TY - JOUR
T1 - The safety and efficacy of switching stavudine to tenofovir DF in combination with lamivudine and efavirenz in HIV-1-infected patients
T2 - Three-year follow-up after switching therapy
AU - Madruga, José Valdez R.
AU - Cassetti, Isabel
AU - Suleiman, Jamal Muhamad A.H.
AU - Etzel, Arnaldo
AU - Zhong, Lijie
AU - Holmes, Charles B.
AU - Cheng, Andrew K.
AU - Enejosa, Jeffrey
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/11
Y1 - 2007/11
N2 - 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.
AB - 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.
KW - Antiretroviral therapy
KW - Lamivudine
KW - Stavudine
KW - Switch
KW - Tenofovir
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U2 - 10.1310/hct0806-381
DO - 10.1310/hct0806-381
M3 - Article
C2 - 18042503
AN - SCOPUS:37349062681
VL - 8
SP - 381
EP - 390
JO - HIV Research and Clinical Practice
JF - HIV Research and Clinical Practice
SN - 2578-7489
IS - 6
ER -