Examination of Noninferiority, Safety, and Tolerability of Lopinavir/ritonavir and Raltegravir Compared with Lopinavir/ritonavir and Tenofovir/ Emtricitabine in Antiretroviral-Naïve Subjects: The PROGRESS Study, 48-Week Results

Reynes, Jacques; Lawal, Adebayo; Pulido, Federico; Soto-Malave, Ruth; Gathe, Joseph; Tian, Min; Fredrick, Linda; Podsadecki, Thomas; Nilius, Angela M.

doi:10.1310/hct1205-255

Cited by 76 publications

(44 citation statements)

References 8 publications

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“…The PROGRESS study compared (n = 206) lopinavir/ ritonavir plus either tenofovir/emtricitabine or raltegravir: at 48 weeks, raltegravir plus lopinavir/ritonavir led to similar efficacy results (83.2 vs 84.8% with HIV RNA < 50 copies/ ml), similar CD4 recovery (+ 214.9 vs 215 cell/µl) and similar tolerability [47]. The NEAT001 trial compared (n = 805) naive patients receiving darunavir/ritonavir (800/100 mg once daily) plus either tenofovir/emtricitabine or raltegravir; similar 48-week efficacy (81 vs 85% with HIV RNA < 50 copies/ml), CD4 recovery (268 vs 266 cells/µl) and tolerability were observed [48].…”

Section: Clinical Efficacymentioning

confidence: 99%

Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients

Calcagno

D’Avolio

Bonora

2015

Expert Opinion on Drug Metabolism & Toxicology

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Section: Clinical Efficacymentioning

confidence: 99%

Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients

Calcagno

D’Avolio

Bonora

2015

Expert Opinion on Drug Metabolism & Toxicology

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“…Кроме того, показанием может быть упрощение схемы для улучшения приверженности или вследствие побочных эффектов. Первыми вариантами такого упрощения стали схемы «двойной» терапии лопинавир/ритона-вир + ралтенравир и лопинавир/ритонавир + ламиву-дин [21,22]. В случаях, когда пациент принимает тера-пию и хорошо ее переносит, даже если схема более не является предпочтительным вариантом, менять ее не нужно [20].…”

Section: что необходимо учитывать при смене схемы антиретровирусной тunclassified

Selection of an Antiretroviral Regimen Based on the Resistance Data

2017

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Борьба с глобальной эпидемией вируса иммуно-дефицита человека (ВИЧ) в последнее десяти-летие дала свои плоды. По оценкам ВОЗ, число новых случаев инфицирования ВИЧ в 2015 г. сократи-лось на 38% по сравнению с 2001 г. и достигло 2,1 млн. Число людей, умирающих от ассоциированных с ВИЧ причин, также сократилось по сравнению с 2003 г. на 43% и достигло 1,1 млн в 2015 г. [1]. В значительной степени это стало результатом расширения доступа к антиретровирусной терапии. К концу 2015 г. лечение получали более чем 17 млн человек, живущих с ВИЧ. На основе этих достижений и полученного опыта ВОЗ строит глобальную стратегию сектора здравоохранения по ВИЧ на 2016-2021 гг. Основные целевые показате-ли этой программы сформулированы как «90-90-90». Это означает, 90% людей, живущих с ВИЧ, должны знать о своем статусе; 90% людей, живущих с ВИЧ, дол-жны получать антиретровирусную терапию (АРТ); 90% людей, живущих с ВИЧ и получающих лечение, должны достигнуть вирусной супреcсии.Одним из препятствий на пути достижения целей глобальной стратегии является вирусная резистент-ность. Ее распространенность на сегодняшний день изучена недостаточно, особенно в регионах, где про- One of the main obstacles to achieving the goal is HIV resistance to antiretroviral therapy. It occurs when the virus mutates and affinity of active ingredients of drugs for the corresponding viral proteins is reduced. Drugs differ by the genetic barrier. Non-nucleoside reverse-transcriptase inhibitors lose their ability to inhibit the replication after a single mutation, and ritonavir-boosted protease inhibitors -after 5--8th mutation. The key factor for adequate viral suppression and reduction of risks is good adherence to treatment. Medication non-adherence creates a favorable environment in the body for the evolution of the virus. In the Russian Federation, the prevalence of primary resistance reaches 6.02%, and poor adherence equals 26%. The data and the results of examinations for mutations should be considered when selecting an antiretroviral regimen and approach to patient to improve adherence.

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“…The potency of the INSTIs prompted clinical trials revisiting the concept of dual therapy. The PROGRESS study provides the first demonstration that a PI/r (LPV/r) plus an INSTI (RAL) might achieve similar virological outcomes than LPV/r plus 2 NRTIs, in treatment naïve individuals [53]. Given that failure to a NNRTI regimen is associated frequently with the emergence of NRTI resistant mutations, this strategy might be a potential alternative to the current PI/r plus 2 NRTIs option in a second line.…”

Section: Dual Therapy With Integrase Inhibitorsmentioning

confidence: 99%

What to do Next? Second-line Antiretroviral Therapy

Figueroa

Sued

Cahn

2014

Curr Treat Options Infect Dis

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Opinion statementHighly-active antiretroviral therapy (HAART) has been one of the major advances in medicine in the 20 th century. Millions of lives have been saved all over the world since triple drug combinations were adopted as the standard of care for HIV disease. Firstline regimens may fail, generate side effects, and long term toxicities. In the past, HAART regimens were also complex and difficult to adhere to. So, second line regimens were necessary to preserve the main goal of ARV therapy: suppression viral replication and restoration of the immune system in order to keep patients alive and healthy. From a public health perspective, the impact of HIV treatment as prevention highlights the importance of having safe and effective second line options for patients unable to maintain full viral suppression with first line therapy. New strategies with effective, tolerable drugs are essential components of these regimens. The gap between wealthy and developing countries is particularly evident in the second line scenario.

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Examination of Noninferiority, Safety, and Tolerability of Lopinavir/ritonavir and Raltegravir Compared with Lopinavir/ritonavir and Tenofovir/ Emtricitabine in Antiretroviral-Naïve Subjects: The PROGRESS Study, 48-Week Results

Abstract: The HIV treatment regimen of LPV/r + RAL resulted in noninferior efficacy and comparable safety and tolerability compared with a traditional NRTI-containing regimen through 48 weeks of treatment. These results support further evaluation of the LPV/r + RAL regimen.

Cited by 76 publications

References 8 publications

Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients

Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients

Selection of an Antiretroviral Regimen Based on the Resistance Data

What to do Next? Second-line Antiretroviral Therapy

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