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Tenofovir disoproxil fumarate
Therese Chapman1, Jane McGavin, Stuart Noble
1Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
Drugs
|July 31, 2003
Summary
Tenofovir disoproxil fumarate (tenofovir DF) significantly reduces HIV-1 RNA in patients on stable antiretroviral therapy. Viral suppression was maintained long-term, with infrequent resistance mutations and good tolerability.
Area of Science:
- Antiviral therapy
- HIV/AIDS research
- Nucleotide reverse transcriptase inhibitors
Background:
- Tenofovir disoproxil fumarate (tenofovir DF) is a prodrug of tenofovir, a potent nucleotide reverse transcriptase inhibitor.
- HIV infection remains a significant global health challenge requiring effective antiretroviral treatments.
Purpose of the Study:
- To evaluate the efficacy and safety of tenofovir DF in HIV-1 infected patients.
- To assess viral load reduction and resistance development during tenofovir DF therapy.
Main Methods:
- Two large, placebo-controlled clinical trials and a 3-year comparative trial were conducted.
- Patients received tenofovir DF 300 mg/day in addition to existing stable antiretroviral therapy.
- Virological substudies monitored viral load and resistance mutations.
Main Results:
- Tenofovir DF demonstrated significant HIV-1 RNA reduction compared to placebo at 24 weeks.
- Viral load reductions were maintained up to 96 weeks in an extension study.
- Preliminary data suggest comparable efficacy to stavudine in treatment-naive patients.
- Viral suppression persisted in patients developing new mutations; K65R mutation was infrequent.
Conclusions:
- Tenofovir DF is an effective component of antiretroviral therapy for HIV-1 infection.
- The drug is generally well-tolerated, with primarily gastrointestinal adverse events.
- Tenofovir DF contributes to sustained viral suppression and has a low propensity for resistance development.