Epivir HBV: Effective Chronic Hepatitis B Viral Suppression
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Synonyms | |||
Epivir HBV is a prescription antiviral medication specifically formulated for the management of chronic hepatitis B virus (HBV) infection in adults and pediatric patients. It belongs to the nucleoside analogue class of drugs, working by inhibiting the reverse transcriptase enzyme, which is crucial for viral replication. This action helps to reduce the viral load in the body, a key objective in the long-term management of this condition. By suppressing HBV DNA levels, it supports the improvement of liver enzyme levels and can contribute to histological improvement in the liver.
Features
- Active pharmaceutical ingredient: Lamivudine 100 mg film-coated tablets.
- Mechanism of Action: Nucleoside reverse transcriptase inhibitor (NRTI).
- Standard dosage form: Oral tablet.
- Bioavailability: Approximately 86% for the 100 mg tablet.
- Protein binding: Less than 36% to plasma proteins.
- Metabolism: Minimal hepatic metabolism, primarily cleared renally.
- Half-life: 5 to 7 hours in patients with normal renal function.
- Excretion: Primarily via the urine as unchanged drug.
Benefits
- Achieves significant and sustained suppression of hepatitis B viral replication, as measured by reduction in serum HBV DNA levels.
- Leads to biochemical improvement, evidenced by the normalization of serum aminotransferases (ALT levels).
- Can induce hepatitis B e antigen (HBeAg) seroconversion, a marker of improved immune control over the virus.
- Contributes to histological improvement in the liver, reducing inflammation and fibrosis.
- Offers a well-characterized safety and efficacy profile based on extensive clinical trial data.
- Provides a convenient once-daily oral dosing regimen to support patient adherence to long-term therapy.
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), and histological evidence of active liver inflammation and/or fibrosis. It is used in both adult and pediatric patients. Treatment decisions should be based on a comprehensive evaluation by a healthcare professional, including the patient’s virological, biochemical, and histological markers.
Dosage and direction
The recommended oral dosage of Epivir HBV for adults and adolescents (16 years of age and older) is 100 mg once daily. For pediatric patients, the recommended dosage is 3 mg per kg once daily, up to a maximum of 100 mg daily. It may be taken with or without food. Dosage adjustment is necessary in patients with impaired renal function (creatinine clearance <50 mL/min); consult the full prescribing information for specific dosing guidelines in renal impairment. Treatment should be initiated and monitored by a physician experienced in the management of chronic hepatitis B.
Precautions
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues. Suspend treatment if clinical or laboratory findings suggest this condition.
- Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Epivir HBV. Monitor hepatic function closely for several months after discontinuation.
- HIV-1 co-infection: Epivir HBV alone is not recommended for patients with unrecognized or untreated HIV-1 infection, as it may lead to HIV-1 resistance.
- Pancreatitis has been reported; use with caution in pediatric patients with a history of pancreatitis or significant risk factors for it.
- Renal impairment: Dosage adjustment is required. Monitor renal function before and during treatment.
- Patients should be advised that therapy has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Contraindications
Epivir HBV is contraindicated in patients with a history of hypersensitivity to lamivudine or any of the excipients in the formulation.
Possible side effect
Common adverse reactions (≥10%) observed in clinical trials include:
- Headache
- Fatigue
- Nausea
- Diarrhea
- Cough
- Nasal signs and symptoms
Other reported side effects include:
- Neutropenia
- Elevated liver enzymes (AST/ALT)
- Pancreatitis (rare, primarily in pediatric patients)
- Peripheral neuropathy
- Insomnia
- Rash
- Abdominal pain
- Arthralgia
- Myalgia
Drug interaction
- Drugs affecting renal function: Co-administration with drugs that reduce renal function or compete for active tubular secretion (e.g., trimethoprim/sulfamethoxazole) may increase lamivudine plasma concentrations. Monitor for adverse events.
- Sorbitol: Concomitant use with sorbitol-containing medicines may decrease lamivudine exposure, potentially reducing its therapeutic effect. This is due to sorbitol-induced decreased absorption. An alternative should be considered.
- Interferon alfa: Concurrent use with interferon alfa-2b was associated with an increased risk of neutropenia.
- Zidovudine: Coadministration may result in a modest increase in zidovudine exposure.
Missed dose
If a dose is missed, it should be taken as soon as the patient remembers. However, if it is almost time for 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 one.
Overdose
There is limited experience with overdosage of Epivir HBV. Lamivudine can be removed by continuous hemodialysis; however, the value of this intervention in a clinical overdose is unknown. If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Storage
Store Epivir HBV tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed and protect from moisture. Keep out of the reach of children and pets.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
“Epivir HBV has been a cornerstone in my practice for managing appropriate patients with chronic HBV. Its efficacy in achieving viral suppression is well-documented, and the once-daily dosing supports excellent long-term adherence in my patient population.” – Hepatologist, 15 years of experience.
“In clinical trials, lamivudine demonstrated a favorable profile for inducing HBeAg seroconversion and normalizing ALT levels. While resistance can develop over time, it remains a valuable option within a structured treatment plan.” – Clinical Researcher, Infectious Diseases.
“After discussing the risks and benefits with my doctor, I started on Epivir HBV. The daily routine is simple, and my follow-up tests have shown a significant and sustained decrease in my viral load, which is very encouraging.” – Patient, 4 years on therapy.