No slide title

Similar 96-week Renal Safety Profile of
Tenofovir Disoproxil Fumarate (TDF) versus
Stavudine (d4T) when used in Combination
with Lamivudine (3TC) and Efavirenz (EFV) in
Antiretroviral Naïve Patients
JE Gallant1, AL Pozniak2, S Staszewski3, B Lu4, J Sayre4 and
A Cheng4 for the Study 903 Team
1Johns Hopkins Univ School of Medicine, Baltimore, MD, USA; 2 Chelsea and Westminster
Hosp, London, UK; 3University Hospital, J.W. Goethe-Universität, Frankfurt, Germany;
4Gilead Sciences, Foster City, CA, USA.
43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
September 14-17, 2003
Chicago, Illinois
Poster No. H- 840
Background
Study 903 is an ongoing 144 week, randomized,double-blind, international multicenter trial whichcompares TDF and d4T when used in combinationwith EFV and 3TC in antiretroviral treatment naïvepatients.
Case reports of renal dysfunction have recentlybeen published1-6 Main Inclusion Criteria
• HIV-1 infected patients naïve to antiretroviral treatment• 18 - 65 years of age• Plasma HIV RNA > 5,000 copies/mL• No significant laboratory or clinical abnormalities• No CD4+ cell count criteria• Serum Creatinine < 1.5 mg/dL• Serum Phosphorus ≥ 2.2 mg/dL• Calculated Creatinine Clearance ≥ 60 mL/min Study Design: Randomization
ART-naive
d4T placebo BID
patients
Stratification by:
• plasma HIV RNA >/< 100,000 c/ml
• CD4 count >/< 200 cells/mm³
randomized
TDF placebo QD
Baseline Characteristics
TDF + 3TC + EFV
d4T + 3TC + EFV
Serum Creatinine
Maximum Toxicity Grade
TDF + 3TC + EFV
d4T + 3TC + EFV
0-96 Weeks in mg/dL
Consecutive Visits with Graded Creatinine
TDF+3TC+EFV
d4T+3TC+EFV
Pat
of
er
b
m
Consecutive Visits
Serum Phosphorus
Maximum Toxicity Grade
TDF + 3TC + EFV
d4T + 3TC + EFV
0-96 Weeks in mg/dL
Consecutive Visits with Graded Serum
Phosphorus
TDF+3TC+EFV
d4T+3TC+EFV
tien
a
f P 10
Consecutive Visits
Proteinuria
Maximum Toxicity Grade
TDF + 3TC + EFV
d4T + 3TC + EFV
0-96 Weeks in mg/dL
Glucosuria
Maximum Toxicity Grade
TDF + 3TC + EFV
d4T + 3TC + EFV
0-96 Weeks in mg/dL
Mean Increase from Baseline in Calculated
Creatinine Clearance (Calc Cr Cl)
TDF + 3TC + EFV
d4T + 3TC + EFV
Summary of Results: Parameters through
96 weeks
Parameters through 96 weeks
TDF+3TC+EFV
d4T+3TC+EFV
Mean Change from Baseline inCalc Cr Cl* (mL/min) Conclusions
• The renal safety profile was similar between the
patients receiving tenofovir DF or stavudine plus
lamivudine and efavirenz through 96 weeks
• No patients discontinued study due to tenofovir
DF-related renal abnormalities
• No patient developed Fanconi’s Syndrome
through 96 weeks
References
1Blick G, et al. 10th CROI, Boston, MA, February 10-14, 2003. Poster 718 2Reynes J, et al. 10th CROI, Boston, MA, February 10-14, 2003. Poster 717 5Murphy MD, et al. CID 2003; 36:1082-1085 6Shere-Wolfe KD, et al. CID 2002; 35:1137

Source: http://www.thebody.org/confs/icaac2003/pdfs/H-840_slides.pdf