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Clinical Trial
. 2017 May;18(3):118-125.
doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30.

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

Jose R Arribas  1 , Edwin DeJesus  2 , Jan van Lunzen  3 , Christine Zurawski  4 , Manuela Doroana  5 , William Towner  6 , Adriano Lazzarin  7 , Mark Nelson  8 , Damian McColl  9 , Kristen Andreatta  9 , Raji Swamy  9 , Javier Szwarcberg  9 , Thai Nguyen  9
Affiliations
Clinical Trial

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

Jose R Arribas et al. HIV Clin Trials. 2017 May.

Erratum in

  • Addendum.
    [No authors listed] [No authors listed] HIV Clin Trials. 2018 Aug;19(4):163. doi: 10.1080/15284336.2018.1436794. Epub 2018 May 17. HIV Clin Trials. 2018. PMID: 29770750 No abstract available.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01475838.

Keywords: HIV; INSTI; Patient-reported outcomes; Protease inhibitor; Randomized trial; Simplification; Single-tablet regimen; Superiority; Switch.

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