Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

Pozniak, Anton; Flamm, Jason; Antinori, Andrea; Bloch, Mark; Ward, Douglas J.; Berenguer, Juan; Côté, Pierre; Andreatta, Kristen; Garner, William; Szwarcberg, Javier; Nguyen-Cleary, Thai; McColl, Damian J.; Piontkowsky, David

doi:10.1080/15284336.2017.1338844

Cited by 17 publications

(26 citation statements)

References 17 publications

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“…Favorable effects on lipids have also been reported in switches to EVG. In the STRATEGY-PI clinical trial patients switching from lopinavir (but not from atazanavir) to TDF/FTC/cobicistat(C)/EVG obtained significant TC decline after 96 weeks [ 23 ] and the same was also seen in the SRTATEGY-NNRTI trial in patients switching from EFV to TDF/FTC/C/EVG, although without significant changes in TC/HDL ratio [ 24 ]. It has been widely demonstrated that TG/HDL ratio correlates with insulin resistance [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA)

et al. 2018

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BackgroundDyslipidemia represents a significant non-infectious comorbidity among people living with HIV. The aim of this study is to evaluate the impact on lipid profile of switches from an efavirenz (EFV) or protease inhibitor/ritonavir (PI/r)-based regimen to a rilpivirine (RPV) or a once-daily integrase inhibitor-based regimen.MethodsWe analyzed data from SCOLTA prospective database. All patients with HIV-RNA < 50 copies/ml in therapy with two NRTI + EFV or PI/r were included if they switched from EFV to dolutegravir (group EFV-DTG), elvitegravir (EFV-EVG), or RPV (EFV-RPV) and from PI/r to DTG (PI/r-DTG), PI/r to EVG (PI/r-EVG), or PI/r to RPV (PI/r-RPV). Total cholesterol (TC), TC/HDL ratio, LDL-cholesterol (LDL) and triglycerides (TG) were compared at baseline, six months and one year. Comparisons among groups were performed by a general linear model.ResultsFour hundred and ninety patients were enrolled, 24.9% female, mean age 47.3 years (±10.1). According to ART switch, 11.4% were classified in group EFV-DTG, 3.9% in EFV-EVG, 23.9% in EFV-RPV, 17.6% in PI/r-DTG, 17.8% in PI/r-EVG, and 25.5% in PI/r-RPV. After adjusted analysis, TC significantly decreased in all groups but EFV-EVG, TC/HDL in all but EFV-DTG and EFV-EVG, while the reduction of TG was significant only in switches to RPV (EFV-RPV and PI/r-RPV). The one year decrease of TC, TC/HDL, LDL and TG was higher in patients with higher baseline levels of the same variable (p < .0001 for all).ConclusionsIn SCOLTA, all switches from PI/r regimens gave advantages on lipid profile, while stopping EFV had consistently favorable lipid effects only if replaced by RPV.

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Section: Discussionmentioning

confidence: 99%

Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA)

et al. 2018

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“…In clinical trials, treatment-related AE discontinuations were seen in 7 patients: 1 for generalized edema 22 ; 1 for allergic pruritis 22 ; 1 for worsening renal function 20 ; 1 for renal transplant 22 ; 1 for suicidal ideation, depression, and paranoia 20 ; and 2 for dysgeusia. 21…”

Section: Resultsmentioning

confidence: 99%

Optimizing Antiretroviral Therapy in Treatment-Experienced Patients Living with HIV: A Critical Review of Switch and Simplification Strategies. An Opinion of the HIV Practice and Research Network of the American College of Clinical Pharmacy

Chastain

Badowski

Huesgen

et al. 2019

J Int Assoc Provid AIDS Care

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Simplifying or switching antiretroviral therapy (ART) in treatment-experienced people living with HIV (PLWH) may improve adherence, tolerability, toxicities, and/or drug–drug interactions. The purpose of this review is to critically evaluate the literature for efficacy and safety associated with switching or simplifying ART in treatment-experienced PLWH. A systematic literature search using MEDLINE was performed from January 1, 2010 to April 30, 2018. References within articles of interest, the Department of Health and Human Services guidelines, and conference abstracts were also reviewed. Switch/simplification strategies were categorized as those supported by high-level clinical evidence and those with emerging data. Rates of virologic suppression were noninferior for several switch/simplification strategies when compared to baseline ART. Potential for reducing adverse events was also seen. Additional evidence for some strategies, including most 2-drug regimens, is needed before they can be recommended.

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“…Given the convenience of a single‐tablet regimen with proven efficacy from studies 102 and 103, STRATEGY‐PI and STRATEGY‐NNRTI assessed the efficacy of switching patients who were virologically suppressed on the respective PI‐ or NNRTI‐based regimen, respectively, to an EVG‐based regimen. Similar to 48‐week data, available 96‐week data from the STRATEGY‐PI study revealed statistical superiority in patients switching from their baseline PI‐based regimen .…”

Section: Methodsmentioning

confidence: 99%

“…In contrast to the STRATEGY‐PI study, the STRATEGY‐NNRTI study randomized patients (2:1) to switch to an EVG‐based regimen or continue their EFV‐based regimen . In the switch arm, 87% (251/290) of patients achieved HIV‐1 RNA levels below 50 copies/ml versus 80% (115/143) in patients continuing the EFV‐based regimen at week 96 (difference 6.1% [95% CI −1.3 to 14.2]).…”

Section: Methodsmentioning

confidence: 99%

Integrase Inhibitors: After 10 Years of Experience, Is the Best Yet to Come?

et al. 2019

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The era of the integrase strand transfer inhibitors (INSTIs) for the treatment of human immunodeficiency virus (HIV) infection began with raltegravir in 2007. Since that time, several other INSTIs have been introduced including elvitegravir, dolutegravir, and, most recently, bictegravir, that have shown great utility as part of antiretroviral regimens in both treatment-naive and treatment-experienced patients. At present, antiretroviral guidelines fully endorse the INSTI class as part of all first-line treatment regimens. After 10 years of experience with INSTIs, newer agents are on the horizon such as cabotegravir and MK-2048 for potential use as either HIV pre-exposure prophylaxis or maintenance therapy. This review provides a brief overview of the INSTI class including agents currently available and those still in development, reviews available data from both completed and ongoing clinical trials, and outlines simplification strategies using INSTIs. AUC = area under the curve; CYP = cytochrome P450; DHHS = U.S. Department of Health and Human Services; MATE1 = multidrug and toxin extrusion protein; OCT2 = organic cationic transporter 2; P-gp = P-glycoprotein; S cr = serum creatinine concentration; UGT = uridine diphosphate-glucuronosyltransferase. a Class drug-drug interactions: Integrase strand transfer inhibitor exposures are reduced when administered with polyvalent cation-containing supplements including acid-suppressive therapies and with potent CYP3A4/UGT1A1 inducers (e.g., carbamazepine, phenytoin, and rifamycins). b Stribild contains elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate; available only as a single-table formulation. c Genvoya contains elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; available only as a single-table formulation. d Biktarvy contains bictegravir, emtricitabine, and tenofovir alafenamide; available only as a single-table formulation. EXPERIENCE WITH INTEGRASE INHIBITORS Brooks et al

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Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

Abstract: E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen.

Cited by 17 publications

References 17 publications

Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA)

Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA)

Optimizing Antiretroviral Therapy in Treatment-Experienced Patients Living with HIV: A Critical Review of Switch and Simplification Strategies. An Opinion of the HIV Practice and Research Network of the American College of Clinical Pharmacy

Integrase Inhibitors: After 10 Years of Experience, Is the Best Yet to Come?

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