The safety and efficacy of switching stavudine to tenofovir DF in combination with lamivudine and efavirenz in HIV-1-infected patients: Three-year follow-up after switching therapy

José Valdez R. Madruga, Isabel Cassetti, Jamal Muhamad A.H. Suleiman, Arnaldo Etzel, Lijie Zhong, Charles B. Holmes, Andrew K. Cheng, Jeffrey Enejosa

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) with stavudine (d4T), in combination with lamivudine (3TC) and efavirenz (EFV), and an ongoing 336-week open-label extension phase. Method: Patients in 3 countries completing the d4T treatment phase were allowed to switch d4T to TDF and receive once-daily TDF+3TC+EFV in the extension phase. Results: At the time of switch, 100% and 99% of patients (n = 85; 60% male, 64% White; mean age 37 years; mean CD4 = 650 cells/mm3) had HIV RNA <400 and <50 copies/mL. At 144 weeks after the switch, 89% (missing = failure) had HIV RNA <400 copies/mL and 87% had HIV RNA <50 copies/mL. Mean CD4 cell count increased 155 cells/mm 3. No patient had virologic failure. Significant decreases from switch to week 144 in mean fasting total cholesterol (-22 mg/dL, p < .0001) and triglycerides (-78 mg/dL, p < .0001) were observed. Mean limb fat increased significantly from 4.5 kg to 5.8 kg, 144 weeks after switch (p < .0001). Conclusion: In virologically suppressed patients, switching d4T to TDF as part of a once-daily regimen with 3TC and EFV resulted in maintenance of virologic suppression and continued CD4 cell increases through 144 weeks, with significant improvements in metabolic parameters.

Original languageEnglish (US)
Pages (from-to)381-390
Number of pages10
JournalHIV Clinical Trials
Volume8
Issue number6
DOIs
StatePublished - Nov 2007

Keywords

  • Antiretroviral therapy
  • Lamivudine
  • Stavudine
  • Switch
  • Tenofovir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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