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JOURNAL ARTICLE
Irene Nakatudde, Elizabeth Katana, Eva Laker Agnes Odongpiny, Esther Alice Nalugga, Barbara Castelnuovo, Mary Glenn Fowler, Philippa Musoke
BACKGROUND: Dolutegravir (DTG)-based antiretroviral therapy (ART) is currently the preferred first-line treatment for persons living with HIV (PLHIV) including children and adolescents in many low- and middle-income countries including Uganda. However, there are concerns about excessive weight gain associated with DTG especially in adults. There remains paucity of current information on weight-related outcomes among adolescents on DTG. We determined the prevalence of excessive weight gain and associated factors among adolescents living with HIV (ALHIV) receiving DTG-based ART in Kampala, Uganda...
April 18, 2024: AIDS Research and Therapy
#2
JOURNAL ARTICLE
Anna Turkova, Man K Chan, Cissy Kityo, Adeodata R Kekitiinwa, Philippa Musoke, Avy Violari, Ebrahim Variava, Moherndran Archary, Tim R Cressey, Suwalai Chalermpantmetagul, Kanokkorn Sawasdichai, Pradthana Ounchanum, Suparat Kanjanavanit, Sakulrat Srirojana, Ussanee Srirompotong, Steven Welch, Alasdair Bamford, Cristina Epalza, Clàudia Fortuny, Angela Colbers, Eleni Nastouli, Simon Walker, Dan Carr, Magda Conway, Moira J Spyer, Nazia Parkar, Iona White, Alessandra Nardone, Margaret J Thomason, Rashida A Ferrand, Carlo Giaquinto, Deborah Ford
BACKGROUND: There is increasing interest in utilising two-drug regimens for HIV treatment with the goal of reducing toxicity and improve acceptability. The D3 trial evaluates the efficacy and safety of DTG/3TC in children and adolescents and includes a nested pharmacokinetics(PK) substudy for paediatric drug licensing. METHODS: D3 is an ongoing open-label, phase III, 96-week non-inferiority randomised controlled trial(RCT) conducted in South Africa, Spain, Thailand, Uganda and the United Kingdom...
April 16, 2024: Contemporary Clinical Trials
#3
JOURNAL ARTICLE
Elfride Irawati Sianturi, Viona Stephany Longe, Retha Arjadi, Nur Fadilah Bakri, Elsye Gunawan, Ego Srivajawaty Sinaga
Suicide remains a major public health problem, with nearly 1 million deaths per year. The number tends to increase over time and factors leading to suicide suicidal behaviors are complex. However, there is a paucity of evidence on suicidal behaviors and the associated factors among people living with HIV (PLWH) in Indonesia. Therefore, this study aimed to estimate the prevalence and associated factors of suicidal behavior between indigenous and non-indigenous living with HIV who were on Dolutegravir and Efavirenz therapies...
April 15, 2024: Journal of Immigrant and Minority Health
#4
JOURNAL ARTICLE
Lucky Makonokaya, Alice Maida, Louiser Upile Kalitera, Alice Wang, Lester Kapanda, Dumbani Kayira, Madalitso Bottoman, Harrid Nkhoma, Shalom Dunga, Zuze Joaki, Rachel Chamanga, Kondwani Nkanaunena, Susan Hrapcak, Rose Nyirenda, Brown Chiwandira, Martin Maulidi, Godfrey Woelk, Rhoderick Machekano, Thulani Maphosa
Viral suppression (VS) in children has remained suboptimal compared to that in adults. We evaluated the impact of transitioning children weighing < 20 kg to a pediatric formulation of dolutegravir (pDTG) on VS in Malawi. We analyzed routine retrospective program data from electronic medical record systems pooled across 169 healthcare facilities in Malawi supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). We included children who weighed < 20 kg and received antiretroviral therapy (ART) between July 2021-June 2022...
April 13, 2024: AIDS and Behavior
#5
JOURNAL ARTICLE
Leonore Greybe, Shaun Barnabas, Mark Cotton, Penelope Rose, Helena Rabie, Lisa Frigati
BACKGROUND: We assessed the Pathological Determinants of Atherosclerosis in Youth (PDAY) score and other potential cardiovascular disease risk factors in adolescents previously enrolled in the Children with HIV Early antiRetroviral (CHER) and International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1060 clinical trials. METHODS: Coronary artery and abdominal aorta (AA) PDAY scores were calculated for 56 participants over 15 years of age using a weighted combination of dyslipidemia, cigarette smoking, hypertension, obesity, and hyperglycemia...
March 26, 2024: Pediatric Infectious Disease Journal
#6
JOURNAL ARTICLE
Jennifer Jao, Lauren B Bonner, Katrina Dobinda, Kathleen M Powis, Shan Sun, Justine Legbedze, Keolebogile N Mmasa, Joseph Makhema, Mompati Mmalane, Samuel Kgole, Gosego Masasa, Sikhulile Moyo, Mariana Gerschenson, Terence Mohammed, Elaine J Abrams, Irwin J Kurland, Mitchell E Geffner
BACKGROUND: There are little data on changes in insulin sensitivity during the first few years of life following in utero human immunodeficiency virus (HIV) and antiretroviral (ARV) exposure. METHODS: The Tshilo Dikotla study enrolled pregnant persons with HIV (PWH) (receiving tenofovir/emtricitabine or lamivudine plus dolutegravir or efavirenz) and pregnant individuals without HIV, as well as their liveborn children. Newborns were randomized to receive either zidovudine (AZT) or nevirapine (NVP) postnatal prophylaxis...
March 26, 2024: Clinical Infectious Diseases
#7
JOURNAL ARTICLE
Tom G Jacobs, Dorothy Okemo, Anthony Ssebagereka, Kenneth Mwehonge, Emily M Njuguna, David M Burger, Angela Colbers, Fatima Suleman, Aukje K Mantel-Teeuwisse, Gaby I Ooms
INTRODUCTION: The large number of deaths among children with HIV is driven by poor antiretroviral treatment (ART) coverage among this cohort. The aim of the study was to assess the availability and stock-outs of paediatric and adult ART formulations in Kenya and Uganda across various regions and types of health facilities. METHODS: A survey on availability and stock-outs of paediatric ART at health facilities was adapted from the standardized Health Action International-WHO Medicine Availability Monitoring Tool...
March 18, 2024: HIV Medicine
#8
JOURNAL ARTICLE
Akash Devendra, Maurus Kohler, Motlatsi Letsika, Hape Khooa, Lipontso Motaboli, Malebanye Lerotholi, Nadine Tschumi, Niklaus D Labhardt, Jennifer A Brown
BACKGROUND: Treatment failure is common among children and adolescents with HIV. Antiretroviral therapy (ART) containing dolutegravir has recently been rolled out across Africa, though long-term real-world data in paediatric populations are lacking. Here, we report treatment outcomes among children and adolescents in Lesotho who transitioned from non-nucleoside reverse transcriptase inhibitor- (NNRTI-) to dolutegravir-based ART through two years' follow-up. METHODS: Data were derived from two open cohort studies in Lesotho...
January 10, 2024: AIDS
#9
JOURNAL ARTICLE
Stephen A Spector, Sean S Brummel, Audrey Chang, Andrew Wiznia, Theodore D Ruel, Edward P Acosta
BACKGROUND: Dolutegravir plasma concentrations and pharmacokinetic (PK) parameters in children display considerable variability. Here, the impact of genetic variants in ABCG2 421C>A (rs2231142), NR1I2 63396 C>T (rs2472677) and UGT1A1 (rs5839491) on dolutegravir PK was examined. METHODS: Children defined by age and administered dolutegravir formulation had AUC24 at steady state, Cmax and C24h determined. Associations between genetic variants and PK parameters were assessed using the dominant inheritance model...
January 3, 2024: Journal of Acquired Immune Deficiency Syndromes: JAIDS
#10
JOURNAL ARTICLE
Caterina Casalini, Yema D'Almeida, Moussa Ariziki Nassam, Essopha Kokoloko, Souley Wade, Jean Paul Tchupo, Messan Damarly, Justin Mandala, Michele Lanham, Natasha Mack, Chris Akolo, Vincent Polakinam Pitche, Hugues Guidigbi, Claver Anoumou Dagnra
BACKGROUND: According to UNAIDS, Togo halved AIDS-related deaths among children ages 0-14 from 2010 to 2020. However, available data show low dolutegravir (DTG)-containing antiretroviral therapy (ART) coverage and low viral load suppression (VLS) among children living with HIV (CLHIV). We analyzed routine facility data before and after implementation of root-cause-based solutions for improving DTG coverage, viral load (VL) testing coverage, and VLS among CLHIV. DESCRIPTION: We analyzed routine data for CLHIV ≤14 years from October 2019 through September 2022...
2023: PloS One
#11
JOURNAL ARTICLE
Michelle A Bulterys, Irene Njuguna, Maureen King'e, Daisy Chebet, Hellen Moraa, Laurén Gomez, Alvin Onyango, Kenneth Malavi, Gladys Nzia, Martin Chege, Jillian Neary, Anjuli D Wagner, Kendall A Lawley, Dalton Wamalwa, Sarah Benki-Nugent, Grace John-Stewart
INTRODUCTION: Predictors of neurodevelopment among children who are HIV-exposed uninfected (CHEU) are poorly understood. METHODS: Mothers with and without HIV and their children were enrolled during 6-week postnatal care visits across seven sites in Kenya between March 2021 and June 2022. Infant neurodevelopment was assessed using the Malawi Developmental Assessment Tool, including social, language, fine motor and gross motor domains. We used multivariate linear mixed effects models to identify associations between 1-year neurodevelopment scores, HIV and antiretroviral therapy (ART) exposures, and household factors, adjusted for potential confounders and clustered by the site...
October 2023: Journal of the International AIDS Society
#12
JOURNAL ARTICLE
Juan Ambrosioni, Laura Levi, Jasmini Alagaratnam, Kathrin Van Bremen, Andrea Mastrangelo, Hylke Waalewijn, Jean-Michel Molina, Giovanni Guaraldi, Alan Winston, Christoph Boesecke, Paola Cinque, Alasdair Bamford, Alexandra Calmy, Catia Marzolini, Esteban Martínez, Cristiana Oprea, Steven Welch, Anna Koval, Luis Mendao, Jürgen K Rockstroh
BACKGROUND: The European AIDS Clinical Society (EACS) guidelines were revised in 2023 for the 19th time, and all aspects of HIV care were updated. KEY POINTS OF THE GUIDELINES UPDATE: Version 12.0 of the guidelines recommend the same six first-line treatment options for antiretroviral treatment (ART)-naïve adults as versions 11.0 and 11.1: tenofovir-based backbone plus an unboosted integrase inhibitor or doravirine; abacavir/lamivudine plus dolutegravir; or dual therapy with lamivudine or emtricitabine plus dolutegravir...
November 2023: HIV Medicine
#13
RANDOMIZED CONTROLLED TRIAL
Linda Namutebi Barlow-Mosha, Grace Miriam Ahimbisibwe, Elizabeth Chappell, Pauline Mary Amuge, Annet Nanduudu, Elizabeth Kaudha, Timothy Amukele, David Balamusani, Bosco Kafufu, Audrey Nimwesiga, Hajira Kataike, Rosemary Namwanje, Gladys Kasangaki, Alice Mulindwa, Gerald Agaba Muzorah, Dickson Bbuye, Victor Musiime, Emmanuel Mujyambere, Mark Ssenyonga, Disan Mulima, Raymonds Crespo Kyambadde, Josephine Namusanje, Richard Isabirye, Mariam Nabalamba, Barbara Musoke Nakirya, Cissy Kityo, Adeodata R Kekitiinwa, Carlo Giaquinto, Andrew Copp, Diana M Gibb, Deborah Ford, Philippa Musoke, Anna Turkova
INTRODUCTION: Dolutegravir-based antiretroviral therapy (ART) is the preferred antiretroviral treatment for children and adolescents living with HIV. A large surveillance study in Botswana previously raised concerns about an association between pre-conception dolutegravir and neural tube defects. Before these concerns were subsequently resolved, we set up a sub-study to look at the effect of dolutegravir on levels of folate and vitamin B12 in children and adolescents within the randomized ODYSSEY trial, as folate and vitamin B12 are known to play a crucial role in neural tube development...
September 2023: Journal of the International AIDS Society
#14
JOURNAL ARTICLE
Hardik Chandasana, Mita Thapar, Siobhan Hayes, Mark Baker, Diana M Gibb, Anna Turkova, Deborah Ford, Theodore Ruel, Andrew Wiznia, Lee Fairlie, Mutsa Bwakura-Dangarembizi, Hilda Mujuru, Carmelita Alvero, Mona Farhad, Rohan Hazra, Ellen Townley, Ann Buchanan, Pauline Bollen, Hylke Waalewijn, Angela Colbers, David Burger, Edward P Acosta, Rajendra Singh
BACKGROUND AND OBJECTIVE: HIV treatment options remain limited in children. Dolutegravir is a potent and well-tolerated, once-daily HIV-1 integrase inhibitor recommended for HIV-1 infection in both adults and children down to 4 weeks of age. To support pediatric dosing of dolutegravir in children, we used a population pharmacokinetic model with dolutegravir data from the P1093 and ODYSSEY clinical trials. The relationship between dolutegravir exposure and selected safety endpoints was also evaluated...
August 21, 2023: Clinical Pharmacokinetics
#15
RANDOMIZED CONTROLLED TRIAL
Anna Turkova, Ellen White, Adeodata R Kekitiinwa, Vivian Mumbiro, Elizabeth Kaudha, Afaaf Liberty, Grace Miriam Ahimbisibwe, Tumelo Moloantoa, Ussanee Srirompotong, Nozibusiso Rejoice Mosia, Thanyawee Puthanakit, Robin Kobbe, Clàudia Fortuny, Hajira Kataike, Dickson Bbuye, Sathaporn Na-Rajsima, Alexandra Coelho, Abbas Lugemwa, Mutsa F Bwakura-Dangarembizi, Nigel Klein, Hilda A Mujuru, Cissy Kityo, Mark F Cotton, Rashida A Ferrand, Carlo Giaquinto, Pablo Rojo, Avy Violari, Diana M Gibb, Deborah Ford
BACKGROUND: Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. METHODS: This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment...
October 2023: Lancet Child & Adolescent Health
#16
MULTICENTER STUDY
Kristina M Brooks, Jennifer J Kiser, Lauren Ziemba, Shawn Ward, Yasha Rani, Tim R Cressey, Gaerolwe R Masheto, Haseena Cassim, Jaime G Deville, Ponego L Ponatshego, Faeezah Patel, Linda Aurpibul, Shaun L Barnabas, Iris Mustich, Anne Coletti, Barbara Heckman, Chelsea Krotje, Mark Lojacono, Dwight E Yin, Ellen Townley, Jack Moye, Sai Majji, Edward P Acosta, Kevin Ryan, Hardik Chandasana, Cynthia H Brothers, Ann M Buchanan, Helena Rabie, Patricia M Flynn
BACKGROUND: Child-friendly fixed-dose combination (FDC) antiretroviral therapy (ART) options are limited. We evaluated the pharmacokinetics, safety, and tolerability of dispersible and immediate-release FDC abacavir, dolutegravir, and lamivudine taken once per day in children younger than 12 years with HIV. METHODS: IMPAACT 2019 was an international, phase 1-2, multisite, open-label, non-comparative dose-confirmation study of abacavir, dolutegravir, and lamivudine in children younger than 12 years...
August 2023: Lancet HIV
#17
JOURNAL ARTICLE
Vincent J Tukei, Nicole Herrera, Matseliso Masitha, Lieketseng Masenyetse, Majoalane Mokone, Mafusi Mokone, Limpho Maile, Michelle M Gill
INTRODUCTION: We describe transition of HIV-positive children from efavirenz- or nevirapine-based antiretroviral therapy (ART) to optimal dolutegravir (DTG) or lopinavir/ritonavir (LPV/r) (solid formulation)-based ART in Lesotho. METHODS: We followed a cohort of children less than 15 years of age who were initiated on ART on or after January 1, 2018 from 21 selected health facilities in Lesotho. From March 2020 to May 2022, we collected data retrospectively through chart abstraction and prospectively through caregiver interviews to cover a period of 24 months following treatment initiation...
2023: PloS One
#18
JOURNAL ARTICLE
Michelle M Gill, Nicole Herrera, Rui Guilaze, Abdul Mussa, Nataniel Dengo, Amancio Nhangave, Jaciara Mussá, Patricia Perez, Nilesh Bhatt
BACKGROUND: Dolutegravir (DTG) was scaled up globally to optimize treatment for children living with HIV. We evaluated the rollout and virological outcomes after DTG introduction in Mozambique. METHODS: Data from children 0-14 years with visits from September 2019 to August 2021 were extracted from records in 16 facilities in 12 districts. Among children ever on DTG, we report treatment switches, defined as changes in anchor drug, regardless of changes to nucleoside reverse transcriptase inhibitor (NRTI) backbones...
July 6, 2023: Pediatric Infectious Disease Journal
#19
JOURNAL ARTICLE
Erik Belfrage, Sandra Soeria-Atmadja, Lars Navér
BACKGROUND: Pediatric HIV infection cause retardation in height and weight. However, effective antiretroviral therapy (ART) result in desirable weight gain. Concerns have emerged regarding excessive weight gain related to the integrase inhibitor dolutegravir in adults but knowledge about the circumstances in children/adolescents is limited. We studied if dolutegravir containing ART or switch to dolutegravir affected body mass index (BMI) and described height development in the Stockholm pediatric/adolescent HIV cohort...
July 4, 2023: BMC Pediatrics
#20
JOURNAL ARTICLE
Joseph Fokam, Alex Durand Nka, Flore Yollande Mamgue Dzukam, Jeremiah Efakika Gabisa, Yagai Bouba, Michel Carlos Tommo Tchouaket, Aude Christelle Ka'e, Ezechiel Ngoufack Jagni Semengue, Desire Takou, Sylvie Moudourou, Nadine Fainguem, Willy Pabo, Rachel Audrey Nayang Mundo, Aurelie Minelle Kengni Ngueko, Collins Ambe Chenwi, Junie Flore Yimga, Marie Krystel Nnomo Zam, Rachel Simo Kamgaing, Charlotte Tangimpundu, Nelly Kamgaing, Anne-Esther Njom-Nlend, Paul Ndombo Koki, Daniel Kesseng, Suzie Ndiang Tetang, Etienne Kembou, Lifanda Ebiama Lifanda, Bouba Pamen, Alice Ketchaji, Edith Saounde Temgoua, Serge Clotaire Billong, Anne-Cecile Zoung-Kanyi Bissek, Hamsatou Hadja, Edie Gregory Halle, Vittorio Colizzi, Carlo-Federico Perno, Samuel Martin Sosso, Alexis Ndjolo
This study aimed to compare viral suppression (VS) between children, adolescents, and adults in the frame of transition to dolutegravir (DTG)-based antiretroviral therapy (ART) in the Cameroonian context. A comparative cross-sectional study was conducted from January 2021 through May 2022 amongst ART-experienced patients received at the Chantal BIYA International Reference Centre in Yaounde-Cameroon, for viral load (VL) monitoring. VS was defined as VL < 1000 copies/mL and viral undetectability as VL < 50 copies/mL...
May 19, 2023: Medicine (Baltimore)
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