Once-daily quadruple-drug therapy with adefovir dipivoxil, Lamivudine, Didanosine, and efavirenz in treatment-naive human immunodeficiency virus type 1-infected patients

J Infect Dis. 2002 Oct 1;186(7):1028-33. doi: 10.1086/343740. Epub 2002 Sep 13.

Abstract

A 48-week open-label study of 11 antiretroviral-naive, human immunodeficiency virus type 1 (HIV-1)-infected adults evaluated once-daily treatment with adefovir dipivoxil, lamivudine, didanosine, and efavirenz. At baseline, the median plasma HIV-1 RNA level was 4.99 log(10) copies/mL, and the median CD4 cell count was 471 cells/mm(3). At 24 and 48 weeks after initiation of treatment, median HIV-1 RNA levels decreased from baseline by 4.77 and 4.99 log(10) copies/mL, respectively, and median CD4 cell counts increased by 135 and 177 cells/mm(3), respectively. The regimen was generally well tolerated. No patients withdrew from the study because of adverse events. However, 7 patients developed adefovir-related nephrotoxicity after >/=20 weeks of treatment; this resolved without sequelae after adefovir was discontinued. Overall adherence was 85%. Once-daily quadruple-drug therapy with adefovir, lamivudine, didanosine, and efavirenz provides pronounced and durable suppression of HIV-1 RNA and elevation of CD4 cell counts over the course of 48 weeks, with generally good tolerability and adherence.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use*
  • Adult
  • Alkynes
  • Benzoxazines
  • CD4 Lymphocyte Count
  • Cyclopropanes
  • Didanosine / administration & dosage
  • Didanosine / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV-1* / isolation & purification
  • Humans
  • Kidney Diseases / chemically induced
  • Lamivudine / administration & dosage
  • Lamivudine / therapeutic use*
  • Male
  • Organophosphonates*
  • Oxazines / administration & dosage
  • Oxazines / therapeutic use*
  • Pulse Therapy, Drug
  • RNA, Viral / blood
  • Reverse Transcriptase Inhibitors / administration & dosage
  • Reverse Transcriptase Inhibitors / adverse effects
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Alkynes
  • Benzoxazines
  • Cyclopropanes
  • Organophosphonates
  • Oxazines
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Lamivudine
  • Adenine
  • efavirenz
  • Didanosine
  • adefovir dipivoxil