Sanoldi Alfosbuvir Tablets

1. Indications and Usage
Alfosbuvir tablets are indicated for the treatment of adult patients with chronic hepatitis B virus (HBV) infection who have compensated liver function.
2. Dosage and Administration
Recommended Dose: The recommended dosage for adults is 10 mg taken orally once daily.
Administration: The tablets should be swallowed whole with water. They can be taken with or without food.
Renal Impairment: Dosage adjustment is necessary for patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) or end-stage renal disease.
Missed Dose: If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose.
3. Mechanism of Action
Alfosbuvir is an orally active prodrug of acyclic nucleoside phosphonate. It enters hepatocytes and is converted intracellularly into its active metabolite, which selectively inhibits the HBV polymerase (reverse transcriptase). This inhibition blocks viral reverse transcription and DNA synthesis, thereby suppressing HBV replication.
4. Safety and Warnings
Hepatic Exacerbation: Severe acute exacerbations of hepatitis have been reported in patients who discontinued alfosbuvir. Patients should be monitored closely after stopping the medication.
Nephrotoxicity: As with other nucleoside analogs, renal impairment and changes in renal function markers (e.g., creatinine, phosphaturia) may occur.
Lactic Acidosis: Lactic acidosis and severe hepatomegaly with steatosis, rare but potentially fatal reactions associated with nucleoside analogs, have been reported.
HBV Resistance: Long-term use may lead to the emergence of HBV polymerase gene mutations associated with drug resistance.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include fatigue, headache, abdominal pain, nausea, and elevated liver enzymes (ALT/AST).
Clinical Research: Clinical trials have demonstrated that alfosbuvir significantly reduces serum HBV DNA levels and improves histological liver scores in patients with chronic HBV infection.
6. Drug Interactions
Nephrotoxic Agents: Caution is advised when co-administering alfosbuvir with other agents known to cause nephrotoxicity.
Renal Excretion Inhibitors: Concomitant use with drugs that compete for active tubular secretion may increase serum concentrations of alfosbuvir or its metabolites.
7. Pharmaceutical Information
Composition: The active ingredient is alfosbuvir (mg).
Appearance: Tablets are typically film-coated and may vary in color and shape depending on the manufacturer.
Storage: Store at controlled room temperature (20°C-25°C) in a dry place, protected from light.