TY - JOUR
T1 - Effectiveness of switching to darunavir/cobicistat in virologically-suppressed HIV-positive patients receiving ritonavir-boosted protease inhibitor-based regimen: the "STORE" Study
AU - Gori, Andrea
AU - Antinori, Andrea
AU - Vergori, Alessandra
AU - Cossu, Maria Vittoria
AU - Menzaghi, Barbara
AU - Sterrantino, Gaetana
AU - Rusconi, Stefano
AU - Cattelan, Anna Maria
AU - Castelli, Francesco
AU - Gianotti, Nicola
AU - Orofino, Giancarlo
AU - Ripamonti, Diego
AU - Savinelli, Stefano
AU - Manzillo, Elio
AU - Santantonio, Teresa Antonia
AU - Celesia, Benedetto Maurizio
AU - Cauda, Roberto
AU - Maserati, Renato
AU - DʼArminio Monforte, Antonella
AU - Stingone, Christof
AU - Bonora, Stefano
AU - Uglietti, Alessia
AU - Termini, Roberta
AU - Rucci, Francesco
AU - Mancusi, Daniela
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - haart
KW - therapy
KW - haart
KW - therapy
UR - http://hdl.handle.net/10807/148131
U2 - 10.1097/QAI.0000000000002331
DO - 10.1097/QAI.0000000000002331
M3 - Article
SN - 1525-4135
VL - 2020
SP - N/A-N/A
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
ER -