June 2014 - University Health Services

MINISTRY OF HEALTH
GUIDELINES ON USE OF ANTIRETROVIRAL DRUGS
FOR TREATING AND PREVENTING HIV INFECTION
RAPID ADVICE
June 2014
ThisguidelineisundercopyrightoftheNationalAIDSandSTIControlProgramme(NASCOP),
Ministry of Health, Kenya. You may print one copy for personal use. Any other use of this
guidelinerequireswrittenpermissionofNASCOP.
This guideline contains all critical updates required by health care providers in the use of
Antiretroviral Drugs for treating and preventing HIV infection as of the date of issue. All
reasonable precautions have been taken by NASCOP to verify the information in this
publication.Forclari icationscontactNationalAIDSandSTIControlProgram(NASCOP)onP.O.
Box1936100202,NairobiKenya,Tel:2540202630867,Email:[email protected],Website:
www.nascop.or.ke
Recommendedcitationforthisguidelineshouldbeasfollows:
“MinistryofHealth;NationalAIDSandSTIControlProgram(NASCOP).GuidelinesonUseof
AntiretroviralDrugsforTreatingandPreventingHIVInfection:Arapidadvice,2014.”
ISBN-13978-9966-038-05-0 2
TableofContents
Foreword.............................................................................................................................................
Acknowledgent.................................................................................................................................
Abbreviations....................................................................................................................................
1.HIVTestingandCounseling...................................................................................................
2.UseofAntiretroviralTherapyinchildren.......................................................................
2.1.WhentoStartARTinChildren..........................................................................................
2.2.FirstLineARTinChildren...................................................................................................
2.3.SecondLineARTinChildren..............................................................................................
2.4.ARTinChildrenwithTB/HIVCo-infection..................................................................
2.5.EfavirenzDosinginChildren..............................................................................................
2.6.RitonavirDosingforSuper-BoostingLPVinChildrenTakingRifampicin.....
2.7.ARVProphylaxisforHIV-ExposedInfants...................................................................
2.8NevirapinedosingforHIVExposedInfants.................................................................
2.9CotrimoxazoledosingforHIVExposedInfantsandHIV-infectedchildren....
4
5
6
7
9
9
10
11
12
13
14
14
15
15
3.UseofARTinAdolescentsandAdults...............................................................................
3.1WhentoStartARTinAdolescentsandAdults............................................................
3.2.FirstLineARTinAdolescentsandAdults....................................................................
3.3.SecondLineARTinAdolescentsandAdults...............................................................
3.4DosingandAdministrationforAtazanavir/ritonavir(ATV/r).............................
3.5.ARTinAdolescentsandAdultswithTB/HIVCo-Infection...................................
16
16
17
18
18
20
4.ThirdlineARTforchildren,adolescentsandadults...................................................
21
5.IntensiveCaseFindingandIsoniazidPreventiveTherapy.......................................
5.1.IndicationsforIsoniazidPreventiveTherapy............................................................
5.2DurationandDoseofINHforIPT.....................................................................................
DoseofINHforIPT.........................................................................................................................
5.3.DosingofPyridoxineforAllPatientstakingIsoniazid...........................................
5.4FollowUpofPatientsonIPT...............................................................................................
5.5ContraindicationstoIPT.......................................................................................................
5.6.UseofXpertMTB/Rif(GeneXpert)inDiagnosisofTBforPLHIV.....................
22
22
22
22
22
23
23
23
6.LaboratoryMonitoringforPLHIV.......................................................................................
6.1.UseofCD4CountforMonitoringPLHIV.......................................................................
6.2.UseofViralLoadinARTmonitoring..............................................................................
7.PreconceptionCare....................................................................................................................
8.Post-ExposureProphylaxis(PEP)........................................................................................
9.Pre-ExposureProphylaxis(PrEP)........................................................................................
24
24
25
26
28
29
Annex1.PaediatricARVDrugDosingChart........................................................................
Annex2.Viralloadtestingalgorithm.....................................................................................
Annex3.UseofGeneXpertforDiagnosisofDrugResistanceandSurveillance..
Annex4:ImplementationGuidanceforServiceProviders...........................................
30
32
33
34
3
Foreword
ManagementofHIVinfectionisdynamicandfastevolvingduetothecontinuousemerging
scienti icandprogrammaticevidence.TheWorldHealthOrganization(WHO)hasbeeninthe
forefrontinprovidinggenericguidanceevery2-3yearsforcountriestoadapt.TheMinistryof
Health(MOH)hasovertheyearsprovidednationalguidelinesonHIVinfectionprevention,
careandtreatmentinlinewiththeWHOrecommendations,globalandlocalevidenceand
country level applicability. The latest editions of guidelines for antiretroviral Therapy and
guidelinesforPreventionofMothertoChildTransmissionofHIVwerereleasedin2011and
2012 respectively. In June 2013, WHO issued consolidated guidelines on the use of
antiretroviraldrugsfortreatingandpreventingHIVinfection.
InlinewiththelatestguidanceissuedbyWHO,andreviewofglobalandlocalevidence,the
MOHhasreviewedtheguidelinesonHIVinfectionpreventionandtreatment.Thisguideline
recommends early HIV diagnosis for all populations, earlier initiation of Antiretroviral
Therapy for children, adolescents and adults including HIV-infected pregnant and
breastfeeding women, HIV-infected spouses and sexual partners in sero-discordant
relationships,theuseofsimpli iedonce-a-day ixed-dose-combinationARVpilltoimprove
adherence,androutineviralloadtestingforallclientsonART.
This guideline has been developed for all health workers in a health care setup including;
medical specialists, medical of icers, clinical of icers, nurses, pharmacists, pharmaceutical
technologists,nutritionists,socialworkersandlaboratorytechnologistsamongotherservice
providerswhodirectlyorindirectlyprovideHIVCareservices.Additionallythisdocument
should guide County health management teams, local NGO’s, implementing partners, civil
societyorganization,networksofPersonsLivingwithHIVandotherstakeholdersontheuseof
AntiretroviralDrugsforpreventingandtreatingHIV.
Iamcon identthattherecommendationscontainedhereinaretimelyascountiescontinueto
expandaccessandenhancethescaleupandqualityofHIVprogrammes.
Asthisguidelinesdocumentcontainsonlyspeci icupdateswhichwererevised,updatedor
required special emphasis, reference should be made to other existing guidelines for HIV
Prevention, Care and Treatment on other comprehensive components of care that remain
unchanged.
Hon.JamesMacharia
CabinetSecretary,MinistryofHealth
4
Acknowledgement
The development of this guidelines document was through determined efforts of multiple
stakeholders led by the Ministry of Health team who discussed, developed, edited and
reviewedtherecommendationscontainedherein.
SincereappreciationtotheNationalAIDSandSTIControlprogram(NASCOP)teamthatledthe
numerous deliberations and eventual development of the guidelines and all stakeholders
including bilateral and multilateral donors , implementing partners, academic institutions,
othergovernmentdepartmentsamongothers.
SpecialthanksgotomembersoftheARTtaskforceandPMTCTtechnicalworkinggroupfor
theirtirelesseffortsindevelopingtherecommendationsandguidelines.
Theprocessesofdevelopment,reviewandeventualprintingofthisdocumentweresupported
byPEPFARthroughtheCentreforDiseaseControl&Prevention,theHealthPolicyProject
(FuturesGroup)andtheWorldHealthOrganization.
DrFrancisKimani
DirectorofMedicalServices,MinistryofHealth
5
Abbreviations
3TC
Lamivudine
ABC
Abacavir
AIDS Acquiredimmunode iciencysyndrome
ANC
Antenatalclinic
ART
Antiretroviraltherapy
ATVAtazanavir
ATV/r Atazanavir/ritonavir
AZT
Zidovudine
CD4
T–lymphocytecellbearingCD4receptor
DBS
Driedbloodspot
DNA
Deoxyribonucleicacid
DOTS Directobservedtreatmentsupervision
DR
Drugresistance
DRV
Darunavir
DRV/r Darunavir/ritonavir
DST
Drugsensitivitytesting
EFV
Efavirenz
EID
Earlyinfantdiagnosis
ELISA Enzyme-linkedimmunosorbentassay
FQ
Fluoroquinolones
Hb
Haemoglobin
HIV
Humanimmunode iciencyvirus
ICF
Intensivecase inding
INH
Isoniazid
IPT
Isoniazidpreventivetherapy
LPV
Lopinavir
LPV/r Lopinavir/ritonavir
MDRTB
Multidrug-resistantTB
NASCOPNationalAIDsandSTIControlProgramme
NLTD-Unit
NationalTB,Leprosyandlungdiseaseunit
NNRTI Non-nucleosidereverse-transcriptaseinhibitor
NRTI Nucleosidereverse-transcriptaseinhibitor
NVP Nevirapine
OI
Opportunisticinfections
PCR
Polymerasechainreaction
PCP
Pneumocystispneumonia
PDR
Polydrugresistant
PEP
Postexposureprophylaxis
PI
Proteaseinhibitor
PLHIV PeoplelivingwithHIV
PMTCT Preventionofmother-to-childtransmissionofHIV
PPIProtonPumpInhibitor
PrEP Pre-exposureprophylaxisofHIV
RNA Ribonucleicacid
RPR Rapidplasmareagin
RTV Ritonavir
SS
Sputumsmear
STIs Sexuallytransmittedinfections
TB
Tuberculosis
TDF Tenofovirdisoproxilfumarate
TWG Technicalworkinggroup
USFDA UnitedStatesFoodanddrugadministration
WHO WorldHealthOrganization
XDRTB
ExtremelydrugresistantTB
6
1.HIVTestingandCounseling
Knowledge of HIV status is the entry point to HIV care, treatment and prevention. Service
providersshouldseekeveryopportunitytoofferHIVtestingandpreventionmessagestoall
clientsirrespectiveoftheirreasonforvisittothehealthfacility.Referenceshouldbemadeto
thenationalguidelinesforHIVTestingandCounseling(HTC)inKenya.ForthosewhotestHIV
negative,re-testingshouldbedoneafter3months.Thereafterallre-testingforHIVnegative
peopleshouldbedoneannuallyforthegeneralpopulationandquarterlyforkeypopulations.
InadditiontoprovisionoffacilitybasedHIVtestingandcounseling,Community-basedHIV
testing and counseling should target speci ic population needs including key populations
(femalesexworkers,malesexworkers,menhavingsexwithmen,andintravenousdrugusers)
with linkage to HIV prevention, care and treatment services. The table below provides a
summaryofrecommendationforHIVtestingandcounselingfordifferentpopulations.
TopicandpopulationRecommendations
HIVtestingandcounseling
ofinfantsandchildrenaged
lessthan18months
•HIVexposurestatusofallinfantsshouldbeestablishedat
the6-weekimmunizationvisitorat irstcontactthereafter,
usingmaternalmedicalinformation
•ConductHIVantibodytestingformotherorchildrenless
than18monthsofageandofunknownstatustoestablish
theirHIVexposurestatus
•AllHIV-exposedinfantsshouldbeofferedroutineDNAPCR
testingatthe6-weekimmunizationvisit,orattheearliest
opportunityforinfantsseenafter6weeksofage
•InfantswithaninitialpositiveHIVDNAPCRresultsshould
bepresumedtobeHIVinfectedandstartedonARTinline
withnationalguidelines
HIVtestingandcounseling
ofchildrenolderthan
18months
•ConductHIVtestingandcounselingforallchildren
presentingtothehealthfacilityirrespectiveofreasonfor
theirvisittothehealthfacility
•ConductHIVtestingandcounselingforallchildrenof
HIVinfectedadultsassoonaspossible,withinonemonth
ofcon irmingtheHIVpositivestatusoftheadult
7
TopicandpopulationRecommendations
HIVtestingandcounseling
ofadolescents
•ConductHIVtestingandcounselingforalladolescents
includingkeypopulationspresentingtothehealthfacility
irrespectiveofreasonfortheirvisittothehealthfacility
•Alladolescentsidenti iedHIVpositiveshouldbelinkedto
prevention,careandtreatmentservices
•Alladolescentsshouldbecounseledaboutthepotential
bene itsandrisksofdisclosureoftheirHIVstatusand
empoweredandsupportedtodetermineif,when,howand
towhomtodisclose
•Forsexuallyactiveadolescentswithpartners,HIVtesting
andcounselingshouldbeofferedtotheirpartnersand
children
HIVtestingandcounseling
forpregnantand
breastfeedingwomen
•Allpregnantwomenshouldbecounseledandtestedfor
HIVduringtheir irstANCvisitandrepeattesting
conductedinafter3monthsforallwomenwhotest
HIVnegativeatthe irstANCvisit.
•AllbreastfeedingwomenwhotestedHIVnegativeduring
ANCorwhoseHIVstatusisunknownshouldbeofferedHIV
testingandcounseling;ifnegative,re-testingshouldbe
doneaspernationalguidelines
•Allpregnantandbreastfeedingwomenwhoopt-outor
declineHIVtestingduringthe irstclinicvisitshouldbe
offeredHIVcounselingandtestinginsubsequentvisit(s)
•HIVtestingandcounselingshouldbeofferedtoall
spouses/sexualpartnersofHIV-infectedpregnantand
breastfeedingwomen
HIVtestingandcounseling
ofsexualpartner/s&
children
ofindexcase(de inedas
HIVpositivepersonwhois
alreadyinHIVcare)
•HIVtestingandcounselingshouldbeofferedforallfamily
membersofindexcaseincludingsexualpartnersand
childrenwithlinkagetoprevention,careandtreatment
DisclosureofStatusto
HIV-infectedchildrenand
adolescents
HealthServiceProvidersshouldsupportandadvise
caregiverstoinitiatedisclosureofHIVstatustotheHIV
infectedchildpreferablyfromageof6Years
FullDisclosureshouldoccurwhenthechildis
developmentallyreadyideallybyageof10years
(Beforeadolescence)
8
2.UseofAntiretroviralTherapyinChildren
Thissectionoftheguidelinerecommendsearlierantiretroviraltreatmentinitiationforchildren
livingwithHIV.Inadditiontheguidelinesrecommenduseofthemostpotent,effectiveand
feasible irst-line,second-lineandthirdlineARVtreatmentregimensforchildren,androutine
viralloadtestingfortreatmentmonitoring.
2.1.WhentoStartARTinChildren
PopulationRecommendations
•ARTshouldbeinitiatedinallHIV-infectedchildrenaged
WhentostartARTin
childrenlessthan15years 10yearsandbelow,regardlessofWHOstageor
CD4count/%.
•ARTshouldbeinitiatedinallHIVinfectedchildrenabove
10yearsofagewithCD4cellcount≤500cells/mm3,
regardlessofWHOstage
•AllHIV-infectedchildrenabove10yearswithWHOstage3
and4disease,HepatitisBVirus/HIV,TB/HIVco-infection
shouldbeinitiatedonARTirrespectiveofCD4count
•IncircumstanceswhereDNAPCRtestingisnotreadily
availableARTshouldbeinitiatedinanychildyoungerthan
18monthsofagewhomeetscriteriaforpresumptive
diagnosisofsevereHIVdisease,con irmatoryDNAPCR
testingshouldbedoneassoonaspossible
9
2.2.FirstLineARTinChildren
AgePreferredregimenRecommendations
Childrenlessthan3years
ABC+3TC+LPV/r*
AZT+3TC+LPV/r*
**Children≥3-10yearsand ABC+3TC+EFV
adolescents<35kg
ABC+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
Adolescents(>10-14years) TDF+3TC+EFV
andweight≥35kg
TDF+3TC+NVP
ABC+3TC+EFV
ABC+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
Anadolescentisapersonaged10to19years
*Childrenlessthan3yearswhoarenotNVPexposedandareunabletotolerate
Lopinavir/ritonavircanbesubstitutedtoanNNRTIbasedregimen
**ConsidertransitioningfromABCbasedregimentoasimpli iedoncedailyTDF/3TC/EFV
basedregimeninchildreniftheirweightremainsconsistentlyabove35kg
(atleast2readings,1monthapart)forbetteradherence
Aviralloadtestshouldbeconductedbeforeanysingledrugsubstitutiontorule
outtreatmentfailure.
10
2.2.FirstLineARTinChildren
IfFirstlineARTregimenThenSecondlineARTregimen
ABC+3TC+EFV/NVP
AZT/D4T+3TC+EFV/NVP
AZT+3TC+LPV/r
ABC+3TC+LPV/r
ABC+3TC+LPV/r
AZT+3TC+LPV/r
AZT+3TC+DRV/r*
ABC+3TC+DRV/r
TDF+3TC+EFV
Preferred:AZT+3TC+LPV/r
Alternative:AZT+3TC+ATV/r**
*AccesstoDRV/rforsecondlineART(forchildrenfailing irstlinePIbasedART)willbe
madeavailablethroughconsultationwithregionalorNASCOPtherapeuticTWG.DRV/ris
notapprovedforuseinchildrenlessthan3yearsofage.ForchildrenonLPV/r irstline
whofailtreatmentatlessthan3yearsofage,othertreatmentoptionssuchasIntegrase
inhibitors(e.g.Raltegravir)shouldbeconsidered.
**Childrenabove6yearsofagecanbegivenATV/rbutcurrentlychildfriendly
formulationsarenotavailable.ATV/risnotapprovedforuseinchildrenbelow6years
ofage.
Currentadultformulationof300mg/100mgofATV/ravailableinKenyacanonlybeused
inchildrenweighing>40kg
Children,whohavehadmultiplesingledrugsubstitutionoftheirNRTIduring irstline
ARTandsubsequentlyfail irstline,mayposeachallengeinselectinganappropriate
NRTIforuseinsecondlineART.Insuchcases,consultationwithaseniorexperienced
clinicianatregionalornationallevelonsecondlineARToughttobedone.
11
2.4.ARTinChildrenwithTB/HIVCo-infection
ChildrennewlydiagnosedwithTBandHIV(ARTnaıv̈e)
•StartTBtreatmentimmediatelyasperthenationalTBguidelines
•StartappropriateARTafterTBtreatmentistolerated,preferablywithin2-8weeks
AgePreferredAlternativeComments
regimenregimen
0-3years ABC+3TC+LPV/r
+RTV(addextra
doseofRTVto
maketheLPV/RTV
ratio1:1(super
boostedLPV)
AZT+3TC+LPV/r
ABC+3TC+EFV*
AZT+3TC+EFV*
ABC+3TC+AZT**
*Note:USFDAhasapproveduseofEFVin
children3monthsoldandaboveand
weighingmorethan3.5kg.Currentlyin
Kenya,useofEFVinchildrenaged<3years
andweighing<10kgisrecommended
ONLYinTB/HIVco-infectionmanagement
withoutpriorexposuretoNVPforPMTCT
**ABC+3TC+AZT(triplenucleoside)isan
inferiorregimenandshouldonlybeusedif
otherregimensarenottolerated.After
completionofTBtreatment,changethe
triplenucleosidebasedARTregimento
ABC+3TC+LPV/r
≥3-10
years
>10-14
years
ABC+3TC+EFV
AZT+3TC+EFV
(<35kgs)ABC+3TC AZT+3TC+EFV
+EFV
(>35kgs)TDF+3TC
+EFV
ChilddevelopsTBwhileonART
•AssessfortreatmentfailureifpatienthasbeenonARTforaperiodofmorethan6months
changethe irstlineregimentoanappropriate2ndlineregimeniftreatmentfailureis
con irmed
AgeCurrentregimen RecommendedComment
ARTsubstitution
whileonTB
treatment
0-10
years
IfEFV-basedART
Continue
EFV-basedART
IfNVP-basedART
ChangeNVPto
EFV
Conductviralloadtoruleouttreatment
failureandmanageasperthenational
guidelines
IfLPV/r-basedART SuperboostLPV/r SwitchbacktonormaldoseofLPV/rafter
(LPV:Ritonavir
=1:1)
completionofTBtreatment
Conductviralloadtoruleouttreatment
failureandmanageasperthenational
guidelines
12
AgeCurrent
regimen
RecommendedComment
ARTsubstitution
whileonTB
treatment
Alternative:Triple Pleasenotethattriplenucleosideisan
inferiorregimenandshouldonlybeused
nucleosideof
inchildrennotabletotoleratesuper
ABC+3TC+AZT
boostedLPV/r
Triplenucleosideshouldnotbeusedin
childrenwhohavefailed1stlineART;in
suchcasesclinicianshouldconsult/refer
toaspecialistformanagement
SwitchbacktoLPV/r-basedregimenafter
completionofTBtreatment
>10yrs EFV-basedART
ContinueEFV-based
ART
NVP-basedART
ChangeNVPtoEFV
IfLPV/r-based
ART
If<35kgweight:
SuperboostLPV/r
(LPV:Ritonavir=1:1)
withrifampicinbasedTBtreatment
Conductviralloadtoruleouttreatment
failureandmanageasperthenational
guidelines
SwitchbacktonormaldoseofLPV/rafter
completionofTBtreatment
Conductviralloadtoruleouttreatment
failureandmanageasperthenational
guidelines
Conductviralloadtoruleouttreatment
Ifweightis>35kg:
failureandmanageasperthenational
Continuecurrent
guidelines
regimenanduse
Rifabutin(150mg
oncedaily)insteadof
rifampicin
Note:RifabutindosingforTBtreatmentinTB/HIVpatientsonPIbasedARThasbeen
reviewed.RifabutinshouldbeadministeredasONCEDAILYdosingof150mginstead
of150mgthreetimesaweekalongsideotheranti-TBdrugs.
2.5.EfavirenzDosinginChildren
Weight(kg)EFVdose(mg)*Quantities
Tablets
3.5to4.9
5to7.4
7.5to13.9
14to19.9
20to24.9
25to34.9
35andabove
100
150
200
300
300
400
600
½ofthe200mgdoublescoredtablet
¾of200mgdoublescoredtablet
1ofthe200mgtablet
1½ofthe200mgdoublescoredtablet
1½tabletofthe200mgdoublescoredtablet
2ofthe200mgtablets
1ofthe600mgtablet
13
Ritonavirdosingforsuper-boostingLPV/rinchildrentakingrifampicin
Ritonavirsuper-boostingforTB/HIVco-infection
Weight
Range
(kg)
Lopinavir/ritonavir(LPV/r)Additionaldosingofritonavir
forchildrentakingrifampicin
TWICEDailyTWICEDailyTWICEDaily
80mgLopinavir/
20mgritonavir
permlsolution
200mgLopinavir/
50mgritonavir
Tablets
Ritonavirliquid(80mg/ml,in
90mlbottle)Ritonavirdoseis
adjustedtonearestmarkforthe
easeofmeasurement
3-5.9
1.5ml
-
1ml
6-9.9
1.5ml
-
1ml
10-13.9
2ml
-
1.5ml
14-19.9
2.5ml
1tabtwicedaily
2mlor2of100mgcapsules
twicedaily
20-24.9
3ml
1tabtwicedaily
2.5mlor2of100mgcapsules
25-34.9
4ml
2tabinam&
1tabinpm
4mlinam&2mlinpmor2of100mg
capsulesinmorningand3of100mg
capsulesinevening
2.7.ARVProphylaxisforHIV-ExposedInfants
ScenarioMaternalARV InfantARV Durationofinfant
prophylaxis
prophylaxis ARVprophylaxis
1 MotherdiagnosedwithHIV
Initiatematernal
duringpregnancyatany
ART
gestation,labour,delivery
andimmediatepost-partum
irrespectiveoffeeding
option
NVP
•ImmediatelyinitiateNVP
prophylaxisfor12weeks
•DoHIVPCRtestinaccordance
withnationalrecommendations
onearlyinfantdiagnosis;
•Initiatetreatmentiftheinfantis
infected
Initiatematernal
Infantidenti iedasHIV
ART
exposedafterbirth
(throughinfantormaternal 2
HIVantibodytesting)and
isbreastfeeding
NVP
•ImmediatelyinitiateNVP
prophylaxis
•DoHIVPCRtestinaccordance
withnationalrecommendations
onearlyinfantdiagnosis
•Ifresultspositive,initiateARTand
stopNVPprophylaxis
•Ifresultsnegative,continueNVP
prophylaxisupto12weeks
14
ScenarioMaternalARV InfantARV Durationofinfant
prophylaxis prophylaxis ARVprophylaxis
3 Infantidenti iedasHIV
exposedafterbirth(through
infantormaternalHIV
antibodytesting)andisnot
breastfeeding/on
replacementfeeding
MotherreceivingARTbut
interruptsARTregimen
whilebreastfeeding(such
4
astoxicity,stock-outsor
refusaltocontinue)
Refermotherfor
HIVcareand
evaluation
fortreatment
Nodrug
•DoHIVPCRtestinaccordancewith
nationalrecommendationsonearly
infantdiagnosis;
•NoinfantARVprophylaxis;
•Initiatetreatmentiftheinfantis
infected
Determinean
alternativeART
regimenor
solution;
counselregarding
continuingART
without
interruption
NVP
InitiateNVPuntil12weeksafter
maternalARTisrestartedoruntil
1weekafterbreastfeedinghas
endedifmotherdoesnotrestart
ART
DoHIVPCRtestinaccordancewith
nationalrecommendationsonearly
infantdiagnosis;
2.8NevirapinedosingforHIVExposedInfants
Age
NevirapineDose
Birthweight<2500g-10mg(1ml)oncedaily
Birthweight>2500g-15mg(1.5ml)oncedaily
20mg(2ml)oncedaily
25mg(2.5ml)oncedaily
30mg(3ml)oncedaily
40mg(4ml)oncedaily
50mg(5ml)oncedaily
0-6weeks
6weeks-14weeks
14weeksto6months
6months-9months
9months-12months
>12months
2.9CotrimoxazoledosingforHIVExposedInfantsandHIV-infectedchildren
Weight(kg)
Suspension240mg Singlestrength
tablet480mg(SS)
per5ml
Doublestrength
tablet960mg(DS)
1–4
2.5ml
¼SStab
–
5–8
5ml
½SStab
¼DStab
9–16
10ml
1SStab
½DStab
17–30
15ml
2SStabs
1DStab
>30(Adultsand
adolescents)
-
2SStabs
1DStab
Notes:InHIVExposedInfants,cotrimoxazoleprophylaxisshouldonlybediscontinuedwhen
thereisnofurtherexposuretoHIVthroughbreastfeedingandthe inalHIVresultfollowing
completecessationofbreastfeedingisnegative.
ForHIV-infectedchildren,cotrimoxazoleshouldbecontinuedforlife.
15
3.UseofARTinAdolescentsandAdults
Use of antiretroviral drugs in management of HIV infection has transformed HIV from a
debilitating and fatal disease to a manageable chronic disorder. The use of ART has led to
reductionindeathrates,hospitalizationandtheincidenceofopportunisticinfectionsamong
HIV-infected people. Accumulating evidence has shown that treatment of the HIV -infected
sexualpartnersinasero-discordantrelationshipmarkedlyreducestheriskofHIVtransmission
totheHIVnegativepartner.
FurtheremergingevidencehasshownthattheuseofARTinpregnantandbreastfeedingwomen
markedlyreducesthetransmissionofHIVinfectionfrommothertochild.ContinuingARTfor
lifeforthemotherprovidesadditionalbene itofkeepingmothershealthyandalive.
ThisguidelinerecommendsearlierinitiationofARTforadolescentsandadults,allHIV-infected
pregnantandbreastfeedingwomen,andallHIV-infectedspousesandsexualpartnersinserodiscordantrelationships.Theguidelinesfurtherrecommendtheuseofsimpli iedonce-a-day
ixed-dose-combinationARVpill,androutineviralloadfortreatmentmonitoring.
3.1WhentoStartARTinAdolescentsandAdults
PopulationRecommendations
WhentostartARTin
adolescents≥15years
andadults
•AllHIV-infectedadolescentsandadultswithCD4count
<500cells/mm3irrespectiveofWHOstage
•AllHIV-infectedpregnantwomenirrespectiveofCD4
count,WHOstageorgestationage*
•AllHIV-infectedbreastfeedingwomenirrespectiveofCD4
count,WHOstage*
•AllHIV-infectedspousesandsexualpartnersin
sero-discordantrelationshipsirrespectiveoftheirWHO
stageorCD4cellcount
•AllHIV-infectedadolescentsandadultswithWHOstage3
and4diseaseirrespectiveofCD4count
•AllHepatitisBVirus/HIVco-infectedpersonsirrespective
ofCD4count
•AllTB/HIVco-infectedpersonsirrespectiveofCD4count
*Noteforpregnantandbreastfeedingwomen
TheuseofARTinpregnantandbreastfeedingwomenmarkedlyreducesthetransmission
ofHIVinfectionfrommothertochild.ContinuingARTforlifeforthemotherprovides
additionalbene itofkeepingmothershealthyandalive,andmayalsoofferbene itsfor
preventingsexualtransmissionofHIVinsero-discordantrelationships.
TheMinistryofHealthrecommendsimmediateinitiationoflife-longARTinpregnant
andbreastfeedingwomenuponHIVdiagnosiswithcontinuousadherencesupport.
EvidenceshowsthatHIVpositivewomencominglateforANCandinitiatedonARThave
highlikelihoodofdefaultingonHIVtreatment.Deliberateandfocusedpatientsupport
anddefaultertrackingmechanismneedtobeputinplacetoensurecomplianceto
HIVtreatment.
16
3.2.FirstLineARTinAdolescentsandAdults
PreferredregimenAlternativeregimen
First-lineARTregimensfor
adolescents(≥15years)and
Adults
TDF*+3TC+EFV
TDF+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
First-lineARTregimensfor
HIV-infectedsexualpartner
inasero-discordant
relationship
TDF*+3TC+EFV
TDF+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
First-lineARTregimensfor
pregnantwomenand
breastfeedingmothers
TDF*+3TC+EFV**
TDF+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
FirstlineARTregimentostartinallwomenwithpreviousexposuretoNVP
throughPMTCT
Lessthan24monthssince
previousNVPExposure
TDF*+3TC+ATV/r***
Morethan24monthssince
previousNVPexposure
TDF*+3TC+EFV
TDF+3TC+LPV/r
AZT+3TC+ATV/r
AZT+3TC+LPV/r
TDF+3TC+NVP
AZT+3TC+EFV
AZT+3TC+NVP
*Forpatientswithpre-existingrenaldiseaseinitiatingART,ABC+3TC+EFVispreferred.
NodoseadjustmentsisrequiredforABC
**Systematicreviewandmeta-analysisdataincludingARVpregnancyregistryreviewshave
notfoundanincreaseinoverallbirthdefectsinpregnantwomenusingEfavirenzcompared
tootherARVexposureinpregnancy.TheWorldHealthOrganization(WHO)June2013
guidelinesonuseofAntiretroviraldrugsrecommenduseofEfavirenzatanygestationwith
moreheightenedsurveillanceforanybirthdefects.
***Hyperacidityandhenceuseofoverthecounterantacidsarecommonoccurrencein
pregnancy.CautionshouldbeexercisedinpregnantwomeninitiatingARTregimens
containingATV/rwhoconcomitantlyuseantacids.LPV/rremainsanalternativeinsuch
cases.ServiceprovidersshouldactivelyaskaboutOTCmedications.Referto3.4on
administrationofantacidsandATV/r
17
3.3.SecondLineARTinAdolescentsandAdults
IfFirstlineARTregimenPreferredSecondlineARTAlternateSecondlineART
regimen
TDF+3TC+EFV
AZT+3TC+ATV/r
AZT+3TC+LPV/r*
AZT+3TC+EFV/NVP
D4T+3TC+EFV/NVP
TDF+3TC+ATV/r
TDF+3TC+LPV/r
TDF+3TC+ATV/r/LPV/r
AZT+3TC+DRV/r**
-
•ATV/risthepreferredPIforstartingnewpatientonsecondlineART.ATV/rcanbe
usedasanalternateinpatientswhodonottolerateLPV/rduetoAdversedrug
reactions
•PatientscurrentlyonLPV/rbasedARTregimenwhohavenointolerance,neednotbe
changedtoATV/rbasedART
**AccesstoDRV/rforsecondlineART(foradultsfailing irstlinePIbasedART)willbe
madeavailablethroughconsultationwithregionalorNASCOPtherapeuticTWG
3.4DosingandAdministrationforAtazanavir/ritonavir(ATV/r)
Atazanavir(ATV)isaproteaseinhibitorinthesameclassasLopinavir(LPV)and
requirespharmacologicboostingwithritonavirasdoesLopinavir.TheavailableATV/r
tabletisaco-formulationofATVandritonavir.Itistakenoncedaily.
RecommendedDosage
Adultsandchildren>40kg
•1 ixeddosecombinationtabletofATV300mg/RTV100mggivenoncedaily
Children
•ATV/risnotrecommendedforchildrenagedlessthan6years
Dosingforchildrenaged6-18years
Weight(kg)Oncedailydose
ATV150mgplusRTV100mg,oncedailywithfood
15to<20kg
ATV200mgplusRTV100mg,oncedailywithfood
20to<40kg
ATV300mgplusRTV100mg,oncedailywithfood
≥40kg
NB:Formulationsforchildrenweighingbelow40kgsarecurrentlyNOTavailableinthe
nationalprogram.TheATV300/RTV100mgtabletshouldNOTbecrushedorsplit.
18
Dosinginformation
•Atazanavir/ritonavirmustbetakenwithfoodtoenhanceabsorption.
•TabletsshouldbetakenwholeandshouldNOTbecrushedorsplit
Co-administrationwithothermedicines
•ATVabsorptionisdependentonlowgastricpH;thereforeATV/rco-administeredwith
proton-pumpinhibitors(PPI)egOmeprazol,orH2-receptorantagonists(egcimetidine,
ranitidine)shouldbeavoided.Ifgivenitshouldbeadministeredwithfoodabout12hours
aftertheproton-pumpinhibitororH2-receptorantagonists.
•ATV/rshouldbeusedwithcautioninpatientstakingantacids,ATV/rshouldbetaken2
hoursbeforeor1houraftertheuseofantacids
•Patientwithpepticulcerdiseasewhoarelikelytocontinuouslyuseantacids,PPIorH2receptorantagonistshouldpreferablybestartedonLPV/r
Generalinformation:
•ATV/rissafetouseinpregnancy
•ATV/rco-administeredwithrifampicinresultsinreducedbloodlevelsofATV/r.InTB/HIV
co-infectedpatientonATV/r,RifampicinshouldbereplacedwithRifabutin150mgonce
daily.
Contra-indications/pre-cautions
•Notrecommendedforuseinchildrenagedlessthan6years
CommonToxicities
Atazanavir/ritonavirisgenerallywelltolerated,ithasfewerGIintoleranceandlesseffects
onlipidpro ilecomparedtoLPV/rpartlyasaresultofreducedritonavirused.
Commontoxicitiesincludeheadache,fever,arthralgia,depression,insomnia,dizziness,
nausea,vomiting,anddiarrhea.Theseeffectstendtogoawaywithtimeinthecourseof
treatment.
PatientstakingATV/rmayexperienceasymptomaticelevationofindirectbilirubin
(uncobjugatedbilirubin)whichmayresultinjaundiceoricterus.Jaundicefrom
unconjugatedhyperbilirubinemiaislargelyacosmeticissueandnotrelatedtohepatitisor
liverdamage.Serviceprovidersshouldexcludeothercausesofjaundiceandadviceclients
appropriately.Adverseeventsevenwhencosmeticmaybedisturbingtothepatients;
serviceprovidersshouldofferasubstitutiontoLPV/rtopatientwhoexperiencesigni icant
jaundice.
Kidneystones(nephrolithiasis)hasbeenreportedinpatienttakingATV/r,althoughthisisa
rareoccurrence,healthserviceprovidersshouldbemonitorpatientsclosely.
19
3.5.ARTinAdolescentsandAdultswithTB/HIVCo-Infection
TBpatientnewlydiagnosedwithHIV(ART-naıv̈e)
•StartTBtreatmentimmediatelyasperthenationalTBguidelines
•IfART-naıv̈e,startARTafterTBtreatmentistolerated,within2-8weeks
ScenarioARTregimenComments
NewlydiagnosedHIV Preferred:TDF+3TC+EFV
inaTBpatient
Alternative:AZT+3TC+EFV
(ARTnaive)
ContinuesameARTregimenafter
completingTBtreatment.ARTisnot
consideredtobefailingwithin
6monthsofinitiation
PatientdevelopsTBwhileonART
•Carryoutaviralload(VL)testifpatienthasbeenonARTforaperiodofmore
than6monthsanddoesnothavearecentundetectableviralload;changethe
irstlineregimentoanappropriate2ndlineregimeniftreatmentfailureis
con irmed
IfonNVP-based
irstlineART
regimen
IfonLPV/ror
ATV/r-based
regimen
ChangeNVPtoEFV
Continuecurrentregimen
anduseRifabutin(150mg
givenoncedaily)insteadof
rifampicin*forTBtreatment
•Assessfortreatmentfailure
•Continueadditionaladherence
counselingandsupport
•Assessfortreatmentfailure
•Continueadditionaladherence
counselingandsupport
*RifampicinusewithLPV/r
orATV/rshouldbeavoided
duetodruginteractions
Incircumstanceswhere
Rifabutinisnotavailable,
alternativeoptionsinclude
•SuperboostLPV/rwith
ritonavirtomakeLPV:
Ritonavirrationto1:1
•DoublethedoseofLPV/r
Note:Thesetwoscenarios
increasesintolerabilityto
LPV/rhencepreference
forRifabutin
20
4.ThirdlineARTforchildren,adolescentsandadults
Currentlytherearelimitedtreatmentoptionsbeyondthedrugsrecommendedforsecond-line
ART.Durableviralsuppressionon irstlineARTisthekeytotreatmentsuccessandlonglife.As
such,patientsshouldbemadeawarethatadherenceto irstlineARTisverykeyfortreatment
success.AdherencetoARTmustbesupportedtothelargestextentpossible,bothatfacility
and community levels. ARVs for constituting a third line ART regimens are not readily
available,howeverifanARTclientisinneedofthirdline,clinicalsummaryformshouldbe
senttotheNationalTherapeuticsTWGthrough3rdline@nascop.or.keforguidanceonfurther
management. The patient should continue with current 2nd line ART with intensi ied
adherenceeffortsincludingadherencecounseling,DirectObservedTreatmentSupervision
(DOTS)andhomevisits.
•Patientsshouldnotbestartedonthird-linedrugsunlesstheyarefullypreparedandare
readyforthetreatment.
•MonitoringrequirementsforpatientsonthirdlineARTarethesameasforotherpatients.
The irstvisitshouldbeat2weeksfollowing3rdlineARTinitiationandthereaftermonthly
tilladherenceisassuredandthenlessfrequentlyasappropriate.
•Directlyobservedtreatmentsupervisionshouldbeinstitutedforthe irst3monthsof
treatment.Thisshouldinvolveengagingatreatmentsupporterincludingfamilymemberora
communityhealthworker
•Adherenceassessmentmustbeconductedateachvisit(e.g.pillcount,self-reports),both
withthetreatmentsupporter/CHW/familymemberandwiththepatient.
ARVdrugsforconstitutingathirdlineregimenwillincludenewdrugswithminimal
riskofcross-resistancetopreviouslyusedregimens.Theseincludeintegrase
inhibitors,new-generationNNRTIsandPIs.Thirdlineregimenmustbebasedon
HIVdrugresistancepatternsinnon-adherentpatient.
21
5.IntensiveCaseFindingandIsoniazidPreventiveTherapy
•Symptom-basedTBscreeningusingICFtoolMUSTbedoneforallPLHIVateveryvisitto
ruleoutactiveTB
•InfectioncontrolmeasuresshouldbegivenprioritytoreduceTBtransmissioninall
settingsthatprovidepatientcare
•InvestigationsforTBshouldbeperformedinaccordancewithexistingnationalguidelines
•Chestradiographyisnotrequiredaspartofroutinescreening;howeverpatientsdeemedto
beTBsuspects,shouldhaveachestXraywheresputumisunavailable
5.1.IndicationsforIsoniazidPreventiveTherapy
•HIV-infectedchildrenlessthan12monthsofagewhohavehadrecentcontactwithactive
TBdiseasewithnoevidenceofTB
•AllPLHIVabove12monthsofagewhoscreennegativeforTBusingtheICFtool
•Allchildrenunder5yearsirrespectiveofHIVstatuswhohadrecentclosecontact(past12
months)ofsmearpositiveTBcase
•Prisoners,irrespectiveofHIVstatus
Note:
•PasthistoryofTBandcurrentpregnancyarenotcontraindicationsforstartingisoniazid
preventivetherapy.IPTcanbestartedatanytimeaftersuccessfulcompletionofTB
treatment.
•IPThasnotbeenshowntoincreasetheriskofdevelopingisoniazid-resistantTB.
5.2DurationandDoseofINHforIPT
•IPTshouldbegivenatadoseof10mg/kg/day(maximum300mg)fordurationof6
months
DoseofINHforIPT
WeightDoseinmgNumberof100mgNumberof300mg
range(kg)INHtablets(Adult)tablet
50
½tablet
<5
100
1tablet
5.1-9.9
150
1½tablet
10-13.9
½tablet
200
2tablets
14-19.9
250
2½tablets
20-24.9
300
3tablets
>25
1tablet
300
Adults
1tablet
5.3.DosingofPyridoxineforAllPatientstakingIsoniazid
AllpatientstakingINH(whetherforIPTorTBtreatment)shouldalsoreceivedaily
pyridoxinetoreducetheriskofdevelopingperipheralneuropathy.
22
Doseofpyridoxine
Weight(kg)Numberoftabletsofpyridoxine(50mg)
5-7
8-14
≥15
(1/4)quartertabletdaily
(1/2)halftabletdaily
(1)onefulltabletdaily
5.4FollowUpofPatientsonIPT
AllpatientsonIPTshouldbe;
Reviewedmonthlyandadherencemessagesreinforced
•ScreenedforactiveTBduringeachclinicvisitusingtheintensivecase inding(ICF)
form
•ShouldhavetheirICFcardsandIPTregisterrecordupdatedateveryvisitandoutcome
documentedoncompletionoftherapy
•MonitoredforINHadverseeventsateveryvisit(coadministerwithpyridoxineto
minimizeadverseevents)
•ThefacilityshouldmaintainaTBcontactregister
5.5ContraindicationstoIPT
•Activehepatitis(acuteorchronic)
•Regularandheavyalcoholconsumption
•Symptomsofperipheralneuropathy
IPTshouldbediscontinuedinsymptomaticpatientswithALT/ASTmorethanthree
timestheuppernormallimits
5.6.UseofXpertMTB/Rif(GeneXpert)inDiagnosisofTBforPLHIV
GeneXpertisamoleculardiagnostictestforTBdiseasethatcandetectMycobactrium
tuberculosisDNAandRifampicinresistancefromsputumspecimeninlessthan2hours.
ThistechnologyismoresensitivethansputummicroscopyindetectingTB.Inaddition,its
abilitytodetectsmearnegativeTBprovidesaddedadvantageinpeoplelivingwithHIV.
GeneXpertisincreasinglyavailableinKenyainthepublichealthsectorandisnow
recommendedbyMinistryofHealth-NLTD-UnitforTBdiagnosisinallHIV-infected
personssuspectedtohaveTBusingtheICF/IPTscreeningtool.
Note:Refertothealgorithmon“UseofGeneXpertforDiagnosisofDrugResistanceand
SurveillanceofTB”(Annex3)
23
6.LaboratoryMonitoringforPLHIV
6.1.UseofCD4CountforMonitoringPLHIV
IndicationsforCD4Count
•ACD4countshouldbeperformedforallPLHIVattimeofenrollmentintocareto
supporteligibilitycriteriaforART.Thiswillalsoserveasabaselineformonitoring
clinicalprogressofthosenotqualifyingforARTimmediately.
•AllPLHIVwhoarenotonARTshouldbereceiveCD4counttestingevery6monthsto
determinetheireligibilityforART
•AllpatientsonARTwhoareonsecondary luconazoleprophylaxisshouldreceiveCD4
counttestingevery6monthstodeterminewhentodiscontinuetheirprophylaxis
•Whereviralloadmonitoringisnotreadilyavailable,6monthlyCD4counttestingisstill
recommendedformonitoringARTresponse
•CD4countmaybeperformedtoaidinthedifferentialdiagnosisofPLHIVwhopresent
withnewsigns/symptomsofanOI,regardlessofARTstatus.Forexampleinapatient
presentingwithfocalneurologicalsignswithCD4cellcountoflessthan100cells/mm3
toxoplasmosisislikely,whileifCD4cellcountis400cells/mm3Toxoplasmosisisunlikely,
justasapatientpresentingwithworseningdyspneaandwithaCD4of500cells/mm3is
unlikelytohavePCP
Note:ThefollowingpopulationsdonotrequireCD4counttestingtodetermine
eligibilityforARTe.g.childrenlessthan10years,pregnantwomenandotherclinical
conditionsmentionedinprevioussections(2.1,3.1)henceCD4counttestingshould
notdelayARTinitiationinsuchpopulations.However,baselineCD4cellcountis
recommendedforallPLHIVatenrolment
24
6.2.UseofViralLoadinARTmonitoring
ViralloadmeasurementisgoldstandardformonitoringARTtreatmentresponse.The
MinistryofHealthnowrecommendsroutineviralloadtestingforallpatientsonART.
Whereroutineviralloadisnotaccessible,CD4countandclinicalmonitoringshouldbe
usedtomonitortreatmentresponseandidentifypatientslikelytobefailingtreatment.
Insuchcircumstances,suspectedtreatmentfailureshouldbecon irmedusingviralload
testing.Healthcareprovidersshouldbefamiliarwithviralloadnetworksintheirregion
andensurepatientsbene itsfromtheseservices.
Itisimportantforhealthcaremanagers(healthfacilityin-charges,medicalsuperintendent
andcountyhealthmanagementteams)toestablishsystemsforviralloadaccessintheir
regionifnoneexist.
RecommendationsforViralLoadTesting
•AllHIV-infectedchildren,adolescentsandadultsinitiatingART(1st,2ndor3rdline
ARTregimens)shouldreceiveaviralloadtest6monthsfollowingARTinitiation,at
12monthsandthereafteroneviralloadtestperyear.
•AllHIV-infectedchildren,adolescentsandadultscontinuingonARTshouldreceiveone
viralloadtestperyearformonitoringtreatmentresponse
•AllHIV-infectedchildren,adolescentandadultsonARTfoundtohavedetectableviral
loads(viralRNA>1,000copies/ml)onroutineviralloadtestingshouldreceivearepeat
viralloadtestafter3monthsfollowingadherenceintensi icationinterventionsto
con irmtreatmentfailure.
•AllHIV-infectedpregnantwomeninitiatingARTshouldreceiveaviralloadtestafter
6monthsofARTinitiation.Ifviralloadis>1,000copies/ml,adherenceshouldbe
optimizedandrepeatviralloadtestingconductedafter3months.Ifadecisionto
changeARTismade,itshouldbeexpedited
•AllHIV-infectedwomenwhobecomepregnantwhileonARTandhavenothadaviral
loadtestinthepreceding6months,shouldhaveaviralloadtestdoneassoonaspossible
upondiagnosisofpregnancy.Ifviralloadis>1,000copies/ml,adherenceshouldbe
optimizedandrepeatviralloadtestingconductedafter3months.Ifadecisiontochange
ARTismade,itshouldbeexpedited.
•Viralloadtestingshouldbeperformedbeforemakinganysingle-ARVdrugsubstitution
ifthepatienthasbeenonARTformorethan6months.
Note:
PatientsonARTandabletoaccessroutineviralloadtestingasdescribedabove
shouldnothaveroutineCD4cellcountmeasurementwhileonART
25
7.PreconceptionCare
Itisimportantthatapregnancyintentionisassessedroutinelyaspartofenrollmentinto
HIVcareandperiodicallyasnecessaryinwomen/couplesofreproductiveage.
Women/coupleswhodonotwishtoconceiveshouldbeofferedeffectivecontraception,
inadditiontocondoms.Further,aspartoffamilyassessmentforHIVcareneeds,spouses
andsexualpartnersshouldbetestedforHIVassoonasdisclosureisdoneandtesting
feasible.Thiswillenablediscordantcouplestobeidenti iedandallowproactivesupport
ofreproductivedesires.
Pre-ConceptionCareforConcordantPositiveorDiscordantCouples
•Intensivecounselingshouldbeofferedtoenhancepreventiontopartnersandthebaby
•TheHIV-infectedpartner/sshouldinitiateARTregardlessofCD4countorWHOstageif
theyareplanningtoconceive(usingrecommendedstandard irst-lineART)
•PregnancyshouldbedeferreduntiltheviralloadisundetectablefortheHIV-infected
partner/s.
•Unprotectedsexualintercourseshouldbelimitedtodayswhenovulationisexpected
andshoulddeferreduntilviralloadsuppressioniscon irmed
•Usebasaltemperaturemonitoring,fertilitycalendarbasedonmenstrualcycles,and/or
anon-linefertilitycalculatortopredictexpectedovulationdays
•Pre-conceptioninvestigationsinclude:
oHb(manageanemiaasearlyaspossible)
oSerumRPRforsyphilisscreening
oSymptomscreeningandsyndromicmanagementforotherSTIs
oCervicalcancerscreening
•Offernutritionalassessmentandcounselingandbeginthewomenonfolicacid
supplementation
•Encouragethecoupletoseekprenatalcareinafacilitywheretheywillbeabletohave
continuityofcareandtherecordsofthepreconceptioncarecaptured.Themalepartner
shouldbeencouragedtoparticipateinprenatalvisitsandassistinbirthplan
26
DiscordantCouplesWhoWanttoConceive,MaleisHIV-infected
•VirologicsuppressionshouldbeensuredintheHIV-infectedmalepriortoattempting
conception.ThisminimizestheriskofHIVtransmissiontotheun-infectedfemale
partnerandsubsequentlytothebaby.
•Wherefeasible,sperm-washingwhichreducestheriskofthewomanbecominginfected
followedbyarti icialinseminationmaybeanoption.Couples,whochoosethisoption,
maybereferredtoacenterwithanobstetrician/gynecologistforspecialistmanagement.
DiscordantCouplesWhoWanttoConceive,FemaleisHIV-infected
•WhenthefemalepartnerisHIV-infected,spermwashingisnotbene icial,butarti icial
inseminationcanstillbeusedwherefeasibletominimizetheriskofthemanfrom
becominginfected
NOTE:ViralsuppressionforHIV-infectedpartner(s)onARTshouldbeoptimized
forclientsplanningtoconceivetominimizeriskofHIVtransmissiontouninfected
partnerandtothebaby.
27
8.Post-ExposureProphylaxis(PEP)
ARVprophylaxisisrecommendedforoccupationalandnon-occupationalhighriskexposure.
Riskassessmentafterexposuretobody luids
LowRiskHighRisk
TypeofExposure
Intactskin
Mucusmembrane/non-intactskin
Percutaneousinjury
Source
HIVnegative
HIVstatusunknown;clinicallywell/
unwell
Material
Saliva,tears,sweat,
faeces,urine,sputum,
vomit
Semen,vaginalsecretions,synovial,
pleural,pericardial,peritoneal,
amniotic luids
Bloodandbloodybodily luids;CSF;
viralculturesinlabs
SummaryofmedicalmanagementofmedicalPEP
ConsiderationsRecommendedAction
Eligibility
Highriskexposure
Exposurewithin72hours
ExposedindividualisnotHIVinfected
SourceindividualHIVpositiveorofunknownHIVstatus
Counselingandtesting
theexposedindividual
Offerinformationonrisksandbene its
Verbalconsentadequate
Base-lineHIVtestinHIVexposedperson
Voluntarytestingforbothexposedandsourceindividuals
ARVagentsforPEP
x1month
Adult:Preferred:TDF+3TC+ATV/r
Children:Preferred:ABC+3TC+LPV/r
Timeofinitiation
Assoonaspossibleafterexposure,butnolaterthanafter
72hours
Durationoftherapy28days
DoseofPEPSameasindicatedforART;usedosingwheelforchildren
28
Follow-up
Followupclientat7days,14daysand28days
Follow-upHIVtestingat3and6monthsafterexposure
Pregnancytesting
Hb(ifAZT-containingregimenusedforPEP)
HepatitisBvaccinationifnotpreviouslyimmunnized
ManagementofsideeffectsduetoPEP
Counseling
Adherencecounseling,riskreduction,traumaandmental
healthcounseling,socialsupportandsafety
Otherservicesfor
sexualassault
STIprophylactictreatmenttoall
Emergencycontraceptivefornon-pregnantwomen
TetanusToxoidforanyphysicalinjuryofskinormucous
membranes
Documentationofclinicalevidenceofassaultandcollection
offorensicevidence
NOTE:RefertoNationalGuidelinesonmanagementofSexual
ViolenceinKenyaforcomprehensivemanagement
Note:Counselingonbehaviorchangeandriskreductionshouldbeofferedtoclients
withrepeatedexposurerisks
9.Pre-ExposureProphylaxis(PrEP)
Pre-exposureprophylaxis(PrEP)forHIVisthedailyuseofARVdrugsbyHIV
uninfectedpeopletopreventtheacquisitionofHIV.
PrEPisnotcurrentlyrecommendedforroutineuseinKenyaexceptin
researchsettings.
29
TWICEDaily
TWICEDaily
60mgZDV
+
30mg3TC
tabs
TWICEDaily
60mgABC
+30mg
3TCtablets
60mgZDV
+
30mg3TC
+50mg
NVPtabs
Zidovudine
(ZDV)
+
Lamivudine
(3TC)
+
Nevirapine
(NVP)
Zidovudine
(ZDV)
+
Lamivudine
(3TC)
Abacavir
(ABC)
+
Lamivudine
(3TC)
200mg
EFVtabs
ONCEDaily
Efavirenz
(EFV)
10mg/ml
suspension
200mg
tabs
ONCEdailyfor irst
2weeksthentwicedaily
Nevirapine(NVP)
(useweightappropriate
formulation)
Singleformulationswhere
Fixeddosecombination
FDCsarenotavailable
LPV/r80/
20mg
perml
solution
TWICEDaily
LPV/r200/
50mgtabs
Lopinavir/
Ritonavir
(LPV/r)
RTVliquid
(80mg/ml
as90ml
bottle)
RTV
capsule
100mg
TWICEDaily
Additionaldosing
forritonavirfor
TB/HIVco-infection
3ml
2.5ml
2tab_1tab4ml
1tabinam
0.5tabinpm
20-24.93tab3tab3tab1.5tab15ml
25-34.9300+150mg300+150mg300/150/
200mg
1tabinam
0.5tabinpm
14-19.92.5tab2.5tab2.5tab1.5tab15ml
2ml2cap
2tabinam
1tabinpm
4mlinam 2capinam
&
&
2mlinpm 3capinpm
1tabtwice
2.5ml2cap
daily
1tabtwice
daily
10-13.92tab2tab2tab1tab10ml0.5tab2ml-1.5ml_
6-9.91.5tab1.5tab1.5tabSeenotes8ml_1.5ml-1ml_
3-5.91tab1tab1tabSeenotes5ml_1.5ml-1ml_
Weight
Range
(kg)
Annex1.PaediatricARVDrugDosingChart
30
Notes:PaediatricARVDrugDosingChart
Paediatric ixeddosecombinations(FDCs)areavailableasABC/3TC,AZT/3TCand
AZT/3TC/NVP.AllchildrenrequiringARTshouldbeputonappropriateFDCsbasedon
theirweight.
ABC/3TCtablets-canbechewedorcrushedordispersedinwater(5-15ml)orontoa
smallamountoffoodandimmediatelyingested.Childrenabove25kgshouldbetreatedas
pertheadultdoseofABC300mg+3TC150mgtwicedaily.
AZT/3TCandAZT/3TC/NVPtabletsarewaterdispersibleandshouldbegivenin5-15ml
ofwater.
ForadolescentsonABCbasedregimenconsidertransitioningtoTDF/3TC/EFViftheir
weightremainsconsistently>35kgs(atleast2readingsonemonthapart)forbetter
adherence.AvailableTenofovir/LamivudineandTenofovir/Lamivudine/EfavirenzFDCs-
canbeusedinchildrenolderthan10yearsandabove35kgs.
Referenceshouldbemadetothenationalguidelinesfordosing.
Singleformulations
TheseformulationsshouldonlybeusedwhereappropriatePaediatricoradultFDCscannot
beused.
Abacavir(ABC)-tabletsmaybeswallowedwholeorcrushed.
Lamivudine(3TC)-tabletsmaybeswallowedwholeorcrushed
Efavirenz200mg-tabletisdoublescoredandmaybedividedintofourortwoequalparts.
Tabletmaybecrushedanddispersedinwater(5-15ml)orontoasmallamountoffoodand
immediatelyingested.
Lopinavir/ritonavir-doseiscalculatedbasedonLopinavircomponent.Oralsolution
shouldbetakenwithfood.Oralsolutionmustberefrigerateduntildispensed.After
removingfromrefrigerationoralsolutionisonlystablefor60days(2months)atroom
temperature(upto25°C).Wheretemperaturesareexpectedtoexceed25°C,thefeasibility
ofdispensingsmalleramountsandgivingmorefrequentre illsshouldbeconsidered(for
instance,nomorethanmonthlysuppliesdispensedatonetime).Theamountofsolution
hasbeenroundeduptonearest½mlforeasiermeasurementasperthemanufacturer’s
recommendation.
RitonavirLiquid-ChildrenwithTB/HIVco-infectionwhoareonLPV/rbasedART,will
needadditionaldosingwithRitonavirtomakeLPV:RTVas1:1(duetoreduced
concentrationofLPV/rwhenusedwithRifampicin)andshouldbegivenasindicated.The
dosingisroundedofftonearestmlforeaseofadministrationofRTV.
UseofEfavirenzinyoungerchildren
TheUSFDAhasapproveduseofEFVinchildren3monthsandaboveandweighingmore
than3.5kg.
CurrentlyinKenya,useofEFVinchildrenaged<3yearsandweighing<10kgis
recommendedONLYinTB/HIVco-infectionmanagementwithoutpriorexposureto
NVPforPMTCT(forEFVdosingreferto2.5)
31
Annex2.Viralloadtestingalgorithm
Collectasampleforviralloadtestings
Viralload>1,000copies/ml
Viralload<1,000copies/ml
Adherenceassessmentandinterventioninall
treatmentfailurepatients;assessfor,treat&/or
stabilizeopportunisticinfections;reviewdrug
interactions;assessforotherpossiblecauses
oftreatmentfailure
Repeatviralloadafter3monthsofexcellentadherence
Viralload>1,000copies/ml
Viralload<1,000copies/ml
Con irmstreatmentfailure,continueadherence
review,preparationandintensivefollow-upplan
If irstlineARTfailureswitchtosecondlineART
asperguidelines.
*If2ndlineARTfailure,summarizecaseandemail
[email protected]
Notreatmentfailure.
DonotswitchART
Continuewiththecurrent
regimenandadherence
support,managedrug
toxicitiesasappropriate
NB:Plasmaremainsthepreferredspecimentypeforviralloadtesting.Facilitiesin
closeproximityandeasyaccesstoatestinglaboratoryshoulduseplasmasamples.
FacilitieswithpooraccessorinremoteareasshoulduseDBS.
GuidanceforsecondlineARTfailure
•*Patientscon irmedtohavefailed2ndlineARTtreatmentfailure:Summarizecase
intheclinicalsummaryformprovidedbyNASCOPandsubmitto3rdline@nascop.or.ke
forapprovalofDrugResistanceTesting
•NASCOPARTTherapeuticsTWGwilldetermineneedforDRtestingandadvisethe
facility.ResultsofHIVDRtestingshouldbesubmittedtothisTWGtodetermineART
regimen
•Meanwhilecontinuewithcurrentregimen
32
Annex3.UseofGeneXpertforDiagnosisofDrugResistanceandSurveillance
IndicationsforGeneXpert
TBDiagnosis
•HIVpositivewithTBsymptomsusingscreeningwithTBICF/IPTtool
•Childrenunder15yearswithTBsymptoms*
MDRTBsurveillance
•Allpreviouslytreatedpatients:a.failures;b.relapses;c.treatmentafterlosstofollowup
•DRTBcontacts
•HealthcareworkerswithTBsymptoms
•PatientswhodevelopTBonIPT
•RefugeeswithsymptomsofTB
•Smearpositiveat2months
InareaswhereGeneXpertisavailable:thisshouldbethe irsttest
PatientsdiagnosedwithGeneXpertshouldbefollowedupwithmicroscopy
ResultsofGeneXpert
TBpositiveandalso
Rifampicinresistance
StartonMDRTB
treatment
andARTifHIV
positive
DST(Firstlineand
secondline)
Ifanyresistancefor
injectablesand/orFQ
useXDRregimen.For
PDRandmono-resistant
TB,treatasperguidelines
Patienthassymptoms
suggestiveofTBbut
GeneXpertisnegative
forTB
TBpositivebutno
resistancetoRifampicin
DocultureandDSTforMDRTB
surveillancegroup*(noculture
&DSTforTBdiagnosis)Treat
catI,II(offerHIVtesting)
Ifnoresistance,
continuetreatment
SputumforSmear
follow-upmonth
2/3and5
SS-ve
SS+ve
Patienthaschest
symptomsbutno
TBbyGeneXpert
X-ray,broadspectrum
antibiotics,clinical
condition
Noimprovement
andstillTB
suspect
Improvement;
Continueand
observe.Ifnone
considerother
diagnosis
CultureandDST
Treatmentsuccess
33
Annex4:ImplementationGuidanceforServiceProviders
County Health management teams and Health facility managers should ensure all service
providers are updated on the new recommendations through facility level CMEs, on-job
trainingsandcontinuedmentorship.
HIVtestingandcounselingandlinkagetoHIVCareandTreatment
•HIVtestingandcounselingservicesshouldbeaccompaniedbyappropriatepre-test
information(whichcanbeprovidedasgrouppre-testinformationinsomesettings)andposttestcounseling.
•Qualityassurancemechanismsandsupportivesupervisionandmentoringsystemsshouldbe
inplacetoensuretheprovisionofqualitycounseling.
•AllClientsidenti iedasHIVpositiveshouldbereferredandlinkedtoappropriateprevention,
careandtreatmentservicesuponHIVdiagnosis.
•Properdocumentationofallreferralsincludingtrackingofreferralsshouldbemaintainedat
thepointsofHIVtesting
EarlyinfantDiagnosis(EID)ofHIVandHIVexposedInfantfollow-up
•Allchildrencomingfortheir6weeksimmunizationvisitshouldbeassessedforHIVexposure
andDBSsamplesforDNAPCRtestingcollectedforallHIV-exposedinfants(HEI).
•Onceinfants/childrenareidenti iedasHIVexposed,aHIVexposedInfantfollowupCard
shouldbeopenedforeachinfant/child.Inadditionthechild’sdetailsshouldbeenteredinthe
HIVexposedinfantregisterwhichshouldbeupdatedregularly.
•ThefollowupofallHIVexposedinfantsshouldbeintegratedintheMCHclinictogetherwith
thatofthemotheruntiltheageof2years
•CohortanalysisforHIVexposedinfantsshouldbeconductedroutinelytodetermine
outcomesat6weeks,9monthsand18monthsbasedontheHEIregister.
•HIV-infectedinfants/childrenidenti iedthroughEIDattheMCHclinicsshouldbefollowedup
andHIVCareservicesincludingARTinitiatedasperguidelinesattheMCHpreferablyupto
theageoftwoyearswhencareforthechildandmothershouldbetransitionedtotheHIV
ComprehensiveCareClinicsdependingonthehealthfacilityset-up.
34
AntiretroviralTherapyforchildren,adolescentsandAdults
Children
•Toensureallchildrenaged10yearsandbelowinitiateARTasperguidelines,health
facilitiesshouldconductimmediate ileandregisterreviewstoensureallsuchpatients
currentlyincareandnotonARTareidenti ied,reachedandinitiatedonARTasrequired
withappropriatetreatmentpreparation.
•Facilitiesshouldprovidecaregivereducationtoallparents/guardiansofchildrenunder
theirCareonHIV&ART,importanceofadherence,retentionandtreatmentsupport.
•ServiceprovidersmusttakeweightmeasurementsoneveryvisitforchildrenonARTand
ensureappropriateweightbaseddoseadjustmentsoftheirARVsaremade.
AdolescentsandAdults
•InviewoftherecommendationtoinitiateARTearlier,healthfacilitiesshouldconduct
immediate ileandregisterreviewstoensurethatallpatientsintheircarewhomeetthe
eligibilitycriteriaforARTandarenotARTareidenti ied,reachedandinitiatedonARTas
requiredwithappropriatetreatmentpreparation.
ServicesforPregnantWomenforPreventionofMothertoChildTransmission
HIV-infectedpregnantwomenidenti iedduringANCvisits
•Allpregnantwomenidenti iedasHIVpositiveduringtheirANCvisitsshouldhave
antiretroviraltherapyinitiatedinthesamedayasthatofHIVDiagnosis.
•Treatmentpreparationsessions,adherencecounselingandpsychosocialcounseling
supportshouldbeinitiatedonsamedayofHIVdiagnosisandsustainedtosupport
adherenceandretention
•SamplesforbaselinetestsincludingANCpro ile,CD4testing,Biochemistryshouldbe
collectedonsamedayofHIVdiagnosisandARTinitiation
•AsupplyofARVsfor1monthshouldbeprovidedtothemother
•Areturnappointmentofone-twoweeksshouldbescheduledtoreceiveresultsof
baselinetests,adherenceassessmentandcounselingandsupportandassessmentfor
toxicities
•Subsequentfollow–upvisitsshouldbescheduledmonthlyforthe irst6monthsand
threemonthlythereafterifstableandshouldprovideARTre ills,adherenceassessment
andsupport,evaluationforadverseeventstoART,OIscreeningandmanagement,
counseledonmaternal,infantandyoungchildfeedingandotherclinicalevaluation
35
•AllpregnantHIV-infectedwomeninadditiontoreceivingARTshouldassessedandm
managedforopportunisticinfections,receivecotrimoxazoleprophylaxis,screenedforTB
andprovidedwithisoniazidprophylaxisifTBisruledout,linkedtopsychosocialsupport
groupsandcounseledonmaternal,infantandyoungchildfeeding.
HIV-infectedwomenidenti iedinlabour/delivery
•Allwomenidenti iedasHIVpositiveduringlabour/deliveryshouldbeprovidedwith
their irstdoseofARTuponHIVdiagnosisandprovidedwithatleast1monthsupplyof
ARTondischarge
•Treatmentpreparationsessions,adherencecounselingandpsychosocialcounseling
supportshouldbeinitiatedintheimmediatepost-partumperiodbeforedischargeand
continuedinthefollowupvisitattwoweeks
•Subsequentfollowupvisitsshouldbescheduledmonthlyforthe irst6monthsand
thereafterthreemonthlyifstable
•ThefollowupvisitsshouldincludebaselineCD4cellcounttesting,VLtestingasper
guidelines,evaluationforadverseeventstoART,adherenceandsupportivecounseling,OI
screeningandmanagement,counselingonmaternal,infantandyoungchildfeedingand
otherclinicalevaluationandARTre ills
PregnantandBreastfeedingwomencurrentlyonOPTIONAorOPTIONB
•Allpregnantandbreastfeedingcurrentlyonshorttermprophylaxis(optionA)shouldbe
switchedtolife-longARTwiththenecessaryadherencecounselingandtreatmentsupport.
ServiceprovidersshouldwithdrawremainingstocksofARVsforprophylaxis(optionA)
heldbythepatientfollowingARTinitiation.
•Allpregnantandbreastfeedingcurrentlyonshorttermprophylaxis(optionB)shouldbe
continuedonsameregimenforlife-longARTwiththenecessaryadherencecounselingand
treatmentsupport.
•Treatmentmonitoringusingviralloadshouldbeinlinewiththeguidelinesonmonitoring
forallnewpatientsonART(at6monthsand12monthsafterARTinitiationand
thereafterannually).Refer6.2
36
RecommendationsforMCHclinicsprovidingARTforMothersandChildren
MCHclinicswillberequiredtoprovideARTforpregnantandbreastfeedingwomenwho
startonARTforPMTCTpurposes.
•Facility/MCHin-chargesshoulddeterminethereadinessoftheMCHtoprovideservices
includingspaceavailability,staf ingtrainedinprovisionofART,accesstobasiclaboratory
tests(suchasCD4,EID,Viralload,Biochemistry),accesstoARVsandOImedicines,
availabilityandaccesstoroutineMandEtoolsforHIVcare,toolsforLogisticsmanagement
•Considerationsshouldbemadeforadditionalstaf ingforMCHclinicsstartingtoprovide
ARTformothersandchildrentoensureservicesinthosesettingsarenotcompromised.
•MCHsstartingtoprovideARTshouldconductanimmediate ile/registerreviewtoidentify
HIV-infectedpregnantorbreastfeedingwomenwhorequireimmediateinitiationofART
•Patients ilesshouldopenedforallpatientsthatincludetheHIVCareCard(MOH257),
clientfollow/encounterformsandotherrelevantclinicalforms
•StandardMOHregistersshouldbeutilizedincludingpre-ARTregister(MOH361A),ART
register(MOH361B),CCCDailyActivityregister(MOH366)andCommoditymanagement
toolsincludingDailyactivityregister(MOH367A),MonthlyARTPatientsregisterand
FCDRR(MOH730)
•Routinemonthlyreportingforpatientnumbersandcommodityconsumptionshouldbe
doneusingroutineMOHtoolsandsystems
•Patient lowshouldbestructuredtominimizeintra-facilityreferraltodifferentservice
points
•MCHclinicsshouldensuretheyhaveconsistentaccesstoandsupplyofARVs,availableOI
medicinesandhaveaccesstorecommendedlaboratorytestsfordiagnosisandmonitoring
eitheron-siteoroff-sitebyreferral
•FacilitiesshouldconductPMTCTcohortanalysistodetermineretentionofmothersstarted
onARTat3months,6monthsand12months.
•CarefortheHIV-infectedinfantsandmothersincludingARTinitiationshouldbeintegrated
intoMCHclinics.Dependingonthehealthfacilityset–upthemother–babypairfollow-up
shouldbetransitionedwhenthebabyreaches2yearsofage.Thetransitionshouldbe
contextualizedtothefacilityset-up
37
PatientSupportSystemsforAdherenceandRetention
•Healthcareprovidersshouldprovideongoingadherencecounselingandsupporttoall
patients
•PeercounselingsupportsystemssuchasmentormothergroupsandotherPLHIVpeer
support,useofphonereminders,pillboxesarerecommendedasstrategiestoimprove
adherence
•Facilitiesshoulduseacombinationofmultipleadherenceassessmentstrategiessuchas
self-reporting,pillcounts,treatmentbuddy/supportervalidation
•Formationofsupportgroupsthattakeintoconsiderationthatdifferentagecategories
andpopulationsisrecommendedtosupportadherenceandretentionincare
•Trackingofclientswhomissappointmentsordefaultfromtreatmentshouldbe
conductedusingvariousapproachesincludingphonetracing,physicalhomevisits
amongothers
CountyandSub-Countyhealthmanagementteams(includingcountylevel
ImplementingPartners)should;
•Conductcapacitysiteassessmentsanddeterminereadinessofhealthfacilitiesthat
currentlyprovidePMTCTonlyservicestoprovideHIVTreatment.Asitecapacity
assessmenttoolisavailableatNASCOP.
•SupportcapacitybuildingofsitestargetedtoofferHIVtreatmentbasedonneedsand
gapsidenti ied,orupgradingofsitestargetedtoactasreferralcentersforlaboratory,
ARVre-supplyorotherspecializedservices
•Establishlaboratoryservicesnetworksandcommoditysupplynetworkstoensure
consistentavailabilityoftestsandsupplies
•ProvideQualityassuranceofHIVservicesincludingsupportivesupervision,
mentorship,andon-jobtrainingandcontinuousprofessionaldevelopment
38
ImportantContacts
FacilitiesshouldcontacttheirRespectiveCountyAIDsandSTICoordinatorsincaseofany
queriesregardingHIV.Inadditionfacilitiesshouldutilizelocalexpertiseofsenior
cliniciansandspecialistsinconsultationregardingpatientmanagement.
IfneedbecontactofthefollowingNASCOPof icersshouldbeusedforvariousissues.
GeneralenquiriesonHIVdirectedto
HeadNASCOP:
DrMartinSirengo;[email protected],
[email protected]
Telephone;+254-0202630867
StrategicInformationandM&E
DrJoyceWamicwe:[email protected]
DrJacobOdhiambo:[email protected]
[email protected]
AntiretroviralTherapyqueries
DrIreneMukui:Email;[email protected]
DrMaureenKimani:[email protected]
VoluntaryMaleMedicalCircumcision
DrGeorgeGithuka;[email protected]
ServicesforKeyPopulations(MARPs)
HelgarMusyoki;[email protected]
Trainingqueries:
[email protected]
Consultationsonthefollowingcategories
ofPatientsreceivingART:
•PatientsfailingsecondlineARTorother
treatmentexperiencedpatientswhorequire
appropriateregimenselectionorDrugresistance
testing
•Patientswithcomplexitiesoftreatmentdueto
co-existingco-morbiditiesorco-infectionsor
complex
•PatientsexperiencingseriousAdverseevents
ordruginteractions
Consultationsshouldbesentto;
[email protected]
PreventionofMothertoChildTransmission
ofHIVqueries
DrRoseWafula;[email protected]
HIVCommoditySupplyandSecurityqueries
DrCarolineOlwande:[email protected]
NutritionandHIVqueries
GladysMugambi;[email protected]
InfectionPreventionControl&Injection
Safety
JaphethGituku;[email protected]
NationalHIVReferenceLaboratories
NancyBowen:[email protected]
HIVtestingandcounselingqueries
DrJoyceWamicwe:[email protected]
39
National AIDS and STI Control Programme (NASCOP)
P.O. Box 19361, Nairobi, Kenya
Tel: 254 20 2729502, 2714972
email: [email protected]