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JOURNAL ARTICLE
Martina Failla, Elisa Pasquali, Luisa Galli, Elena Chiappini
INTRODUCTION: Integrase strand transfer inhibitors (INSTIs), including raltegravir (RAL), dolutegravir (DTG), elvitegravir (EVG), bictegravir (BIC), and cabotegravir (CAB), are increasingly used given excellent data on their efficacy, effectiveness, and tolerability profile in adults, while data in children are accumulating. OBJECTIVE AND METHODS: To review the most recent evidence on the efficacy, effectiveness, safety, and resistance of INSTIs in children, a quick narrative review of the available literature data was performed using,the MEDLINE/PubMed and Scopus databases, including only English-language studies, published between 2009-2022...
November 9, 2022: AIDS Research and Human Retroviruses
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JOURNAL ARTICLE
Shauna H Gunaratne, Hong-Van Tieu, Timothy J Wilkin, Barbara S Taylor
The 2022 Conference on Retroviruses and Opportunistic Infections provided a rich source of new data and comprehensive reviews on antiviral therapy. For COVID-19, intramuscular sotrovimab was noninferior to intravenous sotrovimab, serostatus did not predict the efficacy of sotrovimab, and molnupiravir appeared safe and modestly effective in decreasing hospitalization rates. Trials from low- and middle-income countries provided data to support transitioning those on first-line therapy with or without virologic suppression and those virologically suppressed on second-line therapy to dolutegravir-based regimens...
October 2022: Topics in Antiviral Medicine
#23
JOURNAL ARTICLE
Jean Pierre de Villartay, Emmanuelle Pannier, Jeanne Sibiude, Pierre Frange, Roland Tubiana, Stéphane Blanche
Effectiveness of anti-HIV in the prevention of perinatal transmission has been established. Assessing the tolerance of drug exposure during pregnancy is of the utmost importance given the number of children exposed. HIV integrase and the Recombinase Activating Gene (RAG) enzyme involved in the establishment of the T-lymphocyte repertoire show structural similarity.. The inhibition of RAG by anti-integrases is observed in vitro, in a variable way according to the molecules. In-utero exposure to raltegravir did not alter the T-lymphocyte repertoire of 12 newborns...
November 7, 2022: Journal of Acquired Immune Deficiency Syndromes: JAIDS
#24
REVIEW
Alexa Vyain Zhao, Rustin D Crutchley, Rakesh Chowdary Guduru, Kathy Ton, Tammie Lam, Amy Cheng Min
Integrase strand transfer inhibitors (INSTIs) have improved the treatment of human immunodeficiency virus (HIV). There are currently four approved for use in treatment-naïve individuals living with HIV; these include first generation raltegravir, elvitegravir, and second generation dolutegravir and bictegravir. The most recent INSTI, cabotegravir, is approved for (1) treatment of HIV infection in adults to replace current antiretroviral therapy in individuals who maintain virologic suppression on a stable antiretroviral regimen without history of treatment failure and no known resistance to its components and (2) pre-exposure prophylaxis in individuals at risk of acquiring HIV-1 infection...
October 22, 2022: Retrovirology
#25
JOURNAL ARTICLE
Marie Soleil R Smith, Haneesha Mohan, Abhinav Ajaykumar, Anthony Y Y Hsieh, Lou Martineau, Ronil Patel, Izabella Gadawska, Christopher Sherwood, Lena Serghides, James M Piret, Hélène C F Côté
BACKGROUND: Each year, approximately 1.1 million children are exposed in utero to HIV antiretrovirals, yet their safety is often not well characterized during pregnancy. The Tsepamo study reported a neural tube defect signal in infants exposed to the integrase inhibitor (InSTI) dolutegravir from conception, suggesting that exposure during early fetal development may be detrimental. METHODS: The effects of InSTIs on two human embryonic stem cell (hESC) lines were characterized with respect to markers of pluripotency, early differentiation, and cellular health...
September 19, 2022: Journal of Infectious Diseases
#26
JOURNAL ARTICLE
Jennifer Tam, Elaine Lau, Stanley Read, Ari Bitnun
OBJECTIVE: The utility of routine therapeutic drug monitoring (TDM) in children living with HIV has not been extensively studied. The purpose of this study was to assess this strategy. METHODS: This was a single-center, prospective observational study of routine TDM for protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase strand transfer inhibitors (INSTIs) in children living with HIV who were receiving antiretroviral therapy (ART) between February and December 2014...
2022: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
#27
JOURNAL ARTICLE
David Torres-Fernandez, Santiago Jiménez de Ory, Claudia Fortuny, Talía Sainz, Dolores Falcón, Enrique Bernal, Miguel Cervero Jiménez, Marta Navarro Vilasaró, Cristina Epalza, Marisa Navarro, José Tomás Ramos, África Holguín, Luis Prieto
BACKGROUND: Although integrase inhibitor (INI)-based regimens are now the first-line choice for all people living with HIV, experience among children and adolescents is still scarce. We describe the characteristics and outcomes of a paediatric/adolescent cohort on INI-based ART. METHODS: Retrospective analysis of HIV-infected patients below 18 years of age who started an INI-based regimen from 2007 to 2019, enrolled in the Spanish National Adult (CoRIS) and Paediatric (CoRISpe) cohorts...
August 16, 2022: Journal of Antimicrobial Chemotherapy
#28
JOURNAL ARTICLE
Theodore D Ruel, Edward P Acosta, Jessica P Liu, Kathryn P Gray, Kathleen George, Nicole Montañez, Stephanie Popson, Ann M Buchanan, Mattie Bartlett, Dale Dayton, Patricia Anthony, Cynthia Brothers, Cynthia Vavro, Rajendra Singh, Lucy Koech, Tichaona Vhembo, Blandina T Mmbaga, Jorge A Pinto, Els F M Dobbels, Moherndran Archary, Kulkanya Chokephaibulkit, Pradthana Ounchanum, Jaime G Deville, Rohan Hazra, Ellen Townley, Andrew Wiznia
BACKGROUND: Safe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children. METHODS: International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093 is a phase 1-2 ongoing multicentre, open-label, non-comparative study of dolutegravir...
May 2022: Lancet HIV
#29
JOURNAL ARTICLE
Michael R Jordan, Leonard Bikinesi, Laimi Ashipala, Nicholus Mutenda, Mary Brantuo, Gillian Hunt, Andreas Shiningavamwe, Gram Mutandi, Anita Beukes, Suzanne Beard, Katherine Battey, Eric J Dziuban, Elliot Raizes, Paul Adjei, Alice Tang, Amalia Giron, Steven Y Hong
Background: The World Health Organization (WHO) recommends routine surveillance of pretreatment human immunodeficiency virus (HIV) drug resistance (HIVDR) in children <18 months of age diagnosed with HIV through early infant diagnosis (EID). In 2016, 262 children <18 months of age were diagnosed with HIV in Namibia through EID. Levels of HIVDR in this population are unknown. Methods: In 2016, Namibia surveyed pretreatment HIVDR among children aged <18 months following WHO guidance...
May 2022: Open Forum Infectious Diseases
#30
JOURNAL ARTICLE
Jason M Bacha, Sandile Dlamini, Florence Anabwani, Judith Gwimile, Jacqueline Balungi Kanywa, John Farirai, Menard Bvumbwe, Teresa Steffy, Diane Nguyen, Richard S Wanless, Heather Haq
BACKGROUND: While achievements have been made globally since the UNAIDS 90-90-90 targets were announced, paediatric data remains sparse. We describe achievements towards ART uptake and viral load suppression, existing gaps, and potential best practices among CALHIV across six Eastern and Southern African countries. SETTING: Baylor College of Medicine International Paediatric AIDS Initiative (BIPAI) Network sites in Botswana, Eswatini, Lesotho, Malawi, Tanzania, and Uganda...
April 1, 2022: Journal of Acquired Immune Deficiency Syndromes: JAIDS
#31
JOURNAL ARTICLE
Lene Ryom, Rosa De Miguel, Aoife Grace Cotter, Daria Podlekareva, Charles Beguelin, Hylke Waalewijn, Josè R Arribas, Patrick W G Mallon, Catia Marzolini, Ole Kirk, Alasdair Bamford, Andri Rauch, Jean Michel Molina, Justyna Dominika Kowalska, Giovanni Guaraldi, Alan Winston, Christoph Boesecke, Paola Cinque, Steven Welch, Simon Collins, Georg M N Behrens
BACKGROUND: The European AIDS Clinical Society (EACS) Guidelines were revised in 2021 for the 17th time with updates on all aspects of HIV care. KEY POINTS OF THE GUIDELINES UPDATE: Version 11.0 of the Guidelines recommend six first-line treatment options for antiretroviral treatment (ART)-naïve adults: tenofovir-based backbone plus an unboosted integrase inhibitor or plus doravirine; abacavir/lamivudine plus dolutegravir; or dual therapy with lamivudine or emtricitabine plus dolutegravir...
September 2022: HIV Medicine
#32
JOURNAL ARTICLE
Isaac Tsikhutsu, Margaret Bii, Nicole Dear, Kavitha Ganesan, Alex Kasembeli, Valentine Sing'oei, Kevin Romboisia, Christopher Ochieng, Priyanka Desai, Vanessa Wolfman, Peter Coakley, Elizabeth H Lee, Patrick W Hickey, Jeffrey Livezey, Patricia Agaba
BACKGROUND: Children and adolescents living with HIV (CALHIV) face unique challenges, including poorer treatment outcomes, risk for drug resistance mutations (HIVDRM), and limited drug formulations. We estimated viral suppression (VS) prevalence, and evaluated predictors of VS and HIVDRMs in Kenya. METHODS: From 2018-2020, CALHIV 1-19 years on ART for >6 months were enrolled in this cross-sectional study. Participants underwent viral load (VL) testing; those with VL ≥1000 copies/mL had HIVDRM testing...
January 29, 2022: Clinical Infectious Diseases
#33
RANDOMIZED CONTROLLED TRIAL
Anna Turkova, Ellen White, Hilda A Mujuru, Adeodata R Kekitiinwa, Cissy M Kityo, Avy Violari, Abbas Lugemwa, Tim R Cressey, Philippa Musoke, Ebrahim Variava, Mark F Cotton, Moherndran Archary, Thanyawee Puthanakit, Osee Behuhuma, Robin Kobbe, Steven B Welch, Mutsa Bwakura-Dangarembizi, Pauline Amuge, Elizabeth Kaudha, Linda Barlow-Mosha, Shafic Makumbi, Nastassja Ramsagar, Chaiwat Ngampiyaskul, Godfrey Musoro, Lorna Atwine, Afaaf Liberty, Victor Musiime, Dickson Bbuye, Grace M Ahimbisibwe, Suwalai Chalermpantmetagul, Shabinah Ali, Tatiana Sarfati, Ben Wynne, Clare Shakeshaft, Angela Colbers, Nigel Klein, Sarah Bernays, Yacine Saïdi, Alexandra Coelho, Tiziana Grossele, Alexandra Compagnucci, Carlo Giaquinto, Pablo Rojo, Deborah Ford, Diana M Gibb
BACKGROUND: Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART). METHODS: We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method...
December 30, 2021: New England Journal of Medicine
#34
JOURNAL ARTICLE
Cindy Vavro, Theodore Ruel, Andrew Wiznia, Nicole Montañez, Keith Nangle, Joseph Horton, Ann M Buchanan, Eugene L Stewart, Paul Palumbo
P1093 is a multicenter, open-label, phase I/II study of pharmacokinetics, safety, and tolerability of dolutegravir plus an optimized background regimen in pediatric participants aged 4 weeks to <18 years with HIV-1. Most participants were highly treatment experienced. We report the mechanisms of emergent integrase strand transfer inhibitor (INSTI) resistance among adolescents and children receiving dolutegravir. Plasma was collected at screening and near protocol-defined virologic failure (PDVF) for population- and, for some samples, clonal-level integrase genotyping, phenotyping, and replication capacity...
October 25, 2021: Antimicrobial Agents and Chemotherapy
#35
JOURNAL ARTICLE
George A Yendewa, Sulaiman Lakoh, Sahr A Yendewa, Khadijah Bangura, Andrés Tabernilla, Lucia Patiño, Darlinda F Jiba, Alren O Vandy, Samuel P Massaquoi, Nuno S Osório, Gibrilla F Deen, Foday Sahr, Robert A Salata, Eva Poveda
Human immunodeficiency virus (HIV) drug resistance (HIVDR) is widespread in sub-Saharan Africa. Children and pregnant women are particularly vulnerable, and laboratory testing capacity remains limited. We, therefore, used a cross-sectional design and convenience sampling to characterize HIV subtypes and resistance-associated mutations (RAMs) in these groups in Sierra Leone. In total, 96 children (age 2-9 years, 100% ART-experienced), 47 adolescents (age 10-18 years, 100% ART-experienced), and 54 pregnant women (>18 years, 72% ART-experienced) were enrolled...
August 26, 2021: Genes
#36
JOURNAL ARTICLE
Pierre Frange, Stephane Blanche, Florence Veber, Veronique Avettand-Fenoel
OBJECTIVES: Although widely recommended, data about dolutegravir efficacy in HIV-1-infected children/adolescents are scarce, limited to short-term follow-up and mainly extrapolated from studies in adults with good adherence to treatment. This study aimed to provide long-term data about the risk of virological failure (VF) and acquired genotypic resistance in children and adolescents receiving dolutegravir. METHODS: This retrospective monocentric study included 134 paediatric patients who received a dolutegravir-based regimen for ≥ 12 months in 2014-2020...
November 2021: HIV Medicine
#37
JOURNAL ARTICLE
Aditya H Gaur, Mark F Cotton, Carina A Rodriguez, Eric J McGrath, Elizabeth Helström, Afaaf Liberty, Eva Natukunda, Pope Kosalaraksa, Kulkanya Chokephaibulkit, Heather Maxwell, Pamela Wong, Danielle Porter, Sophia Majeed, Mun Sang Yue, Hiba Graham, Hal Martin, Diana M Brainard, Cheryl Pikora
BACKGROUND: Bictegravir is a potent integrase strand-transfer inhibitor (INSTI) with a high genetic barrier to resistance. Bictegravir, coformulated with emtricitabine and tenofovir alafenamide, is recommended by key European and US HIV treatment guidelines as the preferred single-tablet regimen for adults and adolescents. The aim of this study was to assess the pharmacokinetics, safety, and efficacy of switching to this regimen in virologically suppressed children and adolescents with HIV...
July 21, 2021: Lancet Child & Adolescent Health
#38
JOURNAL ARTICLE
Wei Li A Koay, Sahera Dirajlal-Fargo, Matthew E Levy, Paige Kulie, Anne Monroe, Amanda D Castel, Natella Y Rakhmanina
We conducted a retrospective analysis of 38 children and youth with human immunodeficiency virus (aged 0-19 years) in the United States and report an increased rate of change of BMI-for-age z score after initiating integrase strand transfer inhibitors (+0.19 z score units/year [95% confidence interval, .01-.37]; P = .036) for a median follow-up of 527.5 days.
July 2021: Open Forum Infectious Diseases
#39
REVIEW
Rachael M Burke, Hannah M Rickman, Vindi Singh, Elizabeth L Corbett, Helen Ayles, Andreas Jahn, Mina C Hosseinipour, Robert J Wilkinson, Peter MacPherson
BACKGROUND: HIV and tuberculosis are frequently diagnosed concurrently. In March 2021, World Health Organization recommended that antiretroviral therapy (ART) should be started within two weeks of tuberculosis treatment start, at any CD4 count. We assessed whether earlier ART improved outcomes in people with newly diagnosed HIV and tuberculosis. METHODS: We did a systematic review by searching nine databases for trials that compared earlier ART to later ART initiation in people with HIV and tuberculosis...
July 2021: Journal of the International AIDS Society
#40
JOURNAL ARTICLE
Banda Marco, Herrera Cristina, Reynaga Cristhian, Rangel Sigfrido, Josue Del Angel, Angel Reyes, Prudente Isidoro
Integrase strand-transfer inhibitors (INSTI) are the latest class of antiretrovirals registered in Mexico. They include raltegravir (RAL), elvitegravir/cobicistat (EVG/c), dolutegravir (DTG) and bictegravir (BIC). Along with international guidelines, Mexico adopted the use of INSTI about two years ago as initial antiretroviral therapy (ART). This is partially due to the increase in the pre-treatment resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI), mainly efavirenz (EFV). Furthermore, INSTI depict greater efficacy, safety and less drug-drug interactions than NNRTI and protease inhibitors (PI)...
July 1, 2021: AIDS Reviews
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