ANSWER KEY
MODULE IV: Antiretroviral Treatment
Which three classes of ARVs are commonly used in Uganda?
1. NNRTIs
2. NRTIs
3. PIs
Do you know the basics facts about Paediatric ARVs?
1. ARV drugs may be taken for several years, but then stopped when the child has an
undetectable viral load or high CD4 count.
False
2. It is best to use a combination therapy (two or more antiretroviral drugs at a time) in adults,
but NOT in children.
False
3. Missing doses or not taking ARVs on time lowers the amount of antiretroviral chemicals in
the body, which means the virus is then able to replicate faster, increasing the chance of it
becoming resistant. True
4. Sometimes side effects can be so strong, intolerable or even life-threatening that the
treatment must be changed. True
5. In cases involving severe opportunistic infections, such as cryptococcal meningitis or
tuberculosis, it may be necessary to stop antiretroviral therapy whilst the infection is
treated. False
6. Antiretroviral treatment does not reduce illness and mortality among children living with HIV
in the same way that it does among adults. It is less effective. False
7. CD4 counts in young children are generally much higher than in adults, and change with the
child’s age. This means that adult guidelines on when to start antiretroviral treatment do not
apply. True
8. Those taking ARVs and who have an undetectable viral load are ‘safe’ from becoming reinfected. False
9. A few of the antiretroviral drugs have harmful effects when used together and should not be
combined (an example is stavudine and zidovudine). True
10. Some antiretroviral drugs have been combined into one pill, which is known as a ‘triple dose
combination’. False
What is the preferred 1st line ART regimen in children?
AZT + 3TC + (NVP or EFV)
What if a child is exposed to NVP during PMTCT?
If child was exposed to NVP during PMTCT, substitute LPV/r into 1 st line for NVP (if LPV/r not
available, use NVP
Immunological failure or not?
Patient takes D4T+3TC+NVP for 1 year and 6 months. CD4 was measured at baseline (50
cells/ml), month 6 (143), month 12 (247), month 18 (220).
• Not enough indications to say it’s failure.
• CD4 physiological variation more probable.
• Look also at CD4%; less variable.
• In case of doubt, and before deciding on treatment switch, do another CD4 test (same
machine, same lab) +/- 1 or 2 months later
CASE STUDY PRACTICE: Clinical Failure or IRIS?
Case 1:
John is a one year old, HIV +ve child who was started on AZT+3TC and NVP at 2 months of age.
The child has been adherent to his treatment. His CD4+ has fallen from 500 to 150 cells over 6
months. He was well until 2 weeks ago when he developed oral thrush. He has been treated
with Ketoconazole with no improvement.
Qn1: What is his Treatment Stage?
 Stage 3
Qn2: Would you switch John’s therapy? Why?
 Yes: Length on treatment >24 weeks, Adherent to treatment yes. So switch because
there is clinical and immunological failure.
Qn3: What ARV regimen would you give?
 ABC +3TC+LPV/r
Case 2:
Na-gundi is a 4 year old girl who has been on AZT+3TC+ NVP for the past 3 months, and she has
not missed her drugs. Her mother reports that she has developed symptoms of cough and
difficulty in breathing. Her mother also reports that she thinks that Na-gundi gets a bit hot
especially in the afternoon and sweats a lot at night. Na-gundi was treated with IV ceftriaxone
for 5 days with no improvement.
Qn1: What could be the diagnosis in Na-gundi?
• I RIS – TB
• Pneumonia
Qn 2: What other investigations would you do in this child?
 Sputum ZN
 CXR
 Mantoux test
 Early CD4 counts
Qn 3: Would you switch Na-gundi’s treatment and why?
 No
 She needs substitution to AZT + 3TC +EFV
 To avoid the interaction between NVP and TB drugs
Case 3
Mukonogum is an 8 year old boy. He has been on AZT+ 3TC + NVP for 3 years now. He has been
adherent and doing very well until 1 month ago when he developed skin rashes and
pneumonia. His CD4 count when he started treatment was 200. His CD4 as per last month was
300. It was repeated 2 days ago and it was 90 cells/mm .
Qn 1: From this information do you think Mukonogum is failing on his first line regimen?
• Yes - Duration on ART >24 weeks, Adherent-Yes, Clinical failure- yes , Immunological
failure-Yes
Qn 2: If yes, which regimen are you likely to switch him to?
• ABC+ 3TC + LPV/Rtr
Qn3: What factors do you need to clarify on before you initiate him on the second line?
Factors for clarification:
 Adherence
 Tolerability (e.g. side effects)
 Pharmacokinetic issues (food/fasting requirements)
 Drug-drug interactions
 Potency of current ARTs
 Prior ART experience
- Potential for or known resistance
CASE Study PRACTICE: Identifying & Managing Side Effects of ARVs
Scenario #1
Nabatanzi is a 7 month old girl who was started on triommune baby tablets 6 days ago.
Her grandmother returns today to see you because Nabatanzi has developed an itchy rash on
her neck and back last evening, and she is worried that it appears to be spreading even other
parts of her body. Nabatanzi has no fever, and the rash has not formed any blisters. Her
neighbour, who also has a child with HIV, has told her the rash is a sign that the drugs make the
child sicker and asked her to stop them. She is confused.
1: Which drug do you think caused the rash?
Nevirapine
2: What would you tell the grandmother?
 Reassure her that while the reaction may be bothersome, it does not require change of
therapy.
 Remind her to continue monitoring the child and to report immediately if the rash gets
worse and develops blistering.
Scenario #2
Mbabazi is a 5 year old child who has been on Combivir, and Nevirapine for 10 days now. His
concerned mother brings him to see you because he has developed peeling and ulceration of
his skin and mucous membranes. His mother says his condition began as a rash all over the
body and has steadily gotten worse over the last 2 days. She denies he has been burned.
1. Which drug do you think is responsible for this clinical picture?
Nevirapine
2. How would you manage the child?
 Immediately discontinue all ARV drugs, manage the child as for burns
 Ensure the child has adequate hydration & nutrition
 Keep in a sterile environment, cover with antibiotics, and give pain killers.
 Monitor the child’s vital sign closely
Scenario #3
Acayo is a 4 year old child who has been on combivir and EFV for 4 months now.
She has been brought in for a routine monitoring visit. You notice that she tires easily, when
she runs around your office. You also notice that her hands and conjuctiva are pale. On
reviewing her labs, her baseline Hb was10mg/dl. You request for a repeat Hb, a differential
count and a blood slide to rule out malaria. The Hb returns as 6.3mg/dl, the blood slide is
negative, and the differential count showed a normal white cell distribution.
1. What drug is responsible for this clinical picture?
Zidovudine
2. How would you manage this patient?
 Get her admitted and assessed for blood transfusion, supplement with haematinics
 Stop AZT and substitute with either Abacavir, Tenofovir or Stavudine
Scenario #4
Karamagi, an 8 year old boy, has been taking his antiretroviral drugs for 3 weeks now.
His older brother, Kato, 14 years, sleeps in the same room with him and has noted that:
Karamagi wakes up at night screaming, describes strange dreams and seems depressed, and he
keeps to himself and is often irritable. Kato is also on ARVs and has developed a buffalo hump,
gaunt appearance, breast tissue enlargement, tingling sensation in the feet. Their mother is
worried about them.
1. Which ARV in Karamagi’s regimen could be responsible for what is being observed?
Efavirenz
2. Should Karamagi’s offending drug be substituted now?
No, do not substitute it now, watch him closely and if the side effects do not disappear over the
next 2 weeks or they are getting worse, substitute EFV for NVP
3. Which ARV in Kato’s regimen could be responsible for what is being observed?
Stavudine
4. Should Kato’s drug be switched?
Yes, switch to Zidovudine or Abacavir
PRACTICE: Prescribing correct doses of Paediatric FDCs
1. For a 9kg child on the regimen AZT + 3TC + NVP:
a) Which formulation would you use for this child?
Triple FDC
b) What is the average daily dose of this formulation?
1.5 BD
c) How many tablets should you dispense for 30 days?
90 tablets
2. For a 16kg child on the regimen ABC + 3TC + EFV:
a) Which formulations would you use for this child?
Dual FD of ABC + 3TC, and single dose tablet of EFV
b) What is the average daily dose of these formulations?
ABC 2.5 BD, 300mg of EFV
c) How many tablets of each formulation should you dispense for 30 days?
ABC + 3TC = 150 tablets
For EFV, need to decide on the best formulation for the patient
Is there a 300 mg tablet? NO.
So if you use:
EFV 100mg only = 90 tablets
EFV 200mg only = 45 tablets (200mg = 1 plus a half of another)
EFV 200 mg and 100 mg together = 60 tablets
OR
Use an adult dose, which is 600 mg – and so you would give them only 15 tablets for the 30
days.
Remember to check if the adult dose has a ‘scored blade’ and is easy for the caregiver to cut. If it
does not have the blade, be sure to cut the tablets for the mother before she takes them home.
PRACTICE: Prescribing Syrups versus FDCs
You have a patient who weighs 5 kg. You prescribe a regimen of AZT/3TC/NVP.
1st: Calculate the AM and PM dose if you were to use syrups.
a) What is the total volume needed for a 30-day supply?
AZT = 360 ml, 3TC = 180 ml , NVP = 300 ml
2nd: Calculate the AM and PM dose if you were to use FDCs.
b) What is the total number of tablets needed for a 30-day supply?
FDC = 60 tablets
Case Study PRACTICE: Paediatric ART Dosing
Case #1
Osofia is 3 months old and weighs 5 kg. She was given single dose NVP for PMTCT but went on
to get HIV infected. You are planning to start her on ARVs but you do not have kaletra syrup at
your facility.
a) Which ARV regimen would you initiate her on?
AZT/3TC/NVP
b) What formulations will you use for the first 2 weeks of treatment?
Triple FDC of AZT/3TC/NVP and Duo fixed dose AZT/3TC
c) How much would you prescribe of each formulation?
Triple FDC AZT/3TC/NVP-1 od and AZT/3TC 1 od
d) If you are giving her a 14-day supply, how many tablets should you give of each
formulation?
AZT/3TC/NVP 14 tablet and AZT/3TC -14 tablets
Case # 2
IBU is a 6 month old infant who is HIV positive. He received NVP syrup for prophylaxis. He is not
anemic and he weighs 6 kg. You have both abacavir and kaletra syrup in you facility.
a) What regimen should he be given?
AZT/3TC/Kaletra
b) What formulations should you use?
FDC- AZT/3TC and Syrup for kaletra
c) How much would you prescribe of each formulation?
AZT/3TC- 1.5 BD and Kaletra 1.5 mls BD
d) If you are giving them a 30-day supply, how much would prescribe of each formulation?
AZT/3TC 90 tablets and Kaletra 90mls for 30 days
Case #3
Mary is 4 years old and weighs 15 kg. She was diagnosed for HIV. She is anemic and you don’t
have abacavir in your facility.
a) What criteria would you use to determine if Mary is eligible for ARV’s?
CD4 %- less than 25% or CD count <750 or WHO clinical stage 3 or 4
If she is eligible for ARV’s
b) What regimen should she be given?
D4T/3TC/NVP
c) What formulations should you use?
Triple FDC of D4T/3TC/NVP baby and Duo FDC D4T/3TC baby
d) How much would you prescribe of each formulation?
D4T/3TC/NVP 2.5 A.M. and D4T/3TC 2.5 P.M.
e) If you are giving her a 14-day supply, how many tablets should you give her of each
formulation?
D4T/3TC/NVP 35 tablets and D4T/3TC 35 tablets
f) If she comes back for after 14 days as she has tolerated the drugs what formulation
would you give, what dose and how many tablets would you dispense for 30 days?
D4T/3TC/NVP baby , 2.5 BD and 150 mg
Case #4
Aki is a 7 year old HIV positive boy. He is anemic and is eligible to start ARV’s. You have abacavir
in you facility. He is 18 kg
a) What regimen should he be given?
ABC/3TC/NVP or ABC/3TC/EFV
b) What formulations should you use?
Duo FDC for ABC/3TC and single Tablets NVP
or
Duo FDC ABC/3TC and single tablet EFV
c) How much would you prescribe of each formulation?
ABC/3TC 2.5 BD and Tab NVP 1 in morning and 0.5 in Evening
or
ABC/3TC 2.5 BD and Tab EFV(600mg) 0.5 mg od
d) If you are giving them a 30-day supply, how many tablets should you give them of each
formulation?
ABC/3TC 150 tablets and NVP 45 tablets
or
ABC/3TC 150 tablets and EFV 15 tablets
Note:
 If you are using a NVP based regimen, always remember to lead it in as you watch the side
effects
 If possible, always avoid breaking un-scored tablets especially Efavirez 600 mgs. Use the
200mg and 100 mgs, add them up and make up the correct dose.
 Whenever you round off the dose, please give the dose at the upper limit.
Case #5
Popo is a 9 year old boy who is HIV+. He is not on ARVs and was diagnosed with TB. His weight
is 21kg
He is eligible to start ARVs
a) When would you start him on ARVs?
2-8 weeks after initiation of anti TB treatment
b) What regimen should he be given?
AZT/3TC/EFV
c) What formulations should you use?
Dou FDC AZT/3TC and single tablet EFV
d) How much would you prescribe of each formulation?
AZT/3TC 3BD and EFV (600mg) 0.5 once a day or make up 300 mgs using a 200 mg tablet
and a 100 mg tablet
e) If you are giving them a 30-day supply, how many tablets should you give them of each
formulation?
AZT/3TC 180 tablets and EFV(600mg) 15 tables