ODYSSEY trial finds dolutegravir-based HIV treatment is better for babies

19 Jul 2021

The anti-HIV drug dolutegravir, given in combination with other anti-HIV drugs, improves outcomes for babies and young children living with HIV, compared to standard anti-HIV treatment combinations. This is according to results from the ODYSSEY trial ‘baby cohort’ that were presented at the International AIDS Society meeting yesterday.

This is consistent with previous results from older children the ODYSSEY trial, which showed that dolutegravir-based treatment combinations were better than other anti-HIV treatments for children weighing at least 14kg.

Dolutegravir has a number of potential advantages, including:

  • Few drug-to-drug interactions, making it easier to use when treating people need treatment for other conditions such as tuberculosis
  • High potency at a low milligram dose, meaning tablets can be small
  • High genetic barrier to resistance
  • Low cost

Trials of dolutegravir in combination treatments in adults with HIV have shown that it is as good as or better than other drugs. ODYSSEY is the first trial to look at whether treatment combinations based on dolutegravir are effective and safe for children living with HIV. Children who joined the trial were from clinical centres in several countries in Africa, Asia and Europe. They were randomly allocated to receive either the current standard treatment combination, or one that included dolutegravir.

The results presented yesterday were from 85 children weighing <14kg from Uganda, Zimbabwe and South Africa. Innovative methodology was used to allow information from the older children (previously presented) to also be taken into account in the analysis.

The results showed children on dolutegravir-based treatment were more likely to keep their virus suppressed than those on standard treatment.

ODYSSEY has already had an impact, with data from the trial contributing to regulators approving a 5mg dispersible tablet for young children in both USA (FDA), Europe (EMA) and other countries.
These latest results strongly support latest WHO guidelines, which recommend dolutegravir-based treatment as the first choice for all children over 4 weeks of age living with HIV.

The ODYSSEY trial was sponsored by the Penta Foundation, and coordinated by the MRC Clinical Trials Unit at UCL, as well as INSERM, PHPT and HIV-NAT. 89% children in this global trial were enrolled from Africa, including all the children in the ‘baby cohort’ of young children <14kg. It was funded by ViiV Healthcare and the PENTA Foundation.

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