Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial

Grinsztejn, Beatriz; Castro, Nathalie De; Arnold, Vincent; Veloso, Valdiléa G.; Morgado, Mariza G.; Pilotto, José Henrique; Brites, Carlos; Madruga, José Valdez; Barcellos, Nêmora Tregnago; Santos, Breno; Vorsatz, Carla; Fagard, Catherine; Santini-Oliveira, Marília; Patey, O.; Delaugerre, Constance; Chêne, Geneviève; Molina, Jean‐Michel

doi:10.1016/s1473-3099(14)70711-x

Cited by 93 publications

(84 citation statements)

References 18 publications

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“…An alternative, if available, is for an integrase inhibitor such as raltegravir to replace the nevirapine during the 8‐week BU treatment (Grinsztejn et al . ).…”

Section: Antiretroviral Treatment and Bu Treatment Interactionsmentioning

confidence: 97%

Management of BU–HIV co‐infection

O’Brien

Ford

Vitória

et al. 2014

Tropical Med Int Health

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Abstractbackground Buruli Ulcer (BU)-HIV co-infection is an important emerging management challenge for BU disease. Limited by paucity of scientific studies, guidance for management of this co-infection has been lacking.methods Initiated by WHO, a panel of experts in BU and HIV management developed guidance principles for the management of BU-HIV co-infection based on review of available scientific evidence, current treatment experience, and global recommendations established for management of HIV infection and tuberculosis.

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“…An alternative, if available, is for an integrase inhibitor such as raltegravir to replace the nevirapine during the 8‐week BU treatment (Grinsztejn et al . ).…”

Section: Antiretroviral Treatment and Bu Treatment Interactionsmentioning

confidence: 97%

Management of BU–HIV co‐infection

O’Brien

Ford

Vitória

et al. 2014

Tropical Med Int Health

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“…In individuals co-infected with HIV/TB, the ANRS 12 180 (REFLATE TB) study investigated the use of RAL-based ART in individuals receiving drug-sensitive TB treatment including rifampicin. In an analysis of 153 individuals randomized to either RAL 400mg twice daily, RAL 800mg twice daily or EFV 600mg once daily, all in combination with TDF/3TC, RAL 400mg twice daily performed similarly to either dose-escalated RAL 800mg twice daily or EFV-based regimens: week 24 virologic suppression rates were RAL 400mg, 76%; RAL 800mg, 78%; and EFV, 63% [65]. Studies investigating the use of INSTI based ART in HIV and hepatitis C virus (HCV) co-infected individuals are lacking.…”

Section: Pharmacokinetics In Special Populationsmentioning

confidence: 99%

Comparative Clinical Pharmacokinetics and Pharmacodynamics of HIV-1 Integrase Strand Transfer Inhibitors

Podany

Scarsi

Fletcher³

2016

Clin Pharmacokinet

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Dolutegravir (DTG), elvitegravir (EVG) and raltegravir (RAL), are members of latest class of antiretrovirals (ARV) available to treat human immunodeficiency virus (HIV) infection, the integrase strand transfer inhibitors (INSTI). INSTIs are potent inhibitors of the HIV integrase enzyme with IC90/95 values in the low nanogram per milliliter range and they retain antiviral activity against strains of HIV with acquired resistance to other classes of ARVs. Each of the INSTIs have unique pharmacokinetic / pharmacodynamic properties, influencing their role in clinical use in specific subsets of patients. RAL and DTG have minimal drug-drug interaction profiles, as their metabolism has minimal cytochrome P450 (CYP) involvement. Conversely, EVG metabolism occurs primarily via CYP3A4 and requires pharmacokinetic boosting to achieve systemic exposures amenable to once daily dosing. EVG and DTG have the added benefit of the availability of fixed dose combination tablets, allowing for convenient and simplified ARV regimens. RAL is the only INSTI to be listed as a preferred agent on the current United States perinatal guidelines. All three of the INSTI agents are recommended regimens for treatment-naïve individuals on the United States Adult and Adolescent HIV treatment guidelines. This review summarizes and compares the pharmacokinetics and pharmacodynamics of the INSTI agents, and describes specific pharmacokinetic considerations for special patient conditions: hepatic impairment, renal dysfunction, pregnancy and co-infections.

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“…RAL has been shown to be an effective option in the treatment of HIV/TB‐coinfected adults 169. There are no data available for coinfected children.…”

Section: Coinfectionsmentioning

confidence: 99%

Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV‐1 infection 2015: optimizing health in preparation for adult life

et al. 2015

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The 2015 Paediatric European Network for Treatment of AIDS (PENTA) guidelines provide practical recommendations on the management of HIV‐1 infection in children in Europe and are an update to those published in 2009. Aims of treatment have progressed significantly over the last decade, moving far beyond limitation of short‐term morbidity and mortality to optimizing health status for adult life and minimizing the impact of chronic HIV infection on immune system development and health in general. Additionally, there is a greater need for increased awareness and minimization of long‐term drug toxicity. The main updates to the previous guidelines include: an increase in the number of indications for antiretroviral therapy (ART) at all ages (higher CD4 thresholds for consideration of ART initiation and additional clinical indications), revised guidance on first‐ and second‐line ART recommendations, including more recently available drug classes, expanded guidance on management of coinfections (including tuberculosis, hepatitis B and hepatitis C) and additional emphasis on the needs of adolescents as they approach transition to adult services. There is a new section on the current ART ‘pipeline’ of drug development, a comprehensive summary table of currently recommended ART with dosing recommendations. Differences between PENTA and current US and World Health Organization guidelines are highlighted and explained.

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Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial

Cited by 93 publications

References 18 publications

Management of BU–HIV co‐infection

Management of BU–HIV co‐infection

Comparative Clinical Pharmacokinetics and Pharmacodynamics of HIV-1 Integrase Strand Transfer Inhibitors

Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV‐1 infection 2015: optimizing health in preparation for adult life

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