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Paediatric First line ART
Initiation and Follow-up
Paediatric First line ART: Initiation
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Session ObjectivesAt the end of the session, we will understand
Provision of ART to children with HIV based on the
national guidelines
When, how and what to start ART in children When, how and what to start ART in TB and HIV
co infected children
Appropriate Prescriptions: ART formulations with
appropriate dosages
Process of Monitoring and follow up after ART
initiation
2Paediatric First line ART: Initiation
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Pre-ART Care
How will you assess the child after the
diagnosis of HIV is confirmed?
How will you manage the child?
Paediatric First line ART: Initiation 3
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Pre-ART Evaluation and Follow up
Clinical Evaluation - Baseline and at every visit:
Clinical Evaluation
Weight; Height; BMI; Head circumference
Nutritional status and needs Opportunistic Infections:
Clinical staging
Treatment needs
Prevention; prophylaxis and adherenceInvestigations:
Baseline: CD4 count (%), X-ray chest, WBC, Hb% and ALT
6-Monthly: CD4 count (%), WBC and Hb%
Paediatric First line ART: Initiation 4
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Similar pathogenesis of HIV infection
General virological and immunologic
principles for antiretroviral therapy Unique considerations in infants, children
and adolescents
Paediatric First line ART: Initiation 5
ART in Adults and Children
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Diagnostic issues
Pharmacokinetic issues
Availability of paediatric formulations
Age-related differences in virological and
immunologic markers
Adherence issues
Paediatric First line ART: Initiation 6
Special Considerations
in Paediatric ART
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Age-related differences between childrenand adults
Body composition
Renal excretion
Liver metabolism
Gastrointestinal function
Enzyme maturation
Paediatric First line ART: Initiation 7
Changing Pharmacokinetics
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Use combination ARV therapy with at least
3 drugs
Slows disease progression
Improves survival and quality of life
Sustains virologic response better
Normalises immune function Delays development of resistance
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Goals of ART
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The decision-making process relies on
Clinical and / or
Immunological assessment
Paediatric First line ART: Initiation 9
When to Start ART?
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Evaluation of the social environment of the child
Caregivers understand ARV therapy, possible side
effects, limitations, adherence schedule, etc
Caregiver is ready for treatment adherence
Caregiver is actively involved in the care of the child
Family and / or social support available
Availability of paediatric formulations
Consistent drug supply
Paediatric First line ART: Initiation 10
Other Factors Influencing
Initiation of ART
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Starting ARV therapy for the individual child is
rarely an emergency!
Management of life-threatening opportunistic
infections can be an emergency
Treat opportunistic infections before starting ART
Paediatric First line ART: Initiation 11
When to Start ART?
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Pooja is 2 years and 3 months old
She is HIV seropositive
In the last 6 months she has been suffering from 2
episodes of pneumonia, requiring hospitalisation
She also has persistent oral thrush
She has achieved normal developmental milestones,
but has failed to gain weight and height as expected
Paediatric First line ART: Initiation 12
Case study
Case-detai ls cont inu ed in next s l ide
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O/E:
wt8kg
Ht75 cm
Cervical lymphadenopathy
Hepatosplenomegaly
Her CD4 count is 500/cmm
Should she be started on ART?
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Case study
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Clinical and Immunological Criteria
for starting ART in Infants (
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Clinical and Immunological Criteria
for starting ART in Children (>24 Months)
Children >24 Months-upto age of 5 years:
HIV-infected children >24 months according toclinical and CD4% criteria
Clinical status:
Initiate ART for all clinical stage 3 and 4, irrespectiveof CD4 count or percentage
In children with TB, LIP, OHL, thrombocytopenia
(stage 3): Use CD4 to guide ART initiationChildren >5 years of age:
Follow CD4 count as in Adult ART Guidelines
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Immunological
MarkerAge-specific recommendation to initiate ART
24 months-35 months 36 months-59 months 5 years
CD4 % 20% 15%Follow Adult ART
GuidelinesCD4 count 750
cells/mm3 350cells/mm3 ART should be initiated by these cut-off levels, regardless of clinical
stage; a drop of CD4 below these levels significantly increases the
risk of disease progression and mortality
CD4% is preferred for children
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Paediatric First line ART: Initiation
%CD4 Count = X 100Absolute CD4 T-Lymphocyte Count
Total lymphocyte count
Absolute CD4 +T-lymphocyte count: As obta ined by the f low cytometer
Total lymphocyte count (TLC) can be obtained by a cell counter
or alternatively obtained using the following formula:
TLC =Total no. of lymphocy tes (DC) x Total leucocytes count
100
Total leucoc yte coun t can be ob tained either through a countin g
chamber or u sing a haematology analyser wi th the blood sample
drawn at the same time as CD4 sample
Formula for calculating CD4%
when CD4 absolute count is available
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Nucleoside reverse transcriptase inhibitor
Zidovudine (AZT)
Stavudine (d4T)
Lamivudine (3TC)
Non-nucleoside reverse transcriptase
inhibitor Nevirapine (NVP)
Efavirenz (EFV)
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What to Start?
First line Antiretroviral Drugs
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Paediatric First line ART Regimens
Paediatric First line ART: Initiation
Paediatric
RegimenRegimen Remarks
Regimen P IZidovudine + Lamivudine +
NevirapinePreferred paediatric regimen
for children with Hb >9 g/dL
Regimen P I (a)Stavudine + Lamivudine +
NevirapineFor children with Hb 9 g/dL and
age >3 yr and weight >10 kg
Regimen P II (a)Stavudine + Lamivudine +
Efavirenz
for children on anti-TB treatment
tuberculosis treatment;
Hb 3 yr and weight >10 kg
1. Efavirenz is the preferred drug over Nevirapine, whenever children arebeing treated with Rifampicin containing drug regimen for TB co infection
2. However, in Children aged
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Pooja, has to be started on ART on the basisof her clinical staging of the disease (WHO-
stage 3) and immunologic staging (severe).
What are the baseline investigations to
be done before starting ART ?
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Case study (Contd.)
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Hb, WBC
X-ray Chest
LFT
RFT
Blood sugar
It was found that Pooja had a Hb of 7g/dL
What should be the preferred ART
prescribed to her?
Base line Investigations
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Zidovudine1st choice in non-anaemic children
(Hb >9 g/dL)
Stavudine1st choice in those who are anaemic
(Hb
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Arun is a 6 year old HIV infected boy, who presented
with the symptoms of cough and low grade fever for
last 1 month. His father was recently detected to
have pulmonary TB.
After thorough clinical examination and
investigations, Arun was diagnosed to be suffering
from pulmonary TB and put on Category I ATT.
His CD4 count was 195/l.
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ART in CLHIV with TB co infection
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Does he need to be started with ART
immediately?
If and when ART is started, what drugsshould be used?
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ART in CLHIV with TB co infection
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Type of TB
Eligible
Clinical Stagingand CD4 Counts
Timing of ART in relation
to start of TB treatment
ART
Recommendations
Pulmonary
TB
(Clinical
Stage III)
Start ART
irrespective of
any clinicalstage
and
irrespective of
any CD4 count
Start ATT first
(Category I or II)
Start ART as soon asTB treatment is
tolerated
(after 2 weeks &
before 2 months)
Start Efavirenz
containingART Regimen
(Regimen II or
Regimen II a)
Extra
pulmonary
TB
(Clinical
Stage IV)
1. Efavirenz is the preferred drug over Nevirapine, whenever children are
being treated with Rifampicin containing drug regimen for TB co infection
2. However, in Children aged
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Age Group /Body weight ART regimen
Age 3 years
Body weight: >10 kg
P II: Zidovudine + Lamivudine + Efavirenz
Preferred for children with Hb >9 g/dL and
bodyweight >10 kgP II a: Stavudine + Lamivudine + Efavirenz
Preferred for children with Hb 10 kg
Age
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ARV drug Formulations available
for CLHIV in ART Centres
Paediatric First line ART: Initiation
Drug Regimen Preparation Drugs
Drugs used in First line ART
Prescribed
according to
weight band
d4T6+3TC (disp.tab)
d4T6+3TC+NVP (disp.tab)
AZT60+3TC30
AZT60+3TC30+NVP50
EFV 200 mg (Tab)
EFV 50 mg (tab)NVP Syrup (50mg/5ml)
Adult preparations
prescribed
according to
weight band
AZT/3TC (Adult)
d4T30/3TC (Adult)
AZT/3TC/NVP (Adult)
d4T30/3TC/NVP (Adult)
Drugs used in Second line ART
and alternate first line ART
Prescribed
according to
weight band
ABC60+3TC30
DDI 125
DDI 200
LPV/ r 125
LPV/ r syrup
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Counsel the patient / caregiver
Adherence monitoring
Evaluate efficacy of treatment
Monitor for Adverse Events (AE)
Detect Opportunistic infections (OIs), if any
Diagnose Immune reconstitution inflammatorysyndrome (IRIS)
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Components of Follow-up Visits
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Monitoring of Growth
Weight / Length or Height / Head Circumference
Assessment of Neurodevelopment
Clinical Evaluation for:
Detecting Adverse Effects of ARVs
Diagnosing Opportunistic Infections
Determining efficacy of therapy
Fill up Follow up details in the white card
Paediatric First line ART: Initiation 29
Follow-up Visits: Clinical Evaluation
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Monitoring
tool
DAY 0
Baseline 15thDAY
1ST
Month
2ND
Month
3RD
Month
6TH
Month
Clinical &
Adherence
Counselling
Each and Every Visit
Hb. Yes
Yes
(if on
AZT)
Yes
(if on
AZT)
Yes Yes
ALT Yes
Yes
(if on
NVP)
Yes
(if on
NVP)
Yes* Yes*
CD4 Count Yes Yes
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Monitoring & Follow up of ART
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Continue ART
Check for new
clinical events
Repeat Adherence counsellingRe-enforce treatment support
Immunological
improvement
Good
Adherence
Good
Nutritional
support
Repeat Adherence counselling
Re-enforce treatment support
Continue ART
No
No
No
No
Yes
Yes
Yes
Yes
Clinical
improvement
Evaluating
a child
on ART
at follow-up visit
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Evaluating response to ART in a child
with no clinical and immunological
improvement at follow up visit
Paediatric First line ART: Initiation
Check for other
causes
New Clinical
EventContinue ART
New OIARV Related
Toxicity
Drug interaction
IRIS Treatment
failure
No
Yes
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Key Points
All the HIV infected infants and young children(2years) based on clinical and age-based CD4%or absolute CD4 count criteria
First line regimens in India is based on 3-drug
combinations (Zidovudine or Stavudine +
Lamivudine + Nevirapine or Efavirenz)
Both the child and the caregiver should have
been counselled before initiating ART
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