Drugs

, Volume 69, Issue 16, pp 2245–2256

Tenofovir Disoproxil Fumarate

In Chronic Hepatitis B

Authors

    • Adis, a Wolters Kluwer Business
  • Dene Simpson
    • Adis, a Wolters Kluwer Business
Adis Drug Profile

DOI: 10.2165/10482940-000000000-00000

Cite this article as:
Perry, C.M. & Simpson, D. Drugs (2009) 69: 2245. doi:10.2165/10482940-000000000-00000

Abstract

  • ▴ Tenofovir disoproxil fumarate (tenofovir DF) is an orally administered ester prodrug of tenofovir, a nucleotide reverse transcriptase inhibitor that shows potent in vitro activity against both hepatitis B virus (HBV) and HIV-1.

  • ▴ As a component of antiretroviral combination therapy regimens, tenofovir DF is well established in the treatment of adults with HIV-1 infection. Tenofovir DF, administered once daily, is also used in the treatment of adults with chronic hepatitis B (CHB) [the main focus of this profile].

  • ▴ In CHB, the efficacy of tenofovir DF against HBV has been evaluated in two large randomized, phase III clinical studies in hepatitis B e antigen (HBeAg)-negative or HBeAg-positive adults, with compensated liver function. The trials (planned duration 8 years) were double-blind for the first 48 weeks; thereafter, patients received open-label tenofovir DF. Results at 48 and 96 weeks are available.

  • ▴ In these studies, at week 48, a significantly greater proportion of recipients of tenofovir DF 300 mg once daily than oral adefovir dipivoxil 10 mg once daily achieved a complete response (primary endpoint). A complete response was defined as a reduction from baseline in plasma HBV DNA level to <400 copies/mL and histological improvement (reduction of 2 or more points in Knodell necroinflammatory score without worsening of fibrosis).

  • ▴ The efficacy of tenofovir DF in the treatment of CHB was also demonstrated over a 96-week treatment period in both studies.

  • ▴ Tenofovir DF was generally well tolerated by adults with CHB in the two phase III trials.

Copyright information

© Adis Data Information BV 2009