Effectiveness of switching to darunavir/cobicistat in virologically-suppressed HIV-positive patients receiving ritonavir-boosted protease inhibitor-based regimen: the "STORE" Study

Roberto Cauda, Andrea Gori, Andrea Antinori, Alessandra Vergori, Maria Vittoria Cossu, Barbara Menzaghi, Gaetana Sterrantino, Stefano Rusconi, Annamaria Cattelan, Francesco Castelli, Nicola Gianotti, Giancarlo Orofino, Diego Ripamonti, Stefano Savinelli, Elio Manzillo, Teresa Antonia Santantonio, Benedetto Maurizio Celesia, Renato Maserati, Antonella Dʼarminio Monforte, Christof StingoneStefano Bonora, Alessia Uglietti, Roberta Termini, Francesco Rucci, Daniela Mancusi

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

OBJECTIVE: This study investigates the effectiveness and tolerability of switching to darunavir/cobicistat (DRV/c)-based antiretroviral regimen (ART) from a ritonavir-boosted protease inhibitor (PI/r)-based regimen in virologically suppressed human immunodeficiency virus (HIV)-positive patients. DRV trough values were also investigated. SETTING: Prospective, multicenter, single-country, non-interventional, cohort study. METHODS: This study included patients on a PI/r-based ART for at least twelve months having plasma HIV-1 RNA <50 copies/mL for at least six months. Primary endpoint: HIV-1 RNA <50 copies/mL at 48 ± 6 weeks from baseline. A secondary analysis was performed using the time to loss of virological response (TLOVR) algorithm. Biochemical parameters including DRV trough samples were collected as per clinical practice and measured using high-performance liquid chromatography. RESULTS: Of 336 patients enrolled, 282 completed the study: 70.8% had plasma HIV-1 RNA <50 copies/mL at 48 weeks; using the TLOVR algorithm, 82.7% maintained virological suppression. Virological failure (VF) was observed in 6 patients (1.8%). Adverse event (AE)-related discontinuations were 4.5%. After 48 weeks, we found a significant improvement in both triglycerides (median, 130.0 mg/dL to 113.5 mg/dL, p=0.0254) and HDL cholesterol (48 to 49 mg/dL, p<0.0001) but no change in other biomarkers. DRV trough concentrations in 56 subjects showed a median value of 2862.5 (1469.5-4439.0) ng/mL, higher in females than in males (4221 ng/mL vs. 2634 ng/mL, p=0.046). CONCLUSIONS: In stable HIV-1 positive virologically suppressed patients, the switch to DRV/c-based ART was beneficial in terms of low rates of VF and AEs due to its high tolerability and improvement in triglycerides.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaJournal of Acquired Immune Deficiency Syndromes
Volume2020
DOI
Stato di pubblicazionePubblicato - 2020

Keywords

  • haart
  • therapy

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