Pediatric Prescribing Brief: Critical Importance of Practicing and Adhering to Weight-Based Dosing of Preferred

1L ARV Formulations for Children living with HIV; June 2021

Current WHO Treatment Guidelines for Children Living with HIV (CLHIV)
Since July 2018, WHO has recommended DTG as part of the preferred first-line (1L) treatment for all people living with HIV, including CLHIV. The recommended dosing of
DTG, and the make up of the other ARVs in the child’s regimen, differ based on the child’s weight.

ARV 3 – 5.9kg 6 – 9.9kg 10 – 13.9kg 14 – 19.9kg 20 – 24.9kg 25 – 29.9kg ≥30 kg

ABC/3TC 120/60mg scored dispersible tablet transition to
1 1.5 2 2.5 3 ABC/3TC 600/300 -
transition to DTG
DTG 10mg scored dispersible tablet 50mg - -
0.5 1.5 2 2.5
ABC/3TC 600/300mg tablet - - - - - -
1
DTG 50 mg tablet - - - - transition to TLD
1 1
TDF/3TC/DTG 300/300/50mg tablet (TLD FDC) - - - - - - 1

Background Recommendations for Clinicians and HCWs: Best Practices

Data from several countries showed a portion
of children are being transitioned early to TLD.
This memo outlines the critical importance of
practicing weight-based dosing and
prescribing of optimal ARVs for children &
adolescents living with HIV.
Concerns about Using TLD Fixed Dose
Combination (FDC) in Children <30kg
Although the doses of lamivudine (3TC) and
dolutegravir (DTG) in TLD FDC is safe for children
<30kg, the 300mg dose of tenofovir (TDF) in TLD
FDC is not. Concerns include:
Affects bone mineralization: In children
<30kg, especially before they reach 10 years
of age, the foundation for bone growth is
still being built. TDF 300mg can affect this
process, weakening a child’s bones, putting
them at elevated risk of spontaneous
fractures. A history of bone aches following
long term TDF use should give a high index
of suspicion.
Kidney toxicity: TDF is also associated with a
risk of acute kidney injury and reduced
kidney function in children. Depending on
severity, this could also lead to the loss of
vital minerals and proteins.
Perform a dose check every clinic visit to ensure the correct prescribed dose has been taken since the last visit.
Weigh children at every appointment to ensure they are still on the right dose and ART regimen.
Participate in pediatric dosing and data review meetings and trainings to stay up to date with latest guidelines.
Use available dosing tools and job aids, and notify facility supervisor if these resources are unavailable.
Emphasize to caregivers / older children the importance of adhering to the specific dosing prescribed.
Accurately document ART regimens and weight in patient charts.
Prescribing Guidance: If…. Then:
A child ≥20 and <30kg is on a regimen containing a Transition them from EFV to DTG 50mg single tablet, maintain
sub-optimal, but weight appropriate, ARV like EFV on ABC until they reach 30kg, and then transition to TLD
A child <30kg is failing on current 1L regimen of Transition to appropriately sequenced 2L option as per the
ABC/3TC+DTG client’s history and country national guidelines
A child is <30kg, and ABC is not available / stocked out Substitute with AZT until replenishment of ABC stock
A child >25kg has chronic hepatitis B Consider TAF/X/D if available and consult an expert/specialist
A caregiver asks for child <30kg to be on TLD Explain why children must be ≥30kg to take TLD, referencing job aides
TDF-induced nephrotoxicity is Perform creatinine and urinalysis. If abnormal readings (GFR is < 60mls/min), then
suspected substitute with ABC. If ABC is contraindicated, substitute with AZT
Keep them on ABC/3TC+DTG. It can take some time for a child to reach 30kg (i.e., it can take
A child is close to 30kg
12-18 months for a child to go from 25 to 30kg). Transition them only once they are 30kg