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Multicenter Study
. 2020 Jul 1;84(3):290-294.
doi: 10.1097/QAI.0000000000002331.

Effectiveness of Switching to Darunavir/Cobicistat in Virologically Suppressed HIV-Positive Patients Receiving Ritonavir-Boosted Protease Inhibitor-Based Regimen: The "STORE" Study

Andrea Gori  1   2 , Andrea Antinori  3 , Alessandra Vergori  3 , Maria Vittoria Cossu  4 , Barbara Menzaghi  5 , Gaetana Sterrantino  6 , Stefano Rusconi  7 , Anna Maria Cattelan  8 , Francesco Castelli  9 , Nicola Gianotti  10 , Giancarlo Orofino  11 , Diego Ripamonti  12 , Stefano Savinelli  13 , Elio Manzillo  14 , Teresa Antonia Santantonio  15 , Benedetto Maurizio Celesia  16 , Roberto Cauda  17   18 , Renato Maserati  19 , Antonella d'Arminio Monforte  20 , Christof Stingone  21 , Stefano Bonora  22 , Alessia Uglietti  23 , Roberta Termini  23 , Francesco Rucci  24 , Daniela Mancusi  23
Affiliations
Multicenter Study

Effectiveness of Switching to Darunavir/Cobicistat in Virologically Suppressed HIV-Positive Patients Receiving Ritonavir-Boosted Protease Inhibitor-Based Regimen: The "STORE" Study

Andrea Gori et al. J Acquir Immune Defic Syndr. .

Abstract

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.

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Conflict of interest statement

A.G. received a grant from Janssen-Cilag, ViiV Healthcare, MSD, BMS, Abbvie, Gilead Sciences, Novartis, Pfizer, Astellas, AstraZeneca and Angelini; he received consulting fees or honorarium from Janssen-Cilag, ViiV Healthcare, MSD, BMS, Abbvie, Gilead Sciences, Novartis, Pfizer, Astellas, AstraZeneca and Angelini. A.A. received a grant from Gilead Sciences, ViiV Healthcare and Janssen-Cilag; he received consulting fees or honorarium from ViiV Healthcare, Janssen-Cilag and Merck. S.R. received grants research support, compensation for CME activities or advisory boards form ViiV Healthcare, MSD, Gilead Sciences and Janssen. S.B. has received grants, travel grants and consultancy fees from Abbvie, BMS, MSD, Gilead, Janssen-Cilag, and ViiV. A.U., R.T., and D.M. are Janssen employees. The remaining authors have no conflicts of interest to disclose.

Figures

FIGURE 1.
FIGURE 1.
Kaplan–Meier curves depicting the probability of remaining in the study according to different causes of discontinuation.
See this image and copyright information in PMC

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