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- Open Access
The 10 year safety and efficacy of tenofovir disoproxil fumarate (TDF)-containing once-daily highly active antiretroviral therapy (HAART)
© Madruga et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Study 903 was a Phase III randomized double-blind (DB) 3 year study comparing TDF to stavudine (d4T) each in combination with lamivudine (3TC) and efavirenz (EFV) in HIV-1 infected antiretroviral naïve patients. TDF was associated with durable efficacy and safety (better lipid profile, and less lipodystrophy and peripheral neuropathy). A subset of these patients now provides 10 years of longitudinal efficacy and safety data of TDF-containing once-daily HAART.
Subjects in Argentina, Brazil, and the Dominican Republic who completed the 3 year DB period of study were eligible to roll-over into an open-label (OL) study (Study 903E) of the once-daily HAART regimen, TDF+3TC+EFV. At DB baseline 86 subjects were randomized to TDF (62% male, 70% white, mean age 33 yrs, mean HIV RNA=4.9 log10 c/mL, and mean CD4 count=299 cells/mm3). At OL baseline, 85 subjects (60% male, 64% white, mean age 37 yrs, median CD4=621 cells/mm3) switched from d4T to TDF. The results reflect only the period of TDF exposure.
Weeks on HAART/TDF
HIV RNA < 50 (copies/mL) at Week 480 (ITT, M=F)
HIV RNA < 50 (copies/mL) at Week 480 (ITT, M=E)
Change in Mean (SD) CD4, cells/mm3
Drug-related Adverse Events (Grades 1-4)
Change in Mean (SD) Creatinine Clearance, mL/minβ
Median Limb Fat at Year 10, kg
Percent Change in Mean (SD) Spine BMDχ
Percent Change in Mean (SD) Hip BMD
Discontinuations during open-label extension
Suboptimal virologic response
LTFUε, Nonadherent, Pregnancy, Consent Withdrawn, Death
Antiretroviral-naïve subjects who received TDF-containing once-daily HAART for up to 10 years demonstrated sustained virologic and immunologic benefit, improved limb fat, stable renal function, and their BMD remained stable after a clinically insignificant decrease that occurred during the first year of TDF therapy.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.