Dolutegravir-based regimens are more effective than standard HIV treatment for children and adolescents
The international study, ODYSSEY, compared the efficacy and safety of dolutegravir (DTG) – based HIV regimens with standard treatment protocols for children starting first-line or second-line antiretroviral therapy (ART) – the results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2021) last week.
The study recruited children and adolescents weighing 14KG and above, and in total 707 children were enrolled from Uganda, Zimbabwe, South Africa, Thailand and Europe. They were assigned to either a DTG-based regimen (350) or a standard Efavirenz or protease inhibitor-based regimen (357).
After 96 weeks of follow up, 14% of the participants in the DTG group and 22% in the standard therapy group showed clinical and virologic evidence of therapy failure. This trend was observed in both arms of the standard therapy group.
Across all study groups, there was no observable difference in mortality and severe clinical complications, or in the frequency of serious adverse reactions. However, in children on standard therapy it was more likely that treatment regimens would need to be modified as a result of side effects – 32% versus 4% in the DTG group.
ODYSSEY as looked at the dynamics of weigh gain in the groups. Weigh, height and BMI increased slightly more in the DTG group than the standard treatment groups (differences between groups 1KG (0.4), 0.7cm (0.3), 0.3 KG / m2 (0.1) respectively at 96 weeks).
“The study results support the WHO recommendations that recommend DTG-based regimens as the preferred ART for children weighing less than 14KG starting first- or second-line antiretroviral therapy, thus aligning them with treatment programs for adults,” concluded Anna Turkova, researcher at the Medical Research Council (MRC) in London, UK.
When asked by Life4me+ about children weighing less than 14KG, Anna Turkova replied: “We have now presented data from the main study. Children weighing less than 14KG are also participating in a similar study and are currently being followed up. Results for this group will be presented later this year”.