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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.
Antivir Ther. 2012; 17(8):1521-31.AT

Abstract

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.

Authors+Show Affiliations

South East Asia Research Collaboration with Hawaii, Bangkok, Thailand. Nittaya.P@SearchThailand.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23220732

Citation

Phanuphak, Nittaya, et al. "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." Antiviral Therapy, vol. 17, no. 8, 2012, pp. 1521-31.
Phanuphak N, Ananworanich J, Teeratakulpisarn N, et al. 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. Antivir Ther. 2012;17(8):1521-31.
Phanuphak, N., Ananworanich, J., Teeratakulpisarn, N., Jadwattanakul, T., Kerr, S. J., Chomchey, N., Hongchookiat, P., Mathajittiphun, P., Pinyakorn, S., Rungrojrat, P., Praihirunyakit, P., Gerschenson, M., Phanuphak, P., Valcour, V., Kim, J. H., & Shikuma, C. (2012). 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. Antiviral Therapy, 17(8), 1521-31. https://doi.org/10.3851/IMP2497
Phanuphak N, et al. 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. Antivir Ther. 2012;17(8):1521-31. PubMed PMID: 23220732.
* Article titles in AMA citation format should be in sentence-case
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 -