Hepatitis B infection

Active Ingredient: Tenofovir disoproxil

Indication for Tenofovir disoproxil

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)

Therapeutic intent: Curative procedure

Tenofovir disoproxil is indicated for the treatment of chronic hepatitis B in adults with:

compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
evidence of lamivudine-resistant hepatitis B virus.
decompensated liver disease.

Tenofovir disoproxil is indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to <12 years who weigh from 17 kg to less than 35 kg, and in adolescents 12 to <18 years of age with:

compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

For this indication, competent medicine agencies globally authorize below treatments:

245 mg once daily

For:

Dosage regimens

Oral, 245 milligrams tenofovir disoproxil, once daily to meals.

Detailed description

Adults and adolescents aged 12 to <18 years and weighing ≥35 kg

The recommended dose of tenofovir disoproxil for the treatment of HIV is 245 mg once daily taken orally with food.

The decision to treat adolescent patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus and the uncertainties as regards the long term impact of bone and renal toxicity.

Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.

Duration of therapy in adult and adolescent patients with chronic hepatitis B

The optimal duration of treatment is unknown. Treatment discontinuation may be considered as follows:

In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy. Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.

Missed dose

If a patient misses a dose of tenofovir within 12 hours of the time it is usually taken, the patient should take tenofovir disoproxil with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of tenofovir by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 1 hour of taking tenofovir, another tablet should be taken. If the patient vomits more than 1 hour after taking tenofovir they do not need to take another dose.

Dosage considerations

Should be taken once daily, orally with food.

For patients 6-12 years old 123 mg, 204 mg or 163 mg once daily based on body weight and for patients >2 years old 6.5 mg/kg body weight once daily

For:

Dosage regimens

Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 17 kg and patient weight is ≤ 22 kg, oral, 123 milligrams tenofovir disoproxil, once daily.

Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 22 kg and patient weight is ≤ 28 kg, oral, 163 milligrams tenofovir disoproxil, once daily to meals.

Regimen C: In case that patient age in years is ≥ 6 and patient weight is ≥ 28 kg and patient weight is ≤ 35 kg, oral, 204 milligrams tenofovir disoproxil, once daily to meals.

Regimen D: In case that patient age in years is ≥ 2, oral, 6.5 milligrams tenofovir disoproxil, once daily to meals.

Detailed description

The recommended dose for the treatment of HIV-1 infection in paediatric patients aged 6 to <12 years weighing 17 kg to <22 kg is 123 mg once daily taken orally with food.

For patients weighing 22 kg to <28 kg the recommended dose is 163 mg once daily and for patients weighing 28 kg to <35 kg the recommended dose is 204 mg once daily taken orally with food.

Tenofovir disoproxil granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to <6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate. The recommended dose is 6.5 mg per kilogram of body weight once daily taken with food.

The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus and the uncertainties as regards the long term impact of bone and renal toxicity.

Duration of therapy in paediatric patients with chronic hepatitis B

The optimal duration of treatment is unknown. Treatment discontinuation may be considered as follows:

In HBeAg positive patients without cirrhosis, treatment should be administered for at least 12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) is confirmed or until HBs seroconversion or there is loss of efficacy. Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. Treatment discontinuation may also be considered after stable virological suppression is achieved (i.e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.

Missed dose

If a patient misses a dose of tenofovir within 12 hours of the time it is usually taken, the patient should take tenofovir with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of tenofovir by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 1 hour of taking tenofovir, another tablet should be taken. If the patient vomits more than 1 hour after taking tenofovir they do not need to take another dose.

Dosage considerations

Should be taken orally with food.

Active ingredient

Tenofovir disoproxil
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Read more about Tenofovir disoproxil

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