Selective intracellular activation of a novel prodrug of the human immunodeficiency virus reverse transcriptase inhibitor tenofovir leads to preferential distribution and accumulation in lymphatic tissue

Antimicrob Agents Chemother. 2005 May;49(5):1898-906. doi: 10.1128/AAC.49.5.1898-1906.2005.

Abstract

An isopropylalaninyl monoamidate phenyl monoester prodrug of tenofovir (GS 7340) was prepared, and its in vitro antiviral activity, metabolism, and pharmacokinetics in dogs were determined. The 50% effective concentration (EC(50)) of GS 7340 against human immunodeficiency virus type 1 in MT-2 cells was 0.005 microM compared to an EC(50) of 5 microM for the parent drug, tenofovir. The (L)-alaninyl analog (GS 7340) was >1,000-fold more active than the (D)-alaninyl analog. GS 7340 has a half-life of 90 min in human plasma at 37 degrees C and a half-life of 28.3 min in an MT-2 cell extract at 37 degrees C. The antiviral activity (>10 x the EC(50)) and the metabolic stability in MT-2 cell extracts (>35 x) and plasma (>2.5 x) were also sensitive to the stereochemistry at the phosphorus. After a single oral dose of GS 7340 (10 mg-eq/kg tenofovir) to male beagle dogs, the plasma bioavailability of tenofovir compared to an intravenous dose of tenofovir was 17%. The total intracellular concentration of all tenofovir species in isolated peripheral blood mononuclear cells at 24 h was 63 microg-eq/ml compared to 0.2 microg-eq/ml in plasma. A radiolabeled distribution study with dogs resulted in an increased distribution of tenofovir to tissues of lymphatic origin compared to the commercially available prodrug tenofovir DF (Viread).

MeSH terms

  • Adenine / analogs & derivatives*
  • Adenine / pharmacokinetics
  • Adenine / pharmacology*
  • Alanine
  • Animals
  • Anti-HIV Agents / pharmacology
  • Area Under Curve
  • CD4-Positive T-Lymphocytes / metabolism
  • Chromatography, High Pressure Liquid
  • Dogs
  • HIV-1
  • Humans
  • In Vitro Techniques
  • Lymphatic System / metabolism*
  • Male
  • Organophosphonates / pharmacokinetics
  • Organophosphonates / pharmacology*
  • Prodrugs / pharmacokinetics
  • Prodrugs / pharmacology*
  • Reverse Transcriptase Inhibitors / pharmacokinetics
  • Reverse Transcriptase Inhibitors / pharmacology*
  • Spectrophotometry, Ultraviolet
  • Tenofovir
  • Tissue Distribution

Substances

  • Anti-HIV Agents
  • Organophosphonates
  • Prodrugs
  • Reverse Transcriptase Inhibitors
  • Tenofovir
  • tenofovir alafenamide
  • Adenine
  • Alanine