Tenofovir alafenamide

Chronic Hepatitis B, Acquired Immunodeficiency Syndrome

Drug Status

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

NO

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Known Teratogen

NO

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Pharmaceutical Class

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Controlled Drug Substance

No

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Drug Ingredient

Tenofovir alafenamide

Summary

  • Tenofovir alafenamide is primarily used for treating chronic hepatitis B virus (HBV) infections in patients aged 6 years and older with compensated liver disease. It helps lower the amount of the virus in the blood, reduces liver inflammation and minimizes the risk of disease progression to cirrhosis or liver cancer.

  • Tenofovir alafenamide is a prodrug that gets converted inside liver cells to its active form, tenofovir diphosphate. This compound blocks an enzyme called HBV reverse transcriptase that the virus needs to reproduce, effectively halting the virus's ability to multiply.

  • The usual dose for adults and children aged 6 years or older weighing at least 25 kg is 25 mg taken once daily with food. No dose adjustment is needed for mild-to-moderate renal impairment, but patients with severe kidney or liver problems may require additional monitoring or alternative therapies.

  • Common side effects include headaches (12% of patients), abdominal pain (9%), fatigue (6%), and nausea (6%). Serious risks include kidney damage, lactic acidosis, and worsening liver function. Regular blood tests are needed to monitor for these complications.

  • Patients with severe liver impairment, untreated HIV, or allergies to Tenofovir alafenamide should avoid this medication. It should also not be used with certain drugs like rifampin or St. John's Wort due to potential drug interactions.

Indications and Purpose

How does Tenofovir alafenamide work?

Tenofovir alafenamide is a prodrug converted inside liver cells to its active form, tenofovir diphosphate. This compound blocks HBV reverse transcriptase, an enzyme required for viral replication, effectively halting the virus’s ability to reproduce.

Is Tenofovir alafenamide effective?

Yes, clinical trials show Tenofovir alafenamide is effective in suppressing HBV DNA in over 90% of patients by week 48. It also has a favorable safety profile compared to older drugs like Tenofovir disoproxil fumarate (TDF), especially in terms of kidney and bone health.

What is Tenofovir alafenamide?

Tenofovir alafenamide is an antiviral drug used primarily for chronic hepatitis B virus (HBV) infections. It belongs to nucleoside reverse transcriptase inhibitors (NRTIs) and works by reducing the amount of the virus in the blood. While it doesn’t cure HBV, it prevents complications like cirrhosis and liver cancer by stopping viral replication.

Directions for Use

For how long do I take Tenofovir alafenamide?

Treatment duration depends on your condition and your doctor’s recommendation. Chronic HBV treatment is often long-term, sometimes for years, until lab results indicate it’s safe to stop. Regular monitoring is essential to assess the continued need for therapy.

How do I take Tenofovir alafenamide?

Take Tenofovir alafenamide exactly as prescribed by your doctor, once daily with food. It’s important to maintain a consistent dosing schedule. Do not skip doses, as missed doses may allow the virus to replicate, potentially leading to resistance.

How long does it take for Tenofovir alafenamide to start working?

The medicine begins to lower HBV levels in the blood soon after starting treatment. However, significant improvement in liver function and viral suppression may take weeks to months, depending on the individual’s response and baseline condition.

How should I store Tenofovir alafenamide?

Store this medicine at room temperature (20–25°C) in a dry place, away from heat and moisture. Keep it in its original container and out of reach of children. Dispose of expired medication safely through a take-back program.

What is the usual dose of Tenofovir alafenamide?

The usual dose for adults and children aged 6 years or older weighing at least 25 kg is 25 mg taken once daily with food. No dose adjustment is needed for mild-to-moderate renal impairment, but patients with severe kidney or liver problems may require additional monitoring or alternative therapies.

Warnings and Precautions

Can I take Tenofovir alafenamide with other prescription drugs?

Certain drugs, such as anticonvulsants (e.g., carbamazepine) and NSAIDs, may interfere with this medication, increasing the risk of kidney damage or reducing its effectiveness. Inform your doctor about all medications you are taking.

Can Tenofovir alafenamide be taken safely while breastfeeding?

Trace amounts of the drug can pass into breast milk, but no adverse effects have been reported in nursing infants. Discuss with your doctor whether to continue breastfeeding while on this medication, especially if you are HBV-positive.

Can Tenofovir alafenamide be taken safely while pregnant?

Studies show no significant risk of birth defects with Tenofovir alafenamide use during pregnancy. However, your doctor will evaluate the benefits and risks, as HBV suppression during pregnancy can help prevent transmission to the baby.

Is it safe to drink alcohol while taking Tenofovir alafenamide?

Moderate alcohol consumption is generally safe but may increase liver strain, particularly in patients with hepatitis B. It’s best to limit or avoid alcohol to protect liver health.

Is it safe to exercise while taking Tenofovir alafenamide?

Exercise is generally safe and encouraged to maintain overall health. However, if you feel fatigued or experience side effects like dizziness, consider reducing the intensity of your activity and consult your doctor.

Is Tenofovir alafenamide safe for the elderly?

Yes, Tenofovir alafenamide is generally safe for elderly patients, but they may require closer monitoring due to the potential for age-related kidney or liver function changes. Doctors may recommend routine blood tests for safety. 

Who should avoid taking Tenofovir alafenamide?

Patients with severe liver impairment (Child-Pugh B or C), untreated HIV, or allergies to Tenofovir alafenamide should avoid this medication. It should also not be used with certain drugs like rifampin or St. John’s Wort due to potential drug interactions.