How to treat anti-HBV virus in patients with renal insufficiency

  For antiviral therapy in patients with combined renal insufficiency, care should be taken to adjust the dosing interval and/or dose according to the patient’s creatinine clearance, hemodialysis or not, peritoneal dialysis status, etc. The specific dose adjustment plan can be referred to the relevant drug instructions.  1.Tibivudine [Dosage and Administration]: Patients must use this product under the guidance of a physician experienced in the treatment of chronic hepatitis B. The recommended dose for adults and adolescents (>=16 years of age) is 600 mg orally once daily with or without a meal. The optimal duration of treatment has not been determined. Do not exceed the recommended dose. Patients with renal impairment and creatinine clearance >= 50 ml/min should take the recommended dose and dosage; patients with renal impairment and creatinine clearance <50 ml/min, including patients with end-stage renal disease (ESRD) on hemodialysis, should have the dose and dosage adjusted under medical supervision. Patients with end-stage renal disease (ESRD) should take this product after completion of hemodialysis. In patients with hepatic impairment, no change in recommended dose or usage is necessary. Biochemical parameters, virological parameters and serum markers of hepatitis B should be monitored regularly at least once every 6 months while taking this product.  2. Lamivudine [Caution] The clinical condition and virological parameters of the patient should be checked regularly during treatment. 2. Hepatitis may worsen in a small number of patients after discontinuation of this product. Therefore, if this product is discontinued, the patient should be closely observed, and if hepatitis worsens, treatment with this product should be considered again.3. Renal insufficiency in patients can affect the excretion of lamivudine, and the use of this product is not recommended for patients with creatinine clearance <30 ml/min. Hepatic impairment does not affect the drug metabolism of lamivudine.4. The patient cannot be prevented from infecting others with hepatitis B virus through sexual contact or blood-borne transmission during treatment with this product, so appropriate protective measures should still be taken.5. There is no data to show that maternal-to-child transmission of hepatitis B virus can be inhibited in pregnant women after taking this product. Therefore, routine immunization against hepatitis B should still be given to newborns.  3. Patients with renal impairment of adefovir Adefovir is excreted by the kidneys, so patients with renal insufficiency need to adjust the dosing interval. Patients with creatinine clearance ≥50 mL/min do not need to adjust the dosing interval. Detailed adjustment regimens for dosing intervals in patients with creatinine clearance <50 mL/min are shown in the table below. The number of doses should not exceed the recommended number in the table (see [Haverix Precautions] - Renal Function). Although pharmacokinetic studies have included patients with renal impairment, these guidelines for dosing interval adjustments have not been evaluated for safety and efficacy in the clinical setting. Therefore, the clinical efficacy of these patients should be closely monitored. Studies have not been conducted in patients with creatinine clearance below 10 ml/min. Therefore, there is no dosing regimen available.  For creatinine clearance of 20-49 mL/min, the recommended dose is 10 mg every 48 hours between doses; for creatinine clearance of 10-19 mL/min, the recommended dose is 10 mg every 72 hours between doses; and for hemodialysis patients, 10 mg every 7 days after dialysis (the recommended dosing regimen is derived from a study of 3 high-flow dialysis sessions per week).  4, entecavir [dosage] Patients should take this product under the guidance of an experienced physician. Recommended dose: Adults and young adults over 16 years of age should take this product orally once daily at 0.5 mg. Patients with viremia or lamivudine resistance mutations on lamivudine therapy should take 1.0 mg once daily (0.5 mg two tablets). This product should be taken on an empty stomach (at least 2 hours before or after a meal). Renal insufficiency:In patients with renal insufficiency, the oral clearance of entecavir performance decreases with creatinine clearance (see Pharmacokinetics: Special Populations). Dosing should be adjusted in patients with creatinine clearance <50 ml/min (including patients treated with hemodialysis or CAPD). Table 7: Recommended dose of entecavir in patients with renal insufficiency Creatinine clearance (mL/min) Usual dose (0,5 mg),Lamivudine treatment failure (1,0 mg) ≥50 ,0,5 mg once daily,1,0 mg once daily,30 to <50,0,25 mg once daily,0,5 mg once daily,10 to < Duration of treatment:The optimal duration of treatment for this product and the relationship between long-term treatment outcomes, such as cirrhosis and hepatocellular carcinoma, are not yet known.