The updated PMTCT

guidelines

Mopani symposium

May 2013

Presented by CN Mnyani

Outline

• What are the updated PMTCT

guidelines?

• Why the new guidelines?

• Implications of the new

guidelines

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

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

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.)

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

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

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

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

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

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

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

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

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

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

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

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

Use of AZT

• If in doubt, start AZT…

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

Extended NVP dosing

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

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

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

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

…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

…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

Conclusion

Yes we can…

…Thank you