ODYSSEY

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

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,

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

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,

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.

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.

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,

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.

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,

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.

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,

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,

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.

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.

We are pleased to announce the launch of the brand new ODYSSEY website!

Included among the various features on the site are a background of the study, the objectives set, treatment overview with news updates, and a link to the reserved area on the PENTA website. It has been carefully designed with a vibrant user-friendly interface that,