ART: Initiation and Initial Regimen

Initiation of ART in Children and Adolescents Living with HIV
  • We recommend the initiation of ART in all children and adolescents diagnosed with HIV irrespective of age, clinical stage, CD4 count and VL
  • We emphasise the need for urgent diagnosis for infants born to women living with HIV and prompt treatment of infants diagnosed with HIV infection
  • We endorse the “U=U” campaign (undetectable (defined as VL < 200 copies/mL for > 6 months) = untransmissible) for sexual transmission of HIV, which is particularly relevant to sexually active adolescents and is potentially a motivational message to enhance adherence and prevent onward HIV transmission
Initial Combination Regimen for ART-naïve Children and Adolescents Living with HIV
  • See Table 1
  • Where available, baseline resistance testing should be performed
  • All first line regimens currently include 2 NRTIs together with a drug from a different class (third agent)
  • DTG plus 2NRTI combination is the preferred option in all children over 4 weeks of age and 3 Kg
  • Evidence for superiority of DTG compared to NNRTI or PI/b has been demonstrated by the ODYSSEY trial
  • Whilst “preferred options” are recommended, “alternative options” are acceptable and remain important choices in settings where ART availability is limited or in individuals at particular risk of specific toxicity or DDIs
  • Whenever possible first line 3rd agents with high barrier to resistance have been selected in view of potential difficulties with adherence in children and adolescents
  • Potential transmitted resistance and resistance resulting from maternal or infant ART exposure during failed prevention of vertical transmission should also be considered when choosing a regimen
  • When NVP has been used in pregnancy non-NNRTI-based ART, including RAL from birth, LPV/r from 2 weeks and DTG from 4 weeks are preferred
Additional Specific Paediatric Considerations
  • It should be noted that these Guidelines occasionally include recommendations for use of ARVs outside their European licence
  • Local policy for the use of unlicensed medication in children and adolescents should be followed
  • Apart from decisions on standard first line in high prevalence setting, options should ideally be discussed within a multidisciplinary team (MDT)/paediatric virtual clinic (PVC)
  • If local MDT or PVC are unavailable, an international PVC is accessible by contacting the Guideline Team.
  • Adherence is key to achieving and maintaining viral suppression and adherence support and assessment should be provided at/prior to initiation of ART and at all subsequent visits
  • The use of peer mentors, where available, is strongly recommended
  • Although age cut offs are used in Table 1 it should be noted that weight as well as age restrictions are also included in the licensing of ARVs in children
  • Detailed guidance on paediatric dosing is available from the Penta website,
  • Drug formulations that are useful for paediatric dosing and administration are summarised in Table 2