ODYSSEY confirms dolutegravir-based treatment is best for children living with HIV

07 Mar 2024

The newer anti-HIV drug dolutegravir is better than alternative treatments for prevention of treatment failure in children over the long term, according to new extended follow-up results from the global ODYSSEY trial

The findings from this global trial, which were presented today at the 2024 Conference on Retroviruses and Opportunistic Infections, reveal that by around 3.5 years, 13% less children had experienced treatment failure on dolutegravir-based treatment compared to children on older drug combinations. This was true whether children started dolutegravir as part of their first-line treatment or switched to it after an alternative first-line combination had failed.

ODYSSEY was the first randomised controlled trial to look at whether dolutegravir-based combinations are effective and safe for children living with HIV. Children who joined the trial were randomly allocated to receive either dolutegravir or the standard treatment combination at the time.

ODYSSEY included 792 children aged 4 weeks to 18 years at the time of enrolment; 683 children from clinical centres in Uganda, Zimbabwe, South Africa and Thailand took part in the extended follow-up. After 192 weeks, researchers compared the proportion of children whose treatment had failed to suppress the virus in each group. Treatment failure was defined if the virus levels were confirmed as raised in the blood, or if the child had an HIV-related clinical diagnosis or died.

Children taking dolutegravir were less likely to experience treatment failure by 192 weeks, of participants taking standard treatment. This means that, on average, for every eight children treated with dolutegravir instead of alternative anti-HIV drug combinations, one child will avoid treatment failure.

Earlier results from ODYSSEY showed that dolutegravir-based treatment was more effective than other drug combinations for children and babies followed for 96 weeks. These findings led to medicines regulators around the world rapidly approving dispersible dolutegravir tablets for young children. The World Health Organization also updated its HIV treatment guidelines to recommend dolutegravir-based combinations as the first choice of treatment for all children living with HIV over the age of four weeks.

By the end of extended follow-up, 99% of ODYSSEY participants who were taking other drug combinations switched to dolutegravir due to changes in national guidelines, with most treatment changes taking place after 192 weeks. Overall, 90% of participants were virologically suppressed on dolutegravir after switching.  

The ODYSSEY team wish to thank the trial participants and investigators at the following African and Thai clinical centres, which took part in the extended follow-up: Joint Clinical Research Centre, Baylor College of Medicine Children’s Foundation, and MUJHU Research Collaboration in Uganda; UZCRC in Zimbabwe; FAM-CRU, PHRU, Klerksdorp Tshepong Hospital Complex, Durban International Clinical Research Site, and AHRI in South Africa; and HIV-NAT, Prapokklao Hospital, Phayao Hospital, Chiangrai Prachanukroh Hospital, Nakornping Hospital, Khon Kaen Hospital, and Mahasarakam Hospital in Thailand.

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