Long-term therapy with tenofovir is effective for patients co-infected with human immunodeficiency virus and hepatitis B virus

Gastroenterology. 2010 Dec;139(6):1934-41. doi: 10.1053/j.gastro.2010.08.045. Epub 2010 Aug 26.

Abstract

Background & aims: We investigated the long-term efficacy and renal safety of tenofovir disoproxil fumarate (TDF), administered to patients co-infected with human immunodeficiency virus and hepatitis B virus (HBV) as part of an antiretroviral therapy.

Methods: We performed a multicenter, prospective cohort study of 102 patients co-infected with human immunodeficiency virus and HBV who were treated with TDF.

Results: At baseline, 80% of patients had a detectable viral load (HBV DNA >20 IU/mL). Among patients positive for hepatitis B e antigen (HBeAg) (n = 67), 92% had a virologic response (HBV DNA <20 IU/mL) after 5 years of treatment. There was no difference between patients with or without lamivudine resistance at baseline (P = .39). Loss rates of HBeAg and hepatitis B s antigen (HBsAg) were 46% and 12%, respectively. Among HBeAg-negative patients (n = 15), 100% had a virologic response after 4 years of treatment and 2 (13%) lost HBsAg. Twenty subjects (20%, all HBeAg-negative) had undetectable HBV DNA at baseline; during a median follow-up period of 52 months (interquartile range, 41-63 mo), 19 (95%) maintained a virologic response and 2 (10%) lost HBsAg. Overall, one patient acquired a combination of resistance mutations for anti-HBV drugs and experienced a virologic breakthrough. Three (3%) patients discontinued TDF because of increased serum creatinine levels. The estimated decrease in renal function after 5 years of TDF therapy was 9.8 mL/min/1.73 m(2), which was most pronounced shortly after TDF therapy was initiated.

Conclusions: TDF, administered as part of antiretroviral therapy, is a potent anti-HBV agent with a good resistance profile throughout 5 years of therapy. Only small nonprogressive decreases in renal function were observed.

Publication types

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

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / adverse effects
  • Antiviral Agents / administration & dosage
  • CD4 Lymphocyte Count
  • DNA, Viral / blood
  • Drug Resistance, Viral
  • Female
  • Follow-Up Studies
  • Guanine / administration & dosage
  • Guanine / analogs & derivatives
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • Hepatitis B virus / drug effects*
  • Hepatitis B virus / genetics
  • Hepatitis B virus / growth & development
  • Hepatitis B, Chronic / complications
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Kaplan-Meier Estimate
  • Kidney / drug effects
  • Male
  • Middle Aged
  • Organophosphonates / administration & dosage*
  • Organophosphonates / adverse effects
  • Prospective Studies
  • Tenofovir
  • Time Factors
  • Virus Replication / drug effects

Substances

  • Anti-HIV Agents
  • Antiviral Agents
  • DNA, Viral
  • Organophosphonates
  • entecavir
  • Guanine
  • Tenofovir
  • Adenine