HIV | Penta HIV Trials

Growth trajectories before and after switching to dolutegravir in children living with HIV in the ODYSSEY trial

2025

Authors: Chan MK, Crichton S, Mujuru HA, Kekitiinwa AR, Lugemwa A, Kityo CM, Ahimbisibwe GM, Variava E, Violari A, Cotton M, Archary M, Cressey TR, Puthanakit T, Bandi S, Bwakura-Dangarembizi M, Bbuye D, Atwine L, Kaudha E, White E, Giaquinto C, Rojo P, Gibb DM, Turkova A, Ford D, and the ODYSSEY Trial Team

Presented at: International workshop on pediatrics and HIV

Pregnancies among adolescents and young women on dolutegravir vs standard-of-care in the ODYSSEY trial and effects of the dolutegravir neural tube defect safety alert

2025

Authors: Ahimbisibwe G, Wyncoll J, Mngqibisa R, White E, Bwakura-Dangarembizi M, Kekitiinwa AR, Lugemwa A, Kityo CM, Variava E, Liberty A, Kataike H, Ngampiyaskul C, Cotton MF, Riault Y, Archary M, Smit T, Puthanakit T, Shakeshaft C, Nhema R, Bbuye D, Atwine L, Kaudha E, Giaquinto C, Rojo P, Bamford A, Gibb DM, Turkova A, Ford D, Musoke P, and the ODYSSEY Trial Team

Presented at: International Workshop on Pediatrics and HIV

Predictors of treatment failure in children living with HIV starting first-line antiretroviral therapy in the ODYSSEY trial

2025

Authors: Wyncoll J, Archary M, Kamolrattana R, Mujuru HA, Kekitiinwa AR, Violari A, Na-Rajsima S, Lugemwa A, Variava E, Cotton M, Kityo CM, Puthanakit T, Königs C, Behuhuma O, Welch S, Saïdi Y, Marques L, Ahimbisibwe GM, Holden L, Giaquinto C, Rojo P, Gibb DM, Turkova A, White E, Ford D, and the ODYSSEY Trial Team

Presented at: IAS 2025

Efficacy of second-line dolutegravir- versus boosted protease inhibitor-based ART in children and adolescents living with HIV at 96 and 144 weeks: pooled analysis of the ODYSSEY and CHAPAS-4 trials

2025

Presented by: Amuge P on behalf of the CHAPAS-4 trial, ODYSSEY trial and UNIVERSAL teams

Presented at: International Workshop on HIV and Pediatrics

Assessment of the steady-state drug-drug interactions between dolutegravir and ritonavir-boosted darunavir in adolescents

2025

Authors: Abdalla S, Compagnucci A, Bamford A, Chan MK, Ramos JT, Riault Y, Saidi Y, Constant V, Nguyen T, Giaquinto C, Tréluyer JM, Cressey TR, Hirt D, the SMILE Study Group, Bologna R, Reliquet V, Elenga N, Pavia-Ruz N, et al

Published in: AIDS

Virological outcomes and genotypic resistance on dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

2025

Authors: White E, Kityo C, Spyer MJ, Mujuru HA, Nankya I, Kekitiinwa AR, Lugemwa A, Kaudha E, Liberty A, Cassim H, Archary M, Cotton MF, Ahimbisibwe GM, Cressey TR, Ngampiyaskul C, Srirompotong U, Behuhuma O, Saidi Y, Bamford A, Kobbe R, Nastouli E, Rojo P, Giaquinto C, Gibb DM, Ford D, Turkova A; on behalf of the ODYSSEY trial team.

Published in: The Lancet HIV

ODYSSEY 192-week follow-up evidences superior efficacy of DTG for children on first/second-line ART

2024

Authors: Mujuru AH, White E, Kekitiinwa A, Lugemwa A, Kityo C, Musoke P, Cressey RT, Variava E, Violari A, Archery M, Cotton M, Puthanakit T, Rojo P, Turkova A

Presented at: CROI 2024

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Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial

2023

Authors: Abdalla S, Compagnucci A, Riault Y, Chan KM, Bamford A, Nolan A, Ramos TJ, Constant V, Nguyen T, Zheng Y, Tréluyer J, Froelicher-Bournaud L, Neveux N, Saidi Y, Cressey RT, Hirt D on behalf of the SMILE study group

Published in: Antimicrobial Agents and Chemotherapy

Effect of dolutegravir on folate, vitamin B12 and mean corpuscular volume levels among children and adolescents with HIV: a sub-study of the ODYSSEY randomized controlled trial 

2023

Authors: Barlow-Mosha L.N., Ahimbisibwe G.M., Chappell E., Amuge P.M., Nanduudu A., Kaudha E., Amukele T., Balamusani D., Kafufu B., Nimwesiga A., Kataike H., Namwanje R., Kasangaki G., Mulindwa A., Muzorah, G.A., Bbuye D., Musiime V., Mujyambere E., Ssenyonga M., Mulima D., Kyambadde R.C., Namusanje J., Isabirye R., Nabalamba M., Nakirya B.M., Kityo C., Kekitiinwa A.R., Giaquinto, C., Copp A., Gibb, D.M., Ford, D., Musoke P., Turkova A

Published in: Journal of the International AIDS Society

Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV – Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial

2023

Authors: Compagnucci A, Chan KM, Saïdi Y, Cressey RT, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Morkunaite G, Amuge P, Musiime V, Violari V, Cotton M, Kekitiinwa RA, Kaudha E, Groenewald M, Liberty AA, Kanjanavanit S, Volokha A, Bologna R, Ruz PN, Tato PL, Paioni P, Marques L, Reliquet V, Niehues T, Welch BS, Ford D, Giaquinto C, Gibb MD, Babiker A, Amador RTJ, SMILE-PENTA17-ANRS 152 Trial Group

Published in: eClinicalMedicine

Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial

2022

Authors: Amuge P, Lugemwa A, Wynne B, Mujuru AH, Violari A, Kityo MC, Archary M, Variava E, White E, Turner MR, Shakeshaft C, Ali S, Nathoo JK, Atwine L, Liberty A, Bbuye D, Kaudha E, Mngqibisa R, Mosala M, Mumbiro V, Nanduudu A, Ankunda R, Maseko L, Kekitiinwa RA, Giaquinto C, Rojo P, Gibb MD, Turkova A, Ford D on behalf of the ODYSSEY Trial Team

Published in: The Lancet HIV

Population pharmacokinetics of unbound and total plasma dolutegravir concentrations in children ≥ 12 years old: A pharmacokinetic sub-study of the SMILE trial-PENTA17-ANRS 152

2022

Authors: Abdalla S, Compagnucci A, Riault Y, Cressey T, Saidi Y, Chan M, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Volokha A, Bologna R, Pavia Ruz N, Morkunaite G, Giaquinto C, Tréluyer JM, Zheng Y, Bamford A, Ramos Amador J, Hirt D

Presented at: International Workshop on HIV and Pediatrics

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Voluntary Consent to Research on HIV-infected Children in the CHAPAS-4 and ODYSSEY HIV Clinical Trials

2022

Authors: Makumbi S, Bajunirwe F, Ford D, Turkova A, Lugemwa A, Musiime V, Gibb D, Tamwesigire K.I

Presented at: International Workshop on HIV & Pediatrics 2022

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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

2022

Authors: Turkova A, Waalewijn H, Chan M, Bollen P, Bwakura-Dangarembizi M, Kekitiinwa A, Cotton M, Lugemwa A, Variava E, Ahimbisibwe MG, Srirompotong U, Mumbiro V,Amuge P, Zuidewind P, Ali S, Kityo C,Archary M, Ferrand R, Violari A, Gibb D,Burger D, Ford D, Colbers A, on behalf of the ODYSSEY Trial Team

Published in: The Lancet

Borrowing information across patient subgroups in clinical trials, with application to a paediatric trial

2022

Authors: R.M. Turner, A Turkova, C.L. Moore, A Bamford, M Archary, L.N. Barlow-Mosha, M.F. Cotton, T.R. Cressey, E Kaudha, A Lugemwa, H Lyall, H.A. Mujuru, V Mulenga, V Musiime, P Rojo, G Tudor-Williams, S.B. Welch, D.M. Gibb, D Ford, I.R. White & and the ODYSSEY Trial Team

Published in: BMC Medical Research Methodology

Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

2022

Authors: H Waalewijn, M.K Chan, P.D.J Bollen, H.A Mujuru, S Makumbi, A.R Kekitiinwa, E Kaudha, T Sarfati, G Musoro, A Nanduudu, A Lugemwa, P Amuge, C.L Moore, P Rojo, C Giaquinto, A Colbers, D.M Gibb, D Ford, A Turkova, D.M Burger

Published in: The Lancet

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

2021

Authors: A Turkova, E White, HA. Mujuru, AR. Kekitiinwa, CM. Kityo, A Violari, A Lugemwa, TR. Cressey, P Musoke, E Variava, MF. Cotton, M Archary, et al for the ODYSSEY Trial Team

Published in: New England Journal of Medicine

Dolutegravir-based ART is superior to standard of care ART in young children <14kg living with HIV

2021

Authors: Kaudha E on behalf of the ODYSSEY trial

Presented at: PEPFAR Uganda Science Summit

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Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)

2021

Authors: Anna Turkova on behalf of the ODYSSEY trial team

Presented at: CHIVA 2021

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Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the main ODYSSEY trial (≥14kg)

2021

Authors: White E and Kityo C on behalf of the ODYSSEY trial team

Presented at: CHIVA 2021

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No age-related difference in dolutegravir metabolic glucuronidation ratio in children between 3 months and 18 years old in the ODYSSEY trial

2021

Authors: T.G Jacobs, A. Colbers, H. Waalewijn, P. Amuge, D. Bbuye, E. Kaudha, A. Nanduudu, S. Makumbi, L. Atwine, S. Mudzingwa, K. Nathoo, J. Hakim, A. Liberty, A.J. Van Rensburg, M. Archary, D.M Gibb, D. Ford, A. Turkova, D.M Burger, ODYSSEY trial team

Published in: IAS 2021

Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

2021

Authors: L. Barlow-Mosha, G. Ahimbisibwe, E. Chappell, P.M. Amuge, A. Nanduudu, E. Kaudha, T. Amukele, D. Balamusani, B. Kafufu, A. Nimwesiga, C. Kityo, A.R Kekitiinwa, R. Namwanje, G. Kasangaki, A. Mulindwa, G.A. Muzorah, D. Bbuye, M. Nolan, C. Giaquinto, D.M Gibb, D. Ford, P. Musoke, A. Turkova, The ODYSSEY Trial Team

Presented at: International workshop on HIV pediatrics 2021

Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: E White, A Turkova, HA Mujuru, I Nankya, B Wynne, S Ali, A Kekitiinwa, A Lugemwa, E Kaudha, A Liberty, H Cassim, M Archary, M Cotton, L Barlow-Mosha, TR Cressey, C Ngampiyasakul, U Srirompotong, O Behuhuma, Y Saidi, A Bamford, R Kobbe, P Rojo, C Giaquinto, DM Gibb, D Ford on behalf of the ODYSSEY trial team

Published in: International Workshop on HIV and pediatrics

Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)

2021

Authors: Turkova A on behalf of the ODYSSEY trial team     

Presented at: CHIVA 2021

Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: A Turkova, A Kekitiinwa, E White, V Mumbiro, E Khauda, A Liberty, E Dobbels, GM Ahimbisibwe, T Moloantoa, L Atwine, S Kanjanavanit, NR Mosia, T Puthanakit, T Smit, R Kobbe, C Fortuny, E Chidziva, RC Kyambadde, D Bbuye, T Sarfati, A Coelho, Y Saïdi, A Lugemwa, N Klein, M Bwakura-Dangarembizi, C Kityo, M Cotton, C Giaquinto, P Rojo, DM Gibb, D Ford, the ODYSSEY trial team

Published in: IAS 2021

Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: Violari A, Kekitiinwa A, White E, Mumbiro V, Rutebarika D, Dobbels E, Kataike H, Moloantoa T, Atwine L, Nazzinda R, Mbabazi R, Kanjanavanit S, Mosia N, Na-Rajsimax S, Techakunakorn P, Nakabuye S, Puthanakit T, Smit T, Kobbe R, Fortuny C, Chidziva E, Nansamba W, Kakayi B, Bbuye D, Sarfati T, Shakeshaft C, Coelho A, Saïdi Y, Lugemwa A, Klein N, Mujuru H, Bwakura- Dangarembizi M, Musiime V, Cotton M, Giaquinto C, Rojo P, Gibb D, Ford D, Turkova A

Published in: International workshop on HIV and pediatrics 2021

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Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

2021

Authors: L. Barlow-Mosha, G. Ahimbisibwe, E. Chappell, P.M. Amuge, A. Nanduudu, E. Kaudha, T. Amukele, D. Balamusani, B. Kafufu, A. Nimwesiga, C. Kityo, A.R Kekitiinwa, R. Namwanje, G. Kasangaki, A. Mulindwa, G.A. Muzorah, D. Bbuye, M. Nolan, C. Giaquinto, D.M Gibb, D. Ford, P. Musoke, A. Turkova, The ODYSSEY Trial Team

Presented at: IAS 2021   

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Dolutegravir-Based ART is Superior to Standard of Care in Young Children Living With HIV

2021

Authors: P Amuge on behalf of the ODYSSEY trial team

Published in: International workshop on HIV and pediatrics 2021

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Weight Gain in Children and Adolescents on Dolutegravir vs Standard-of-Care in the ODYSSEY Trial

2021

Authors: Mujuru H , Lugemwa A, Puthanakit T, Amuge P, Kityo C, Compagnucci A, Variava E, Kekitiinwa A, Musiime V, BarlowMosha L, Ngampiyaskul C, Zuidewind P, Tumusiime J, Mngqbisa R, Kaudha E, Behuhuma N, Kataike H, Musoro G, Nandudu A, Bwakura M, Ahimbisibwe G, Ounchanum P, Mulindwa A, Nazzinda R, Ssenyonga M, Kanjanavanit S, Nathoo K, Makumbi S, Danaviah S, Nakabuye S, Chalermpantmetagul S, Rutebarika D, Nalusiba S, Srirompotong U, Ali S, Wynne B, Riault Y, Welch S, Cressey T, Violari A, Giaquinto C, Rojo P, Gibb D, Ford D, Turkova A

Published in: IAS 2021 and International Workshop on HIV Pediatrics 2021

View International Workshop on HIV Pediatrics abstract book

A randomised comparison of DTG-based ART vs Standard of Care in infants and young children living with HIV weighing 3 to 14kg: results from the ODYSSEY trial

2021

Authors: A Lugemwa, H Mujuru, B Wynne, A Violari, AR Kekitiinwa, CM Kity, M Archary, E Variava, T Sarfati, C Shakeshaft, R Turner, K Nathoo, E Chidziva, L Atwine, N Ramsagar, A Liberty, P Amuge, E Kaudha, A Nanduudu, R Mngqibisa, R Mosia, MF Cotton, TR Cressey, T Puthanakit, A Compagnucci, C Giaquinto, P Rojo, D Ford, DM Gibb, A Turkova, the ODYSSEY trial team

Published in: IAS 2021

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Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: C. Kityo, E. White, A. Turkova, H.A Mujuru, I. Nankya, B. Wynne, S. Ali, A. Kekitiinwa, A. Lugemwa, E. Kaudha, A. Liberty, H. Cassim, M. Archary, M. Cotton, L. Barlow-Mosha, T.R Cressey, C. Ngampiyasakul, U. Srirompotong, O. Behuhuma, Y. Saidi, A. Bamford, R. Kobbe, P. Rojo, C. Giaquinto, D. Gibb, D. Ford

Published in: IAS 2021

A randomised comparison of DTG-based ART vs Standard of Care in infants and young children living with HIV weighing 3 to 14kg: results from the ODYSSEY trial

2021

Authors: LugemwaA, Mujuru H, Wynne B, Violari A, Kekitiinwa R.A, Kityo M.C, Archary M, Variava E, Sarfati T, Shakeshaft C, Turner  R, Nathoo R, Chidziva E, Atwine L, Ramsagar N, Liberty A, Amuge P, Kaudha E, Nanduudu A, Mngqibisa R, Mosia R, Cotton F.M, Cressey R.T, Puthanakit T, Compagnucci A, Giaquinto C, Rojo P, Ford D, Gibb M.D, Turkova A, the ODYSSEY trial team

Presented at: IAS 2021

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Neuropsychiatric manifestations and sleep disturbances in children and adolescents randomised to dolutegravir-based ART vs standard-of-care in the ODYSSEY trial

2021

Authors: Turkova A, Kekitiinwa A, White E, Mumbiro V, Khauda E, Liberty A, Dobbels E, Ahimbisibwe M.G, Moloantoa T, Atwine T, Kanjanavanit S, Mosia R.N, Puthanakit T, Smit T, Kobbe R, Fortuny C, Chidziva E, Kyambadde C.R,  Bbuye d, Sarfati T, Coelho A, Saïdi Y, Lugemwa A, Klein N, Bwakura- Dangarembizi M, Kityo C, Cotton M, Giaquinto C, Rojo P, Gibb M.D, Ford D, the ODYSSEY trial team

Presented at: IAS 2021

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Weight gain in children and adolescents on dolutegravir vs standard of care in the ODYSSEY trial

2021

Authors: Turkova A, Kityo C, Mujuru A.H, Variava E, Kekitiinwa A, Lugemwa A, Barlow-Mosha L, Ngampiyaskul C, Zuidewind P, Puthanakit T, Mngqbisa R, Behuhuma O.N, Kataike H, Musoro G, Nandudu A, Amuge P, Makumbi S, Danaviah S, Ali S, Wynne B, Riault Y, Welch S, Cressey R.T, Violari A, Compagnucci A, Hakim J, Rojo P, Giaquinto C,  Gibb M.D, Ford D, the ODYSSEY trial team

Presented at : IAS 2021

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Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

2021

Authors: Kityo C, White E, Turkova A, Mujuru A.H, Nankya I, Wynne B, Ali S, Kekitiinwa A, Lugemwa A, Kaudha E, Liberty A, Cassim H, Archary M, Cotton M, Barlow-Mosha L, Cressey R.T, Ngampiyasakul C, Srirompotong U, Behuhuma O, Saidi Y, Bamford A, Kobbe R, Rojo P, Giaquinto C, Gibb M.D, Ford D on behalf of the ODYSSEY trial team

Presented at: IAS 2021

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Once daily integrase inhibitor (INSTI) with boosted darunavir is non-inferior to standard of care in virologically suppressed children – Week 48 results of the SMILE Penta-17 Trial

2021

Authors: Compagnucci A, Chan M, Saïdi Y, Cressey T, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Kekitiinwa A, Kaudha E,Groenewald M, Liberty A, Kanjanavanit S, Volokha A, Bologna R, Pavia Ruz N, Prieto Tato L, Paioni P, Marques L, Reliquet V, Welch S, Ford D, Giaquinto C, Gibb D, Babiker A, Ramos Amador JT, The SMILE-PENTA17-ANRS 152 Trial Group

Presented at: IAS 2021

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Once-Daily Integrase Inhibitor (Insti) With Boosted Darunavir is Non- Inferior to Standard of Care in Virogically Suppressed Children, Week 48 Results of the SMILE PENTA-17 Trial

2021

Authors: Compagnucci A , Chan M , Saïdi Y , Cressey T , Bamford A , Riault Y , Coelho A , Nolan A ,Chalermpantmetagul S , Amuge P , Musiime V , Violari A , Cotton M , Kekitiinwa A , Kaudha E , Groenewald M, Liberty A , Kanjanavanit S , Volokha A , Bologna R , Muñoz Hernández R , Fortuny-Guasch C , Paioni P , Marques L , Reliquet V , Welch S , Ford D , Giaquinto C , Gibb D , Babiker A , Ramos Amador J and The SMILE-PENTA17-ANRS 152 Trial Group

Published in: International Workshop of HIV Pediatrics 2021

“Because we all have to grow up”: supporting adolescents in Uganda to develop core competencies to transition towards managing their HIV more independently

2021

Authors: Chloe Lanyon, Janet Seeley, Stella Namukwaya, Victor Musiime, Sara Paparini, Helen Nakyambadde, Christine Matama, Anna Turkova, Sarah Bernays

Published in: Journal of International Aids Society

DOLUTEGRAVIR-BASED ART IS SUPERIOR TO NNRTI/PI- BASED ART IN CHILDREN AND ADOLESCENTS

2021

Authors: Anna Turkova1, for the ODYSSEY/PENTA-20 Trial Team

Published in: CROI 2021

ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

2021

Authors: Cecilia L. Moore, Anna Turkova , Hilda Mujuru , Adeodata Kekitiinwa, Abbas Lugemwa, Cissy M. Kityo, Linda N. Barlow-Mosha, et al, ODYSSEY trial team

Published in: BMC Infectious Diseases

Pediatric dolutegravir (DTG) dosing recommendations derived from combined P1093 and ODYSSEY Population Pharmacokinetic analysis

2020

Authors: Singh R, Baker M, Thapar M, Gibb D, Turkova A, Ford D, Ruel T, Wiznia A, Farhad M, Alvero C, Green J, Bollen P, Colbers A, Burger D, Acosta E

Published in: 12th International Workshop on HIV Pediatrics

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Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial

2020

Authors: Bollen P,  Moore CL ,  Mujuru H et al; the ODYSSEY trial team

Published in: LANCET HIV. 2020;8:e533-e544

Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years

2020

Authors: Waalewijn H, Mujuru HA, Amuge P, Cotton M, Bollen P, Chan M, Ali S, Variavan E, Makumbi S, Colbers A, Gibb D, Ford D, Burger D, Turkova A, and the ODYSSEY-trial team

Published in27th Conference on Retroviruses and Opportunistic Infections, March 8th –11th, 2020 – Boston.

Adeqaute dolutegravir exposure dosed BID with rifampicin in children 6 to < 18 years

2020

Authors: Waalewijn H, Mujuru HA, Amuge P, Cotton M, Bollen P, Chan M, Ali S, Variavan E,Makumbi S, Colbers A, Gibb D, Ford D, Burger D, Turkova A, and the ODYSSEY-trial team

Published in: Oral presentation at 27th Conference on Retroviruses and Opportunistic Infections, March 8th –11th, 2020 – Boston.

Analysing small groups within clinical trials, while borrowing information from larger groups

2019

Authors: Turner B, Ford D, Moore C, Gibb D, Turkova A,  White I, and ODYSSEY trial team

Published in: Oral Presentation atInternational Society for Clinical Biostatics; July 16th 2019

Pharmacokinetics of dolutegravir 5mg dispersible tablets in children weighing 6 to <20kg dosed using WHO weight bands

2019

Authors: Waalewijn H, Bollen PDJ, Moore C, Kekitiinwa A, et al. The ODYSSEY Trail Team

Published in: Oral Presentation at 10th IAS Conference, July, 21-24th 2019

Adult dolutegravir 50mg film-coated tablets in children living with HIV weighing 20 to <25 kg

2019

Authors: Bollen P, Turkova A, Mujuru H, et al. for the ODYSSEY Trial Team

Published in: 26th Conference on Retroviruses and Opportunistic Infections, March 4th – 7th, 2019– Seattle. P_830

Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries

2018

Authors: Tierrablanca LE, Ochalek J, Ford D, et al; for BREATHER (PENTA 16) Trial Group

Published in: Medicine (Baltimore). 2018;97(5):e9698

Objectives To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs.

Methods We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial. BREATHER is a randomized trial investigating the effectiveness of SCT and continuous therapy in 199 participants aged 8 to 24 years and taking efavirenz-based first-line ARV drugs in 11 countries worldwide. Alongside nationally representative unit costs/prices, these data were used to estimate costs and quality adjusted life years (QALYs). An incremental cost-effectiveness comparison was performed using a multilevel bivariate regression approach for total costs and QALYs. Further analyses explored cost-effectiveness in low- and middle-income countries with access to low-cost generic ARV drugs and high-income countries purchasing branded ARV drugs, respectively.

Results At 48 weeks, SCT offered significant total cost savings over continuous therapy of US dollar (USD) 41 per patient in countries using generic drugs and USD 4346 per patient in countries using branded ARV drugs, while accruing nonsignificant total health benefits of 0.008 and 0.009 QALYs, respectively. Cost-effectiveness estimates were similar across settings with access to generic ARV drugs but showed significant variation among high-income countries where branded ARV drugs are purchased.

Conclusion SCT is a cost-effective treatment alternative to continuous therapy for young people infected with HIV in countries where viral load monitoring is available.

Weekends-off efavirenz -based antiretroviral therapy in HIV infected children, adolescents and young adults (BREATHER): extended follow-up results of a randomised, open-label, non-inferiority trial

2018

Authors: Turkova A, Moore CL, Butler K, et al. for BREATHER (PENTA 16) Trial Group.

Published in: PLos One. 2018;13(4):e0196239.

Background Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks. Planned follow-up was extended to 144 weeks, maintaining original randomisation.

Methods BREATHER was an open-label, non-inferiority trial. Participants aged 8-24yrs with virologi- cal suppression on efavirenz-based first-line ART were randomised 1:1, stratified by age and African/non-African sites, to remain on CT or change to SCT. The Kaplan-Meier method was used to estimate the proportion of participants with viral rebound (confirmed VL?50 copies/mL) under intent-to-treat at 48 weeks (primary outcome), and in extended follow-up at 96, 144, and 192 weeks. SCT participants returned to CT following viral rebound, 3 VL blips or discontinuation of efavirenz.

Findings Of 199 participants (99 SCT, 100 CT), 97 per arm consented to extended follow-up. Median follow-up was 185.3 weeks (IQR 160.9–216.1). 69 (70%) SCT participants remained on SCT at last follow-up. 105 (53%) were male, baseline median age 14 years (IQR 12–18), median CD4 count 735 cells/μL (IQR 576–968). 16 SCT and 16 CT participants had con- firmed VL?50 copies/mL by the end of extended follow-up (HR 1.00, 95% CI 0.50–2.00). Estimated difference in percentage with viral rebound (SCT minus CT) by week 144 was 1.9% (90% CI -6.6–10.4; p = 0.72) and was similar in a per-protocol analysis. There were no significant differences between arms in proportions of participants with grade 3/4 adverse events (18 SCT vs 16 CT participants; p = 0.71) or ART-related adverse events (10 vs 12;

p = 0.82). 20 versus 8 serious adverse events (SAEs) were reported in 16 SCT versus 4 CT participants, respectively (p = 0.005 comparing proportions between groups; incidence rate ratio 2.49, 95%CI 0.71–8.66, p = 0.15). 75% of SAEs (15 SCT, 6 CT) were hospitalisations for a wide range of conditions. 3 SCT and 6 CT participants switched to second-line ART fol- lowing viral failure (p = 0.50).

Conclusions Sustainable non-inferiority of virological suppression in young people was shown for SCT versus CT over median 3.6 years. Standard-dose efavirenz-based SCT is a viable option for virologically suppressed HIV-1 infected young people on first-line ART with 3-monthly VL monitoring.

Steady-state pharmacokinetics and early safety data in HIV-infected African children weighing 14 to <25kg on film-coated dolutegravir 25mg tablets

2018

Authors: Bollen P, Turkova A, Hilda Mujuru H, et al. The ODYSSEY Trial Team

Published in: 10th International Workshop on HIV Pediatrics, Amsterdam, 20-21st July 2018. Poster Number 22

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