33 research outputs found
Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial
- Author
- Abraham Pattamukkil
- Abrams Elaine
- Acero Judith
- Agaba Gerald Muzorah
- Ahimbisibwe Grace
- Ahimbisibwe Grace Miriam
- Ainebyoona Barbara
- Akhalwaya Yasmeen
- Akobye Winnie
- Akoojee Nazim
- Ali Shabinah
- Ali Shabinah S
- Amuge Pauline
- Amuge Pauline
- Andrea Catherine
- Ankunda Rogers
- Anugulruengkitt Suvaporn
- Apollo Tsitsi
- Archary Moherndran
- Archary Moherndran
- Arendze Ronelle
- Ategeka Juliet
- Atim Eunice
- Atwine Lorna
- Babiker Abdel
- Babirye Sarah
- Babu Enock
- Baddokwaya Joanita Nankya
- Bagirigomwa Edward
- Baita Angella
- Balamusani David
- Baliram Patsy
- Baliruno David
- Ball Colin
- Balwa Henry
- Bamford Alasdair
- Bandi Srini
- Barker Dominique
- Barlow-Mosha Linda
- Bbuye Dickson
- Begum Shazia
- Behuhuma Osee
- Bernays Sarah
- Besigye Rogers
- Bester Maria
- Bhiri Joyline
- Bilardi Davide
- Bird Kristien
- Bollen Pauline
- Bollen Pauline DJ
- Borg Chiara
- Borges Da Silva Anne-Marie
- Brown Jackie
- Bruno Elena
- Bunupuradah Torsak
- Burger David
- Burger David M
- Buthelezi Nomzamo
- Bwakura-Dangarembizi Mutsa
- Bwakura-Dangarembizi Mutsa F
- Byaruhanga Africanus
- Calvert Joanna
- Casey Petronelle
- Cassim Haseena
- Cebekhulu Sphiwee
- Chailert Sanuphong
- Chalermpantmetagul Suwalai
- Chamjamrat Wanna
- Chan Man
- Chan Man K
- Chandiwana Precious
- Chankun Thannapat
- Chanthaburanun Sararut
- Chanto Nuttawut
- Chidziva Ennie
- Chikowore Minenhle
- Chimanzi Joy
- Chinwong Dujrudee
- Chitongo Stuart
- Chitsamatanga Moses
- Choga Joshua
- Chutima Duangrat
- Clark Basiimwa Roy
- Clayden Polly
- Coelho Alexandra
- Colbers Angela
- Colbers Angela
- Compagnucci Alexandra
- Constança Mendes Ana
- Conway Magda
- Cotton Mark F
- Cotton Mark F
- Crawley Jane
- Cressey Tim R
- Crisp Jacky
- Dadan Sumaya
- Daglish Jacqui
- Danaviah Siva
- Daniel Tseleng
- De Rossi Anita
- Denjanta Sukanda
- Dobbels Els
- Dowie Maria
- Dube Benedictor
- Dube Prosper
- Dudakia Nimisha
- Elwana Alice
- Epalza Cristina
- Eram David
- Erasmus Juan
- Erim Peter
- Escosa Garcia Luis
- Essack Zaakirah
- Estepa Carolina
- Etima Monica
- Fernandes Alexandre
- Fernandez Maite
- Ferrand Rashida A
- Fitzgerald Felicity
- Flynn Jacquie
- Ford Deborah
- Ford Deborah
- Fortuny Guasch Claudia
- Foster Caroline
- Fourie George
- Fourie Yolandie
- Foxall Sophie
- Frank Derusha
- Gandhi Kate
- Garcia India
- Gartner Kathleen
- Gasa Gugu
- Gasa Joshua
- Giaquinto Carlo
- Gibb Diana M
- Gibb Diana M
- Gomez Rico Coral
- Gomez-Pena Daniel
- Gondo Secrecy
- Goodman Anna
- Gorreti Nakalema Maria
- Gozhora Winnie
- Greetanukroh Pisut
- Gregorio Maranon Biobanco
- Grossele Tiziana
- Gwande Shamiso
- Gwaze Tapiwa
- Gwenzi Tsitsi
- Hakim James
- Hakiza Emmanuel
- Harley Ashley
- Isaacs Mornay
- Isabirye Richard
- Ishemunyoro Wilber
- Jacobs Tom
- Jafta Lungile
- Jamil Nasir
- Janse van Rensburg Anita Janse
- Jeaven Vinesh
- Jimenez Jose Luis
- Jourdain Gonzague
- Juliet Katabalwa
- Jumpimai Thidarat
- Junkaew Raungwit
- Jupimai Thidarat
- Kaahwa Winfred
- Kabasonga Mildred
- Kaboggoza Olivia
- Kadhuba Rose Jacqueline
- Kaewbundit Ampika
- Kaewmamueng Kanyanee
- Kafufu Bosco
- Kaka Abdul Hamid
- Kakayi Brenda
- Kamboua Phakamas
- Kanjanavanit Suparat
- Kasangaki Gladys
- Kasipong Naruporn
- Kasozi Miriam
- Kataike Hajira
- Katemba Chrispus
- Kaudha Elizabeth
- Kekane Nkata
- Kekitiinwa Adeodata R
- Kekitiinwa Adeodata R
- Keminyeto Edridah
- Khamduang Woottichai
- Khamjakkaew Warunee
- Khamkon Jiraporn
- Khannak Sasipass
- Khatngam Orapin
- Khayanchoomnoom Tassawan
- Khumalo Busi
- Khunene Mirriam
- Khusuwan Suwimon
- Kibalama Phionah
- Kibenge Robinah
- Kirabira Anthony
- Kityo Cissy M
- Kityo Cissy M
- Kiyimba Lameck
- Klein Nigel
- Klinprung Soraya
- Kobbe Robin
- Kobusingye Olivia
- Kobusungye Josephine
- Kongponoi Areerat
- Koole Olivier
- Kouakam Christelle
- Krueduangkam Nitinart
- Kruenual Namthip
- Kunjaroenrut Nuananong
- Kyambadde Raymonds
- Kyobutungi Priscilla
- Kyomuhendo Flavia
- Kyomukama Erinah
- Königs Christoph
- Lakha Reshma
- Langa Cleopatra
- Laomanit Laddawan
- Lebotsa Emily
- Leenasirimakul Prattana
- Lekku Lawrence
- Lensen Sarah
- Leroy Valériane
- Li Jin
- Liberty Afaaf
- Limplertjareanwanich Juthamas
- Little Emma
- Lugemwa Abbas
- Lugemwa Abbas
- Lutalo Ezra
- Lyall Hermione
- MacDonald Candice
- Machache Gladness
- Madlala Penelope
- Madonsela Tryphina
- Maduna Nomfundo
- Maena Joel
- Mahanontharit Apicha
- Makanga Collin
- Makola Candice
- Makumbi Shafic
- Malgraaf Lucille
- Mamiane Angelous
- Mantkowski Felicia
- Mapfumo Wendy
- Marques Laura
- Maseko Lindiwe
- Masienyane Tshepiso
- Mathiba Ruth
- Matimba Farai
- Matos Ana Cristina
- Mawlana Sajeeda
- Mayanja Emmanuel
- Mayat Fatima
- Mbabazi Ritah
- Mbadaliga Nokuthula
- Mbasani Faith
- McClaughlin Kathleen
- McIlleron Helen
- Meethaisong Watchara
- Mehar (nee Abdulla) Amina Farhana
- Mellado Peña Maria José
- Mendez Garcia Patricia
- Miranda Carlota
- Miwanda Annet
- Mkhize Siphiwe
- Mmolawa Kgosimang
- Mngqibisa Rosie
- Mohamed Fatima
- Moloantoa Tumelo
- Monametsi Maletsatsi
- Montero Samuel
- Moore Cecilia L
- Mosia Rejoice
- Moyo Columbus
- Mthethwa Mumsy
- Mudzingwa Shepherd
- Mudzviti Tawona
- Mugagga Agnes Mary
- Mujuru Hilda
- Mujyambere Emmanuel
- Mukanganiki Trust
- Mukisa Williams Cynthia
- Mulder Mark
- Mulima Disan
- Mulindwa Alice
- Mumbiro Vivian
- Mumbiro Vivian
- Mupambireyi Zivai
- Murciano Cabeza Alba
- Murungi Herbert
- Murungu Dorothy
- Musarurwa Sandra
- Musiime Alex V
- Musiime Victor
- Musisi Maria
- Musoke Nakirya Barbara
- Musoke Philippa
- Musoro Godfrey
- Mustafa Sobia
- Musumba Sharif
- Mutsai Shirley
- Muñoz Fernandez Maria Angeles
- Mwesigwa Rubondo Phyllis
- Na-Rajsima Sathaporn
- Naabalamba Mariam
- Nagawa Immaculate
- Naidoo Allemah
- Nakabuye Sarah
- Nakabuye Shamim
- Nakalanzi Sarah
- Nakawungu Zaam Zinda
- Nalubwama Justine
- Nalugo Annet
- Nalusiba Stella
- Namajja Clementine
- Namanda Sylvia
- Namayanja Paula
- Nambi Esther
- Namuddu Rachael Kikabi
- Namukwaya Stella
- Namuli Florence
- Namusanje Josephine
- Namwanje Rosemary
- Nanan-kanjee Anusha
- Nanduudu Annet
- Nankunda Charity
- Nannungi Maria
- Nansamba Winnie
- Nanthapisal Kesdao
- Nanyonjo Juliet
- Nasaazi Claire
- Nascimento Helena
- Nastouli Eleni
- Nathoo Kusum
- Natuhurira Ian
- Nazzinda Rashidah
- Ncgaba Thabisa
- Ndigendawani Milly
- Ndlovu Makhosonke
- Nentsa Georgina
- Ngampiyaskul Chaiwat
- Ngcobo Ntombenhle
- Ngo Giang Huong Nicole
- Ngwaru Pia
- Nhema Ruth
- Ninsiima Emily
- Ninsiima Gloria
- Nkalo Phiri Misheck
- Noguera Julian Antoni
- Nolan Monica
- Noppakaorattanamanee Thornthun
- Nsibuka Kisekka Muzamil
- Nsirim Eniola
- Nundlal Rashina
- Nunes Rosita
- Nyantsa Lungile
- Nyati Mandisa
- O'Riordan Sean
- Ocitti Labeja Paul
- Odoch Denis
- Oguntimehin Rachel
- Ojok Martin
- Onen Geoffrey
- Orange Wilma
- Ouma Benson
- Ounchanum Pradthana
- Padrao Andreia
- Pako Deborah
- Parker Anna
- Pasko-Szcech Malgorzata
- Patel Reena
- Peongjakta Rukchanok
- Petpranee Turian
- Phillips Tasmin
- Philps Jackie
- Picault Laura
- Pieterse Sonja
- Pinheiro Helena
- Pongprapass Supawadee
- Pozniak Anton
- Prendergast Andrew
- Prieto Tato Luis
- Puangmalai Patcharee
- Puthanakit Thanyawee
- Rakgokong Modiehi
- Ramos Helena
- Ramsagar Nastassja
- Rau Cornelius
- Riault Yoann
- Rojo Conejo Pablo
- Rubanga Eddie
- Rubinga Baker
- Ruklao Chutima
- Runarassamee Pattira
- Rutebarika Diana Antonia
- Rutebarika Diana Antonia
- Saenjum Chalermpong
- Saewtrakool Chayakorn
- Saidi Yacine
- Sainz Costa Talia
- Saisaengjan Chutima
- Sakwa Rebecca
- Sarfati Tatiana
- Sbisi Noshalaza
- Scheppers Dihedile
- Schultze-Strasser Stephan
- Schulze-Sturm Ulf
- Scott Karen
- Seeley Janet
- Serunjogi Robert
- Sewnarain Leora
- Shakeshaft Clare
- Shibemba Mercy
- Shingadia Delane
- Sidhoo Subashinie
- Singh Sheleika
- Sirirungsi Wasna
- Sithebe Sibongile
- Smit Theresa
- Smith Kurt
- Smuts Marlize
- Songtaweesin Wipaporn Natalie
- Spyer Moira
- Sripaoraya Worathip
- Srirompotong Ussanee
- Srirompotong Ussanee
- Srisuk Warunee
- Ssenyonga Mark
- Sudsaard Patamawadee
- Sukrakanchana Praornsuda
- Tearsansern Pathanee
- Teixeira Carla
- Than-in-at Kanchana
- Thapwai Thitiwat
- Thaweesombat Yupawan
- Thewsoongnoen Jutarat
- Thiébaut Rodolphe
- Thomason Margaret
- Thrasyvoulou Laura
- Thungkham Khanungnit
- Tikabibamu Judith
- Tinago Gloria
- Trairat Ketmookda
- Tudor-Williams Gareth
- Tukamushaba Mercy
- Tukwasibwe Deogratiuos
- Tumusiime Julius
- Tuna Joana
- Turkova Anna
- Turkova Anna
- Turner Rebecca
- Udomvised Arttasid
- Vadee Aasia
- Van Huyssteen Hesti
- Van Looy Nadine
- Variava Ebrahim
- Variava Ebrahim
- Vaughan-Gordon Yvonne
- Vecchia Giulio
- Violari Avy
- Violari Avy
- Vowden Richard
- Waalewijn Hylke
- Waalewijn Hylke
- Wampamba Rebecca
- Welch Steve
- Weller Ian
- Weza Sibusisiwe
- White Ellen
- White Ian
- Widuch Kaja
- Wilkes Helen
- Wimonklang Sookpanee
- Wynne Ben
- Yingyong Pacharaporn
- Zuidewind Peter
- Zuidewind Peter
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/07/2022
- Field of study
Background:
Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB.
Methods:
We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to <18 years) with HIV-associated TB who were receiving rifampicin and twice-daily dolutegravir were eligible for inclusion. We did a 12-h pharmacokinetic profile on rifampicin and twice-daily dolutegravir and a 24-h profile on once-daily dolutegravir. Geometric mean ratios for trough plasma concentration (Ctrough), area under the plasma concentration time curve from 0 h to 24 h after dosing (AUC0–24 h), and maximum plasma concentration (Cmax) were used to compare dolutegravir concentrations between substudy days. We assessed rifampicin Cmax on the first substudy day. All children within ODYSSEY with HIV-associated TB who received rifampicin and twice-daily dolutegravir were included in the safety analysis. We described adverse events reported from starting twice-daily dolutegravir to 30 days after returning to once-daily dolutegravir. This trial is registered with ClinicalTrials.gov (NCT02259127), EudraCT (2014–002632-14), and the ISRCTN registry (ISRCTN91737921).
Findings:
Between Sept 20, 2016, and June 28, 2021, 37 children with HIV-associated TB (median age 11·9 years [range 0·4–17·6], 19 [51%] were female and 18 [49%] were male, 36 [97%] in Africa and one [3%] in Thailand) received rifampicin with twice-daily dolutegravir and were included in the safety analysis. 20 (54%) of 37 children enrolled in the pharmacokinetic substudy, 14 of whom contributed at least one evaluable pharmacokinetic curve for dolutegravir, including 12 who had within-participant comparisons. Geometric mean ratios for rifampicin and twice-daily dolutegravir versus once-daily dolutegravir were 1·51 (90% CI 1·08–2·11) for Ctrough, 1·23 (0·99–1·53) for AUC0–24 h, and 0·94 (0·76–1·16) for Cmax. Individual dolutegravir Ctrough concentrations were higher than the 90% effective concentration (ie, 0·32 mg/L) in all children receiving rifampicin and twice-daily dolutegravir. Of 18 children with evaluable rifampicin concentrations, 15 (83%) had a Cmax of less than the optimal target concentration of 8 mg/L. Rifampicin geometric mean Cmax was 5·1 mg/L (coefficient of variation 71%). During a median follow-up of 31 weeks (IQR 30–40), 15 grade 3 or higher adverse events occurred among 11 (30%) of 37 children, ten serious adverse events occurred among eight (22%) children, including two deaths (one tuberculosis-related death, one death due to traumatic injury); no adverse events, including deaths, were considered related to dolutegravir.
Interpretation:
Twice-daily dolutegravir was shown to be safe and sufficient to overcome the rifampicin enzyme-inducing effect in children, and could provide a practical ART option for children with HIV-associated TB
Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial
- Author
- Abraham Pattamukkil
- Abrams Elaine
- Acero Judith
- Agaba Gerald Muzorah
- Ahimbisibwe Grace
- Ahimbisibwe Grace Miriam
- Ainebyoona Barbara
- Akhalwaya Yasmeen
- Akobye Winnie
- Akoojee Nazim
- Ali Shabinah S
- Amuge Pauline
- Andrea Catherine
- Ankunda Rogers
- Anugulruengkitt Suvaporn
- Apollo Tsitsi
- Archary Moherndran
- Arendze Ronelle
- Ategeka Juliet
- Atim Eunice
- Atwine Lorna
- Babiker Abdel
- Babirye Sarah
- Babu Enock
- Baddokwaya Joanita Nankya
- Bagirigomwa Edward
- Baita Angella
- Balamusani David
- Baliram Patsy
- Baliruno David
- Ball Colin
- Balwa Henry
- Bamford Alasdair
- Bandi Srini
- Barker Dominique
- Barlow-Mosha Linda
- Bbuye Dickson
- Bbuye Dickson
- Begum Shazia
- Behuhuma Osee
- Bernays Sarah
- Besigye Rogers
- Bester Maria
- Bhiri Joyline
- Bilardi Davide
- Bird Kristien
- Bollen Pauline
- Borg Chiara
- Borges Da Silva Anne-Marie
- Brown Jackie
- Bruno Elena
- Bunupuradah Torsak
- Burger David
- Buthelezi Nomzamo
- Bwakura-Dangarembizi Mutsa
- Bwakura-Dangarembizi Mutsa F
- Byaruhanga Africanus
- Calvert Joanna
- Casey Petronelle
- Cassim Haseena
- Cebekhulu Sphiwee
- Chailert Sanuphong
- Chalermpantmetagul Suwalai
- Chamjamrat Wanna
- Chan Man
- Chandiwana Precious
- Chankun Thannapat
- Chanthaburanun Sararut
- Chanto Nuttawut
- Chidziva Ennie
- Chikowore Minenhle
- Chimanzi Joy
- Chinwong Dujrudee
- Chitongo Stuart
- Chitsamatanga Moses
- Choga Joshua
- Chutima Duangrat
- Clark Basiimwa Roy
- Clayden Polly
- Coelho Alexandra
- Coelho Alexandra
- Colbers Angela
- Compagnucci Alexandra
- Constança Mendes Ana
- Conway Magda
- Cotton Mark F
- Cotton Mark F
- Crawley Jane
- Cressey Tim R
- Crisp Jacky
- Dadan Sumaya
- Daglish Jacqui
- Danaviah Siva
- Daniel Tseleng
- De Rossi Anita
- Denjanta Sukanda
- Dobbels Els
- Dowie Maria
- Dube Benedictor
- Dube Prosper
- Dudakia Nimisha
- Elwana Alice
- Epalza Cristina
- Eram David
- Erasmus Juan
- Erim Peter
- Escosa Garcia Luis
- Essack Zaakirah
- Estepa Carolina
- Etima Monica
- Fernandes Alexandre
- Fernandez Maite
- Ferrand Rashida A
- Fitzgerald Felicity
- Flynn Jacquie
- Ford Deborah
- Ford Deborah
- Fortuny Guasch Claudia
- Fortuny Clà udia
- Foster Caroline
- Fourie George
- Fourie Yolandie
- Foxall Sophie
- Frank Derusha
- Gandhi Kate
- Garcia India
- Gartner Kathleen
- Gasa Gugu
- Gasa Joshua
- Giaquinto Carlo
- Giaquinto Carlo
- Gibb Diana M
- Gibb Diana M
- Gomez Rico Coral
- Gomez-Pena Daniel
- Gondo Secrecy
- Goodman Anna
- Gorreti Nakalema Maria
- Gozhora Winnie
- Greetanukroh Pisut
- Gregorio Maranon Biobanco
- Grossele Tiziana
- Gwande Shamiso
- Gwaze Tapiwa
- Gwenzi Tsitsi
- Hakim James
- Hakiza Emmanuel
- Harley Ashley
- Isaacs Mornay
- Isabirye Richard
- Ishemunyoro Wilber
- Jacobs Tom
- Jafta Lungile
- Jamil Nasir
- Janse van Rensburg Anita Janse
- Jeaven Vinesh
- Jimenez Jose Luis
- Jourdain Gonzague
- Juliet Katabalwa
- Jumpimai Thidarat
- Junkaew Raungwit
- Jupimai Thidarat
- Kaahwa Winfred
- Kabasonga Mildred
- Kaboggoza Olivia
- Kadhuba Rose Jacqueline
- Kaewbundit Ampika
- Kaewmamueng Kanyanee
- Kafufu Bosco
- Kaka Abdul Hamid
- Kakayi Brenda
- Kamboua Phakamas
- Kanjanavanit Suparat
- Kasangaki Gladys
- Kasipong Naruporn
- Kasozi Miriam
- Kataike Hajira
- Kataike Hajira
- Katemba Chrispus
- Kaudha Elizabeth
- Kaudha Elizabeth
- Kekane Nkata
- Kekitiinwa Adeodata R
- Kekitiinwa Adeodata R
- Keminyeto Edridah
- Khamduang Woottichai
- Khamjakkaew Warunee
- Khamkon Jiraporn
- Khannak Sasipass
- Khatngam Orapin
- Khayanchoomnoom Tassawan
- Khumalo Busi
- Khunene Mirriam
- Khusuwan Suwimon
- Kibalama Phionah
- Kibenge Robinah
- Kirabira Anthony
- Kityo Cissy
- Kityo Cissy M
- Kiyimba Lameck
- Klein Nigel
- Klein Nigel
- Klinprung Soraya
- Kobbe Robin
- Kobbe Robin
- Kobusingye Olivia
- Kobusungye Josephine
- Kongponoi Areerat
- Koole Olivier
- Kouakam Christelle
- Krueduangkam Nitinart
- Kruenual Namthip
- Kunjaroenrut Nuananong
- Kyambadde Raymonds
- Kyobutungi Priscilla
- Kyomuhendo Flavia
- Kyomukama Erinah
- Königs Christoph
- Lakha Reshma
- Langa Cleopatra
- Laomanit Laddawan
- Lebotsa Emily
- Leenasirimakul Prattana
- Lekku Lawrence
- Lensen Sarah
- Leroy Valériane
- Li Jin
- Liberty Afaaf
- Liberty Afaaf
- Limplertjareanwanich Juthamas
- Little Emma
- Lugemwa Abbas
- Lugemwa Abbas
- Lutalo Ezra
- Lyall Hermione
- MacDonald Candice
- Machache Gladness
- Madlala Penelope
- Madonsela Tryphina
- Maduna Nomfundo
- Maena Joel
- Mahanontharit Apicha
- Makanga Collin
- Makola Candice
- Makumbi Shafic
- Malgraaf Lucille
- Mamiane Angelous
- Mantkowski Felicia
- Mapfumo Wendy
- Marques Laura
- Maseko Lindiwe
- Masienyane Tshepiso
- Mathiba Ruth
- Matimba Farai
- Matos Ana Cristina
- Mawlana Sajeeda
- Mayanja Emmanuel
- Mayat Fatima
- Mbabazi Ritah
- Mbadaliga Nokuthula
- Mbasani Faith
- McClaughlin Kathleen
- McIlleron Helen
- Meethaisong Watchara
- Mehar (nee Abdulla) Amina Farhana
- Mellado Peña Maria José
- Mendez Garcia Patricia
- Miranda Carlota
- Miwanda Annet
- Mkhize Siphiwe
- Mmolawa Kgosimang
- Mngqibisa Rosie
- Mohamed Fatima
- Moloantoa Tumelo
- Moloantoa Tumelo
- Monametsi Maletsatsi
- Montero Samuel
- Moore Cecilia L
- Mosia Nozibusiso Rejoice
- Mosia Rejoice
- Moyo Columbus
- Mthethwa Mumsy
- Mudzingwa Shepherd
- Mudzviti Tawona
- Mugagga Agnes Mary
- Mujuru Hilda
- Mujuru Hilda A
- Mujyambere Emmanuel
- Mukanganiki Trust
- Mukisa Williams Cynthia
- Mulder Mark
- Mulima Disan
- Mulindwa Alice
- Mumbiro Vivian
- Mumbiro Vivian
- Mupambireyi Zivai
- Murciano Cabeza Alba
- Murungi Herbert
- Murungu Dorothy
- Musarurwa Sandra
- Musiime Alex V
- Musiime Victor
- Musisi Maria
- Musoke Nakirya Barbara
- Musoke Philippa
- Musoro Godfrey
- Mustafa Sobia
- Musumba Sharif
- Mutsai Shirley
- Muñoz Fernandez Maria Angeles
- Mwesigwa Rubondo Phyllis
- Na-Rajsima Sathaporn
- Na-Rajsima Sathaporn
- Naabalamba Mariam
- Nagawa Immaculate
- Naidoo Allemah
- Nakabuye Sarah
- Nakabuye Shamim
- Nakalanzi Sarah
- Nakawungu Zaam Zinda
- Nalubwama Justine
- Nalugo Annet
- Nalusiba Stella
- Namajja Clementine
- Namanda Sylvia
- Namayanja Paula
- Nambi Esther
- Namuddu Rachael Kikabi
- Namukwaya Stella
- Namuli Florence
- Namusanje Josephine
- Namwanje Rosemary
- Nanan-kanjee Anusha
- Nanduudu Annet
- Nankunda Charity
- Nannungi Maria
- Nansamba Winnie
- Nanthapisal Kesdao
- Nanyonjo Juliet
- Nasaazi Claire
- Nascimento Helena
- Nastouli Eleni
- Nathoo Kusum
- Natuhurira Ian
- Nazzinda Rashidah
- Ncgaba Thabisa
- Ndigendawani Milly
- Ndlovu Makhosonke
- Nentsa Georgina
- Ngampiyaskul Chaiwat
- Ngcobo Ntombenhle
- Ngo Giang Huong Nicole
- Ngwaru Pia
- Nhema Ruth
- Ninsiima Emily
- Ninsiima Gloria
- Nkalo Phiri Misheck
- Noguera Julian Antoni
- Nolan Monica
- Noppakaorattanamanee Thornthun
- Nsibuka Kisekka Muzamil
- Nsirim Eniola
- Nundlal Rashina
- Nunes Rosita
- Nyantsa Lungile
- Nyati Mandisa
- O'Riordan Sean
- Ocitti Labeja Paul
- Odoch Denis
- Oguntimehin Rachel
- Ojok Martin
- Onen Geoffrey
- Orange Wilma
- Ouma Benson
- Ounchanum Pradthana
- Padrao Andreia
- Pako Deborah
- Parker Anna
- Pasko-Szcech Malgorzata
- Patel Reena
- Peongjakta Rukchanok
- Petpranee Turian
- Phillips Tasmin
- Philps Jackie
- Picault Laura
- Pieterse Sonja
- Pinheiro Helena
- Pongprapass Supawadee
- Pozniak Anton
- Prendergast Andrew
- Prieto Tato Luis
- Puangmalai Patcharee
- Puthanakit Thanyawee
- Puthanakit Thanyawee
- Rakgokong Modiehi
- Ramos Helena
- Ramsagar Nastassja
- Rau Cornelius
- Riault Yoann
- Rojo Conejo Pablo
- Rojo Pablo
- Rubanga Eddie
- Rubinga Baker
- Ruklao Chutima
- Runarassamee Pattira
- Rutebarika Diana Antonia
- Rutebarika Diana Antonia
- Saenjum Chalermpong
- Saewtrakool Chayakorn
- Saidi Yacine
- Sainz Costa Talia
- Saisaengjan Chutima
- Sakwa Rebecca
- Sarfati Tatiana
- Sbisi Noshalaza
- Scheppers Dihedile
- Schultze-Strasser Stephan
- Schulze-Sturm Ulf
- Scott Karen
- Seeley Janet
- Serunjogi Robert
- Sewnarain Leora
- Shakeshaft Clare
- Shibemba Mercy
- Shingadia Delane
- Sidhoo Subashinie
- Singh Sheleika
- Sirirungsi Wasna
- Sithebe Sibongile
- Smit Theresa
- Smith Kurt
- Smuts Marlize
- Songtaweesin Wipaporn Natalie
- Spyer Moira
- Sripaoraya Worathip
- Srirompotong Ussanee
- Srirompotong Ussanee
- Srisuk Warunee
- Ssenyonga Mark
- Sudsaard Patamawadee
- Sukrakanchana Praornsuda
- Tearsansern Pathanee
- Teixeira Carla
- Than-in-at Kanchana
- Thapwai Thitiwat
- Thaweesombat Yupawan
- Thewsoongnoen Jutarat
- Thiébaut Rodolphe
- Thomason Margaret
- Thrasyvoulou Laura
- Thungkham Khanungnit
- Tikabibamu Judith
- Tinago Gloria
- Trairat Ketmookda
- Tudor-Williams Gareth
- Tukamushaba Mercy
- Tukwasibwe Deogratiuos
- Tumusiime Julius
- Tuna Joana
- Turkova Anna
- Turkova Anna
- Turner Rebecca
- Udomvised Arttasid
- Vadee Aasia
- Van Huyssteen Hesti
- Van Looy Nadine
- Variava Ebrahim
- Vaughan-Gordon Yvonne
- Vecchia Giulio
- Violari Avy
- Violari Avy
- Vowden Richard
- Waalewijn Hylke
- Wampamba Rebecca
- Welch Steve
- Weller Ian
- Weza Sibusisiwe
- White Ellen
- White Ellen
- White Ian
- Widuch Kaja
- Wilkes Helen
- Wimonklang Sookpanee
- Wynne Ben
- Yingyong Pacharaporn
- Zuidewind Peter
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/10/2023
- Field of study
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. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. FINDINGS: Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality. INTERPRETATION: The numbers of neuropsychiatric adverse events and reported neuropsychiatric symptoms were low. However, numerically more participants had psychiatric events and reported suicidality ideation in the dolutegravir group than the standard-of-care group. These differences should be interpreted with caution in an open-label trial. Clinicians and policy makers should consider including suicidality screening of children or adolescents receiving dolutegravir
SLCO5A1 and synaptic assembly genes contribute to impulsivity in juvenile myoclonic epilepsy
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- Adams L
- Agrawal A
- Andrade DM
- Angus-Leppan H
- Aram J
- Aram J
- Backhouse C
- Baker M
- Bala P
- Ball J
- Bartholomew J
- Begum S
- Beier CP
- Belderbos R
- Bharat R
- Bland J
- Brown T
- Busby C
- Calder V
- Camara B
- Campbell C
- Castle G
- Ceballos JP
- Chang M
- Charles L
- Chhibda A
- Chung S-K
- Clegg R
- Clough A
- Cock H
- Cockerill H
- Collier H
- Collingwood A
- Collins V
- Connon M
- Cotta J
- Cotter C
- Crooks J
- Daglish J
- Daly D
- Davis J
- Deekollu D
- Deneubourg C
- Desurkar A
- Dickerson D
- Duran A
- Easton P
- Edwards C
- Egginton D
- Ehiorobo L
- Ellawela S
- Fanto M
- Fonferko-Shadrach B
- Fong CY
- Francis S
- Frattaroli P
- Galizia E
- Gardella E
- Gardella E
- Gaurav A
- Gesche J
- Ghaus N
- Giavasi C
- Glenton J
- Greenberg DA
- Gribbin A
- Hall A
- Hamandi K
- Hamilton C
- Harrison R
- Haslam Z
- Henry J
- Holliday C
- Holroyd K
- Home M
- Howell A
- Hyde A
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- Irwin K
- Jayachandran D
- Jegathasan U
- Jungbluth H
- Kajsova M
- Keenan K
- Khan M
- Kilroy S
- Kirkpatrick M
- Kitching A
- Koutroumanidis M
- Kumar S
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- Lanyon K
- Lim KS
- Lin F
- Lozsadi D
- MacDonald B
- MacFarlane S
- Mackay G
- Macleod A
- Maguire M
- Majeed T
- Makawa L
- Mariguddi S
- Mcaleer D
- McAlinden P
- McQueen A
- Mencias M
- Mewies C
- Mhandu H
- Milner M
- Mirabella F
- Miranda M
- Mohanraj R
- Moller RS
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- Natarajan J
- Navarra H
- Needle A
- Nelson L
- Ng CC
- Nortcliffe T
- O' Malley M
- O'Donoghue M
- Orsini A
- Orsini A
- Pal DK
- Pandey R
- Panjwani N
- Papathanasiou A
- Parker V
- Pastore A
- Patel S
- Peacey C
- Petrova B
- Pickrell O
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- Pracoviste C
- Quamina C
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- Richardson MP
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- Roshandel D
- Rubboli G
- Sacre E
- Said N
- Salim H
- Samakomva T
- Sanders EJ
- Saraswatula A
- Sargent M
- Sargent M
- Sastry S
- Scott F
- Selmer KK
- Shakeshaft A
- Sharman S-J
- Sidebottom J
- Skinner D
- Slaght SJ
- Smith AB
- Smith J
- Sobiskova Z
- Stavropoulos I
- Stephen E
- Stern W
- Striano P
- Striano P
- Strug LJ
- Sudarsan N
- Sudarsan N
- Swain A
- Swingler R
- Syvertsen M
- Takon I
- Talvik I
- Taylor M
- Thomas RH
- Thow C
- Thrasyvoulou L
- Tittensor S
- Topp S
- Truscott S
- Uka S
- Waite C
- Walding L
- Wane R
- Warriner S
- West C
- White S
- Whitehouse W
- Woodhead L
- Yeung L
- Young M
- Zarubova J
- Publication venue
- 'Nature Research Society'
- Publication date
- Field of study
Genetic mechanisms of critical illness in COVID-19.
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- A A Roger Thompson
- A Abraheem
- A Agasou
- A Ahmed
- A Ali
- A Allan
- A Altabaibeh
- A Alvaro
- A Aspinwall
- A Ayers
- A Bamford
- A Barron
- A Bashyal
- A Bellini
- A Bociek
- A Botello
- A Bowes
- A Brady
- A Brayne
- A Brown
- A Brown
- A Butler
- A Campbell
- A Carter
- A Collins
- A Cowley
- A Cowton
- A Cowton
- A Cox
- A Crew
- A Dance
- A Daniel
- A Daniels
- A Dela Rosa
- A Drummond
- A Durie
- A E Heron
- A Easthope
- A Easthope
- A Evans
- A Fofano
- A Gales
- A Ganesan
- A Gardner
- A Garg
- A Gherman
- A Gordon
- A Gratrix
- A Gulati
- A Gupta
- A Haigh
- A Haldeos
- A Harrison
- A Harvey
- A Hayes
- A Higham
- A Higham
- A Hilldrith
- A Holden
- A Hormis
- A Hutcheon
- A Javaid
- A Joseph
- A Kaliappan
- A Katary
- A Kay
- A Kayani
- A Kent
- A Kirkby
- A Knight
- A Kubisz-Pudelko
- A Kuravi
- A Lewis
- A Loveridge
- A Lyle
- A Mayer
- A McAlpine
- A McCarthy
- A McGregor
- A McGregor
- A Meikle
- A Mitchell
- A Mitra
- A Morris
- A Morrison
- A Naranjo
- A Nicholson
- A Nicholson
- A Nilsson
- A Noakes
- A Patel
- A Pickard
- A Poole
- A Price
- A Puxty
- A Quinn
- A Quinn
- A Raithatha
- A Rattray
- A Reddy
- A Reed
- A Reyes
- A Rose
- A Rose
- A Rostron
- A Roy
- A Roynon-Reed
- A S Raj
- A Salberg
- A Sanderson
- A Serrano-Ruiz
- A Solesbury
- A Sukha
- A Swain
- A Tariq
- A Thomas
- A Thomas
- A Todd
- A Tomas
- A Tridente
- A Tucci
- A Turnbull
- A Uriel
- A Ustianowski
- A Vochin
- A Vuylsteke
- A Waite
- A Walden
- A Whileman
- A Wilkinson
- A Williams
- A Williams
- A Wilson
- A Zak
- A Zaki
- Achille Iolascon
- Adam Auton
- Adam Brown
- Agnese Verzuri
- Agostino Ognibene
- Agostino Riva
- Ailsa Golightly
- Alan Maclean
- Alessandra
- Alessandra Stella
- Alessandra Vergori
- Alessia Giorli
- Alexander J Mentzer
- Alice Donati
- Alison M Meynert
- Alistair Nichol
- Ana da Silva Filipe
- Andrea Antinori
- Andrea Cossarizza
- Andrea Ganna
- Andrea Tommasi
- Andrew Rambaut
- Andrew Stenhouse
- Andy Law
- Anjali J Shastri
- Anna Canaccini
- Anna Maria Pinto
- Annarita Giliberti
- Annemarie B Docherty
- Antonella D'Arminio Monforte
- Antonia Ying Wai Ho
- Antonio Di Biagio
- Antony Symons
- Arianna Emiliozzi
- Arianna Gabrieli
- Audrey Coutts
- B Anwar
- B Attwood
- B Baines
- B Blackledge
- B Borislavova
- B Chandler
- B Charles
- B Creagh-Brown
- B David
- B Deacon
- B Deacon
- B Digby
- B Faulkner
- B Fuller
- B Gumbrill
- B Gurung
- B Hadebe
- B Hairsine
- B Hopkins
- B Johnston
- B Lenagh
- B Masunda
- B Ogg
- B Patel
- B Player
- B Purewal
- B Scholefield
- B Shelley
- B Sloan
- B Thomas
- B Wadams
- B Welsh
- B Wilkinson
- B Winter-Goodwin
- B Yates
- Baillie J Kenneth
- Barbara Rossetti
- Beale Rupert
- Beatrice Alex
- Benjamin Bach
- Bretherick Andrew D
- Bruno Frediani
- C Adams
- C Ahmed
- C Almaden-Boyle
- C Ashbrook-Raby
- C Basikolo
- C Battle
- C Beazley
- C Beith
- C Borra
- C Brandwood
- C Brantwood
- C Burnett
- C Castro Delgado
- C Clark
- C Clulow
- C Collins
- C Cruz
- C Davis
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- C Sicat
- C Stuart
- C Summers
- C Swan
- C Thompson
- C Thorpe
- C Tibke
- C Tierney
- C Vigurs
- C Wells
- C Whitton
- C Whyte
- C Wrey Brown
- Cameron J Fairfield
- Carmelo Piscopo
- Carmen Marciano
- Caroline Abernathy
- Carrol Gamble
- Caterina Lo Rizzo
- Catherine A Shaw
- Catherine H Weldon
- Caulfield Mark
- Ceilia Boz
- Cesira Nencioni
- Chelsea Ye
- Chiara Fallerini
- Chiara Gabbi
- Chiara Spertilli
- Chloe Donohue
- Chris Ponting
- Christoper A Green
- Cinthia E Jannes
- Clare Jackson
- Clohisey Sara
- Cristina Mussini
- D Antcliffe
- D Bakthavatsalam
- D Banach
- D Baptista
- D Bell
- D Branney
- D Brealey
- D Brealey
- D Butcher
- D Butcher
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- D Clarke
- D Collier
- D Collier
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- D Golden
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- D Hamilton
- D Hawcutt
- D Hope
- D Horner
- D Kallon
- D Kaye
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- D Potoczna
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- D Smyth
- D Strachan
- D Tetla
- D Thornton
- D Trodd
- D Vedage
- D Walker
- D Warren
- D Williams
- D Wood
- D Wright
- Daniela Francisci
- Daniella Coker
- Danilo Tacconi
- David A van Heel
- David Bennet
- David L Robertson
- David Stuart
- Dawn Law
- Debby Bogaert
- Derek Murphy
- Domenico A Coviello
- E Abaleke
- E Allan
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- E Dooks
- E Fisher
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- E Goff
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- Elisabetta Schiaroli
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- Emmanuelle Marques
- Enrico Martinelli
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- F Anderson
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- Furniss James
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- Ho Antonia
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- J Kenneth Baillie
- J Kenneth Baillie
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- J Scriven
- J Scriven
- J Shiel
- J Singh
- J Singleton
- J Smith
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- J Summers
- J Taylor
- J Tebbutt
- J Texeira
- J Thomas
- J Thrush
- J Tomlinson
- J Valentine
- J Whiteside
- J Wilkins
- J Willson
- J Zamikula
- Jake Dunning
- Jane Weaver
- Janet Harrison
- Janet T Scott
- Janie F Shelton
- Jen Meikle
- Jo Dalton
- Johnny Millar
- Jorge Esparza-Gordillo
- Jose E Krieger
- Julian A Hiscox
- K Archer
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- K Xavier
- Katarzyna Hafezi
- Keating Sean
- Kenneth A Mclean
- Kirstie Morrice
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- Klenerman Paul
- Knight Julian
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- Stefania Mantovani
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- Stefano Ceri
- Stefano Rusconi
- Stella Aslibekyan
- Stephanie Roberts
- Stephen R Knight
- Summers Charlotte
- Susanna Croci
- Susanna Guerrini
- T Anderson
- T Arden
- T Baird
- T Behan
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- Tammy Gilchrist
- Tenesa Albert
- Teresa Filshtein-Sonmez
- Thomas M Drake
- Thushan de Silva
- Tim Walsh
- Tom Fletcher
- Tom Solomon
- Tony Wackett
- Trevor Paterson
- Tullio Trotta
- Turtle Lance
- U Poultney
- V Amin
- V Anumakonda
- V Bastion
- V Cannons
- V Crickmore
- V Gopal
- V Irvine
- V Kasipandian
- V Krishnamurthy
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- V Linnett
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- V Waugh
- Valentina Anemoli
- Vanessa Sancho-Shimizu
- Victoria Shaw
- Vitart Veronique
- W Harrison
- W Khaliq
- W Khaliq
- W McCormick
- W Woodyatt
- Walker Susan
- Walsh Timothy
- Wang Bo
- Wei Shen Lim
- Wendy S Barclay
- William A Paxton
- William Greenhalf
- Wilson James F
- Wrobel Nicola
- Wu Yang
- X Qiu
- Y Baird
- Y Choudhury
- Y Hussain
- Y Jackson
- Y Thirlwall
- Yang Jian
- Yang Zhijian
- Z Alldis
- Z Belagodu
- Z Bradshaw
- Z Coton
- Z Daly
- Z Farzad
- Z Fernandez
- Z Garland
- Z Maqsood
- Z Omar
- Z Prime
- Z Scott
- Zechner Marie
- Zhai Ranran
- Zheng Chenqing
- Publication venue
- Nature
- Publication date
- 01/01/2020
- Field of study
Host-mediated lung inflammation is present1, and drives mortality2, in the critical illness caused by coronavirus disease 2019 (COVID-19). Host genetic variants associated with critical illness may identify mechanistic targets for therapeutic development3. Here we report the results of the GenOMICC (Genetics Of Mortality In Critical Care) genome-wide association study in 2,244 critically ill patients with COVID-19 from 208 UK intensive care units. We have identified and replicated the following new genome-wide significant associations: on chromosome 12q24.13 (rs10735079, P = 1.65 × 10-8) in a gene cluster that encodes antiviral restriction enzyme activators (OAS1, OAS2 and OAS3); on chromosome 19p13.2 (rs74956615, P = 2.3 × 10-8) near the gene that encodes tyrosine kinase 2 (TYK2); on chromosome 19p13.3 (rs2109069, P = 3.98 ×  10-12) within the gene that encodes dipeptidyl peptidase 9 (DPP9); and on chromosome 21q22.1 (rs2236757, P = 4.99 × 10-8) in the interferon receptor gene IFNAR2. We identified potential targets for repurposing of licensed medications: using Mendelian randomization, we found evidence that low expression of IFNAR2, or high expression of TYK2, are associated with life-threatening disease; and transcriptome-wide association in lung tissue revealed that high expression of the monocyte-macrophage chemotactic receptor CCR2 is associated with severe COVID-19. Our results identify robust genetic signals relating to key host antiviral defence mechanisms and mediators of inflammatory organ damage in COVID-19. Both mechanisms may be amenable to targeted treatment with existing drugs. However, large-scale randomized clinical trials will be essential before any change to clinical practice
Whole-genome sequencing reveals host factors underlying critical COVID-19
- Author
- Abd Elghafar M. S.
- Abdel-Aziz M.
- Abdelrazik M.
- Abdollahi H.
- Abdullah T.
- Abecasis G. R.
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- Abel L.
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- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/2022
- Field of study
Critical COVID-19 is caused by immune-mediated inflammatory lung injury. Host genetic variation influences the development of illness requiring critical care1 or hospitalization2–4 after infection with SARS-CoV-2. The GenOMICC (Genetics of Mortality in Critical Care) study enables the comparison of genomes from individuals who are critically ill with those of population controls to find underlying disease mechanisms. Here we use whole-genome sequencing in 7,491 critically ill individuals compared with 48,400 controls to discover and replicate 23 independent variants that significantly predispose to critical COVID-19. We identify 16 new independent associations, including variants within genes that are involved in interferon signalling (IL10RB and PLSCR1), leucocyte differentiation (BCL11A) and blood-type antigen secretor status (FUT2). Using transcriptome-wide association and colocalization to infer the effect of gene expression on disease severity, we find evidence that implicates multiple genes—including reduced expression of a membrane flippase (ATP11A), and increased expression of a mucin (MUC1)—in critical disease. Mendelian randomization provides evidence in support of causal roles for myeloid cell adhesion molecules (SELE, ICAM5 and CD209) and the coagulation factor F8, all of which are potentially druggable targets. Our results are broadly consistent with a multi-component model of COVID-19 pathophysiology, in which at least two distinct mechanisms can predispose to life-threatening disease: failure to control viral replication; or an enhanced tendency towards pulmonary inflammation and intravascular coagulation. We show that comparison between cases of critical illness and population controls is highly efficient for the detection of therapeutically relevant mechanisms of disease
Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
- Author
- Abani O.
- Abbas A.
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- Abbas M.
- Abbasi S.
- Abbass H.
- Abbott A.
- Abdallah N.
- Abdelaziz A.
- Abdelfattah M.
- Abdelqader B.
- Abdul Rasheed A.
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- Abdul-Kadir R.
- Abdul-Raheem R.
- Abdulakeem A.
- Abdulmumeen A.
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- Abdusamad K.
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- Abedalla M.
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- Aboaba A.
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/05/2021
- Field of study
Background:
In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.
Methods:
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).
Findings:
Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001).
Interpretation:
In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.
Funding:
UK Research and Innovation (Medical Research Council) and National Institute of Health Research
Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
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- Publication venue
- 'Elsevier BV'
- Publication date
- 29/05/2021
- Field of study
Background:
Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19.
Methods:
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
Findings:
Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79).
Interpretation:
In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes.
Funding:
UK Research and Innovation (Medical Research Council) and National Institute of Health Research
Whole-genome sequencing reveals host factors underlying critical COVID-19
- Author
- Abd Elghafar M.S.
- Abdel-Aziz M.
- Abdelrazik M.
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- Publication venue
- Springer Science and Business Media LLC
- Publication date
- 07/07/2022
- Field of study
Critical COVID-19 is caused by immune-mediated inflammatory lung injury. Host genetic variation influences the development of illness requiring critical care1 or hospitalization2,3,4 after infection with SARS-CoV-2. The GenOMICC (Genetics of Mortality in Critical Care) study enables the comparison of genomes from individuals who are critically ill with those of population controls to find underlying disease mechanisms. Here we use whole-genome sequencing in 7,491 critically ill individuals compared with 48,400 controls to discover and replicate 23 independent variants that significantly predispose to critical COVID-19. We identify 16 new independent associations, including variants within genes that are involved in interferon signalling (IL10RB and PLSCR1), leucocyte differentiation (BCL11A) and blood-type antigen secretor status (FUT2). Using transcriptome-wide association and colocalization to infer the effect of gene expression on disease severity, we find evidence that implicates multiple genes—including reduced expression of a membrane flippase (ATP11A), and increased expression of a mucin (MUC1)—in critical disease. Mendelian randomization provides evidence in support of causal roles for myeloid cell adhesion molecules (SELE, ICAM5 and CD209) and the coagulation factor F8, all of which are potentially druggable targets. Our results are broadly consistent with a multi-component model of COVID-19 pathophysiology, in which at least two distinct mechanisms can predispose to life-threatening disease: failure to control viral replication; or an enhanced tendency towards pulmonary inflammation and intravascular coagulation. We show that comparison between cases of critical illness and population controls is highly efficient for the detection of therapeutically relevant mechanisms of disease
A co-fumigation strategy utilizing reduced rates of phosphine (PH3) and sulfuryl fluoride (SF) to control strongly resistant rusty grain beetle, Cryptolestes ferrugineus (Stephens) (Coleoptera: Laemophloeidae)
- Author
- Publication venue
- 'Wiley'
- Publication date
- 01/01/2021
- Field of study
BACKGROUND Managing resistance to phosphine (PH3) in rusty grain beetle, Cryptolestes ferrugineus, is challenging, as strongly resistant insects of this species require very high concentrations over lengthy exposure periods (>10 days). Recently, approaches that enhance the efficacy of PH3 have gained momentum to control this pest, especially co-fumigations. In this study, efficacy of co-fumigating PH3 with another commercially available fumigant, sulfuryl fluoride (SF), has been evaluated against adults and eggs of two PH3-resistant strains of C. ferrugineus. Concentrations of the mixture, representing lower than current application rates of both fumigants, were tested towards its field use. RESULTS Co-fumigation of PH3 with SF was achieved in two patterns: over a continuous exposure period of 168 h simultaneously and sequentially over two periods of 78 h, in which insects were exposed to SF first followed by PH3 with 12 h aeration in-between. Results of simultaneous fumigations identified two effective co-fumigation rates, SF 185 + PH3 168 g hm−3 and SF 370 + PH3 84 g hm−3 that yielded complete control of adults and eggs. These two rates also were equally effective when they were applied sequentially and produced consistent results. Irrespective of application methods, concentrations of both PH3 and SF failed individually in achieving complete mortality of either adults or eggs or both. CONCLUSION Our results confirmed that a co-fumigation strategy involving half the current standard rate of PH3 (84 g hm−3) with one-fourth of the current maximal registered rate of SF (370 g hm−3) can provide effective control of strongly PH3-resistant C. ferrugineus