for liver disease and in obese patients. Pancreatitis has been reported in pediatric patients; monitor closely for signs and symptoms. Epstein-Barr virus-related lymphomas have been reported in pediatric patients with HIV infection treated with related medications.
Contraindications
Epivir HBV is contraindicated in patients with known hypersensitivity to lamivudine or any component of the formulation. The medication should not be used for treatment of HIV infection, as the dosage is insufficient and may lead to development of HIV resistance. Concomitant use with other medications containing lamivudine or emtricitabine is contraindicated. The oral solution contains sucrose and is contraindicated in patients with hereditary fructose intolerance.
Possible side effect
Common adverse reactions (≥10%) include headache, fatigue, dizziness, nausea, diarrhea, and cough. Less frequent side effects may include pancreatitis, peripheral neuropathy, muscle disorders, and elevated liver enzymes. Rare but serious adverse events include lactic acidosis, severe hepatomegaly with steatosis, and exacerbation of hepatitis upon discontinuation. Hematological abnormalities including neutropenia and thrombocytopenia have been reported. Allergic reactions including rash, urticaria, and angioedema may occur.
Drug interaction
Concomitant administration with trimethoprim/sulfamethoxazole increases lamivudine exposure approximately 40%. Sorbitol-containing products may decrease lamivudine absorption; separate administration by at least 2 hours. Other medications eliminated by active renal secretion may compete with lamivudine excretion. No clinically significant interactions have been observed with many commonly co-administered medications including acetaminophen, cotrimoxazole, and interferon alfa.
Missed dose
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistent daily administration is important for maintaining effective antiviral suppression. Patients should be educated about the importance of adherence to prescribed dosing regimen.
Overdose
There is limited experience with overdosage of Epivir HBV. In case of suspected overdose, general supportive measures should be instituted as required. Since lamivudine is dialyzable, hemodialysis may be used to eliminate the drug in cases of significant overdose. Patients should be monitored for signs of toxicity, particularly hematological parameters and liver function. The oral solution contains a higher concentration of lamivudine than the HIV formulation; ensure proper product identification to prevent dosing errors.
Storage
Store tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep in original container with tightly closed cap to protect from moisture. The oral solution should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze. Keep all medications out of reach of children and pets. Discard any unused oral solution after the expiration date or if contamination is suspected. Do not transfer oral solution to other containers.
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 and professional medical judgment. Patients should consult their healthcare provider for complete prescribing information and any questions regarding their treatment.
Reviews
Clinical studies have demonstrated that Epivir HBV treatment results in significant virological and biochemical response in patients with chronic hepatitis B. In clinical trials, 44% of HBeAg-positive patients achieved HBV DNA loss and ALT normalization after one year of treatment, compared to 16% of placebo recipients. Among HBeAg-negative patients, 60% achieved HBV DNA loss and ALT normalization versus 28% with placebo. Long-term studies show maintained virological suppression in responding patients, though resistance development remains a consideration with extended therapy. Patient-reported outcomes indicate improved quality of life measures related to reduced disease activity.