Ribavirin pharmacodynamics in high-risk patients for acquired immunodeficiency syndrome

Clin Pharmacol Ther. 1987 Oct;42(4):365-73. doi: 10.1038/clpt.1987.165.

Abstract

Ribavirin was administered orally in escalating doses for 2 or 4 weeks to 15 symptom-free, human immunodeficiency virus seropositive homosexual men with generalized lymphadenopathy. Reverse transcriptase activity was inhibited during therapy when steady-state plasma concentrations were greater than 6 mumol/L. These concentrations were achieved with 1200 or 2400 mg/day for 2 weeks or a loading dose of 2400 mg/day for 3 days followed by 600 mg/day for 4 weeks. Drug accumulation occurred at all doses. The elimination half-life appeared to be approximately 2 weeks. Reversible adverse reactions, principally resulting in central nervous system symptoms and anemia, correlated with dose and duration of therapy. Immunologic enhancement of T-lymphocyte-mediated mitogen-induced responses was observed in the majority of patients who had reduction in reverse transcriptase activity. However, specific T4+ lymphocyte-mediated antigen-induced responses increased to within the normal range in only three patients. Significant enhancement appeared to correlate with the severity of baseline antigen-induced functional impairment. These data indicate that oral ribavirin can be given for at least 1 month with acceptable toxicity at doses that appear to inhibit human immunodeficiency virus replication.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acquired Immunodeficiency Syndrome / drug therapy*
  • Acquired Immunodeficiency Syndrome / immunology
  • Administration, Oral
  • Adult
  • Clinical Trials as Topic
  • Double-Blind Method
  • HIV / drug effects
  • HIV / isolation & purification
  • Humans
  • Interferon-gamma / blood
  • Leukocyte Count
  • Lymphocytes / immunology
  • Male
  • Middle Aged
  • Random Allocation
  • Reverse Transcriptase Inhibitors
  • Ribavirin / administration & dosage
  • Ribavirin / adverse effects
  • Ribavirin / pharmacology*
  • Ribonucleosides / pharmacology*
  • Time Factors
  • Viral Plaque Assay
  • Virus Replication / drug effects

Substances

  • Reverse Transcriptase Inhibitors
  • Ribonucleosides
  • Ribavirin
  • Interferon-gamma