PMTCT PROGRAM UPDATES

Presenter: Isaack Kirui –PMTCT

Advisor, AMPATHPlus

Academic Model Providing Access to Healthcare

1
 Background…

Consultants Program Guidance on DTG

• 0ptimizing HIV
prevention and
treatment services
• Better medicines &
diagnostics
• Patient centered
approaches in
service delivery.
• Management of
PLHIV with
advanced HIV
disease
EMTCT Goal: Dual elimination of MTCT of HIV
& syphilis (eMTCT+S)

• EMTCT impact targets are:

– transmission rate of <5% in breastfeeding populations
– < 50 new paediatric HIV infections /100 000 live births
– < 50 cases of congenital syphilis/ 100 000 live births
• There are four process targets
– > 95% antenatal care coverage (at least one visit)
– > 95% coverage of HIV and/or syphilis testing of
pregnant women
– > 95%antiretroviral treatment coverage of HIV-positive
pregnant women
– > 95% treatment of syphilis-seropositive pregnant
women
Scaling up of Targets four key strategies,
or prongs:

• Prevention of primary infection

• Prevention of unintended pregnancy in HIV
infected women
• Interventions aimed at the prevention of
mother to child transmission
• Linkages to treatment (ARVs), care and
support of infected families

5
Preventing un-intended pregnancies

• Reduction in unintended pregnancies reduces the

number of infants born to HIV-positive mothers
• Unmet need for family planning is high,
particularly in sub-Saharan Africa, where HIV
prevalence is also high
• Eliminating MTCT will not be possible without
addressing unmet needs for family planning
• Women should be encouraged to use dual method
– condom to prevent STIs
– more effective method to prevent pregnancy
 Pre-conception care
• High rates of unintended pregnancies have been
reported among HIV-infected women ()
• Preconception care should be offered to all
women of reproductive age
• HIV positive women may be reluctant to bring up
issues about their reproductive desires
• HIV-infected women who
 desire pregnancy should be virally suppressed prior to
conception
 do not desire pregnancy should be offered effective
contraception
Maternal HIV testing guidelines
– 1st Trimester
– 3rd Trimester
– Maternity (labor and delivery) – ALL women
including those who tested negative at 3rd
Trimester.
– 6 weeks post delivery (Linked with 1st CWC visit)
– At 6 months and every 6 months thereafter until
complete cessation of breastfeeding

HIV & Syphilis dual test kits implementation in line with HIV
and Syphilis testing for all at first ANC visit
 Establishing infant’s HIV exposure status

• HIV exposure status of all infants should be

established at first contact
• To establish HIV exposure status of a child less than
18 months of age
– conduct HIV antibody testing for mothers with unknown status or
who previously tested negative during antenatal care, maternity or at
the 6 week immunization.
• If the mother declines or is not available for HIV
antibody testing at the 6 week immunization visit,
then conduct a HIV Ab test on the child
– If infant is HIV Ab positive, manage as a HEI; DNA PCR & Prophylaxis
• As soon as HIV exposure status is established, all
HEIs should start infant ARV prophylaxis
HEI infants testing guidelines
– Birth testing(Testing before 2 weeks)being piloted
– DNA PCR at 6 weeks or at first contact thereafter
– DNA PCR at 6 months and 12 months for those
breastfeeding
– HIV ab test 6 weeks after cessation of
breastfeeding
– HIV Ab test at 18 months and every 6 months
thereafter until complete cessation of
breastfeeding

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 Implications of Testing on MCH
Service Flow
• Preparation on pregnant women on testing
schedule at ANC
• Service flow re-organization in MCH to
maximize testing at post-natal
• Staff capacity/workload; rotations /shifts
– Sub-optimal testing at Maternity
• Modification of CWC Reg & optimal use of PN
Register
• Emphasize 6 months visit to retest
 HEI Prophylaxis and treatment

• HEI infant Prophylaxis

– At least AZT & NVP for 6 weeks and NVP for 6 weeks (for HEI not
breastfeeding – death of mother or separation)
– If breastfeeding NVP prophylaxis to continue up to 6 week after
complete cessation of breastfeeding - regardless of the mother’s viral
suppression status or if infant sero-converts
• If mother seroconverts while breastfeeding
– begin infant prophylaxis immediately – NVP & AZT 6 weeks and NVP
until 6 weeks cessation of Breastfeeding or if infant sero-converts.
– HIV DNA PCR immediately to establish HIV infection status
immediately and repeat testing as per guidelines
• Immediate ART for Infants who test HIV positive –
while waiting for confirmatory DNA PCR and baseline
VL testing
 Breastfeeding guidelines

• There is no separate guidance for breastfeeding

among HEI (will be breastfeed like all other infants)
– Exclusive breastfeeding for 6 months
– Introduction of complementary feeding after 6 months
– Breastfeed up to 24 months and beyond
• VL Monitoring & HEI testing
 Screening for STIs
• All pregnant women should be screened STIs –
particularly syphilis
– affect the baby’s growth and cause congenital anomalies
• Dual HIV/Syphilis screening test recommended at 1st
ANC visit to optimize syphilis testing
• Syphilis testing should ideally be performed before
20 weeks of gestation
• All women and their partners diagnosed with
syphilis should be offered treatment – benzathine
benzylpenicillin, 2.4 million IU, by intramuscular
injection, at a single dose
 Use of ART in Pregnancy & breast
feeding

• Goal of antiretroviral therapy is to suppress viral

replication
• Uninterrupted ART will help maintain
undetectable viral load levels
– Preventing damage to the body’s immune system
– Restoring and maintaining healthy living
• Lifelong ART should be started in all pregnant and
breastfeeding women living with HIV
– Preferred regimen TDF + 3TC (or FTC) + EFV
– High levels of adherence to ART critical to achieve
sustained viral suppression
Monitoring effectiveness of ART
• Viral load monitoring is an effective means
of enhancing adherence
• Monitoring is important to
– ensure successful treatment
– identify adherence problems
– determine treatment failure
• Viral load is the preferred method of
monitoring of pregnant or breastfeeding
women & children on ART
 VL Monitoring

• For pregnant and breastfeeding women newly

initiated on ART;VL 3 months after initiation
– If detectable VL (any value above (LDL): assess for and address
potential reasons for viremia, including intensifying adherence
support, repeat the VL after 3 months of excellent adherence
– If the repeat VL is ≥ 1,000 copies/ml, change to an effective
regimen
– If the repeat VL is detectable but < 1,000 copies/ml consult the
Regional or National HIV Clinical TWG
– If viral load is undetectable, repeat viral load every 6 months until
end of breastfeeding then follow-up as for general population
• For HIV positive women already on ART at the time of
identifying pregnancy, obtain a VL as soon as pregnancy is
confirmed
 Comprehensive services for HEI

The following should be offered to all HIV

Exposed Infants and infected children
– immunization, additional 6 months measles
– malaria prevention in areas with malaria
– growth monitoring
– Cotrimoxazole preventive therapy
– nutritional counseling and support
– tuberculosis screening, prevention and treatment
– confirmatory HIV testing and treatment
 By the end of this talk…

• DTG basics

• DTG warnings with current evidence

• Current guidance for use of DTG in clinical

practice

• Questions and Answers

 Dolutegravir (DTG) Basics
NRTI
Fusion Inhibitor Integrase Inhibitor
NNRTI

PI

CCR5 Antagonist
 Dolutegravir
• PROS
– Once-a-day tablet
– Quick suppression of viral load
– Detectable in breast milk
– Is hard to develop resistance against
– Side effect profile tolerable:
• All <2%
• Insomnia, fatigue, rash, dizziness, paresthesia
 AMPATH Experience
• From Sept-May, 2018, AMPATH transitioned 5063 patients to DTG including 3375
women
Facility /Site 1st Line 2nd Line 3rd Line # Number of
Clients on DTG

AMPATH (n=29) 4,959 79 25 5,063

Pilot Sites Total 3,550 37 24 3,611

(n=4)

MTRH 2,154 22 17 2,193

Webuye 239 4 1 244

Kitale 575 9 0 584

Chulaimbo 582 2 6 590

– 98% were 1st line switches (NVP/TDF/3TC  DTG/TDF/3TC)

– 35 women exposed during pregnancy (most in 2nd, 3rd trimester)
 Viral suppression on DTG
Patients with VL Less than 1000 copies/ml After DTG Transition

Facility /Site Rate of Suppressed Rate of Suppressed VL

VL @ 3 months Greater than 3 months

AMPATH (n=29) 91.6% (217/237) 95% (595/626)

Total (n=4) 91.3% (168/184) 95.1% (561/590)

MTRH 93.1% (109/117) 96.4% (400/415)

Kitale 86.2% (25/29) 88.2% (30/34)

Webuye 81.8% (9/11) 87.8% (36/41)

Chulaimbo 92.6% (25/27) 95% (95/100)

 Tsepamo: Birth Outcomes When Initiating
First-line DTG vs EFV in Pregnancy
• Prospective cohort study in HIV-infected women in Botswana initiating
ART with EFV/FTC/TDF vs DTG/FTC/TDF while pregnant (N = 5438)

DTG EFV aRR*

Adverse Birth Outcomes, n (%)
(n = 845) (n = 4593) (95% CI)
Any 291 (34.4) 1606 (35.0) 1.0 (0.9-1.1)
 Severe 92 (10.9) 519 (11.3) 1.0 (0.8-1.2)
Stillbirth 18 (2.1) 105 (2.3) 0.9 (0.6-1.5)
Neonatal death (< 28 d) 11 (1.3) 60 (1.3) 1.0 (0.5-1.9)

149 (17.8) 844 (18.5) 1.0 (0.8-1.1)

Preterm birth (< 37 wks)
35 (4.2) 160 (3.5) 1.2 (0.8-1.7)
 Very preterm (< 32 wks)

156 (18.7) 838 (18.5) 1.0 (0.9-1.2)

SGA (< 10th percentile weight)
 Very SGA (< 3rd percentile
51 (6.1) 302 (6.7) 0.9 (0.7-1.2)
weight)
Tsepamo: Birth Outcomes When Initiating
First-line DTG vs EFV in Pregnancy

• On May 18, 2018, the US FDA and WHO

announced that cases of neural tube defects
(NTD) had been reported in women on DTG at
the time of conception.

• New data showed that 0.9% of babies (4/426)

who were exposed to DTG (at conception) had
NTD compared with 0.1% (14/11,173)
exposed to other ARVs.
 DTG During Pregnancy: 1st Trimester Exposure

• Botswana (DTG initiated in 1st trimester, after

conception)1
– 116 pregnancies
– No congenital abnormalities
– No difference in outcomes between DTG and EFV

• Antiretroviral Pregnancy Registry2

– 2/110 congenital abnormalities; no NTD
– Equivalent to population-expected rates

• European Cohorts3
– 3/42 congenital abnormalities; no NTD
1. Zash, IAS Conference 2017; 2. Antiretroviral Pregnancy Registry
Interim Report, Dec 2017; 3. Thorne, IAS Conference 2017
 DTG During Pregnancy: 2nd/3rd Trimester Exposure
• Botswana1
– 729 pregnancies
– No congenital abnormalities
– No difference in outcomes between DTG and EFV

• Antiretroviral Pregnancy Registry2

– 2/70 congenital abnormalities; no neural tube defects
(NTD)
– Equivalent to population-expected rates

• European Cohorts3
– 1/39 congenital abnormalities; no NTD

1. Zash, IAS Conference 2017; 2. Antiretroviral Pregnancy Registry Interim Report, Dec 2017; 3. Thorne, IAS Confer
 Summary of Available Data
• Increased risk of NTD with DTG exposure at the
time of conception from a single cohort
– Investigation of the 4 NTD cases is not yet complete
– No reported cases of NTD with DTG exposure from
any other data source

• No safety signals for DTG in pregnancy beyond

conception (including first trimester exposures
after conception)
 Timing of Drug Exposure
Neural tube closes

Conception

LMP 4 weeks 8 weeks 12 weeks

2nd and 3rd trimester:

1st trimester: fetal development
embryogenesis
What is a neural tube defect?
 Current guidance for use of DTG in
clinical practice in Kenya

Refer to attached NASCOP Memo & Flowchart

A women-
centred
approach • Be woman-centred in your
counseling

“But doc, • Discuss again FP options

I don’t
want to
• Counsel on adequate folic acid
stop
DTG…”
• Counsel to present early for
ANC
 in TB…
• If rifabutin available: continue with current
regimen

• If rifabutin NOT available: can use DTG*

– Considerations if not pregnant
– Considerations if pregnant
 EFV intolerance
• DTG is an option!

– If on LARC…

– If pregnant…

– If not on LARC…