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
| Autor: | Kristen Andreatta, Javier Szwarcberg, Damian J McColl, Jan van Lunzen, William J. Towner, Raji Swamy, Adriano Lazzarin, Christine Zurawski, Thai Nguyen, Mark T. Nelson, Edwin DeJesus, Jose R. Arribas, Manuela Doroana |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Adolescent Drug-Related Side Effects and Adverse Reactions Anti-HIV Agents HIV Infections Pharmacology Emtricitabine Young Adult 03 medical and health sciences Antiretroviral Therapy Highly Active medicine Humans Pharmacology (medical) Protease inhibitor (pharmacology) Aged Aged 80 and over Elvitegravir/cobicistat/emtricitabine/tenofovir business.industry Elvitegravir Cobicistat Middle Aged 030112 virology Regimen Treatment Outcome Infectious Diseases Tolerability Female Ritonavir business Tablets medicine.drug |
| Zdroj: | HIV Clinical Trials. 18:118-125 |
| ISSN: | 1945-5771 1528-4336 |
| DOI: | 10.1080/15284336.2017.1330440 |
| Popis: | Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.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.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.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).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. |
| Databáze: | OpenAIRE |
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