Effectiveness of Switching to Darunavir/Cobicistat in Virologically Suppressed HIV-Positive Patients Receiving Ritonavir-Boosted Protease Inhibitor-Based Regimen : The "STORE" Study
OBJECTIVE: This study investigates the effectiveness and tolerability of switching to a darunavir/cobicistat (DRV/c)-based antiretroviral regimen from a ritonavir-boosted protease inhibitor (PI/r)-based regimen in virologically suppressed HIV-positive patients. DRV trough values were also investigated.
SETTING: Prospective, multicenter, single-country, noninterventional cohort study.
METHODS: This study included patients on a PI/r-based ART for at least 12 months having plasma HIV-1 RNA <50 copies/mL since at least 6 months. The primary endpoint, defined as HIV-1 RNA <50 copies/mL, was measured at 48 ± 6 weeks from baseline. A secondary analysis was performed using the time to loss of virological response 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 time to loss of virological response algorithm, 82.7% maintained virological suppression. Virological failure was observed in 6 patients (1.8%). Adverse event-related discontinuations were 4.5%. After 48 weeks, we found a significant improvement in both triglycerides (median, 130 to 113.5 mg/dL, P = 0.0254) and high-density lipoprotein 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) ng/mL, higher in women than in men (4221 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 virological failure and adverse events due to its high tolerability and improvement in triglycerides.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:84 |
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| Enthalten in: |
Journal of acquired immune deficiency syndromes (1999) - 84(2020), 3 vom: 01. Juli, Seite 290-294 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gori, Andrea [VerfasserIn] |
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| Links: |
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| Themen: |
Anti-HIV Agents |
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| Anmerkungen: |
Date Completed 04.01.2021 Date Revised 05.10.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1097/QAI.0000000000002331 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM306942321 |
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| 041 | |a eng | ||
| 100 | 1 | |a Gori, Andrea |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness of Switching to Darunavir/Cobicistat in Virologically Suppressed HIV-Positive Patients Receiving Ritonavir-Boosted Protease Inhibitor-Based Regimen |b The "STORE" Study |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 04.01.2021 | ||
| 500 | |a Date Revised 05.10.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: This study investigates the effectiveness and tolerability of switching to a darunavir/cobicistat (DRV/c)-based antiretroviral regimen from a ritonavir-boosted protease inhibitor (PI/r)-based regimen in virologically suppressed HIV-positive patients. DRV trough values were also investigated | ||
| 520 | |a SETTING: Prospective, multicenter, single-country, noninterventional cohort study | ||
| 520 | |a METHODS: This study included patients on a PI/r-based ART for at least 12 months having plasma HIV-1 RNA <50 copies/mL since at least 6 months. The primary endpoint, defined as HIV-1 RNA <50 copies/mL, was measured at 48 ± 6 weeks from baseline. A secondary analysis was performed using the time to loss of virological response algorithm. Biochemical parameters, including DRV trough samples, were collected as per clinical practice and measured using high-performance liquid chromatography | ||
| 520 | |a RESULTS: Of 336 patients enrolled, 282 completed the study: 70.8% had plasma HIV-1 RNA <50 copies/mL at 48 weeks; using the time to loss of virological response algorithm, 82.7% maintained virological suppression. Virological failure was observed in 6 patients (1.8%). Adverse event-related discontinuations were 4.5%. After 48 weeks, we found a significant improvement in both triglycerides (median, 130 to 113.5 mg/dL, P = 0.0254) and high-density lipoprotein 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) ng/mL, higher in women than in men (4221 vs. 2634 ng/mL, P = 0.046) | ||
| 520 | |a CONCLUSIONS: In stable HIV-1 positive virologically suppressed patients, the switch to DRV/c-based ART was beneficial in terms of low rates of virological failure and adverse events due to its high tolerability and improvement in triglycerides | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 7 | |a HIV Protease Inhibitors |2 NLM | |
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| 650 | 7 | |a Ritonavir |2 NLM | |
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| 650 | 7 | |a Darunavir |2 NLM | |
| 650 | 7 | |a YO603Y8113 |2 NLM | |
| 700 | 1 | |a Antinori, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Vergori, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Cossu, Maria Vittoria |e verfasserin |4 aut | |
| 700 | 1 | |a Menzaghi, Barbara |e verfasserin |4 aut | |
| 700 | 1 | |a Sterrantino, Gaetana |e verfasserin |4 aut | |
| 700 | 1 | |a Rusconi, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Cattelan, Anna Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Castelli, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Gianotti, Nicola |e verfasserin |4 aut | |
| 700 | 1 | |a Orofino, Giancarlo |e verfasserin |4 aut | |
| 700 | 1 | |a Ripamonti, Diego |e verfasserin |4 aut | |
| 700 | 1 | |a Savinelli, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Manzillo, Elio |e verfasserin |4 aut | |
| 700 | 1 | |a Santantonio, Teresa Antonia |e verfasserin |4 aut | |
| 700 | 1 | |a Celesia, Benedetto Maurizio |e verfasserin |4 aut | |
| 700 | 1 | |a Cauda, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Maserati, Renato |e verfasserin |4 aut | |
| 700 | 1 | |a d'Arminio Monforte, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a Stingone, Christof |e verfasserin |4 aut | |
| 700 | 1 | |a Bonora, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Uglietti, Alessia |e verfasserin |4 aut | |
| 700 | 1 | |a Termini, Roberta |e verfasserin |4 aut | |
| 700 | 1 | |a Rucci, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Mancusi, Daniela |e verfasserin |4 aut | |
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