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 |
> 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) |