ODYSSEY

Prediction of C-reactive protein dynamics during meropenem treatment in neonates and infants

2023

Authors: Soeorg H, Padari H, Ilmoja M-L, Herodes K, Kipper K, Lutsar I, Metsvaht T, NeoMero Consortium

Published in: British Journal of Clinical Pharmacology

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What explains the poor contraction of the viral load during paediatric HIV infection?

2023

Authors: Schröter J & De Boer R

Published in: Journal of Theoretical Biology 2023

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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

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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

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Dolutegravir-based HIV treatment is better for babies and young children

2022

Babies and young children treated with the anti-HIV drug dolutegravir, in combination with other anti-HIV drugs, are more likely to keep the virus under control, compared to those treated with standard anti-HIV treatment combinations. This is according to results from part of the ODYSSEY trial that were published yesterday in The Lancet HIV.

This is consistent with previous results from older children in the ODYSSEY trial,

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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

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Double dose of dolutegravir to treat HIV in children also being treated for tuberculosis

2022

Results from a substudy of the ODYSSEY trial show that children being treated for tuberculosis (TB) and HIV at the same time can safely have the anti-HIV medicine dolutegravir twice a day. These results were published yesterday in The Lancet HIV journal.

Around 50,000 children are co-infected with both TB and HIV each year. Treating the two diseases at the same time is complicated, as a commonly used TB drug,

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Borrowing information across patient subgroups in clinical trials

2022

An article by investigators within the ODYSSEY trial has been published as Open Access into BMC Medical Research Methodology. The investigators aimed to evaluate a treatment effect in a pre-defined subgroup of interest while borrowing information from a separate patient subgroup, using a Bayesian analysis. A Bayesian analysis enables evidence from data to be combined with prior information from an external sample.

Phase III clinical trials demonstrate whether or not medical intervention is effective and safe in a specific population.

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Dolutegravir dosing for children with HIV weighing less than 20 kg

2022

The results of an ODYSSEY pharmacokinetic sub-study investigating dolutegravir (DTG) based antiretroviral (ARV) treatments for children weighing 3 to less than 20kg have recently been published in The Lancet HIV as an Open Access article.

DTG has been available for treating HIV in adults globally for many years with paediatric formulations only developed in recent years. Very little pharmacokinetic data were available in young children when the ODYSSEY trial was opened to young children.

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Once-daily DTG more effective in treating HIV in children

2021

The ODYSSEY trial’s final paper Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children has been published in the New England Journal of Medicine. ODYSSEY, sponsored by Penta and funded by ViiV Healthcare, is the first randomised controlled trial to compare the efficacy and safety of dolutegravir-based regimens to non-dolutegravir-based standard-of-care regimens in children and adolescents.

Dolutegravir (DTG) is a drug shown to be highly effective and safe in treating HIV in adults,

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ODYSSEY trial wins 2021 Hector Award

2021

It was announced at the 8th European AIDS Conference that Angela Colbers and David Burger received the Hector Research Award in HIV 2021 in clinical and/or epidemiological science on behalf of the ODYSSEY trial team!

The winning paper Simplified dolutegravir dosing for children with HIV weighting 20kg or more pharmacokinetic and safety substudies of the multicentre randomised ODYSSEY trial, can be found here.

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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

Abstract

ODYSSEY

  • Internationalmulti-centre,randomised96-weeknon- inferiority trial
  • WeaimedtocompareefficacyandsafetyofDTG-basedART with standard-of-care in children and adolescents starting first-line ART (ODYSSEY A) or second-line (ODYSSEY B)

Main trial enrolled children≥14kg

  • Aim to enrol ≥700 children: 310 ODYSSEY A, 390 ODYSSEY B
  • Powered for efficacy (total population and A&B separately)
  • Once enrolment in the main trial was completed,
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New findings from the ODYSSEY trial confirm superiority of dolutegravir-based ART in younger children – A story by WHO

2021

WHO welcomes new findings presented today at International Pediatric HIV Workshop on the superiority of dolutegravir (DTG)-based regimens in young children.

Children living with HIV continue to be left behind by the global AIDS response. In 2020, only 54% of the 1.7 million children living with HIV received antiretroviral therapy in 2020 compared to 74% among adults living with HIV. Among the focus countries, only 40% of children living with HIV (or 74% of children receiving antiretroviral therapy) achieved viral suppression in 2020.

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ODYSSEY team at Radboud receives the RIHS Societal Award 2020

2021

As the world continues to raise its voice towards improving HIV treatment for children, the contributions made by the ODYSSEY trial have not gone unnoticed and as a result, has earned researchers the Radboud Institute for Health Sciences Societal Impact Award.

“We are very proud to have received the Radboud Institute for Health Sciences Societal Impact Award 2020 for our work on a simplified dolutegravir dosing schedule for children of at least 20kg.

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ODYSSEY trial finds new drug is better for treating children living with HIV

2021

The anti-HIV drug Dolutegravir improves outcomes for children with HIV infection when given in a 3-drug combination. These results come from the ODYSSEY trial which was presented yesterday at the Conference on Retroviruses and Opportunistic Infections.

Dolutegravir has a number of potential advantages, including:

  • Few drug-to-drug interactions, making it easier to use when treating people who need treatment for other conditions such as tuberculosis
  • High potency at a low milligram dose,
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EU grants Marketing Authorisation to first-ever dispersible-tablet dolutegravir

2021

On 12 January 2021, the European Medicine Agency approved the use of dolutegravir 5mg dispersible tablets for treating HIV in young children living in Europe. This decision was based, in part, on data from our ODYSSEY trial, which we are conducting in close collaboration with the MRC CTU at the University College London.

The EMA also authorised updating dosing recommendations for dolutegravir film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg,

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Cheaper HIV treatment for children: a report in The Lancet

2020

With the world engulfed by the COVID-19 pandemic, you may not have heard about some of the breakthroughs that the scientific community has made in the treatment of paediatric HIV. One such breakthrough is the development of dispersible dolutegravir.

Find more on how we get to this in this article published in The Lancet on 12 December 2020.

 

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European Medicines Agency approves use of Dolutegravir 5 mg dispersible tablet for younger children living with HIV

2020

On November 12th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for dolutegravir 5mg dispersible tablets for young children living with HIV. This decision was based, in part, on data from the ODYSSEY trial.

These small tablets can now be used in combination with other medicines for treating children living with HIV who are aged at least four weeks and weigh at least 3kg.

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