Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens : week 96 results of STRATEGY-PI
BACKGROUND: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.
OBJECTIVE: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens.
METHODS: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Participants were randomized to switch to E/C/F/TDF (switch group) or to continue their PI + RTV + TVD regimens (no-switch group). Eligibility criteria included no resistance to F/TDF or history of virologic failure, and estimated creatinine clearance ≥70 mL/min.
RESULTS: At week 96, 87% (252/290) of switch and 70% (97/139) of no-switch participants maintained HIV-1 RNA <50 copies/mL (difference: 17%, 95% CI 8.7-26.0%, p < 0.001). Superiority of the switch to E/C/F/TDF vs. no-switch was due to a smaller proportion of both virologic failures (switch, 1% [3/290]; no-switch, 6% [8/139]) and discontinuations for non-virologic reasons (switch, 11% [31/290]; no-switch, 24% [33/139]). No treatment-emergent resistance was observed in switch subjects with virologic failure. Discontinuation rates from adverse events were 3% in both groups (9/293, switch; 4/140, no-switch). Switching from PI + RTV + TVD to E/C/F/TDF was associated with significant improvements in patient-reported outcomes related to gastrointestinal symptoms (nausea and bloating).
CONCLUSION: E/C/F/TDF is a safe, effective long-term alternative to multi-tablet PI + RTV + TVD-based regimens in virologically suppressed, HIV-1-infected adults, and improves patient-reported gastrointestinal symptoms.
| Errataetall: |
ErratumIn: HIV Clin Trials. 2018 Aug;19(4):163. - PMID 29770750 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2017 |
|---|---|
| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
|---|---|
| Enthalten in: |
HIV clinical trials - 18(2017), 3 vom: 24. Mai, Seite 118-125 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Arribas, Jose R [VerfasserIn] |
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| Links: |
|---|
| Anmerkungen: |
Date Completed 20.02.2018 Date Revised 03.03.2018 published: Print-Electronic ClinicalTrials.gov: NCT01475838 ErratumIn: HIV Clin Trials. 2018 Aug;19(4):163. - PMID 29770750 Citation Status MEDLINE |
|---|
| doi: |
10.1080/15284336.2017.1330440 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM272364908 |
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| 100 | 1 | |a Arribas, Jose R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens |b week 96 results of STRATEGY-PI |
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| 500 | |a Date Revised 03.03.2018 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01475838 | ||
| 500 | |a ErratumIn: HIV Clin Trials. 2018 Aug;19(4):163. - PMID 29770750 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills | ||
| 520 | |a OBJECTIVE: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens | ||
| 520 | |a METHODS: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Participants were randomized to switch to E/C/F/TDF (switch group) or to continue their PI + RTV + TVD regimens (no-switch group). Eligibility criteria included no resistance to F/TDF or history of virologic failure, and estimated creatinine clearance ≥70 mL/min | ||
| 520 | |a RESULTS: At week 96, 87% (252/290) of switch and 70% (97/139) of no-switch participants maintained HIV-1 RNA <50 copies/mL (difference: 17%, 95% CI 8.7-26.0%, p < 0.001). Superiority of the switch to E/C/F/TDF vs. no-switch was due to a smaller proportion of both virologic failures (switch, 1% [3/290]; no-switch, 6% [8/139]) and discontinuations for non-virologic reasons (switch, 11% [31/290]; no-switch, 24% [33/139]). No treatment-emergent resistance was observed in switch subjects with virologic failure. Discontinuation rates from adverse events were 3% in both groups (9/293, switch; 4/140, no-switch). Switching from PI + RTV + TVD to E/C/F/TDF was associated with significant improvements in patient-reported outcomes related to gastrointestinal symptoms (nausea and bloating) | ||
| 520 | |a CONCLUSION: E/C/F/TDF is a safe, effective long-term alternative to multi-tablet PI + RTV + TVD-based regimens in virologically suppressed, HIV-1-infected adults, and improves patient-reported gastrointestinal symptoms | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
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| 700 | 1 | |a DeJesus, Edwin |e verfasserin |4 aut | |
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| 700 | 1 | |a Zurawski, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Doroana, Manuela |e verfasserin |4 aut | |
| 700 | 1 | |a Towner, William |e verfasserin |4 aut | |
| 700 | 1 | |a Lazzarin, Adriano |e verfasserin |4 aut | |
| 700 | 1 | |a Nelson, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a McColl, Damian |e verfasserin |4 aut | |
| 700 | 1 | |a Andreatta, Kristen |e verfasserin |4 aut | |
| 700 | 1 | |a Swamy, Raji |e verfasserin |4 aut | |
| 700 | 1 | |a Szwarcberg, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Nguyen, Thai |e verfasserin |4 aut | |
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