Simplification of Antiretroviral Therapy to a Single-Tablet Regimen Consisting of Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Versus Unmodified Antiretroviral Therapy in Virologically Suppressed HIV-1-Infected Patients

DeJesus, Edwin; Young, Benjamin; Morales-Ramirez, Javier O; Sloan, Louis; Ward, Douglas J.; Flaherty, John F.; Ebrahimi, Ramin; Maa, Jen-Fue; Reilly, Karen; Ecker, Janet; McColl, Damian J.; Seekins, Daniel; Farajallah, Awny

doi:10.1097/qai.0b013e3181a572cf

Cited by 122 publications

(113 citation statements)

References 18 publications

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“…39,47,78,79,82 Interventions. Based on the factors responsible for poor adherence, the interventions were categorized as patient related (n = 31), 36 37,62,63,69,83 social and economic factors (n = 1), 77 and condition related (n = 1). 44 The interventions in thirty-nine of these studies targeted only the patient; …”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

Mbuagbaw

Sivaramalingam

Navarro

et al. 2015

AIDS Patient Care and STDs

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We sought to review the effectiveness of interventions designed to improve adherence to antiretroviral therapy (ART) from studies included in a recent Cochrane review that reported a clinical and an adherence outcome, with at least 80% follow-up for 6 months or more. Data were extracted independently and in duplicate, with an adjudicator for disagreements. Risk of bias was assessed using the Cochrane Risk of Bias tool. Of 182 relevant studies in the Cochrane review, 49 were related to ART. Statistical pooling was not warranted due to heterogeneity in interventions, participants, treatments, adherence measures and outcomes. Many studies had high risk of bias in elements of design and outcome ascertainment. Only 10 studies improved both adherence and clinical outcomes. These used the following interventions: adherence counselling (two studies); a once-daily regimen (compared to twice daily); text messaging; web-based cognitive behavioral intervention; face-to-face multi-session intensive behavioral interventions (two studies); contingency management; modified directly observed therapy; and nurse-delivered home visits combined with telephone calls. Patient-related adherence interventions were the most frequently tested. Uniform adherence measures and higher quality studies of younger populations are encouraged.

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Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

Mbuagbaw

Sivaramalingam

Navarro

et al. 2015

AIDS Patient Care and STDs

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“…Activity was restored by omitting the methylene spacer of the R 1 substituent in 9, i.e. exchanging the benzyl group by a phenyl (11). As compound 11 shows a better ligand efficiency 29 and ligand-lipophilicity efficiency 29 compared to 4 (LE: 0.32 vs 0.29; LLE: 2.51 vs 2.33), the subsequent structure modifications were performed based on this compound.…”

Section: Chartmentioning

confidence: 99%

“…12 Hence, there is an urgent need for a one compound therapy of MRSA/HIV-1 co-infections. Combining antibacterial and antiretroviral properties in a single molecule should be beneficial in different aspects: it will improve patient adherence to ART by reduction of medications' regimen, 11 and consequently decrease the probability of treatment failure. Moreover, studies.…”

Section: Introductionmentioning

confidence: 99%

“…However, the evolution of antiretroviral drug resistance is still presenting an intractable problem due to the high viral mutation rate and non-compliance to antiretroviral therapy (ART). [8][9][10] Although the FDA recently approved a combined ART as one pill daily that could improve patient adherence, 11 the resistance issue is not yet solved. Treatment of MRSA/HIV-1 co-infection is even more challenging.…”

Section: Introductionmentioning

confidence: 99%

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Discovery and Structure-Based Optimization of 2-Ureidothiophene-3-carboxylic Acids as Dual Bacterial RNA Polymerase and Viral Reverse Transcriptase Inhibitors

et al. 2016

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We are concerned with the development of novel anti-infectives with dual antibacterial and antiretroviral activities for MRSA/HIV-1 co-infection. To achieve this goal, we exploited for the first time the mechanistic function similarity between the bacterial RNA polymerase (RNAP) "switch region" and the viral non-nucleoside reverse transcriptase inhibitor (NNRTI) binding site. Starting from our previously discovered RNAP inhibitors, we managed to develop potent RT inhibitors effective against several resistant HIV-1 strains with maintained or enhanced RNAP inhibitory properties following a structure-based design approach. A quantitative structure−activity relationship (QSAR) analysis revealed distinct molecular features necessary for RT inhibition. Furthermore, mode of action (MoA) studies revealed that these compounds inhibit RT noncompetitively, through a new mechanism via closing of the RT clamp. In addition, the novel RNAP/RT inhibitors are characterized by a potent antibacterial activity against S. aureus and in cellulo antiretroviral activity against NNRTI-resistant strains. In HeLa and HEK 293 cells, the compounds showed only marginal cytotoxicity.

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“…91 Three hundred patients were randomized to either continue their current regimen, or to switch to a single-dose tablet of EFV-TDF-FTC. QoL was assessed using the Medical Outcomes Study 36-item Short Form survey (SF-36) questionnaire version 2, 92 a validated QoL-assessment tool.…”

Section: Patient Preference and Qolmentioning

confidence: 99%

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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Simplification of Antiretroviral Therapy to a Single-Tablet Regimen Consisting of Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Versus Unmodified Antiretroviral Therapy in Virologically Suppressed HIV-1-Infected Patients

Abstract: Simplification to EFV/FTC/TDF maintained high and comparable rates of virologic suppression vs. SBR through 48 weeks.

Cited by 122 publications

References 18 publications

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

Discovery and Structure-Based Optimization of 2-Ureidothiophene-3-carboxylic Acids as Dual Bacterial RNA Polymerase and Viral Reverse Transcriptase Inhibitors

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

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