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.
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.


METHODS
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/mm3. 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).


CONCLUSIONS
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.
Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil.
José R Valdez
JR
Madruga
Isabel
I
Cassetti
Jamal Muhamad A H
JM
Suleiman
Arnaldo
A
Etzel
Lijie
L
Zhong
Charles B
CB
Holmes
Andrew K
AK
Cheng
Jeffrey
J
Enejosa
D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000273:Adipose Tissue; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D001118:Argentina; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D003521:Cyclopropanes; D004293:Dominican Republic; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos / Q000008:administration & dosage; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*; D000068698:Tenofovir; D014280:Triglycerides / Q000097:blood; D019562:Viral Load
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D063065:Organophosphonates; D010919:Placebos; D014280:Triglycerides; D019259:Lamivudine; D002784:Cholesterol; D000068698:Tenofovir; D018119:Stavudine; D000225:Adenine; C098320:efavirenz