Epivir HBV (lamivudine) is a nucleoside reverse transcriptase inhibitor specifically indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients. As a cornerstone antiviral therapy, it works by inhibiting viral replication, thereby reducing viral load, improving liver enzyme levels, and decreasing the risk of long-term hepatic complications such as cirrhosis and hepatocellular carcinoma. Its well-established efficacy and generally favorable safety profile make it a trusted option in clinical practice for appropriate patient populations.

Features

• Active ingredient: Lamivudine 100 mg (oral tablets) or 5 mg/mL (oral solution)
• Formulation: Film-coated tablets and strawberry-banana flavored solution for pediatric use
• Mechanism: Inhibits HBV reverse transcriptase via DNA chain termination
• Bioavailability: Approximately 86% for tablets, 87% for oral solution
• Half-life: 5–7 hours in adults with normal renal function
• Excretion: Primarily renal (approximately 70% unchanged)

Benefits

• Significantly reduces HBV DNA viral load in a majority of treated patients
• Normalizes ALT levels, indicating reduced hepatic inflammation
• May improve liver histology, slowing fibrosis progression
• Low incidence of serious adverse events with appropriate monitoring
• Convenient once-daily dosing supports adherence
• Available in both tablet and liquid formulations for broad patient accessibility

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 nucleoside-naïve patients and those requiring long-term viral suppression. It may be used as monotherapy or as part of a combination regimen in select cases, though careful consideration of resistance profiles is essential.

Dosage and direction

The recommended oral dose of Epivir HBV for adults is 100 mg once daily, with or without food. For pediatric patients aged 2–17 years, the recommended dose is 3 mg per kg once daily, up to a maximum of 100 mg per day. Dosage adjustment is required in patients with renal impairment (CrCl <50 mL/min):

• CrCl 30–49 mL/min: 100 mg first dose, then 50 mg once daily
• CrCl 15–29 mL/min: 100 mg first dose, then 25 mg once daily
• CrCl 5–14 mL/min: 35 mg first dose, then 15 mg once daily
• CrCl <5 mL/min: 35 mg first dose, then 10 mg once daily

Treatment duration should be individualized based on virologic response, serologic status, and hepatic function.

Precautions

• Periodic monitoring of HBV DNA levels, liver function tests, and renal function is recommended.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported.
• Exacerbations of hepatitis may occur upon discontinuation; monitor patients closely.
• Use with caution in patients with risk factors for liver disease or impaired renal function.
• Not recommended for use in patients co-infected with HIV unless also receiving a fully suppressive HIV regimen.
• Pancreatitis has been reported; use with caution in pediatric patients or those with a history of pancreatitis.

Contraindications

Epivir HBV is contraindicated in patients with known hypersensitivity to lamivudine or any component of the product. It should not be used as monotherapy in patients with unrecognized or untreated HIV-1 co-infection, due to the risk of HIV resistance development.

Possible side effect

Common adverse reactions (≥10%): headache, fatigue, nausea, diarrhea, cough.
Less common: dizziness, insomnia, nasal signs and symptoms, abdominal pain, rash.
Rare but serious: lactic acidosis, severe hepatomegaly with steatosis, pancreatitis, hepatic flares after discontinuation, myopathy, peripheral neuropathy.

Drug interaction

• Trimethoprim/sulfamethoxazole increases lamivudine exposure; monitor for adverse effects.
• Drugs that reduce renal function or compete for active tubular secretion (e.g., probenecid) may increase lamivudine levels.
• Not significantly metabolized by CYP450 enzymes; low potential for interactions with drugs metabolized by these pathways.
• Use with other nephrotoxic agents may require closer renal monitoring.

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. Doubling doses is not recommended.

Overdose

There is limited experience with overdose. Hemodialysis removes lamivudine, and this may be used in the event of significant overdose, particularly in patients with renal impairment. Standard supportive measures should be employed.

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Keep the bottle tightly closed and protect from moisture. Oral solution should not be frozen; discard any unused portion after 30 days of first opening.

Disclaimer

This information is intended for healthcare professionals. It is not exhaustive and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider for personalized recommendations based on individual health status and current clinical guidelines.

Reviews

Epivir HBV has been widely studied in clinical trials and real-world settings, demonstrating consistent virologic suppression and ALT normalization in a significant proportion of patients with chronic HBV. Its once-daily dosing is frequently cited as advantageous for long-term adherence. However, clinicians note the risk of viral resistance with prolonged monotherapy, underscoring the importance of regular monitoring and consideration of alternative or combination therapies in cases of suboptimal response or breakthrough. Overall, it remains a valuable option within the HBV treatment arsenal, particularly in resource-limited settings or for specific patient subgroups.