Replivir 1 mg Tablet is an antiviral medication containing Entecavir, a potent nucleoside analogue used in the management of chronic hepatitis B virus (HBV) infection in adults and children aged 2 years and older. It works by inhibiting the replication of HBV, reducing viral load, and improving liver function, thereby preventing the progression of liver disease, including cirrhosis and hepatocellular carcinoma. Replivir is recommended for both treatment-naïve patients and those with prior lamivudine resistance.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

Antiviral Agent – Nucleoside Analogue

Pharmacology and Mode of Action

Entecavir, the active ingredient in Replivir, is a deoxyguanosine nucleoside analogue that selectively inhibits HBV DNA polymerase. It acts at multiple stages of the viral replication cycle, including:

• Priming of HBV DNA polymerase

• Reverse transcription of the negative strand from pregenomic RNA

• Synthesis of the positive strand of HBV DNA

By interfering with viral DNA synthesis, Entecavir effectively suppresses viral replication, leading to reduced serum HBV DNA levels, improved liver enzyme levels (ALT, AST), and potential histological improvement in the liver over time. Entecavir exhibits a high barrier to resistance, making it a preferred first-line therapy in chronic hepatitis B management.

Indications

Replivir 1 mg Tablet is indicated for:

• Treatment of chronic hepatitis B virus infection in adults and children aged 2 years and older

• Patients with compensated or decompensated liver disease caused by HBV

• Management of HBV in patients with prior lamivudine resistance

• Long-term viral suppression to prevent progression to cirrhosis, liver failure, or hepatocellular carcinoma

Dosage and Administration

The recommended dosage of Replivir 1 mg depends on patient status and liver function:

• Treatment-naïve adults with compensated liver disease: 0.5 mg orally once daily on an empty stomach

• Adults with lamivudine-resistant HBV: 1 mg orally once daily

• Decompensated liver disease: Dosage adjustment may be required under medical supervision

• Children (≥2 years old): Weight-based dosing; administered once daily

• Tablets should be swallowed whole and can be taken with or without food.

Patients are advised to maintain strict adherence to daily dosing to achieve maximal viral suppression and prevent resistance. Long-term therapy may be required based on viral response and clinical evaluation.

Drug Interactions

Entecavir has a low potential for drug interactions as it is minimally metabolized by the liver. Caution is advised when co-administered with nephrotoxic drugs, as Entecavir is excreted primarily via the kidneys. Dose adjustment may be necessary in patients with renal impairment.

Contraindications

• Known hypersensitivity to Entecavir or any component of the formulation

• Caution in patients with severe renal impairment or on dialysis

Side Effects

Replivir is generally well tolerated. Common adverse effects include:

• Headache

• Fatigue

• Nausea

• Dizziness

• Rare cases of lactic acidosis and severe hepatomegaly with steatosis have been reported

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Precautions & Warnings

• Hepatic monitoring: Patients should be monitored for HBV exacerbation after discontinuation

• Renal monitoring: Dose adjustments may be required in renal impairment

• Pregnancy & Lactation: Use only if the potential benefit outweighs the risk; data in humans are limited

Storage Conditions

Store at 25°C, protected from moisture and light. Keep out of reach of children.

Replivir 1 mg Tablet offers a reliable, once-daily treatment option for effective suppression of HBV replication, improving liver health and reducing long-term complications in chronic hepatitis B patients.