The document discusses optimizing pediatric antiretroviral therapy (ART) regimens in South Sudan. It defines optimization as making the best use of antiretrovirals (ARVs) by using those that are potent, less toxic, easy to take, and reduce treatment failure risk. The document reviews common pediatric regimens in South Sudan, World Health Organization recommendations, and new products available. It provides guidance on optimizing regimens, transitioning children to new regimens, monitoring the process, and addressing challenges with administering specific drugs like lopinavir/ritonavir pellets.

1. Optimizing Pediatric ART in South Sudan
Shambel Aragaw
Nov 21, 2019

2. Outline
• What is optimization?
• What is ART optimization? What are the characteristics of optimized regimen?
• What are common pediatric regimens in South Sudan?
• Why pediatric ART optimization in South Sudan?
• What is the current WHO recommendation for pediatric ART?
• Administration of LPV/r pellets
• HEI prophylaxis recommendations

3. What is optimization?
• Optimization refers to making the best or most effective use of a
resource
• Optimized ARVs are those that are:
• Potent and very effective
• Less toxic
• Well tolerated and easy to take
• Reduce the risk of treatment failure
• Have a high genetic barrier to resistance
• Less costly for the program
• Optimized ARVs should also be harmonized across populations but this
is not always possible

4. What is our formulary in South Sudan?
100mg scored

5. We have little, expiry in Feb 2020
Not in our guideline

6. What is the current WHO recommendation for pediatric ART?
• What is preferred first line regimen for neonates?
• What is the preferred first line regimen in children?

9. What is the current WHO recommendation for pediatric ART?
• What is preferred first line regimen for neonates?
• What is the preferred first line regimen in children?
For the shortest time possible, until a solid formulation
of LPV/r or DTG can be used
South Sudan: ABC/3TC+LPV/r

10. South Sudan Optimized Pediatric Regimen

11. South Sudan Alternative Regimen
<14kg

13. South Sudan: second line regimen

14. TB/HIV Coinfection

15. New products in South Sudan
• Raltegravir (RAL)
• Dolutegravir (DTG)
• Ritonavir boosted Lopinavir (LPV/r pellets)

16. Raltegravir (RAL)
• Integrase inhibitor
• Formulations:
 25mg chewable scored tablet- WHO optimal
formulary
 100mg chewable tablet- WHO replaced it with
25mg tablet for dosing flexibility [ this is what we
have in South Sudan]
 Granules for suspension 100mg – WHO limited use
formulary
 400mg tablet >25kg [not part of pediatric formulary]
• Indication/use
• Alternative first line and second line in children
between 3-20kg.
• Major side-effects
• Rash, including Stevens-Johnson syndrome,
hypersensitivity reaction, and toxic epidermal
necrolysis
• Nausea, diarrhea

17. Dolutegravir (DTG)
Integrase inhibitor
Formulations:
 50 mg tablets [ 10mg, 25 mg
tablets]
Indication
Preferred 1st line regimen in children
4weeks -10 years
Currently only the 50mg tab is
available for use in children ≥20kg
Major side-effects
More common: Insomnia and
headache

18. 0
10
20
30
40
50
60
70
80
AZT+3TC+NVP ABC+3TC+NVP TDF+3TC+EFV ABC+3TC+EFV AZT+3TC+EFV
Percent
Regimen
PROPORTION OF CHILDREN BY REGIMEN AUGUST
2019

19. LPV/r
• Protease inhibitor
• Available dosage forms
• Indications/use
• Major side effect

20. Counseling for Caregivers
Administering LPV/r
Oral Pellets to Infants
and Children

21. • Based on your child’s weight, the pharmacist will tell you how
many capsules of pellets to give in the morning and evening.
LPV/r oral granules: Giving the correct dose
Weight (kg) Number of pellets
Morning Evening
3.0-5.9 2 2
6.0-9.9 3 3
10.0-13.9 4 4
14.0-19.9 5 5

22. • You will need the correct number
of capsules, two clean bowls or
cups, a clean plate and a small
spoon.
LPV/r Oral Pellets: Preparing to Give the Pellets

23. • Pellets can be given with breastmilk
• It is easier to give pellets with expressed
breastmilk
Infants <6 months: Giving LPV/r Pellets with Breastmilk

24. • Holding the capsule with the yellow side up,
twist the yellow side to open the capsule
• The pellets will remain in the bottom half of
the capsule
• Do this over the clean plate in case any
pellets spill out of the capsule
Infants <6 Months: Preparing to Give the Pellets

25. • Pour a small amount of expressed
breastmilk over the pellets in the
spoon
• Do not crush or try to dissolve the
pellets in breastmilk
Infants <6 Months: Adding Breastmilk to Pellets

26. • Feed your baby the mixture immediately
after adding the milk
• You can use the spoon or the cup to feed
the baby
• Do not wait for too long to give your baby
the mixture or it will become bitter
• Make sure your baby drinks all the milk and
pellets
Infants <6 Months: Feeding Your Baby the Mixture of Breastmilk
and Pellets

27. • After your baby takes the full mixture you
can breastfeed regularly to make sure all
the pellets are swallowed and no bitterness
remains in the mouth
Infants <6 Months: Making Sure Your Baby Takes All the Pellets

28. Immediately after giving a spoon of
pellets, breastfeed normally so all the
pellets are swallowed quickly before
they develop a bitter taste
Infants <6 Months: Giving Pellets Directly to Your Baby
You can also give pellets directly to your baby
You can use a spoon to give
some pellets to your baby

29. • Your baby will have to take more than one
capsule of pellets
• It may be easiest to give one capsule of
pellets at a time and repeat for all of the
remaining capsules
Infants <6 Months: Giving the rest of the dose

30. • The pellets are only 1 of the ARVs that your
child needs
• You still need to give the other ARVs at the
same time
Giving the other ARVs

31. Wrap-Up

32. • Pellets can be mixed with
soft food
• Some foods you can use
are yogurt, soft porridge,
mashed fruit or any other
soft food your child likes to
eat
• Your child must be able to
swallow this food without
having to chew
• Food should be at room
temperature, but not hot
Infants and children >6 months: LPV/r pellets can be given with soft foods

33. • Put a small amount of soft food
into the clean cup or bowl
• Put only enough food in the small
cup or bowl that you know your
child will take in two or three bites
Infants and children >6 months: Giving LPV/r pellets with soft foods

34. Infants and children > 6 months: Preparing to give the pellets
• The pellets will remain in the
bottom half of the capsule
• Do this over the clean plate in
case any pellets spill out of the
capsule
• Holding the capsule
with the yellow side
up, twist the yellow
side to open the
capsule
• Sprinkle the
pellets over a
small amount of
soft food

35. LPV/r oral pellets: Administering the pellets with soft food
• Use the spoon to feed your child
the pellets and soft food
immediately
• It is important that your child
takes the entire mixture that is in
the bowl
• Give the pellets and food to your
child quickly so the pellets and
food do not develop a bitter taste

36. • Pellets can also be
given with any liquid
such as milk, juice or
clean water
Giving pellets directly with liquid

37. Giving pellets with semi-solid food
• Pellets can also be given inside a
small ball of semi-solid food such as
fufu, ugali, chima or irish potato
• Make sure the ball is small enough for
your child to swallow whole without
chewing

38. • Your child will have to
take more than 1 capsule
of pellets
• It may be easiest to give
one or two capsules of
pellets at a time and
repeat for all of the
capsules
LPV/r oral pellets: Giving the entire dose

39. • The pellets are only one of the ARVs that
your child needs
• You still need to give the other ARVs at the
same time
Giving the other ARVs

40. Wrap-Up

41. 1. Vomiting
2. Refuses to take or spits out because of
bad taste
3. Child chews pellets
4. Child refusing food that has pellets
mixed in
5. Child unable to swallow all pellets
6. Child holding pellets in the mouth
Solving Challenges

42. Child vomiting after taking pellets
• If child has swallowed pellets and vomits
within 20 minutes, re-administer the full dose
• If more then 20 minutes have passed, no need
to repeat the dose
• Try giving the pellets before or after a meal
and see which is easier for the child to
tolerate
• Give fewer pellets at a time (half capsule)

43. Child refuses to take or spits out because
of bitter taste
• Add pellets to food just before administering
• Use food that is at room temperature or a little cold. Hot food
makes the pellets bitter faster.
• Give a spoon of something sweet or sticky that coats the mouth
such as peanut butter before giving the pellets
• If available give something cold/frozen to child to numb mouth
before giving pellets
• If the child enjoys the taste of the dispersible tablet or other
medicine they take (cotrim liquid or multivitamin liquid) give
pellets before and let the child swallow them with the other
medicine

44. Child chews pellets
• Give with something that is more fluid (may add milk or
water to porridge to soften) and have take a few
swallows without chewing of plain food before adding
pellets
• Give with liquid instead of food- pour pellets directly on
the tongue then quickly follow up with water or milk
• Let the child practice swallowing one pellet at a time
without chewing, then increase number of pellets
gradually

45. Child refuses food that pellets are mixed in
• Try different foods that the child enjoys and will eat without
chewing. Do not have to use the same food every time you give
the pellets. Some foods to consider:
• Soft porridge with some
sugar added
• Yogurt
• Syrup or honey
• Mashed beans
• Mashed potato (Irish)
• Give child plain food without pellets then give the pellets with
food
• Alternate foods so child doesn’t associate one particular food
with pellets
• Soup
• Apple sauce or fruit
puree
• Mashed avocado
• Scrambled eggs

46. Child unable to swallow all pellets
• Make sure you are not overfilling the child’s mouth with
food that may make it difficult to swallow. Give pellets
with an amount of food or liquid that the child can
swallow quickly and easily
• Giver fewer pellets at a time and repeat until all dose is
consumed

47. Child holding pellets in the mouth without swallowing
• Make sure you are not overfilling the child’s mouth with
food that may make it difficult to swallow. Give pellets
with an amount of food or liquid that the child can
swallow quickly and easily
• With the child in your lap, pinch his nostrils together so
he will have to breath through his mouth, this will force
him to swallow

48. OF NOTE
The program is transitioning to double strength
ABC/3TC 120mg/60mg tablets. However, stocks
of 60mg/30mg tablets may still be in use.
HCWs should check which formulations are
available in the pharmacy to ensure the
appropriate dose of ABC/3TC is prescribed
CRITICAL NOTE
Pediatric LPV/r (Aluvia) tablets MUST BE
SWALLOWED WHOLE. Crushing or breaking these
tablets should be avoided as it lowers drug levels
significantly and may lead to viral failure and the
development of HIV drug resistance.
At EVERY visit for children on LPV/r-based regimens
• For all children ask about tolerability or if there are challenges giving
LPV/r
• For children on LPV/r pellets ask caregivers to demonstrate or describe
how pellets are being given
• For children on tablets ask caregivers if they are breaking or crushing the
tablets. If yes, change child to pellets and demonstrate to caregiver how
to administer pellets appropriately
Dosing and Administration Guidance for
Optimal Pediatric ARV Regimens

49. Implementation of transition to optimized pediatric regimens

50. Practical steps
• How many children are in care [ current age]?
• What is the regimen each child is taking?
• What is the appropriate optimized regimen for each child?
• What is the current stock of optimized regimen/ARV in each facility?

51. Get the list of all children by facility
S# UAN Date ART start
Age (ART
start)
Current
age
Weight on last
visit
Current
regimen
Optimized
regimen
Next appointment
date

52. Monitoring transition
 Daily
• # of pediatric visits today
• # of children already on optimized regimen
• # transitioned to optimized regimen today
 Monthly
• # of children by regimen

53. Thank You!