Tenofovir Disoproxil

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Jérôme Tourret - One of the best experts on this subject based on the ideXlab platform.

  • Is Tenofovir Alafenamide Safer than Tenofovir Disoproxil Fumarate for the Kidneys?
    Aids Reviews, 2016
    Co-Authors: Blandine Aloy, Imane Tazi, Corinne Isnard Bagnis, Marion Gauthier, Nicolas Janus, Vincent Launay-vacher, Gilbert Deray, Jérôme Tourret
    Abstract:

    Tenofovir Disoproxil fumarate is currently the cornerstone of HIV treatment. Although it shows an overall good safety profile, numerous cases of nephrotoxicity have been reported. Tenofovir alafenamide is a novel Tenofovir prodrug that has been developed to improve renal safety. Pharmacokinetic studies suggest a better renal tolerance of Tenofovir alafenamide than Tenofovir Disoproxil fumarate, probably because Tenofovir plasma concentrations are lower after Tenofovir alafenamide administration. Consistently in clinical trials, renal tolerance seems to be improved in patients treated with Tenofovir alafenamide. However, some questions remain. First, whether Tenofovir can accumulate and lead to nephrotoxicity under specific circumstances after Tenofovir alafenamide administration is unknown. Second, only "real-world practice" will inform us on the long-term renal safety of Tenofovir alafenamide. Last, Tenofovir alafenamide renal safety in patients with chronic kidney disease has not been studied in any randomized clinical trial. In conclusion, Tenofovir alafenamide appears as a very promising drug and long-term safety will be an important determinant of its expanded use.

  • Tenofovir: Is Tenofovir Alafenamide Safer than Tenofovir Disoproxil Fumarate for the Kidneys?
    AIDS reviews, 2016
    Co-Authors: Blandine Aloy, Corinne Isnard Bagnis, Marion Gauthier, Nicolas Janus, Tazi I, Launay-vacher, Jérôme Tourret
    Abstract:

    Tenofovir Disoproxil fumarate is currently the cornerstone of HIV treatment. Although it shows an overall good safety profile, numerous cases of nephrotoxicity have been reported. Tenofovir alafenamide is a novel Tenofovir prodrug that has been developed to improve renal safety. Pharmacokinetic studies suggest a better renal tolerance of Tenofovir alafenamide than Tenofovir Disoproxil fumarate, probably because Tenofovir plasma concentrations are lower after Tenofovir alafenamide administration. Consistently in clinical trials, renal tolerance seems to be improved in patients treated with Tenofovir alafenamide. However, some questions remain. First, whether Tenofovir can accumulate and lead to nephrotoxicity under specific circumstances after Tenofovir alafenamide administration is unknown. Second, only "real-world practice" will inform us on the long-term renal safety of Tenofovir alafenamide. Last, Tenofovir alafenamide renal safety in patients with chronic kidney disease has not been studied in any randomized clinical trial. In conclusion, Tenofovir alafenamide appears as a very promising drug and long-term safety will be an important determinant of its expanded use.

Joel E. Gallant - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/Tenofovir Disoproxil fumarate versus efavirenz/emtricitabine/Tenofovir Disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 result
    Journal of acquired immune deficiency syndromes (1999), 2013
    Co-Authors: Andrew R. Zolopa, Joel E. Gallant, Paul E. Sax, Edwin Dejesus, Anthony Mills, Calvin J. Cohen, David A. Wohl, Hui C. Liu, Andrew Plummer, Kirsten L. White
    Abstract:

    We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/Tenofovir Disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/Tenofovir Disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA

  • a randomized double blind comparison of coformulated elvitegravir cobicistat emtricitabine Tenofovir Disoproxil fumarate versus efavirenz emtricitabine Tenofovir Disoproxil fumarate for initial treatment of hiv 1 infection analysis of week 96 results
    Journal of Acquired Immune Deficiency Syndromes, 2013
    Co-Authors: Andrew R. Zolopa, Joel E. Gallant, Paul E. Sax, Edwin Dejesus, Anthony Mills, Calvin J. Cohen, David A. Wohl, Hui C. Liu, Andrew Plummer, Kirsten L. White
    Abstract:

    We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/Tenofovir Disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/Tenofovir Disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA <50 copies/mL) was maintained at week 96 (84% vs 82%, difference +2.7%, 95% CI: -2.9% to 8.3%). Discontinuation due to adverse events was low (5% vs 7%). Median changes in serum creatinine (mg/dL) at week 96 were similar to week 48. These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF.

  • Renal safety of Tenofovir Disoproxil fumarate.
    The AIDS reader, 2007
    Co-Authors: Paul E. Sax, Joel E. Gallant, Paul E. Klotman
    Abstract:

    Tenofovir Disoproxil fumarate is approved to treat HIV infection in combination with other antiretroviral agents. Although Tenofovir is generally well tolerated, the potential for nephrotoxicity exists based on preclinical data, case reports, and observational studies. Following its approval in the United States in October 2001, a series of case reports of Tenofovir-related renal toxicity brought the issue to the attention of clinicians. While case reports raise the issue of nephrotoxicity, cohort studies and clinical trials have helped to clarify the overall safety profile of Tenofovir. We present a review of the renal safety of Tenofovir and provide a brief summary of the clinical implications of these data.

  • Tenofovir Disoproxil fumarate for the treatment of HIV infection
    Expert opinion on drug metabolism & toxicology, 2006
    Co-Authors: Paul A. Pham, Joel E. Gallant
    Abstract:

    Tenofovir Disoproxil fumarate is a nucleotide analogue reverse transcriptase inhibitor approved by the FDA for the treatment of HIV infection. It is a potent agent with a long intracellular half-life that allows for once-daily dosing. It has been well tolerated in clinical trials, without evidence of the mitochondrial toxicity that has been associated with long-term treatment of some of the nucleoside analogue reverse transcriptase inhibitors. Because of its demonstrated efficacy and favourable safety profile, Tenofovir Disoproxil fumarate has quickly become a favoured nucleoside component of antiretroviral regimens for both treatment-naive and -experienced patients.

  • Tenofovir Disoproxil Fumarate
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2003
    Co-Authors: Joel E. Gallant, Stanley C. Deresinski
    Abstract:

    Tenofovir Disoproxil fumarate (Tenofovir DF) is a bioavailable prodrug of Tenofovir, a potent nucleotide analogue reverse-transcriptase inhibitor with activity against human immunodeficiency virus (HIV) and hepatitis B virus. It is administered as a single 300-mg tablet once daily. It was approved for the treatment of HIV infection on the basis of data from clinical trials demonstrating activity in treatment-experienced patients, and it was subsequently shown to be effective when used as a component of initial therapy. Tenofovir DF is active against some nucleoside-resistant strains of HIV. However, cross-resistance is associated with multiple thymidine analogue mutations that include 41L or 210W. The signature mutation is the K65R mutation, which causes variable loss in susceptibility to Tenofovir DF, didanosine, and abacavir. Tenofovir DF has been well tolerated in clinical trials with durations of follow-up up to 96 weeks. It is associated with more-favorable lipid profiles than stavudine and has not been associated with the mitochondrial toxicity attributed to other nucleoside analogues.

Kirsten L. White - One of the best experts on this subject based on the ideXlab platform.

B.v. Kiran - One of the best experts on this subject based on the ideXlab platform.

  • Development, Validation and Stress Degradation Studies of Emtricitabine and Tenofovir Disoproxil Fumerate by High Performance Liquid Chromatography
    Asian Journal of Research in Chemistry, 2013
    Co-Authors: Battula Sreenivasa Rao, Siva Nagaraju, B.v. Kiran
    Abstract:

    A simple, selective, rapid, precise and accurate reverse phase high pressure liquid chromatographic method has been developed for simultaneous estimation of Emtricitabine and Tenofovir Disoproxil fumerate in pharmaceutical Tablet dosage form. The mobile phase consisted of 65:35% (v/v) of Methanol and 0.1M of potassium di hydrogen ortho phosphate and pH adjusted to 3.2 with ortho phosphoric acid. The method developed is operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic determination of Emtricitabine and Tenofovir Disoproxil fumerate was performed on Phenomenex C18 column (150 X 4.6 mm Id, ODS-2, 5μm). The wavelength of detection is 260 nm. The injection volume is 20μL. The retention time of Emtricitabine is 1.92 ± 0.01 minutes while the retention time of Tenofovir Disoproxil fumerate is 3.17 ± 0.01 minures. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, solution stability, ruggedness, and robustness. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress conditions on Emtricitabine and Tenofovir Disoproxil fumerate was studied. Results indicated that Emtricitabine and Tenofovir Disoproxil fumerate is stable under the experimental conditions. The proposed method has been successfully used for the estimation in tablet dosage forms.

Jian Zong - One of the best experts on this subject based on the ideXlab platform.

  • Steady-state pharmacokinetics of emtricitabine and Tenofovir Disoproxil fumarate administered alone and in combination in healthy volunteers.
    Journal of clinical pharmacology, 2007
    Co-Authors: M. Robert Blum, Gregory E. Chittick, John A. Begley, Jian Zong
    Abstract:

    The approved antiretroviral drugs, emtricitabine and Tenofovir Disoproxil fumarate, were considered good candidates for a fixed-dose combination product that could be administered as a single pill once daily (qd), thereby simplifying existing treatment regimens and promoting patient adherence. As both drugs are extensively renally eliminated, a randomized, 3-way crossover study was conducted in 19 healthy volunteers to formally evaluate the potential pharmacokinetic interaction when the drugs are administered alone and together (ie, 200 mg emtricitabine qd for 7 days, 300 mg Tenofovir Disoproxil fumarate qd for 7 days, and 200 mg emtricitabine plus 300 mg Tenofovir Disoproxil fumarate qd for 7 days) with no washout between treatments. Steady-state pharmacokinetic parameters (AUC(tau), C(max), and C(min)) of emtricitabine and Tenofovir (as Tenofovir Disoproxil fumarate) in combination were essentially equivalent versus each drug alone, providing a pharmacokinetic rationale for combining these products in emtricitabine/Tenofovir Disoproxil fumarate fixed-dose tablets.

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