Durability and tolerability of first-line regimens including two nucleoside reverse transcriptase inhibitors and raltegravir or ritonavir boosted-atazanavir or -darunavir : data from the ICONA Cohort<sup/>
Background We aimed to mimic the ACTG 5257 trial, comparing raltegravir (RAL), ritonavir-boosted atazavavir (ATV/r) and ritonavir-boosted darunavir (DRV/r) in the observational setting. Methods All the ICONA patients starting a first cART with 2NRTI + ATV/r, DRV/r or RAL were included. Primary end-point was treatment failure, i.e. virological failure (confirmed HIV-RNA > 200copies/mL > 6 months therapy) or discontinuation for any reason of the third drug. Secondary end-points: virological failure50 (50 copies/mL threshold), and discontinuation of the third drug due to intolerance/toxicity. Cox regression analyses were run to compare the risk of outcomes between the three regimens. Results 2249 patients were included, 985 (44%) initiated ATV/r, 1023 (45%) DRV/r and 241 (11%) RAL; median follow-up of 3.6 years (IQR: 2.3-5.2). After controlling for baseline confounding factors, patients given ATV/r showed a 26% higher risk of treatment failure (TF) vs. DRV/r (AHR 1.26, 95%CI 1.11-1.43); patients on RAL had a lower risk of TF vs. ATV/r (AHR 0.81, 95%CI 0.66-0.99). The probability of virological failure50 was significantly lower for people initiating RAL vs. DRV/r (AHR 0.46, 95%CI 0.24-0.87) or ATV/r (AHR 0.52, 95%CI 0.27-0.99). In addition, RAL was associated to a lower risk of discontinuation for toxicity vs. both DRV/r (AHR: 0.37, 95%CI: 0.19-0.72) and ATV/r (AHR: 0.18, 95%CI: 0.09-0.34). ATV/r was associated with a higher risk of discontinuing due to toxicity (AHR 2.09, 95%CI 1.63-2.67) vs. DRV/r. Conclusions In our observational study, we confirmed higher risk of treatment failure and lower tolerability of ATV/r-based regimens as compared to those including DRV/r or RAL.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
HIV clinical trials - 19(2018), 2 vom: 01. Apr., Seite 52-60 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
d'Arminio Monforte, Antonella [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 18.03.2019 Date Revised 18.03.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/15284336.2018.1440691 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM281509646 |
|---|
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| 024 | 7 | |a 10.1080/15284336.2018.1440691 |2 doi | |
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| 041 | |a eng | ||
| 100 | 1 | |a d'Arminio Monforte, Antonella |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Durability and tolerability of first-line regimens including two nucleoside reverse transcriptase inhibitors and raltegravir or ritonavir boosted-atazanavir or -darunavir |b data from the ICONA Cohort<sup/> |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
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| 500 | |a Date Completed 18.03.2019 | ||
| 500 | |a Date Revised 18.03.2019 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Background We aimed to mimic the ACTG 5257 trial, comparing raltegravir (RAL), ritonavir-boosted atazavavir (ATV/r) and ritonavir-boosted darunavir (DRV/r) in the observational setting. Methods All the ICONA patients starting a first cART with 2NRTI + ATV/r, DRV/r or RAL were included. Primary end-point was treatment failure, i.e. virological failure (confirmed HIV-RNA > 200copies/mL > 6 months therapy) or discontinuation for any reason of the third drug. Secondary end-points: virological failure50 (50 copies/mL threshold), and discontinuation of the third drug due to intolerance/toxicity. Cox regression analyses were run to compare the risk of outcomes between the three regimens. Results 2249 patients were included, 985 (44%) initiated ATV/r, 1023 (45%) DRV/r and 241 (11%) RAL; median follow-up of 3.6 years (IQR: 2.3-5.2). After controlling for baseline confounding factors, patients given ATV/r showed a 26% higher risk of treatment failure (TF) vs. DRV/r (AHR 1.26, 95%CI 1.11-1.43); patients on RAL had a lower risk of TF vs. ATV/r (AHR 0.81, 95%CI 0.66-0.99). The probability of virological failure50 was significantly lower for people initiating RAL vs. DRV/r (AHR 0.46, 95%CI 0.24-0.87) or ATV/r (AHR 0.52, 95%CI 0.27-0.99). In addition, RAL was associated to a lower risk of discontinuation for toxicity vs. both DRV/r (AHR: 0.37, 95%CI: 0.19-0.72) and ATV/r (AHR: 0.18, 95%CI: 0.09-0.34). ATV/r was associated with a higher risk of discontinuing due to toxicity (AHR 2.09, 95%CI 1.63-2.67) vs. DRV/r. Conclusions In our observational study, we confirmed higher risk of treatment failure and lower tolerability of ATV/r-based regimens as compared to those including DRV/r or RAL | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Cohort study | |
| 650 | 4 | |a antiretroviral regimens | |
| 650 | 4 | |a boosted-atazanavir | |
| 650 | 4 | |a boosted-darunavir | |
| 650 | 4 | |a raltegravir | |
| 650 | 4 | |a therapy discontinuation | |
| 650 | 7 | |a HIV Integrase Inhibitors |2 NLM | |
| 650 | 7 | |a HIV Protease Inhibitors |2 NLM | |
| 650 | 7 | |a Reverse Transcriptase Inhibitors |2 NLM | |
| 700 | 1 | |a Lorenzini, Patrizia |e verfasserin |4 aut | |
| 700 | 1 | |a Cozzi-Lepri, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Mussini, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Castagna, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a Baldelli, Franco |e verfasserin |4 aut | |
| 700 | 1 | |a Puoti, Massimo |e verfasserin |4 aut | |
| 700 | 1 | |a Vichi, Francesca |e verfasserin |4 aut | |
| 700 | 1 | |a Maddaloni, Adelaide |e verfasserin |4 aut | |
| 700 | 1 | |a Lo Caputo, Sergio |e verfasserin |4 aut | |
| 700 | 1 | |a Gianotti, Nicola |e verfasserin |4 aut | |
| 700 | 1 | |a Antinori, Andrea |e verfasserin |4 aut | |
| 700 | 0 | |a the Icona Foundation Study Group |e verfasserin |4 aut | |
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