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.
Effectiveness of switching to darunavir/cobicistat in virologically-suppressed HIV-positive patients receiving ritonavir-boosted protease inhibitor-based regimen : the "STORE" Study / A. Gori, A. Antinori, A. Vergori, M.V. Cossu, B. Menzaghi, G. Sterrantino, S. Rusconi, A. Cattelan, F. Castelli, N. Gianotti, G. Orofino, D. Ripamonti, S. Savinelli, E. Manzillo, T.A. Santantonio, B.M. Celesia, R. Cauda, R. Maserati, A. Dʼarminio Monforte, C. Stingone, S. Bonora, A. Uglietti, R. Termini, F. Rucci, D. Mancusi. - In: JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES. - ISSN 1525-4135. - (2020 Feb 24). [Epub ahead of print] [10.1097/QAI.0000000000002331]
Effectiveness of switching to darunavir/cobicistat in virologically-suppressed HIV-positive patients receiving ritonavir-boosted protease inhibitor-based regimen : the "STORE" Study
A. GoriPrimo
;S. Rusconi;A. Dʼarminio Monforte;F. Rucci;
2020
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.File | Dimensione | Formato | |
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