Backbone switch to abacavir/lamivudine fixed-dose combination: implications for antiretroviral therapy optimization.
Current guidelines recommend treatment optimization in virologically suppressed patients through switching/ simplification strategies to minimize long-term toxicities and improve adherence. The assessment of inflammation/ coagulation profiles may support therapeutic decisions. We undertook a prospective, non-randomized study to evaluate the efficacy and safety of switching to ABC/3TC from ZDV/3TC or TDF/FTC backbones, in 40 HIV-1 infected patients with HIV-RNA levels <37 copies/mL (>24 months). Main endpoints were viral load levels, CD4+ T cells and toxicities after 48 weeks. Serum inflammation/coagulation markers (ESR, CRP, D-dimer and fibrinogen) and pro-inflammatory cytokines (IL-6, TNF-α, adiponectin, resistin) were evaluated. Baseline characteristics were similar in the two arms, with significantly lower values of e-GFR in patients on TDF/FTC. Markers of inflammation/ coagulation and cytokine profile were also similar, except for higher values of resistin in patients on TDF/ FTC. During follow up, CD4+ T cells increased and viral load remained undetectable in both groups. Patient from ZDV/3TC had significantly greater changes in total cholesterol and serum creatinine. Markers of inflammation/ coagulation remained unchanged. Adiponectin significantly increased in patients from ZDV/3TC. Switching to ABC/3TC was effective and safe. Inflammatory markers remained low in both groups. Some changes in metabolic, kidney and cytokine profiles were apparently specific for baseline cART treatment.
Department of Clinical Medicine, Sapienza, University of Rome, Rome, Italy.
Alessandra
A
Fantauzzi
Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità (ISS), Rome, Italy.
Marco
M
Floridia
Department of Molecular Medicine, Sapienza, University of Rome, Rome, Italy.
Francesca
F
Falasca
Department of Experimental Medicine, Sapienza, University of Rome, Rome, Italy.
Pierpaolo
P
Spanedda
Department of Molecular Medicine, Sapienza, University of Rome, Rome, Italy.
Ombretta
O
Turriziani
Department of Public Health and Infectious Diseases, Sapienza, University of Rome, Rome, Italy.
Vincenzo
V
Vullo
Department of Clinical Medicine, Sapienza, University of Rome, Rome, Italy.
Ivano
I
Mezzaroma
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D016207:Cytokines / Q000276:immunology; D015224:Dideoxynucleosides / Q000008:administration & dosage*; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D000099227:Abacavir
D019380:Anti-HIV Agents; D016207:Cytokines; D015224:Dideoxynucleosides; D004338:Drug Combinations; D019259:Lamivudine; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir
Antiretroviral therapy; Backbone regimen; Inflammatory cytokines; Switch strategies