ART: Preferred & Alternative First Line Options, Formulations, Dosing

Table 1. Preferred and Alternative First Line Options in Children and Adolescents Living with HIV
  Backbone  3rd Agent (in alphabetical order)
Age Preferred Alternative Preferred Alternative
 0 - 4 weeks ZDV(i) + 3TC  - LPV/r(ii, iii)
NVP(iii)
RAL(iii)
 -
 4 weeks - 3 years ABC(iv) + 3TC(v) ZDV(i) + 3TC(vi)
TDF(vii) + 3TC
DTG(viii) LPV/r
NVP
RAL
 3 - 6 years ABC(iv) + 3TC(v) TDF + XTC(ix)
ZDV + XTC(ix)
DTG DRV/r
EFV
LPV/r
NVP
RAL
 6 - 12 years ABC(iv) + 3TC(v)
TAF(x) + XTC(ix)
TDF + XTC(ix) DTG

DRV/r
EFV
EVG/c
RAL

 > 12 years ABC(iv) + 3TC(v)
TAF(x) + XTC(ix)
TDF + XTC(ix) BIC(xi)
DTG
DRV/b
EFV(xii)
RAL(xii)
RPV(xii)

Notes

i In view of potential long-term toxicity, any child on ZDV should be switched to ABC or TAF (preferred) or TDF (alternative) once increase in age and/or weight makes licensed formulations available 
ii LPV/r should not be administered to neonates before a postmenstrual age of 42 weeks and a postnatal age of at least 14 days although it may be considered if there is a risk of transmitted NVP resistance and INSTI in appropriate formulations are unavailable. In these circumstances the neonate should be monitored closely for LPV/r related toxicity
iii If starting a non-DTG 3rd agent in the neonatal period it is acceptable to continue this option. However, when over 4 weeks and 3 kg, a switch to DTG is recommended if and when an appropriate formulation is available
iv ABC should NOT be prescribed to HLA-B*57:01 positive individuals (where screening is available). ABC is not licensed under 3 months of age but dosing data for younger children are available from the WHO and DHHS
v At HIV-VL > 100,000 copies/mL ABC + 3TC should not be combined with EFV as 3rd agent
vi If using NVP as a 3rd agent in children aged 2 weeks to 3 years, consider using 3 NRTI backbone (ABC + ZDV + 3TC) until VL consistently < 50 copies/mL
vii TDF is only licensed from 2 years of age
viii DTG is licensed from 4 weeks and 3 kg
ix XTC indicates circumstances when FTC or 3TC may be used interchangeably
x TAF is only licensed in Europe for treatment of HIV in combination with FTC from 12 years of age and 35 kg in TAF/FTC and from 6 years of age and 25 kg in TAF/FTC/EVG/c
xi BIC is a preferred first line option in adult PLWH. At time of writing it is not licensed under 18 years of age but may be considered in those aged 12-18 years following discussion at MDT/PVC
xii Due to predicted poor adherence in adolescence, PI/b are favoured as alternative first line 3rd agent options due their high barrier to resistance

 

Table 2. Antiretroviral Formulations Useful for Paediatric and Adolescent Dosing and Administration
NRTI  
ABC tablet (300 mg) solution (20 mg/mL)
FTC capsule (200 mg) solution (10 mg/mL)
3TC tablet (300, 150 mg) solution (10 mg/mL)
TDF tablet (245, 204, 163, 123 mg) granules (33 mg/g)
ZDV capsule (250 mg, 100 mg) solution (10 mg/mL) iv infusion: 10 mg/mL (20 mL/vial)
TAF/FTC tablet (25/200 mg and 10/200 mg)
TDF/FTC tablet (300/200 mg)
ABC/3TC tablet (600/300 mg)
ZDV/3TC tablet (300/150 mg)
NNRTI  
EFV tablet (600 mg) capsule (200, 100, 50 mg)
NVP tablet (200 mg) prolonged release tablet (400, 100 mg) suspension (10 mg/mL)
RPV tablet (25 mg)
TDF/FTC/EFV tablet (300/200/600 mg)
TAF/FTC/RPV tablet (25/200/25 mg)
TDF/FTC/RPV tablet (300/200/25 mg)
PI  
 DRV tablet (800, 600, 400, 150, 75 mg) solution (100 mg/mL) 
 DRV/c tablet (800/150 mg) 
 LPV/r tablet (200/50 mg and 100/25 mg) solution (80/20 mg/mL)
 RTV tablet (100 mg) powder for oral suspension (100 mg sachet) 
 TAF/FTC/DRV/c tablet (10/200/800/150 mg)
INSTI  
 DTG tablet (50, 25, 10 mg) dispersible tablets (5 mg)
 RAL tablet (600 mg, 400 mg) chewable tablets (100, 25 mg) granules for oral suspension (100 mg)
 ABC/3TC/DTG tablet (600/300/50 mg)
 TAF/FTC/BIC tablet (25/200/50 mg)
 TAF/FTC/EVG/c tablet (10/200/150/150 mg)
 TDF/FTC/EVG/c tablet (300/200/150/150 mg)