Dataset Information

Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial.

ABSTRACT: A randomized controlled noninferiority trial was conducted in HIV-infected patients receiving tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) with virological suppression in a resource-limited setting. Switching to TDF/FTC/rilpivirine was noninferior to continuing TDF/FTC/EFV in terms of maintaining compete viral suppression at 24 weeks and provided better lipid profiles and fewer central nervous system adverse effects.

SUBMITTER: Wiriyatanakorn S

PROVIDER: S-EPMC6641787 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial.

Wiriyatanakorn Sirichai S Sungkanuparph Somnuek S

Open forum infectious diseases 20190626 7

A randomized controlled noninferiority trial was conducted in HIV-infected patients receiving tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) with virological suppression in a resource-limited setting. Switching to TDF/FTC/rilpivirine was noninferior to continuing TDF/FTC/EFV in terms of maintaining compete viral suppression at 24 weeks and provided better lipid profiles and fewer central nervous system adverse effects. ...[more]

PMID: 31341931

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Project description:As a simplification strategy for treatment-experienced HIV-infected patients who have achieved virologic suppression on a multi-drug, multi-class antiretroviral regimen, the aim of this study was to evaluate the safety, efficacy, and pharmacokinetics of once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disproxil fumarate (E/C/F/TDF) with darunavir.A single arm, open-label 48-week study was conducted of regimen simplification to E/C/F/TDF plus darunavir 800 mg daily from stable therapy including two nucleoside/nucleotide reverse transcriptase inhibitors, a ritonavir-boosted protease inhibitor, and an integrase inhibitor. Participants had plasma HIV viral load consistently < 200 copies/mL for ? 6 months, estimated glomerular filtration rate (eGFR) ? 60 mL/min, and no genotypic resistance to major components of the study regimen. Plasma viral load was measured at weeks 2 and 4, then every 4 weeks throughout the study. Safety laboratory assessments were conducted at baseline and at weeks 12, 24, 36, and 48. Antiretroviral drug concentrations were measured at baseline and once ? 2 weeks after the regimen change.Ten HIV-infected adults (8 male and 2 female; median age 50.5 years) were enrolled. All maintained virologic suppression on the new regimen for 48 weeks. One subject experienced a decrease in eGFR from 62 mL/min at baseline to 52 mL/min at week 12; study medications were continued and his eGFR remained stable (50-59 mL/min) thereafter. No subjects discontinued study medications for renal function changes or other adverse events. Darunavir trough concentration were lower on the new regimen than on darunavir/ritonavir 800/100 mg (n = 5; p < 0.05).Despite low darunavir trough concentrations, treatment simplification to a two-pill, once-daily regimen of E/C/F/TDF plus darunavir was safe and effective for 48 weeks among 10 selected treatment-experienced HIV-infected patients. Trial registration The study protocol was registered with ClinicalTrials.gov (NCT02199613) on July 22, 2014.

Dataset Information

Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial.

Publications

Switching Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) to TDF/FTC/Rilpivirine vs Continuing TDF/FTC/EFV in HIV-Infected Patients With Virological Suppression: A Randomized Controlled Trial.

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