TY - JOUR T1 - A 72-week randomized study of the safety and efficacy of a stavudine to zidovudine switch at 24 weeks compared to zidovudine or tenofovir disoproxil fumarate when given with lamivudine and nevirapine. AU - Phanuphak,Nittaya, AU - Ananworanich,Jintanat, AU - Teeratakulpisarn,Nipat, AU - Jadwattanakul,Tanate, AU - Kerr,Stephen J, AU - Chomchey,Nitiya, AU - Hongchookiat,Piranun, AU - Mathajittiphun,Pornpen, AU - Pinyakorn,Suteeraporn, AU - Rungrojrat,Patcharawee, AU - Praihirunyakit,Pairoa, AU - Gerschenson,Mariana, AU - Phanuphak,Praphan, AU - Valcour,Victor, AU - Kim,Jerome H, AU - Shikuma,Cecilia, AU - ,, Y1 - 2012/12/07/ PY - 2012/04/26/accepted PY - 2012/12/11/entrez PY - 2012/12/12/pubmed PY - 2013/6/12/medline SP - 1521 EP - 31 JF - Antiviral therapy JO - Antivir Ther VL - 17 IS - 8 N2 - BACKGROUND: Due to superior long-term toxicity profiles, zidovudine (AZT) and tenofovir disoproxil fumarate (TDF) are preferred over stavudine (d4T) for first-line antiretroviral regimens. However, short-term d4T use could be beneficial in avoiding AZT-induced anaemia. METHODS: We randomized (1:1:1) 150 treatment-naive Thai HIV-infected adults with CD4(+) T-cell count <350 cells/mm(3) to arm 1 (24-week GPO-VIR S30(®) [d4T plus lamivudine (3TC) plus nevirapine (NVP)] followed by 48-week GPO-VIR Z250(®) [AZT plus 3TC plus NVP]), arm 2 (72-week GPO-VIR Z250(®)) or arm 3 (72-week TDF plus emtricitabine [FTC] plus NVP). Haemoglobin (Hb), dual energy x-ray absorptiometry, neuropathic signs, estimated glomerular filtration rate (eGFR), CD4(+) T-cell count, plasma HIV RNA and adherence were assessed. RESULTS: In an intention-to-treat analysis, mean Hb decreased from baseline to week 24 in arm 2 compared with arm 1 (-0.19 versus 0.68 g/dl; P=0.001) and arm 3 (0.48 g/dl; P=0.010). Neuropathic signs were more common in arm 2 compared with arm 3 (20.4 versus 4.2%; P=0.028) at week 24. There were no differences in changes in peripheral fat and eGFR from baseline to weeks 24 and 72 among arms. CD4(+) T-cell count increased more in arm 1 than arms 2 and 3 from baseline to week 24 (168 versus 117 and 118 cells/mm(3); P=0.01 and 0.02, respectively) but the increase from baseline to week 72 was similar among arms. CONCLUSIONS: A 24-week d4T lead-in therapy caused less anaemia and greater initial CD4(+) T-cell count increase than initiating treatment with AZT. This strategy could be considered in patients with baseline anaemia or low CD4(+) T-cell count. If confirmed in a larger study, this may guide global recommendations on antiretroviral initiation where AZT is more commonly used than TDF. SN - 2040-2058 UR - https://www.unboundmedicine.com/medline/citation/23220732/A_72_week_randomized_study_of_the_safety_and_efficacy_of_a_stavudine_to_zidovudine_switch_at_24_weeks_compared_to_zidovudine_or_tenofovir_disoproxil_fumarate_when_given_with_lamivudine_and_nevirapine_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23220732/ DB - PRIME DP - Unbound Medicine ER -