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nation of HIV exposure and definitive diagnosis is critical to allow early initiation of potentially life-

saving ART [5, 1!"

HIV serological testing #anti$ody testing% can diagnose infection in adults and c&ildren 'ore t&an 1(

'ont&s of age" )ecause of t&e passage of 'aternal HIV anti$odies across t&e placenta to t&e $a$y, a

positive HIV serological test in infancy does not confir' HIV infection in t&e infant, $ut does indicate

'aternal HIV infection and exposure of t&e infant" HIV serological tests used for clinical diagnostic

testing s&ould &ave a 'ini'u' sensitivity of **+ and specificity of *(+, under standardied and

validated la$oratory conditions [15!" In order to diagnose HIV infection definitively in infants less t&an 1(

'ont&s of age, assays t&at detect t&e virus or its co'ponents #i"e" virological tests% are reuired"

Virological tests t&at can $e used in infants and c&ildren include. assays to detect HIV /0A,

assays to detect HIV R0A, and ultrasensitive assays to detect p antigen #2p Ag% [13!"

Assays to detect HIV /0A or HIV R0A or $ot& #collectively 4nown as nucleic acid a'plification tests

[0AT!% are co''ercially availa$le using a variety of 'anual and auto'ated platfor's" 0AT tests &ave

$eco'e c&eaper and easier to standardie, and provide several advantages for t&e early diagnosis of

HIV infection in c&ildren and for 'onitoring t&e effectiveness of ART [1!" HIV virological assays used

for t&e purpose of clinical diagnostic testing s&ould &ave a sensitivity of at least *5+ and a specificity of

*(+ or 'ore under uality-assured, standardied and validated la$oratory conditions"

T&e sensitivity of virological tests depends in part on t&e ti'ing of t&e test" )ecause a significant

proportion of HIV infection occurs in t&e peripartu' period, all virological tests are less sensitive in

detecting infection on speci'ens o$tained at $irt&" HIV /0A and R0A are not detected in early

$lood speci'ens $ut usually $eco'e detecta$le at or after 1 6 wee4s of age [13!" In infants wit&

in utero HIV infection, HIV /0A and R0A can $e detected in perip&eral $lood speci'ens o$tained

wit&in ( &ours of $irt&"

HIV /0A assays &ave good accuracy in w&ole $lood and /)7 in 'ost circu'stances" HIV R0A as-

says &ave good accuracy in plas'a and /)7, as do t&e 2p Ag assays" 8nly t&e newer i''une

co'plex-dissociated ultrasensitive version of t&e p antigen assays s&ould $e used [13!"

9alse-positive and false-negative results can occur wit& virological testing, and it is necessary to

confir' positive test results"i:onfir'atory testing 'ay stretc& already constrained &ealt&-care

sys-te's, $ut ensuring accuracy wit& confir'atory tests reduces t&e ris4 of unnecessarily starting

unin-fected infants on lifelong ART"

/)7 speci'ens are easiest to collect, store and process; t&ey do not reuire venepuncture as

t&ey can $e o$tained $y using $lood fro' a finger-stic4 or &eel-stic4" T&ey carry a s'aller

$io&aard ris4 t&an liuid sa'ples, are sta$le at roo' te'perature for prolonged periods and are

easier to trans-port, allowing for centralied la$oratory testing" 7peci'ens fro' /)7 can $e used

for detecting HIV /0A, HIV R0A, or 2p Ag [13!" T&e use of /)7 is very practical for testing

HIV-exposed infants in lower-level &ealt& facilities, and s&ould $e 'ore widely i'ple'ented in

order to i'prove access to diagnostic testing in a range of resource-li'ited settings"

(1)In infants wit& a first positive virological test result, start ART wit&out delay and at t&e sa'e ti'e collect a second speci-'en to confir' t&e initial positive virological test result"

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In c&ildren aged 1( 'ont&s or 'ore, HIV serological tests, including rapid serological tests #eit&er rapid

HIV tests or la$oratory-$ased HIV eny'e i''unoassays [

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3. If t&e 'ot&er is unavaila$le or does not consent to 'aternal HIV testing, t&en $yreco''ending HIV serological testing of t&e infant to detect HIV exposure" aternal orguardian consent is re-uired for suc& testing"

9or infants less t&an 3 wee4s of age wit& un4nown HIV exposure and in settings w&ere t&e HIV

epi-de'ic is generalied #i"e" G1+ prevalence in wo'en attending A0:%, 'aternal and c&ild

&ealt& #:H% progra''es are strongly reco''ended to provide HIV serological testing to

'ot&ers or t&eir infants in order to esta$lis& exposure status"iii,iv

Virological testing s&ould $e conducted at 6 3 wee4s of age for infants 4nown to $e exposed to HIV, or

at t&e earliest possi$le opportunity t&ereafter" Virological testing at 6 3 wee4s of age will identify 'ore

t&an *5+ of infants infected in uteroand intrapartu' [-5!" 7o'e flexi$ility in i'ple'enting t&is

reco''endation 'ay $e reuired, $ased on current national or local postpartu' and infant follow-up

practices" However, delaying testing $eyond t&is ti'e delays diagnosis and puts HIV-infect-ed infants at

ris4 for disease progression and deat&" Results fro' virological testing in infants 'ust $e returned to t&e

clinic and c&ildB'ot&erBcarer as soon as possi$le, $ut at t&e very latest wit&in four wee4s of speci'en

collection" >ositive test results s&ould $e fast-trac4ed to t&e 'ot&er-$a$y pair as soon as possi$le to

ena$le pro'pt initiation of ART"

@ell, HIV-exposed infants eit&er w&o &ave not &ad a virological test or &ave &ad an earlier

negative virological test, are reco''ended to &ave HIV serological testing at around nine 'ont&s

of age #or at t&e ti'e of t&e last i''uniation visit%" T&ose w&o &ave reactive serological assays

at nine 'ont&s s&ould &ave a virological test to identify infected infants w&o need ART"

>ositive virological testing in an infant at any age is considered indicative of HIV infection for pur-

poses of clinical 'anage'ent, and ART is indicated #see :&apter 5%" A repeat test on a separate

speci'en s&ould $e perfor'ed to confir' t&e initial positive test" T&e relia$ility of t&e la$oratory

#deter'ined $y standard uality assess'ent% is funda'ental to ensure relia$le test results [13!"

2rgent HIV diagnostic testing is reco''ended for any infant presenting to &ealt& facilities wit&

signs, sy'pto's or 'edical conditions t&at could indicate HIV infection" In t&is situation, infants

s&ould initially $e tested using HIV serological testing, and t&ose wit& detecta$le HIV anti$odiess&ould &ave virological testing"

9or c&ildren 1 6 1( 'ont&s of age, diagnosis using virological testing is reco''ended" However, in

resource-li'ited settings w&ere access to virological testing is li'ited, it is reco''ended t&at, for t&is

age group, virological tests are perfor'ed only after positive serological testing"

A definitive diagnosis of HIV infection in c&ildren aged 1( 'ont&s or 'ore #wit& 4nown or un4nown HIV

exposure% can $e 'ade wit& HIV serological tests, including rapid serological tests following standard

testing algorit&'s used for adults #see Annex %" T&e confir'ation of a positive serological test result

s&ould follow standard national testing algorit&'s and, at a 'ini'u', s&ould involve du-

(3):ountries 'ay wis& to deter'ine prevalence t&res&olds and ot&er circu'stances w&ere t&is reco''endation s&ould $efollowed"

(4)0ationally or internationally approved rapid HIV serological tests 'ay $e used"

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plicate testing using a different HIV serological test [(!" T&e use of rapid serological tests for

diagnosis &as t&e advantage t&at t&e results $eco'e availa$le at t&e ti'e of t&e clinic visit"

9or c&ildren aged 1( 'ont&s or 'ore wit& signs and sy'pto's suggestive of HIV infection, @H8

strongly reco''ends t&e use of HIV serological testing in accordance wit& national protocols"

7o'e clinical conditions are very unusual wit&out conco'itant HIV infection #e"g" >neu'ocystis

pneu'o-nia, oesop&ageal candidiasis, ly'p&oid interstitial pneu'onitis, aposi sarco'a and

cryptococcal 'eningitis%" T&e diagnosis of t&ese conditions suggests HIV infection and indicates

t&e need to per-for' HIV serological testing"

" /iagnosing HIV infection in $reastfeeding infants and c&ildren

A $reastfeeding infant or c&ild is at ris4 for acuiring HIV infection t&roug&out t&e entire

$reastfeeding period" )reastfeeding s&ould not $e stopped in order to perfor' any 4ind of

diagnostic HIV test" A positive virological test results s&ould $e considered to reflect HIV infection,

and t&e usual confir'a-tory algorit&'s followed" However, interpreting negative results is difficult"

A six-wee4 window period after t&e co'plete cessation of $reastfeeding is advised $efore testing;

only t&en can negative viro-logical test results $e assu'ed to relia$ly indicate HIV infection

status" T&is applies to $reastfeeding infants and c&ildren of all ages"

4.5 /iagnosing HIV infection w&ere 'ot&er or infant &as received ARVdrugs for >T:T

resu'ptive diagnosis of severe HIV disease in HIV-exposed infants andc&ildren less t&an 1( 'ont&s of age

0o single clinical diagnostic algorit&' &as proved &ig&ly sensitive or specific for t&e diagnosis of

HIV infection" :linical algorit&'s vary in t&eir sensitivity and specificity [3-(!, especially wit&

respect to t&e age of t&e c&ild" In particular, t&ey are less relia$le in infants [*!" HIV serological

testing #espe-cially rapid testing% and increased access to early virological testing 'ust $e 'ade

availa$le to &elp clinicians i'ple'ent i'proved diagnostic algorit&'s"

However, w&ere access to virological testing is not yet availa$le, a presu'ptive diagnosis of

severe HIV disease can $e 'ade in infants and c&ildren w&o are less t&an 1( 'ont&s of age wit&

a positive serological HIV test #in eit&er t&e 'ot&er or c&ild%, and w&o &ave specific sy'pto's

suggestive of HIV infection #see section 5"3%" An infant or c&ild w&o 'eets t&ese criteria &assevere HIV disease and needs i''ediate ART" HIV serological testing s&ould $e repeated at 1(

'ont&s of age to confir' HIV infection in t&e c&ild" It s&ould $e e'p&asied t&at @H8 clinical

staging of HIV disease can only $e e'ployed w&ere HIV infection &as $een esta$lis&ed"

1*

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Ta$le D. 7u''ary of testing 'et&ods for infants and c&ildren

a, $

Testing7peci'en >urpose >aediatric :o''ents

'et&odB typeBpopulationfor

assay 'odality testing

HIVserology

@&ole$lood

7creeningtest Infants

Infants of un4nown or uncertainHIV

for HIVJ1 'ont&sof

exposure w&ose 'ot&er is unavaila$leor

exposure age

does not consent for 'aternal

testing":onfir' reactive result wit&virological

test"=ittle data exist on t&e perfor'anceoforal HIV serological assays forpaediatric

populations"

@ell andBorIdentifies potentially uninfectedc&ild if

previously non-reactive result and not $reastfedfor

untested, at least 3 wee4s prior to test"HIV-exposed

:onduct 'aternal or infant HIVserological

infants, ortest for infants w&ose HIV exposurestatus

infants of is un4nown"un4nownHIV

:onfir' reactive result wit&virological

exposureat test"K* 'ont&sof If non-reactive serological test for

ageHIV-exposed, $reastfeeding infant,repeattest 3 wee4s after co'plete cessationof

$reastfeeding"

Infants orIf reactive result, start ART and HIVcare

c&ildrenwit&

for infant or c&ild w&o ualifies,and

signs orconfir' wit& virological test fort&ose

sy'pto's J1( 'ont&s of age"suggestiveof

@&ere virological testing is notavaila$le,

HIVinfection for sic4 c&ildren wit& a reactive

serological test, use t&e clinicalalgorit&'for presu'ptive clinical diagnosis ofHIV

i f i

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InfantsBc&ildren

:onfir' reactive result wit&virological

G* to J1( test"'ont&s ofage

9or $reastfeeding infantBc&ild w&o isHIVexposed wit& non-reactive testresult,repeat test 3 wee4s afterco'plete

cessation of $reastfeeding"

/iagnostic:&ildrenG1(

T&e nationally defined serial - or D-test

'ont&s ofage algorit&' s&ould $e followed"

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Testing7peci'en >urpose >aediatric :o''ents

'et&odB typeBpopulationfor

assay 'odality testing

HIV /0A

@&ole$loodB /iagnostic Infants and

:onfir' reactive result wit& asecond

liuid c&ildren virological test"

HIV /0A

@&ole$loodB /iagnostic Infants and

:onfir' reactive result wit& asecond

/)7 c&ildren virological test"

HIV R0A>las'aBliuid /iagnostic Infants and

las'aBliuid /iagnostic Infants and

2se ot&er virological test in regionsw&ere

c&ildrensu$type / is co''on or if infantis

already on ART"

:onfir' reactive result wit&second

virological test"

2p Ag@&ole$loodB /iagnostic Infants and

2se ot&er virological test in regionsw&ere

/)7 c&ildrensu$type / is co''on or if infantis

already on ART":onfir' reactive result wit&second

virological test"

1 In c&ildren less t&an 1( 'ont&s of age, HIV infection is diagnosed $ased on.6 positive virological test for HIV or its co'ponents #HIV R0A or HIV /0A or 2p Ag%

6 confir'ed $y a second virological test o$tained fro' a separate deter'ination ta4en 'ore t&an four wee4s after $irt&"

2 Virological testing for infants reuires t&at test results $e returned to t&e clinic and t&e c&ildB'ot&erBcaregiver as soon aspos-si$le and, at t&e latest, wit&in four wee4s of speci'en collection" >ositive results s&ould $e fast-trac4ed to t&e 'ot&er 6$a$y pair as soon as possi$le to ena$le pro'pt initiation of ART"

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WHEN TO START ANTIRETROVIRAL THERAPY IN INFANTS

AND CHILDREN

5"1 Reco''endations

5"1"1 Infants

1" Initiate ART for all HIV-infected infants diagnosed in t&e first year of life, irrespective of :/

count or @H8 clinical stage"

(Strong recommendation, moderate quality of evidence)

5"1" :&ildren

2. Initiate ART for all HIV-infected c&ildren $etween 1 and 'ont&s of age irrespective of :/count or @H8 clinical stage"

(Conditional recommendation, very low quality of evidence)

3. Initiate ART for all HIV-infected c&ildren $etween and 5* 'ont&s of age wit& :/ count

L5C cellsB''Dor +:/M L5, w&ic&ever is lower, irrespective of @H8 clinical stage"

(Strong recommendation, very low quality of evidence)

4. Initiate ART for all HIV-infected c&ildren 'ore t&an 5 years of age wit& :/ count LD5CcellsB''

D#as in adults%, irrespective of @H8 clinical stage"

(Strong recommendation, moderate quality of evidence)

5. Initiate ART for all HIV-infected c&ildren wit& @H8 HIV clinical stages D and , irrespective of:/ count"

(Strong recommendation, low quality of evidence)

6. Initiate ART for any c&ild less t&an 1( 'ont&s of age w&o &as $een given a presu'ptiveclinical diagnosis of HIV infection"

(Strong recommendation, low quality of evidence)

:urrent researc& de'onstrates t&at t&e initiation of ART early in infancy and c&ild&ood

dra'atically reduces t&e ris4 of deat& and disease progression [5, 1!" @it&out effective

treat'ent, an esti'ated one t&ird of infected infants will &ave died $y one year of age, and a$out&alf will &ave died $y two years of age [DC, D1!" Niven t&ese data, @H8 &as updated t&e

reco''endations on w&en to $egin ART"

Ta$le .

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'ent [D, DD!" 9or c&ildren aged 1 to 'ont&s, t&e guidelines 'a4e a conditional

reco''endation to initiate ART irrespective of :/ count or @H8 clinical stage" 0ational

aut&orities need to consider w&et&er i'ple'enting t&is reco''endation is li4ely to lead to $etter

&ealt& outco'es for 'ost HIV-infected c&ildren" /espite t&e lac4 of &ig& uality evidence, t&e

guideline panel felt t&at t&e $enefits of adopting t&is approac& outweig& t&e ris4s 6 especially

w&ere access to :/ testing is li'ited and rates of c&ild 'ortality are &ig&"

/eciding w&en to start ART s&ould also consider t&e c&ildQs social environ'ent, including t&e iden-

tification of a clearly defined caregiver w&o understands t&e prognosis of HIV and t&e i'plications of

ART #i"e" lifelong t&erapy, conseuences of non-ad&erence, and t&e ad'inistration, toxicities and

storage of drugs%" Also, identifying a secondary #$ac4-up%, infor'ed caregiver is advised" Access to

adeuate nutrition #see :&apter 1% and support for fa'ilies is eually i'portant" Infor'ing older

c&ildren of t&eir diagnosis of HIV i'proves ad&erence" /isclosure to fa'ily 'e'$ers 'ay i'prove

ad&erence and s&ould $e encouraged [D-D3!" Infor'ing c&ildren and disclosing t&eir HIV status to

t&e' is a process $est perfor'ed wit& support fro' s4illed &ealt& professionals #see :&apter 13%"

5" @&en to initiate ART in HIV-infected infants

All infants wit& confir'ed HIV infection s&ould $e started on ART, irrespective of t&e clinical or i'-

'unological stage"

@&ere viral testing is not availa$le, infants less t&an 1 'ont&s of age wit& clinically diagnosed,

pre-su'ptive severe HIV infection s&ould start ART as soon as possi$le" :onfir'ation of HIV

infection s&ould $e o$tained as soon as possi$le"

)y two years of age, over &alf of HIV-infected c&ildren will die in t&e a$sence of treat'ent [DC, D1,

D, D(!" Recent studies de'onstrated t&at 'ore t&an (C+ of infected infants $eco'e eligi$le to

start ART $efore six 'ont&s of age w&en using t&e CC3 clinical andBor i''unological criteria for

t&e ini-tiation of treat'ent [1D!" 7tarting asy'pto'atic infants on ART as soon as possi$le after

diagnosis leads to a reduction in 'ortality co'pared wit& t&ose in w&o' treat'ent initiation is

delayed until i''unological decline or clinical sy'pto's develop [5!"

5.3 @&en to initiate ART in HIV-infected c&ildren 1'ont&s of age and older

9or c&ildren aged 1 to 'ont&s, t&ese guidelines offer a conditional reco''endation to initiate ART

irrespective of i''unological or clinical stage" Alt&oug& no rando'ied trials support t&is rec-

o''endation, a nu'$er of studies &ave s&own t&at t&e esti'ated ris4 of 'ortality is significantly &ig&er

for HIV-infected c&ildren under years of age [D1, D*, C!" 9urt&er'ore, a syste'atic review contrasting

disease progression in HIV-infected c&ildren in su$-7a&aran Africa and t&e 27A and

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initiation of ART 'ay significantly i'prove &ealt& outco'es for HIV-infected c&ildren" 0ational pro-

gra''es need to deter'ine &ow $est to i'ple'ent t&is reco''endation, and w&et&er to

advocate universal treat'ent for all J 'ont&s or focus on universal treat'ent for infants J1

'ont&s and apply clinical and i''unological criteria for c&ildren $etween 1 and 'ont&s"

9or all c&ildren 'ont&s or older, clinical and i''unological t&res&olds s&ould $e used to

identify t&ose w&o need to start ART"

5" :linical criteria to start ART

T&e @H8 clinical staging of HIV/AIDS for cildren wit esta!lised HIV infection#see Annex :% is

consistent wit& t&e adult clinical classification syste' #Ta$le 5%" :linical staging s&ould $e used

once HIV infection &as $een confir'ed #i"e" once t&ere is serological andBor virological evidence

of HIV infection%"

Ta$le 5" @H8 classification of HIV-associated clinical disease

:lassification of HIV-associated clinical disease@H8 clinical

stage

Asy'pto'atic 1

ild

Advanced D

7evere

Annexes : and / provides furt&er details on staging events and criteria for recogniing t&e'"

A preli'inary analysis of t&e revised @H8 staging, $ased on clinical signs at $aseline and

disease &istory, in c&ildren enrolled in t&e :&ildren wit& HIV Anti$iotic >rop&ylaxis #:HA>% trial

[! s&owed t&at clinical staging in c&ildren not on ART is predictive of 'ortality ris4i [D!" T&e

clinical stage is t&erefore useful to identify w&en to start ART #Ta$le 5%" However, clinical staging

is not as useful in infants and c&ildren less t&an two years of age"

Asy'pto'atic or 'ildly sy'pto'atic HIV-infected c&ildren #i"e" t&ose wit& clinical stages 1 and

disease% s&ould $e considered for ART w&en i''unological values fall near t&e descri$edt&res&old values" A drop $elow t&res&old values s&ould $e avoided"

Treat'ent wit& a potent and efficient ARV regi'en i'proves clinical status and effectively

reverses t&e clinical stage" It is recognied, &owever, t&at reliance solely on clinical criteria 'ay

inappropri-ately delay t&e initiation of ART"

5"5 I''unological criteria to start ART

T&e i''unological para'eters of t&e HIV-infected c&ild of 'ont&s of age and older s&ould $e

d i d & i f HIV l d i d fi i d id d i i

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(1):onfir'ed weig&t-for-age and &ae'oglo$in levels were also predictive of 'ortality in HIV-infected c&ildren" T&e ti'ing oft&e initiation of ART in relation to interventions to prevent or treat 'alnutrition and anae'ia reuires furt&er study"

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'a4ing on t&e initiation of ART" T&e results of :/ 'easure'ent s&ould $e used in conSunction

wit& clinical assess'ent"

T&e :/ t&res&old for starting treat'ent in to 5-year-olds &as c&anged"

All c&ildren to 5 years of age wit& +:/M L5 or :/ a$solute count of L5C

cellsB''Dare eligi$le for ART #Ta$le 3%"

:/ levels in &ealt&y infants w&o are not infected wit& HIV are considera$ly &ig&er t&an t&ose o$served

in uninfected adults, and slowly decline to adult values $y t&e age of a$out five to six years of age"

A$solute :/ count is naturally less constant and 'ore age-dependent t&an percent :/M #+:/M% in

younger c&ildren #i"e" J5 years%" T&erefore, it is not possi$le to define a single t&res&old for w&en tostart ART" :/ 'easure'ents are valua$le for 'a4ing decisions a$out starting t&erapy and @H8

encourages national progra''es to increase access to :/ 'easure'ent tec&nologies"

7erial 'easure'ents are 'ore infor'ative t&an individual values and also reflect trends over

ti'e" @&ere possi$le, t&ese 'easure'ents s&ould co'pare t&e sa'e para'eter; i"e" eit&er

a$solute :/ count or, in c&ildren less t&an 5 years of age, percent :/M" As wit& clinical status,

i''unological recovery occurs wit& successful ART; t&us, :/ 'easure'ents are useful for

'onitoring response to treat'ent"

T&e :/ levels t&at identify t&res&olds for w&en to start ART are derived fro' longitudinal data on HIV-

infected infants and c&ildren and, except in c&ildren less t&an 'ont&s of age, correspond to a 1-

'ont& 'ortality ris4 of up to 5+ [D*!" It s&ould $e noted t&at t&e younger t&e c&ild, t&e less predictive

t&e +:/M or a$solute :/ count of 'ortality" In infants and c&ildren less t&an two years of age, t&ere

is a &ig& ris4 of deat&, even at a &ig& :/ levels #e"g" G1 5CC cellsB''Dor +:/M G5%" T&e availa$le

:/ data for c&ildren are $ased on studies 'ostly fro' resource-ric& countries"

9or c&ildren five years and older, it is reco''ended t&at t&res&olds used for adults to initiate ART

are used to si'plify progra''e approac&es"

Ta$le 3 su''aries t&e reco''endations for initiating ART in HIV-infected infants and c&ildren

ac-cording to t&e clinical stage and t&e availa$ility of i''unological 'ar4ers #revised in C1C%"

Ta$le 3. Reco''endations for initiating ART in infants and c&ildren; revised in C1C

Age Infants and c&ildrenP 'ont&s of age to5* 9ive years of age or

J 'ont&s of

agea,$

'ont&s of age older

+:/M Allc

L5 0A

A$solute :/ Allc

L5C cellsB''D

LD5C cellsB''D

#As in adults%

1 All HIV-infected infants s&ould receive ART due to t&e rapid rate of disease progression"

2 :ountries wit& relia$le access to :/ 'onitoring 'ay c&oose to apply clinical and i''unological criteria for initiation of ARTin c&ildren aged 1 6 D 'ont&s"

3 In c&ildren wit& a$solute ly'p&opaenia, t&e :/ percentage #+:/M% 'ay $e falsely elevated"

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