Weight gain, body composition, and metabolic parameters of dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: an ancillary analysis of the ODYSSEY trial

作者：Anna Turkova, Anna Turkova, Ellen White, Avy Violari, Hilda A Mujuru, Adeodata R Kekitiinwa, Abbas Lugemwa, Elizabeth Kaudha, Sathaporn Na-Rajsima, Grace M Ahimbisibwe, Ebrahim Variavae, Moherndran Archary, Yasmeen Akhalwaya, Thanyawee Puthanakit, Mutsa Bwakura-Dangarembizi, Dickson Bbuye, Mariam Kasozi, Afaaf Liberty, Christoph Königs, Steven B Welch, Yoann Riault, Alasdair Bamford, Tim R Cressey, Philippa Musoke, Cissy Kityo, Rashida Ferrand, Carlo Giaquinto, Pablo Rojo, Diana M Gibb, Deborah Ford, Pattamukkil Abraham, Elaine Abrams, Judith Acero, Gerald Muzorah Agaba, Grace Ahimbisibwe, Barbara Ainebyoona, Yasmeen Akhalwaya, Winnie Akobye, Nazim Akoojee, Shabinah S. Ali, Pauline Amuge, Catherine Andrea, Rogers Ankunda, Suvaporn Anugulruengkitt, Tsitsi Apollo, Moherndran Archary, Ronelle Arendze, Juliet Ategeka, Eunice Atim, Lorna Atwine, Abdel Babiker, Sarah Babirye, Enock Babu, Joanita Nankya Baddokwaya, Themelihle Bafana, Edward Bagirigomwa, Angella Baita, David Balamusani, Patsy Baliram, David Baliruno, Colin Ball, Henry Balwa, Alasdair Bamford, Srini Bandi, Dominique Barker, Linda Barlow-Mosha, Dickson Bbuye, Shazia Begum, Osee Behuhuma, Sarah Bernays, Rogers Besigye, Maria Bester, Joyline Bhiri, Davide Bilardi, Kristien Bird, Pauline Bollen, Chiara Borg, Anne-Marie Borges Da Silva, Jackie Brown, Elena Bruno, Torsak Bunupuradah, David Burger, Nomzamo Buthelezi, Mutsa Bwakura-Dangarembizi, Africanus Byaruhanga, J. Calvert, Petronelle Casey, Haseena Cassim, Sphiwee Cebekhulu, Sanuphong Chailert, Suwalai Chalermpantmetagul, Suwalai Chalermpantmetagul, Wanna Chamjamrat, Man Ho Chan, Precious Chandiwana, Thannapat Chankun, Sararut Chanthaburanun, Nuttawut Chanto, Ennie Chidziva, Minenhle Chikowore, Joy Chimanzi, Dujrudee Chinwong, Dujrudee Chinwong, Stuart Chitongo, Moses Chitsamatanga, Joshua Choga, Duangrat Chutima, Basiimwa Roy Clark, Polly Clayden, Alexandra Coelho, Angela Colbers, Alexandra Compagnucci, Magda Conway, Mark F. Cotton, Jane Crawley, Tim R. Cressey, Tim R. Cressey, Jacky Crisp, Andile Cweya, Sumaya Dadan, Jacqui Daglish, N ontuthuzelo Daizana, Siva Danaviah, Tseleng Daniel, Anita De Rossi, Odoch Denis, Sukanda Denjanta, Els Dobbels, Maria Dowie, Prosper Dube, Benedictor Dube, Nimisha Dudakia, Alice Margaret Elwana, Cristina Epalza, David Eram, Juan Erasmus, Peter Erim, Luis Escosa Garcia, Zaakirah Essack, Carolina Estepa, Monica Etima, Alexandre Fernandes, Maite Fernandez, Felicity Fitzgerald, Jacquie Flynn, Deborah Ford, Clàudia Fortuny Guasch, Caroline Foster, George Fourie, Yolandie Fourie, Sophie Foxall, Derusha Frank, Kate Gandhi, India Garcia, Kathleen Gartner, Gugu Gasa, Joshua Gasa, Carlo Giaquinto, Diana M. Gibb, Coral Gomez Rico, Daniel Gomez-Pena, Secrecy Gondo, Anna Goodman, Maria Gorreti Nakalema, Winnie Gozhora, Pisut Greetanukroh, Biobanco Gregorio Maranon, Tiziana Grossele, Shamiso Gwande, Tapiwa Gwaze, Tsitsi Gwenzi, James Hakim, Emmanuel Hakiza, Ashley Harley, Lily Houlden, Khadija Ibrahim, Mornay Isaacs, Richard Isabirye, Wilber Ishemunyoro, Tom Jacobs, Lungile Jafta, Nasir Jamil, Anita Janse van Rensburg, Vinesh Jeaven, Jose Luis Jimenez, Gonzague Jourdain, Gonzague Jourdain, Katabalwa Juliet, Thidarat Jumpimai, Raungwit Junkaew, Thidarat Jupimai, Winfred Kaahwa, Mildred Kabasonga, Olivia Kaboggoza, Rose J. Kadhuba, Ampika Kaewbundit, Kanyanee Kaewmamueng, Bosco Kafufu, Brenda Kakayi, Brenda Kakayi, Phakamas Kamboua, Suparat Kanjanavanit, Gladys Kasangaki, Naruporn Kasipong, Miriam Kasozi, Hajira Kataike, Chrispus Katemba, Elizabeth Kaudha, Nkata Kekane, Adeodata R. Kekitiinwa, Edridah Keminyeto, Woottichai Khamduang, Warunee Khamjakkaew, Jiraporn Khamkon, Praechadaporn Khannak, Orapin Khatngam, Tassawan Khayanchoomnoom, Busi Khumalo, Mirriam Khunene, Suwimon Khusuwan, Phionah Kibalama, Robinah Kibenge, Anthony Kirabira, Cissy M. Kityo, Lameck Kiyimba, Nigel Klein, Nigel Klein, Soraya Klinprung, Robin Kobbe, Olivia Kobusingye, Josephine Kobusungye, Areerat Kongponoi, Christoph Königs, Olivier Koole, Christelle Kouakam, Nitinart Krueduangkam, Namthip Kruenual, Nuananong Kunjaroenrut, Raymonds Crespo Kyambadde, Priscilla Kyobutungi, F Kyomuhendo, Erinah Kyomukama, Reshma Lakha, Cleopatra Langa, Laddawan Laomanit, Emily Lebotsa, Prattana Leenasirimakul, Lawrence Lekku, Sarah Lensen, Valériane Leroy, Jin Li, Afaaf Liberty, Juthamas Limplertjareanwanich, Emma Little, Abbas Lugemwa, Ezra Lutalo, Hermione Lyall, Candice MacDonald, Gladness Machache, Penelope Madlala, Tryphina Madonsela, Nomfundo Maduna, Joel Maena, Apicha Mahanontharit, Collin Makanga, Candice Makola, Shafic Makumbi, Lucille Malgraaf, Angelous Mamiane, Felicia Mantkowski, Wendy Mapfumo, Laura Marques, Lindiwe Princess Maseko, Tshepiso Masienyane, Ruth Mathiba, Petronilla Matibe, Farai Matimba, Ana Cristina Matos, Sajeeda Mawlana, Emmanuel Mayanja, Fatima Mayat, Ritah Mbabazi, Nokuthula Mbadaliga, Faith Mbasani, Kathleen McClaughlin, Helen McIlleron, Watchara Meethaisong, Amina Farhana Mehar, Maria José MelladoPeña, Ana Constança Mendes, Patricia Mendez Garcia, Carlota Miranda, Annet Miwanda, Siphiwe Felix Mfan'kikile Mkhize, Kgosimang Mmolawa, Rosie Mngqibisa, Fatima Mohamed, Tumelo Moloantoa, Maletsatsi Monametsi, Samuel Montero, Cecilia L. Moore, Rejoice Mosia, Columbus Moyo, Mumsy Mthethwa, Shepherd Mudzingwa, Tawona Mudzviti, Agnes Mary Mugagga, Hilda Mujuru, Emmanuel Mujyambere, Trust Mukanganiki, Cynthia Mukisa Williams, Mark Mulder, Disan Mulima, Alice Mulindwa, Vivian Mumbiro, Maria Angeles Muñoz Fernandez, Zivai Mupambireyi, Zivai Mupambireyi, Alba Murciano Cabeza, Dorothy Murungu, Dorothy Murungu, Sandra Musarurwa, Alex Musiime, Alex Musiime, Victor Musiime, Maria Musisi, Barbara Musoke Nakirya, Barbara Musoke Nakirya, Godfrey Musoro, Sobia Mustafa, Sharif Musumba, Shirley Mutsai, Phyllis Mwesigwa Rubondo, Mariam Naabalamba, Immaculate Nagawa, Allemah Naidoo, Terence Nair, Shamim Nakabuye, Shamim Nakabuye, Sarah Nakalanzi, Zaam Zinda Nakawungu, Justine Nalubwama, Annet Nalugo, Stella Nalusiba, Clementine Namajja, Sylvia Namanda, Paula Namayanja, Esther Nambi, Rachael K. Namuddu, Stella Namukwaya, Florence Namuli, Josephine Namusanje, Rosemary Namwanje, Anusha Nanan-kanjee, Annet Nanduudu, Charity Nankunda, Maria Nannungi, Winnie Nansamba, Kesdao Nanthapisal, Juliet Nanyonjo, Sathaporn Na-Rajsima, Alessandra Nardone, Claire Nasaazi, Helena Nascimento, Eleni Nastouli, KUSUM J. NATHOO, Ian Natuhurira, Rashidah Nazzinda, Thabisa Ncgaba, Milly Ndigendawani, Makhosonke Ndlovu, Georgina Nentsa, Chaiwat Ngampiyaskul, Ntombenhle Ngcobo, Nicole Ngo Giang Huong, Pia Ngwaru, Ruth Nhema, Gloria Ninsiima, Gloria Ninsiima, Misheck Nkalo Phiri, Antoni Noguera Julian, Monica Nolan, Thornthun Noppakaorattanamanee, Muzamil Nsibuka Kisekka, Eniola Nsirim, Rashina Nundlal, Rosita Nunes, Melisha Nunkoo, Lungile Nyantsa, Mandisa Nyati, Sean O'Riordan, Paul Ocitti Labeja, Rachel Oguntimehin, Martin Ojok, Geoffrey Onen, Wilma Orange, Akshmi Ori, Benson Ouma, Pradthana Ounchanum, Andreia Padrao, Deborah Pako, Anna Parker, Malgorzata Pasko-Szcech, Reena Patel, Rukchanok Peongjakta, Rukchanok Peongjakta, Turian Petpranee, Tasmin Phillips, Jackie Philps, Laura Picault, Sonja Pieterse, Collin Pillay, Enbavani Pillay, Helena Pinheiro, Supawadee Pongprapass, A. Pozniak, Andrew Prendergast, Luis Prieto Tato, Patcharee Puangmalai, Thanyawee Puthanakit, Sheroma Rajkumar, Modiehi Rakgokong, Helena Ramos, Nastassja Ramsagar, Cornelius Rau, Yoann Riault, Pablo Rojo Conejo, Eddie Rubanga, Baker Rubinga, Chutima Ruklao, Pattira Runarassamee, Diana Antonia Rutebarika, Diana Antonia Rutebarika, Chalermpong Saenjum, Chayakorn Saewtrakool, Yacine Saïdi, Talía Sáinz Costa, Chutima Saisaengjan, Rebecca Sakwa, Tatiana Sarfati, Noshalaza Sbisi, Dihedile Scheppers, Stephan Schultze-Strasser, Ulf Schulze-Sturm, Karen Scott, Janet Seeley, Robert Serunjogi, Leora Sewnarain, Clare Shakeshaft, Mercy Shibemba, Delane Shingadia, Subashinie Sidhoo, Elishka Singh, Sheleika Singh, Wasna Sirirungsi, Sibongile Sithebe, Theresa Smit, Kurt Smith, Marlize Smuts, Marlize Smuts, Wipaporn Natalie Songtaweesin, Moira Spyer, Moira Spyer, Worathip Sripaoraya, Ussanee Srirompotong, Warunee Srisuk, Mark Ssenyonga, Patamawadee Sudsaard, Praornsuda Sukrakanchana, Pathanee Tearsansern, Carla Teixeira, Kanchana Than-in-at, Thitiwat Thapwai, Yupawan Thaweesombat, Jutarat Thewsoongnoen, Rodolphe Thiébaut, Margaret Thomason, Laura Thrasyvoulou, Khanungnit Thungkham, Judith Tikabibamu, Gloria Tinago, Ketmookda Trairat, Gareth Tudor-Williams, Mercy Tukamushaba, Deogratiuos Tukwasibwe, Julius Tumusiime, Joana Tuna, Anna Turkova, Anna Turkova, Rebecca Turner, Arttasid Udomvised, Aasia Vadee, Hesti Van Huyssteen, Nadine Van Looy, Ebrahim Variava, Yvonne Vaughan-Gordon, Giulio Vecchia, Avy Violari, Richard Vowden, Hylke Waalewijn, Rebecca Wampamba, C Warambwa, Steve Welch, Ian Weller, Sibusisiwe Weza, Ellen White, Ian R. White, Kaja Widuch, Helen Wilkes, Sookpanee Wimonklang, James Wyncoll, Ben Wynne, Nompumelelo Yende, Pacharaporn Yingyong, Peter Zuidewind · 发表于：The Lancet Child & Adolescent Health · 年份：2026 · DOI：10.1016/s2352-4642(25)00339-6 · 被引用次数：1 · 研究领域：HIV-related health complications and treatments、HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions

BACKGROUND: ODYSSEY trial showed superior efficacy of dolutegravir-based antiretroviral therapy (ART) versus then-current, non-dolutegravir standard of care over 96 weeks in children and adolescents living with HIV. The aim of this ancillary analysis was to compare anthropometric and body composition outcomes, including weight, height, BMI-for-age Z score, weight-for-age and height-for-age Z scores (<14 kg), mid-upper-arm circumference (MUAC), waist circumference, hip circumference, and body fat percentage, as well as metabolic outcomes (lipids and glucose), between dolutegravir and standard of care over approximately 5 years of follow-up. METHODS: In this open-label, randomised, non-inferiority trial, children (aged ≥4 weeks and <18 years), weighing 3 kg or more, starting first-line ART (ODYSSEY-A) or switching to second-line ART (ODYSSEY-B) were enrolled in 29 centres in Germany, Portugal, South Africa, Spain, Thailand, Uganda, Zimbabwe, and the UK in two cohorts (children weighing ≥14 kg and children weighing <14 kg). Treatment effects (dolutegravir vs standard of care) were estimated on randomised allocation, accounting for treatment switches (substantial in standard of care arm during extended follow-up) through censoring and inverse-probability-of-censoring-weights. Changes in continuous outcomes were compared using linear mixed models, accounting for correlated slope and baseline value. Proportions of participants with unfavourable outcomes were compared using logistic...