the updated pmtct guidelines - anova health...
TRANSCRIPT
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The updated PMTCT
guidelines
Mopani symposium
May 2013
Presented by CN Mnyani
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Outline
• What are the updated PMTCT
guidelines?
• Why the new guidelines?
• Implications of the new
guidelines
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From April ‘13
• All HIV-infected pregnant women initiated on triple
therapy (FDC) regardless of CD4 count
CD4 ≤350, or WHO stage 3 or 4, life-long ART
CD4 >350 and WHO stages 1 and 2, stop triple
therapy 1 week after cessation of BF if BF, or after
delivery if FF
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From April ‘13
• Triple therapy is an EFV-based FDC
TDF/FTC/EFV
• Initiated
at antenatal booking or anytime during pregnancy
when HIV+ diagnosis made
postpartum if HIV+ diagnosis intrapartum or
postpartum
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Prioritisation for FDC implementation PR
IORI
TY 6
PRIO
RITY
5PR
IORI
TY 2
PRIO
RITY
3PR
IORI
TY 4
PRIO
RITY
7PR
IORI
TY 1
New patients (adults, adolescents and pregnant
women) eligible to start ART
1. All pregnant women needing triple therapy
2. Breast feeding mothers currently stable on a
FDC compatible regimen.
Virally suppressed patients currently on first line
regimen, requiring a switch due to toxicity (e.g.
stavudine)
Patients currently stable on a FDC compatible
regimen, with TB comorbidity
Patients currently stable on TDF-based regimen
who, after counseling, agree to a switch to a FDC
Patients currently stable on TDF-based regimen
and who request a switch to a FDC
Patients currently stable on a FDC compatible
regimen with other comorbidities (e.g. hypertension,
diabetes mellitus, etc.)
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Antenatal 1st visit
• Pregnant women who test HIV+ – counsel about test
result and need to start the FDC
• Need to take a full history and do a full clinical
examination
• Must be recorded in patient’s file
• Good record keeping critical
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Implications of the update
• Pre-ART literacy sessions phased out
• Concurrent and on-going adherence literacy to
strengthen adherence support
• Patients need to be initiated on ART on the day of HIV
Dx, or within 7 days of being assessed as eligible if
investigations need to be done
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Antenatal 1st visit
• Screen for contraindications to starting the FDC; must
exclude:
o renal disease – TDF contraindicated in the presence
of renal dysfunction
o undiagnosed and untreated TB
o active psychosis
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Antenatal 1st visit
• Screening for renal disease:
Pre-pregnancy history of HPT or DM; a previous renal
condition requiring hospitalization; ≥2+ proteinuria on
urine dipstick
• Creatinine >85 in pregnancy a contraindication to
starting a TDF-based ART regimen
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Screening for renal disease
• If screen is positive, i.e. suspicion of renal disease, start
AZT while waiting for the creatinine result
• If creatinine >85, refer for further investigations
• Cause of the renal dysfunction may be:
acute and reversible, or
chronic and irreversible
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Abnormal creatinine
• CD4 count ≤ 350 – individual triple ART without TDF
• Options are: AZT, D4T or ABC
• CD4 count > 350 – continue AZT
• Renal disease is rare in pregnancy – with physiological
changes of pregnancy, renal function usually improves
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Implications of the update
• Will need to have available:
ং The FDC
ং AZT for prophylaxis if contraindications to the FDC
ং Individual ARVs – for patients already on triple
therapy and those with contraindications to the FDC
ং sdNVP and sdTDF/FTC
ং Infant NVP syrup
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Antenatal 1st visit
• TB screening:
All pregnant women (HIV- and HIV+) must be
screened for TB
• Screening questions:
current cough of any duration
fever
drenching night sweats
unintentional weight loss or poor weight gain
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TB
If TB screen is negative, patient
must be investigated for TB
With clinical suspicion of TB, delay
starting the FDC, and start AZT in
the meantime
NB of TB – TB IRIS; vertical
transmission; increased risk of
MTCT
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TB
• If confirmed TB, start TB Rx and AZT
• Once stable on TB Rx, ~ 2 weeks, start the FDC and
stop AZT
• Will need lifelong ART regardless of CD4 count – TB is a
stage 3 disease
• Counsel and monitor for IRIS
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TB
• INH guidelines will also be changing in the future:
• TB screen negative – TST will be done
• TST positive, IPT will be started once patient stable on
ART
• Lifelong ART (CD4≤350) = IPT for 36 months
• FDC Prophylaxis (CD4>350) = IPT for 12 months
• No TST available, continue with current IPT guidelines =
6 months IPT if active TB excluded
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Other…
• Efavirenz may be contraindicated in individuals with
active psychiatric illness – active psychosis
• In practice, any woman with an active psychiatric illness
should not receive an efavirenz-containing antiretroviral
regimen without consultation
– i.e. these patients should be up-referred for a decision
about which ARV regimen to initiate
• Mild depression is not a contraindication to efavirenz
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Use of AZT
• If in doubt, start AZT…
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Initiation of the FDC
• If all contraindications excluded, the FDC is initiated on
the day of HIV+ Dx
• 1 tablet daily at night, at the same time everyday – if time
missed, tablet must be taken as soon as possible
• CD4 count and creatinine done on the same day – to
return for results in 7 days
• Cr Cl and GFR not accurate in pregnancy; ALT only
done if initiating NVP
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Initiation of the FDC
Initiation of the FDC without baseline blood results
Need vigilance on:
existing contraindications to starting the FDC – main
concern renal dysfunction
checking of blood results
acting on abnormal results
avoiding unnecessary treatment switches
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EFV use in pregnancy
• Counsel that FDC safe to use in
pregnancy
WHO guidance based on available
data and programmatic experience:
• EFV use in early pregnancy not
associated with increased birth
defects or other significant
toxicities
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EFV use in pregnancy
• Suggestions that EFV may be clinically superior to NVP:
better long-term viral suppression
fewer adverse events
less risk of resistance
(WHO, 2012)
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Initiation of the FDC
• Common side effects: most self limiting or develop
tolerance
o somnolence/dizziness/strange dreams common, but
usually improve
o must be aware of potential renal toxicity; this will be
monitored
o FDC unlikely to cause rash
o seek attention at clinic/hospital immediately if there is
a problem
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Pregnant woman already on ART
• Check when CD4 count, and monitoring bloods last done
• Repeat CD4 count if none done in the past 6 months
• Do a VL to check if virally suppressed – if not, reinforce
adherence; repeat VL in 4-6 weeks – change to 2nd line
Rx if still raised – PLEASE CONSULT
• Safety bloods
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Routine lab monitoring
• Minimum required monitoring:
• CD4 count – baseline; 12 months post ART initiation; 6
months post cessation of ARV prophylaxis
• Creatinine – baseline; months 3, 6 and 12 post ART
initiation; then annually
• VL – at booking if already on ART; months 6 and 12 post
initiation, then annually
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Co-trimoxazole use in pregnancy
• Pregnant women eligible if:
o CD4 ≤ 350
or
o WHO stages 2, 3 or 4
o Started in the 2nd trimester
CTX stopped when 2 CD4 counts greater than 200
o Avoid initiating CTX on the same day as the FDC
o start CTX at least 1 week after initiating the FDC
o will help avoid overlapping side-effects e.g. rash
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The initially HIV- woman
• Retesting of pregnant and postpartum women who
initially test HIV-
12 weeks after a HIV negative result
by 32 weeks
6 weeks postpartum
3 monthly intervals during BF
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The initially HIV- woman
• HIV status unknown
during labour or last
negative test done at
less than 32 weeks or
more than 3 months ago
– offer repeat HIV test
intrapartum
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Intrapartum HIV+ Dx
• HIV+ Dx for the 1st time in pregnancy: sdNVP, truvada
(FTC/TDF) and 3 hourly AZT
• CD4 count and creatinine
• Counsel about starting the FDC immediately after
delivery, before discharge
• Initiate infant NVP
• Barcode on discharge summary – results to be checked
at local clinic within 7 days
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Postpartum HIV+ Dx
• If seroconverts and still breastfeeding:
o counsel, start FDC immediately if no contraindications
o CD4 count and creatinine – review with results in 7
days
o PCR test for baby same day; antibody test if more
than 18 months
o start NVP syrup for baby
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Postpartum HIV+ Dx
o Review in 1 week:
o CD4 and creatinine results; adherence to the FDC
o PCR result
• PCR positive – discontinue NVP syrup and initiate ART
• PCR negative – continue NVP syrup will need extended NVP, up to 12 weeks, or more. Mother should ideally be on the FDC or triple therapy for 12 weeks before stopping NVP syrup
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Infant prophylaxis
• All HIV-exposed infants still receive 6 weeks NVP syrup
from birth
• Extended NVP syrup if:
mother was on AZT antenatally, and on no ARVs
postpartum
FDC or triple therapy initiated late in pregnancy, or
postpartum
concerns about maternal adherence
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Extended NVP dosing
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Postpartum HIV+ Dx
• If not breastfeeding:
• Management will depend on when the breast feeding
was stopped
• Mother:
o CD4 count and results in 1 week: if CD4 ≤350 – refer
for lifelong ART
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Postpartum HIV+ Dx
• Baby:
o Do PCR test on the same day
o If there’s been exposure to BF within the past 6
weeks, initiate NVP syrup – to be given for 6 weeks;
ensure correct dose
o If no exposure in the past 6 weeks, no need to start
NVP syrup
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Postpartum HIV+ Dx
o If PCR positive, stop NVP syrup if initiated, start ART
o If PCR negative
o If no exposure to BF in the past 6 weeks, it means
that the baby is negative; repeat antibody test at
18 months
o If BF exposure in the past 6 weeks, repeat HIV test
– PCR or antibody test 6 weeks from cessation of
BF to confirm HIV Dx
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Postpartum management
• Stopping FDC prophylaxis:
o FDC prophylaxis continued until 1 week post cessation
of BF
o Assess need for lifelong ART before stopping the FDC
TB
active Hep B
stage 3 or 4 disease
CD4 count > 350
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…Making it work
• Postpartum transition from PMTCT programmes to HIV
care and treatment programmes
• Neonatal services – conflicting evidence on effect of ART
use and rate of PTL, PTD, LBW, and SGA
• Implications of long-term ARV exposure for the fetus and
infant – pharmacovigilance
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…Making it work
• Monitoring and evaluation
drug stocks – all ARVs in use
patient adherence to treatment
• Importance of counselling
Need for clear and accurate counselling messages
On-going – antenatal and postpartum
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Conclusion
Yes we can…
…Thank you