Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial

Molina, Jean Michel; Cahn, Pedro; Grinsztejn, Beatriz; Lazzarin, Adriano; Mills, Anthony; Saag, Michael S.; Supparatpinyo, Khuanchai; Walmsley, Sharon; Crauwels, Herta; Rimsky, L; Vanveggel, Simon; Boven, Katia

doi:10.1016/s0140-6736(11)60936-7

Cited by 357 publications

(366 citation statements)

References 20 publications

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“…Compared with efavirenz, rilpivirine led to minimal changes in LDL-C, HDL-C, TC, and triglycerides in 2 recently reported trials. 22,23 Similar observations were reported when etravirine was compared with efavirenz in the Study of Etravirine Neuropsychiatric Symptoms Versus Efavirenz Trial. 24 In the etravirine group, TC, HDL-C, and LDL-C increased by 0.40 mmol/L, 0.10 mmol/L, and 0.20 mmol/L, respectively.…”

Section: Hiv and Cholesterolsupporting

confidence: 62%

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Advani

Patel²,

Pichardo³

et al. 2014

JMCP

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Section: Hiv and Cholesterolsupporting

confidence: 62%

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Advani

Patel²,

Pichardo³

et al. 2014

JMCP

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“…The fixed-dose combination Atripla and the individual components have been evaluated in a number of clinical trials in comparison to alternate agents including NNRTI (nevirapine, etravirine [ETR], rilpivirine [RPV]), ritonovir-boosted protease inhibitor (PI-r) (lopinavir-ritonavir [LPV-r], atazanavir-ritonavir [ATZ-r]) integrase inhibitors (raltegravir [RAL], elvitegravir), and CCR-5 inhibitors (maraviroc). [25][26][27][28][29][30][31][32][33][34][35] In the studies to date, largely of noninferiority design, and using the primary endpoints as defined by the studies, Atripla has not been beaten for efficacy by any other agent.…”

Section: Efficacymentioning

confidence: 99%

“…22,25,28,29,31,32 In addition to K103N, Y188L, and G190S/A mutations can lead to highlevel EFV resistance. 125,130,132 Other mutations that decrease virologic response to EFV are: L100I, K101P, V106M, V108I, Y181C/I, and P225H.…”

Section: Resistancementioning

confidence: 99%

“…137 Two Phase III clinical trials (ECHO and THRIVE) have shown the Complera combination to be noninferior to Atripla in treatmentnaïve patients with HIV-1 infection. 27,28 Patients taking RPV reported fewer neurological side effects than those taking EFV (17% vs 38%) had a better lipid profile on therapy and were less likely to discontinue the regimen due to treatment side effects (3% vs 8%). In subgroup analysis, patients in the RPV arm with a baseline viral load $ 100,000 copies/mL had a significantly higher rate of virologic failure than in the EFV arm at 48 weeks (15% vs 6%), and viral failure was associated with an increased rate of drug resistance.…”

Section: New Strsmentioning

confidence: 99%

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Issues in resistance, adherence, and comparative efficacy of the single-tablet regimen combination of tenofovir, emtricitabine, and efavirenz in the management of HIV-1 infection

Rebick¹,

Walmsley²

2012

VAAT

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Abstract:Atripla is the first once-daily, single-tablet, triple-combination antiretroviral therapy. It is recommended for the initial treatment of the naïve patient with human immunodeficiency virus-1 (HIV-1) infection in all current guidelines, based on its proven efficacy in numerous head-to-head randomized clinical trials. Not only has it proven efficacy, but the fixed-dose combination, Atripla, has resulted in an improvement in adherence, quality of life, and satisfaction among naïve as well as virally suppressed patients switching from another regimen. Despite the advantages, tolerability issues can arise that are related primarily to the efavirenz component, which is known to cause central nervous side effects such as dizziness, abnormal dreams, and anxiety. Although generally self-limited, these side-effects can lead to treatment discontinuation in the short-or long-term. Based on the observation of neural tube defects in macaque models, and isolated case reports in human fetuses with first trimester exposure, it is rated as Food and Drug Administration pregnancy category D, and considered as contraindicated in the first trimester of pregnancy where alternatives are available. Given the low genetic barrier of each of the individual components, resistance remains an important issue for patients with poor adherence, but is balanced in part by the long half-life of the drugs. Transmitted resistance is described in up to 16% of newly infected patients in population surveys, and is particularly prevalent in men who have sex with men. Minority variants that may impart resistant to efavirenz are not detected with currently used HIV-1 genotype assays, but nonetheless may also be implicated in patients who fail initial treatment. Several single-tablet regimens are recently licensed or in development that will challenge Atripla as the single-tablet first-line option, but none have shown superior efficacy to date.

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“…This simulation study is designed to mimic 2 randomized clinical trials known as ECHO 35 and THRIVE, 36 which compared the antiretroviral drugs rilpivirine and efavirenz for HIV-infected treatment-naive adult patients. Both drugs are non-nucleoside reverse transcriptase inhibitors to be used in combination with other antiretroviral agents.…”

Section: Introductionmentioning

confidence: 99%

Treatment evaluation for a data‐driven subgroup in adaptive enrichment designs of clinical trials

Zhang

Chen

Soon

et al. 2017

Statistics in Medicine

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Adaptive enrichment designs (AEDs) of clinical trials allow investigators to restrict enrollment to a promising subgroup based on an interim analysis. Most of the existing AEDs deal with a small number of predefined subgroups, which are often unknown at the design stage. The newly developed Simon design offers a great deal of flexibility in subgroup selection (without requiring pre-defined subgroups) but does not provide a procedure for estimating and testing treatment efficacy for the selected subgroup. This article proposes a 2-stage AED which does not require predefined subgroups but requires a prespecified algorithm for choosing a subgroup on the basis of baseline covariate information. Having a prespecified algorithm for subgroup selection makes it possible to use cross-validation and bootstrap methods to correct for the resubstitution bias in estimating treatment efficacy for the selected subgroup. The methods are evaluated and compared in a simulation study mimicking actual clinical trials of human immunodeficiency virus infection.

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Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial

Cited by 357 publications

References 20 publications

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Issues in resistance, adherence, and comparative efficacy of the single-tablet regimen combination of tenofovir, emtricitabine, and efavirenz in the management of HIV-1 infection

Treatment evaluation for a data‐driven subgroup in adaptive enrichment designs of clinical trials

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