Tenofovir Alafenamide is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

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Mechanism of Action

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2’-deoxyadenosine monophosphate analog). Tenofovir alafenamide as a lipophilic cell-permeant compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is then converted to tenofovir through hydrolysis primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of toxicity to mitochondria in cell culture.

Dosing & Administration

The recommended dosage of Tenofovir Alafenamide is 25 mg (one tablet) taken orally once daily with or without food.

Elderly patients - Tenofovir Alafenamide dose adjustment is not required in patients aged 65 years and older. In clinical trials, 89 HBV-infected patients aged 65 years and over received TAF 25mg. No differences in safety or efficacy have been observed between elderly patients and those between 18 and less than 65 years of age.

Renal Impairment patients - No dosage adjustment of Tenofovir Alafenamide is required in patients with mild, moderate, or severe renal impairment. Tenofovir Alafenamide is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute). For patients on hemodialysis, on days of hemodialysis, TAF 25mg should be administered after completion of hemodialysis treatment.

Hepatic Impairment patients - No dosage adjustment of Tenofovir Alafenamide is required in patients with mild hepatic impairment (Child-Pugh A). Tenofovir Alafenamide is not recommended in patients with decompensated (Child Pugh B or C) hepatic impairment.

Paediatric population - Safety and effectiveness of Tenofovir Alafenamide in pediatric patients less than 18 years of age havenot been established.

Method of administration

For oral use.

Patients should be instructed to swallow the tablet whole with food

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