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Tenofovir Disoproxil Fumarate

This article examines the use of Tenofovir Disoproxil Fumarate (TDF) in clinical trials for the treatment of chronic hepatitis B. TDF is an antiviral medication that has shown promise in suppressing hepatitis B virus (HBV) replication and improving liver health in patients with chronic HBV infection. The trials discussed here evaluate TDF’s efficacy, safety, and optimal dosing in various patient populations, including treatment-naïve patients, those who have failed previous therapies, and special groups like pregnant women. By reviewing these clinical studies, we can gain insights into TDF’s potential as a key treatment option for chronic hepatitis B.

Table of Contents

What is Tenofovir Disoproxil Fumarate?

Tenofovir Disoproxil Fumarate (TDF) is a medication used to treat various viral infections. It’s known by several brand names, including Viread and Virehepa[3]. TDF belongs to a class of drugs called nucleotide analogue reverse transcriptase inhibitors (NRTIs)[2]. These drugs work by interfering with the ability of viruses to replicate, or make copies of themselves, inside the human body.

What Conditions Does TDF Treat?

TDF is primarily used to treat two main conditions:

  • Chronic Hepatitis B (CHB): This is a long-lasting liver infection caused by the hepatitis B virus (HBV). TDF is effective in reducing the amount of HBV in the body[2][3].
  • Human Immunodeficiency Virus (HIV) infection: TDF is also used as part of combination therapy for treating HIV, the virus that causes AIDS[1].

In addition to these primary uses, researchers are exploring the potential of TDF in treating other conditions:

  • Multiple Sclerosis (MS): There’s ongoing research to see if TDF can help with symptoms and provide neuroprotection (protection of nerve cells) in people with relapsing-remitting multiple sclerosis[5].
  • Parkinson’s Disease: Scientists are investigating whether TDF could be beneficial in treating Parkinson’s disease[6].

How Does TDF Work?

TDF works by inhibiting an enzyme called reverse transcriptase, which viruses like HBV and HIV need to replicate. By blocking this enzyme, TDF helps to reduce the amount of virus in the body[2]. This can help to slow down or prevent damage to the liver in hepatitis B patients, and can help to control HIV infection when used as part of combination therapy.

Dosage and Administration

TDF is typically taken orally (by mouth) in tablet form. The usual dose for adults is 300 mg once daily[3]. However, the exact dosage can vary depending on the condition being treated, the patient’s age, weight, and other factors. It’s important to take TDF exactly as prescribed by your healthcare provider.

Efficacy of TDF

Research has shown that TDF is effective in treating both chronic hepatitis B and HIV:

  • For chronic hepatitis B, studies have found that TDF can significantly reduce levels of HBV DNA (a measure of the amount of virus in the body) in many patients[4].
  • In HIV treatment, TDF is often used as part of a combination therapy regimen. It has been shown to effectively suppress HIV replication when used correctly[1].

Safety and Side Effects

Like all medications, TDF can cause side effects. Common side effects may include:

  • Nausea
  • Diarrhea
  • Headache
  • Fatigue

More serious side effects can occur, though they are less common. These may include kidney problems and a decrease in bone density. Your healthcare provider will monitor you for these potential effects through regular blood tests and other examinations[7].

Use in Special Populations

TDF has been studied in various special populations:

  • Pregnant women: Research has been conducted to evaluate the safety and effectiveness of TDF in preventing mother-to-child transmission of HIV[8].
  • Children: Some studies have looked at the use of TDF in infants born to HIV-positive mothers[8].

It’s important to note that the use of TDF in these populations should be carefully considered and monitored by healthcare professionals.

Ongoing Research and Future Directions

Research on TDF is ongoing, with scientists exploring its potential in new areas:

  • Combination therapies for hepatitis B, including the use of TDF with other antiviral medications[9].
  • Potential applications in neurological conditions like multiple sclerosis and Parkinson’s disease[5][6].

These studies may lead to new uses for TDF in the future, potentially benefiting patients with a wider range of conditions.

Aspect Details
Primary Efficacy Measure Reduction in HBV DNA levels, often to undetectable levels (<20 IU/mL)
Treatment Duration Typically 48 to 144 weeks, with some studies extending longer
Patient Populations Treatment-naïve, treatment-experienced, pregnant women, infants
Common Secondary Outcomes HBeAg/HBsAg loss or seroconversion, ALT normalization, viral breakthrough rates
Safety Monitoring Adverse events, kidney function, bone density, liver function tests
Dosing Typically 300 mg once daily for adults, with adjusted dosing for special populations
Combination Therapies Some trials explore TDF in combination with other antivirals or immune modulators
Long-term Efficacy Studies assess viral suppression maintenance and rates of HBsAg loss over time

FAQ

  • What is Tenofovir Disoproxil Fumarate (TDF)? Tenofovir Disoproxil Fumarate (TDF) is an antiviral medication used to treat chronic hepatitis B. It works by inhibiting the replication of the hepatitis B virus in the body.
  • How effective is TDF in treating chronic hepatitis B? Clinical trials have shown TDF to be highly effective in suppressing HBV DNA levels in many patients. For example, one study found that a significant percentage of patients achieved undetectable HBV DNA levels (<20 IU/mL) after 144 weeks of TDF treatment.
  • Are there any side effects associated with TDF? Like all medications, TDF can have side effects. Common side effects may include nausea, diarrhea, and headache. Some studies also monitor for potential effects on kidney function and bone density. However, most trials report that TDF is generally well-tolerated.
  • Can TDF be used in pregnant women with chronic hepatitis B? Some clinical trials have investigated the use of TDF in pregnant women to prevent mother-to-child transmission of HBV. These studies aim to determine the safety and appropriate dosing of TDF during pregnancy and for newborns.
  • How long do patients typically need to take TDF? Treatment duration with TDF can vary, but many clinical trials evaluate its use over extended periods, often 48 weeks to 144 weeks or longer. Chronic hepatitis B often requires long-term treatment to maintain viral suppression.

Ongoing Clinical Trials on Tenofovir Disoproxil Fumarate

  • Study on Lenacapavir for HIV Prevention in Individuals at Risk of HIV Infection

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study Comparing Weekly Islatravir/Lenacapavir Regimen to Standard Care in HIV Patients with Controlled Viral Load

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany The Netherlands Poland Spain

  • Study on the Effectiveness of Rilpivirine-Based Treatment for HIV Patients with Metabolic Liver Disease Using Dolutegravir, Rilpivirine, and Emtricitabine/Tenofovir Combination

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Hepatitis B virus (HBV): A viral infection that attacks the liver and can cause both acute and chronic disease. Chronic HBV infection can lead to serious liver damage, cirrhosis, or liver cancer.
  • HBV DNA: The genetic material of the hepatitis B virus. Measuring HBV DNA levels in the blood helps determine the amount of virus present and assess treatment effectiveness.
  • Virological response: A decrease in the amount of virus in the blood, usually measured by HBV DNA levels, in response to treatment.
  • HBeAg: Hepatitis B e antigen, a protein produced by the hepatitis B virus. Its presence in the blood indicates that the virus is actively replicating.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus. Its presence in the blood indicates current HBV infection.
  • Seroconversion: The development of antibodies against a specific antigen in the blood. In hepatitis B treatment, it often refers to the loss of HBeAg and development of anti-HBe antibodies.
  • Alanine aminotransferase (ALT): An enzyme found primarily in the liver. Elevated levels in the blood can indicate liver damage or inflammation.
  • Nucleos(t)ide analogue: A class of antiviral drugs that work by inhibiting viral replication. TDF belongs to this class of medications.
  • Viral breakthrough: An increase in viral load (usually HBV DNA) during treatment, after an initial response, indicating potential treatment failure or drug resistance.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.

References

  1. https://clinicaltrials.gov/study/NCT02968576
  2. https://clinicaltrials.gov/study/NCT01671787
  3. https://clinicaltrials.gov/study/NCT03485534
  4. https://clinicaltrials.gov/study/NCT02533544
  5. https://clinicaltrials.gov/study/NCT04880577
  6. https://clinicaltrials.gov/study/NCT06356662
  7. https://clinicaltrials.gov/study/NCT03258710
  8. https://clinicaltrials.gov/study/NCT00120471
  9. https://clinicaltrials.gov/study/NCT04847440