Tenofovir Dosing for Chronic Hepatitis B

Standard Dosing by Patient Population

The American Association for the Study of Liver Diseases recommends TDF 300 mg once daily for patients weighing ≥35 kg 2, 1
For patients ≥12 years and ≥35 kg, the standard dose is TDF 300 mg once daily 2, 1
Alternative dosing for adolescents (12-18 years) is 8 mg/kg daily (up to maximum 300 mg) 2
At week 72, 89% of adolescents achieved virological response (HBV DNA <400 copies/mL) with no resistance development 2

The American College of Clinical Pharmacology recommends dose adjustments for patients with renal impairment, with a standard dose of TDF 300 mg every 24 hours for CrCl ≥50 mL/min 3
For patients with CrCl 30-49 mL/min, the recommended dose is TDF 300 mg every 48 hours 3
For patients with CrCl 10-29 mL/min, the recommended dose is TDF 300 mg every 72-96 hours 3
Hemodialysis patients should receive TDF 300 mg every 7 days or after approximately 12 hours of dialysis 3

The European Association for the Study of the Liver recommends considering TAF, entecavir, or besifovir over TDF for patients with risk factors for renal dysfunction or bone disease 3, 4
Risk factors warranting alternative agents include baseline eGFR <60 mL/min, proteinuria or albuminuria >0.5 mg/dL, hypophosphatemia <2.5 mg/dL, uncontrolled diabetes or hypertension, osteopenia, osteoporosis, or chronic steroid use, and advanced age 4, 3
In a 96-week trial comparing TAF vs TDF, patients with risk factors on TDF had median eGFR decline of -5.0 mL/min vs -0.3 mL/min with TAF 3
Bone mineral density changes were -3.29% with TDF vs +1.23% with TAF 3

The American Association for the Study of Liver Diseases recommends switching patients who develop renal dysfunction or decreased bone density on TDF to TAF 4
After switching from TDF to TAF at week 96, eGFR improved from -4.6 mL/min decline to -0.06 mL/min by week 144 4
Bone mineral density significantly improved after switching to TAF 4

The American College of Gastroenterology recommends a minimum treatment duration of 1 year for HBeAg-positive patients, continuing at least 1 year after HBeAg seroconversion 2
For HBeAg-negative patients, treatment duration is longer than 1 year, but optimal duration is not established 2
Treatment is typically long-term or indefinite for most patients with compensated liver disease 1

The FDA recommends monitoring hepatic function closely with clinical and laboratory follow-up for at least several months after discontinuing tenofovir due to the risk of severe acute exacerbations of hepatitis 1
Renal function should be monitored regularly, including creatinine clearance, serum phosphorus, urine glucose, and urine protein 1
Bone density should be monitored in patients with risk factors for osteoporosis 3, 4
Liver function should be monitored during treatment, including ALT, AST, and HBV DNA levels 1