An open-label study of tenofovir in HIV-1 and Hepatitis B virus co-infected individuals

AIDS. 2003 Jan 3;17(1):F7-10. doi: 10.1097/00002030-200301030-00002.

Abstract

Background: Tenofovir is a novel nucleotide analogue recommended for use in HIV-1 infected treatment-experienced patients. Recent data suggest an effect on Hepatitis B virus (HBV) replication. We therefore investigated the use of tenofovir in HIV-1 and HBV co-infected individuals.

Methods: Twenty HIV-1/HBV co-infected patients with a median of 108 weeks lamivudine experience (range, 0-270 weeks) received tenofovir 245 mg daily in addition to or as part of their combination antiretroviral therapy. Their immunologic parameters and HIV-1 RNA and HBV DNA viral loads were followed over a period of 52 weeks. In addition, their HBV DNA polymerase was sequenced at baseline to measure the frequency of YMDD mutations that are associated with lamivudine resistance.

Findings: A significant decrease in HBV DNA viral load (4 x log ) and alanine aminotransferase levels was observed. There were no significant overall differences between the lamivudine-experienced (n = 15) and -naive (n = 5) individuals and tenofovir was well tolerated. Five patients (25%) underwent HBe antigen seroconversion during the study period. Out of the 15 lamivudine-experienced individuals, 10 had YMDD mutations and one had YIDD mutations in HBV DNA.

Interpretation: These results indicate that 52 weeks of tenofovir in addition to antiretroviral therapy is active against HBV, and it appears to overcome lamivudine resistance.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use*
  • Adult
  • Anti-HIV Agents / therapeutic use
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / analysis
  • Drug Therapy, Combination
  • Follow-Up Studies
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV-1*
  • Hepatitis B virus / isolation & purification
  • Hepatitis B, Chronic / complications
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / virology
  • Humans
  • Lymphocyte Count
  • Male
  • Middle Aged
  • Organophosphonates*
  • Organophosphorus Compounds / therapeutic use*
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Tenofovir
  • Viral Load

Substances

  • Anti-HIV Agents
  • Antiviral Agents
  • DNA, Viral
  • Organophosphonates
  • Organophosphorus Compounds
  • Reverse Transcriptase Inhibitors
  • Tenofovir
  • Adenine