PENTA 20 (Odyssey)

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)

Tags: | September 28th, 2021

Authors: Anna Turkova on behalf of the ODYSSEY trial team

Presented at: CHIVA 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, the trial was opened for ‘under 14kg cohort’

‘Under 14kg’ cohort

  • Aim to enrol ≥20 children in each of the three lower WHO weight bands: 3-<6kg, 6-<10kg and 10-<14kg
  • To confirm efficacy, safety and the most practical dosing
  • Proportions of first- and second-line not pre-specified
  • Children in DTG arm did intensive PK

 

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