Epivir HBV: Effective Viral Suppression for Chronic Hepatitis B
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Synonyms | |||
Epivir HBV (lamivudine) is an oral antiviral medication specifically indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients. As a nucleoside analogue reverse transcriptase inhibitor, it works by inhibiting the reverse transcriptase enzyme, thereby reducing viral replication and slowing disease progression. This agent is a cornerstone in the management of HBV, helping to decrease liver inflammation, lower serum HBV DNA levels, and improve liver histology. Proper patient selection and adherence to treatment guidelines are essential for optimizing therapeutic outcomes and minimizing the risk of resistance.
Features
- Active ingredient: Lamivudine 100 mg
- Formulation: Film-coated tablets or oral solution (5 mg/mL)
- Mechanism: Nucleoside analogue reverse transcriptase inhibitor
- Prescription status: Rx-only
- Manufactured under stringent quality control standards
- Suitable for adults and pediatric patients aged 2 years and older
Benefits
- Effectively suppresses HBV replication, leading to reduced viral load
- Helps normalize serum alanine aminotransferase (ALT) levels, indicating improved liver function
- Can delay the progression of liver fibrosis and reduce the risk of cirrhosis
- May lower the incidence of hepatocellular carcinoma in long-term responders
- Oral administration allows for convenient, at-home dosing
- Generally well-tolerated profile in most patient populations
Common use
Epivir HBV is primarily used for the treatment of chronic hepatitis B infection in patients with evidence of active viral replication and either persistently elevated serum ALT levels or histological evidence of active liver disease. It is suitable for both hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients. Treatment decisions should be based on comprehensive assessment including HBV DNA levels, ALT levels, liver histology when available, and consideration of the patient’s overall clinical status. The medication may be used as monotherapy or in combination with other antivirals in certain clinical scenarios, particularly when resistance is a concern.
Dosage and direction
The recommended oral dose for adults with chronic hepatitis B is 100 mg once daily. For pediatric patients aged 2-17 years, the recommended dose is 3 mg/kg once daily, up to a maximum of 100 mg daily. The oral solution should be used for accurate dosing in pediatric patients and those who have difficulty swallowing tablets. Administration may occur with or without food. Treatment duration should be individualized based on virological response, HBeAg status, and treatment guidelines. Regular monitoring of HBV DNA levels, ALT, and serological markers is essential throughout therapy to assess response and determine optimal treatment duration.
Precautions
Renal impairment requires dosage adjustment based on creatinine clearance. Patients with creatinine clearance <50 mL/min should receive reduced dosing. Hepatic impairment does not typically require dosage adjustment, but patients with decompensated liver disease should be monitored closely. Regular monitoring of HBV DNA levels is crucial to detect possible viral resistance. Patients should be advised that discontinuation 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. Pregnancy category C; use only if potential benefit justifies potential risk to fetus.
Contraindications
Hypersensitivity to lamivudine or any component of the formulation. Concomitant use with other medications containing lamivudine or emtricitabine. Patients with previously demonstrated hypersensitivity reaction to the drug. Not recommended for patients with untreated HIV co-infection due to risk of HIV resistance development. Should not be used as monotherapy in patients with known lamivudine-resistant HBV strains without careful consideration of alternative regimens.
Possible side effect
Common adverse reactions (≥10%) include headache, fatigue, nausea, diarrhea, and cough. Less frequent side effects may include dizziness, nasal signs and symptoms, abdominal pain, musculoskeletal pain, insomnia, and rash. Laboratory abnormalities may include elevated ALT levels, amylase elevation, and decreased neutrophil count. Serious adverse effects include lactic acidosis, hepatic steatosis, pancreatitis, and severe acute exacerbations of hepatitis upon discontinuation. Peripheral neuropathy has been reported in pediatric patients. Allergic reactions including anaphylaxis, urticaria, and angioedema may occur rarely.
Drug interaction
Concomitant administration with other medications containing lamivudine or emtricitabine is contraindicated. Trimethoprim/sulfamethoxazole increases lamivudine exposure by approximately 40%. Drugs that reduce renal function or compete for active tubular secretion may increase lamivudine concentrations. Zalcitabine may inhibit the anti-HBV activity of lamivudine. No clinically significant interactions with adefovir, tenofovir, or interferon alfa have been observed. Caution with nephrotoxic drugs that may impair renal function.
Missed dose
If a dose is missed, it should be taken as soon as possible on the same day. However, if remembered near the time of the next scheduled 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 dosing is important for maintaining effective viral suppression and minimizing the development of resistance. Patients should be educated about the importance of adherence and provided with strategies to help remember daily dosing.
Overdose
Limited experience exists with lamivudine overdose. There is no specific antidote for lamivudine overdose. In the event of overdose, the patient should be monitored and standard supportive treatment applied as required. Since lamivudine is dialyzable, hemodialysis may be considered in cases of significant overdose, particularly in patients with renal impairment. The molecular weight, low protein binding, and elimination characteristics of lamivudine suggest that it may be removed by continuous ambulatory peritoneal dialysis and hemodialysis. Patients should be monitored for signs of toxicity, particularly hematological parameters and lactic acidosis.
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. The oral solution should be stored in the original container at room temperature. Do not freeze. Discard any unused oral solution after the expiration date or if contamination is suspected. Tablets should be kept in their original blister packaging until administration to protect from light and moisture.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be consulted for complete prescribing information. Patients should not initiate or discontinue therapy without medical supervision. The manufacturer’s official prescribing information should be consulted for full details on warnings, precautions, and adverse reactions.
Reviews
Clinical trials have demonstrated that Epivir HBV produces HBV DNA nondetectability in approximately 40-50% of HBeAg-positive patients and 60-70% of HBeAg-negative patients after one year of therapy. Studies show histological improvement in 50-60% of patients after one year of treatment. Long-term data indicate maintained virological suppression in responders, though resistance development increases with treatment duration, reaching approximately 70% after 4 years of therapy. Many hepatologists consider it a valuable option particularly in resource-limited settings or for short-term treatment courses. Patient satisfaction surveys indicate good tolerability and convenience of once-daily dosing.