7 Paediatric First Line ART Initiation and Follow-Up-NACO Specialists Training-April 2012 - Copy-1

8/13/2019 7 Paediatric First Line ART Initiation and Follow-Up-NACO Specialists Training-April 2012 - Copy-1

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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%



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Similar pathogenesis of HIV infection

General virological and immunologic

principles for antiretroviral therapy Unique considerations in infants, children

and adolescents


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


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


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


Goals of ART


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The decision-making process relies on

Clinical and / or

Immunological assessment


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


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


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


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?


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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%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)


What to Start?

First line Antiretroviral Drugs


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Paediatric First line ART Regimens


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 ?


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.


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?


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


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)


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


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


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


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


Documents

7 Paediatric First Line ART Initiation and Follow-Up-NACO Specialists Training-April 2012 - Copy-1