ART: Initiation and Initial Regimen

Initiation of ART in Children and Adolescents
  • 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 with HIV and urgent initiation of treatment for 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 a motivational message to enhance adherence and prevent onward HIV transmission
Initial Combination Regimen for Children and Adolescents who are ART Naive
  • 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 (anchor drug)
  • 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 availability of ART formulations is limited or for individuals at particular risk of specific toxicity or DDIs
  • Whenever possible, first line anchor drugs with high barrier to resistance have been selected in view of potential difficulties with adherence in children and adolescents
  • When choosing a regimen, potential transmitted resistance, including from maternal or infant ART exposure after failed prevention of vertical transmission, should always be considered
  • Dual therapy as first line is not generally recommended outside of a clinical trial but DTG plus 3TC can be considered following discussion with a multidisciplinary team (MDT)/paediatric virtual clinic (PVC)
  • In infants under 4 weeks and/or under 3 kg, when NVP has been used in pregnancy or there is a risk of transmitted NVP resistance, non-NNRTI-based ART, including RAL from birth or LPV/r from 2 weeks are preferred. Once over 4 weeks and 3kg, we recommend switching to DTG based ART as soon as possible to provide a once daily, highly effective, low toxicity, anchor drug with a high barrier to resistance
  • RAL has a relatively low barrier to resistance. If commenced on RAL under 2 weeks of age and DTG is not likely to be available in an appropriate formulation during infancy, then we recommend an interim switch to LPV/r to remove the risk of developing INSTI resistance. It should be noted that LPV/r can also bring challenges with adherence due to poor palatability and this should be taken into account when considering the risk/benefit of this approach
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 ART in high prevalence setting, options should be discussed within an MDT or 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
  • Support from 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 are also included in the licensing of ARVs in children
  • Detailed guidance on paediatric dosing is available from the Penta website
  • Long acting injectable CAB/RPV is not currently licensed for treatment of HIV in individuals aged less than 18 years of age in Europe and although it is not yet recommended as an option for children and adolescents, it may be considered on a case by case basis following discussion at an MDT/PVC and following the same general principles as outlined for adults, see Switch Strategies for Virologically Suppressed Persons
  • TDF/FTC is licensed in Europe for PrEP in adolescents over 12 years and over 35 kg. When other agents are approved for use in the adolescent age range, these agents can also be considered. The same principles should be followed, see Pre-exposure Prophylaxis (PrEP) (EACS PrEP in adults guidance) with additional prioritisation of safeguarding assessments and social as well as medical support for adolescents at significant risk of HIV transmission