We are still using SD NVP prophylaxis even though there is enough evidence that multi-drug regimens are much better. NACO, MoHFW, Govt of India is implementing new PMTCT strategy in Delhi in 2013-14 which will eliminate Pediatric HIV infections in the coming years.The presentation highlights key features of the New PMTCT Strategy of the country.

1. Revised Guidelines for PMTCT and Infant Feeding in
the Context of HIV
Presented
BY
DR. A. K. GUPTA MD(PEDIATRICS)
Additional Project Director
Delhi State AIDS Control Society
Govt of Delhi

2. “We have effective drugs.
There is no reason why any mother
should die of AIDS.
There is no cause for any child to be
born with HIV
If we work hard enough we can
virtually eliminate mother-to-child
transmission.”

3. Risk of Mother-to-Child
HIV Transmission
Background transmission risk: 15-45%
15-30% Risk during pregnancy and delivery
10-20% Additional risk postpartum via breastfeeding
35% Average risk without any intervention
Transmission risk with interventions:
19.8% Sd NVP to MB Pair ( Study by DSACS)
<5% 2010 interventions, BF
<2% 2010 interventions, no BF

4. ANC HIV prevalence HSS
0.31 0.3
0.2 0.2
0.1
2005 2006 2007 2008-09 2010-11
ANC

5. TREND OF ICTC ANC POSITIVITY RATE IN NACP III
250000 0.25
0.23 0.23 0.23
200000 0.20 0.20
0.17 0.17
150000 0.15
100000 0.10
50000 0.05
0 0.00
2007-08 2008-09 2009-10 2010-11 2011-12 UPTO DEC 2012
PRE TEST 82673 152894 176062 166704 208728 159727
TEST 72469 146469 170941 161043 204241 154494
POST TEST 60077 137381 162971 151294 190870 146839
POSITIVE 167 334 386 329 356 258
MB PAIR 81 162 228 222 224 234
% POSIVIVE 0.23 0.23 0.23 0.20 0.17 0.17

6. PMTCT & Early Infant Diagnosis programme
(April 11 -Dec’ 12)
Total Number of ANC Screened for HIV 154494
Total Number of ANC Detected Positive for HIV 258 (0.17%)
Total Number of HIV Positive ANC Delivered 232 (90%)
Total no. of ANC registered at ARTC 229 (89%)
Total Number of CD4 done in registered ANC 217 (95%)
Total Number of ANC eligible for ART (CD4 <=350) 100 (46%)
Total Number of ANC initiated on ART 82 (82%)
DBS Test done in HIV exposed infants 237
DBS HIV-1 DNA Positive 30 (12.7%)
DBS HIV-1 DNA Negative 186 (78.5%)
DBS Report Awaited 21
No. of DBS positive infants tested by WB HIV-1 DNA PCR 28 (93%)
WB DNA PCR Positive 19 (68%)
WB DNA PCR Negative ie false positive DBS tests 9
Number of HIV Infected Infant started on ART 17 ( 90%)

8. The 2010 revised PMTCT recommendations
are based on two key approaches
:
1. Lifelong ART for HIV-infected women in
need of treatment for their own health, which
is also safe and effective in reducing MTCT-
CD4 ≤ 350 ( 40% PW)
2. ARV prophylaxis to prevent MTCT during
pregnancy, delivery and breastfeeding for HIV-
infected women not in need of treatment-
CD4 > 350 (60% PW)

9. WHY ART to Pregnant Women with CD4 <350?
9
• MTCT risk: > 75%
• Account for >80% of postpartum transmission
(BF)
• Account for 85% of maternal deaths within 2
years of delivery
• Strong benefit from initiating ART for maternal
health and PMTCT during pregnancy, labour
and delivery and breastfeeding

10. 1. When is ART indicated In pregnant women with confirmed HIV infection
Indicated for all women with CD4 cell counts of ≤350 cells/mm ,
irrespective of the WHO clinical staging, and for all women in WHO clinical
stage 3 or 4, irrespective of the CD4 cell count.
2. When to start ART in pregnancy
HIV-infected pregnant women in need of ART for their own health should
start ART as soon as feasible regardless of gestational age
3. What ART regimen to initiate
In pregnant women in need of ART for their own health the preferred first-
line ART regimen is AZT + 3TC + NVP /or EFV . Alternative recommended
regimens are TDF + 3TC + EFV/ or NVP. Avoid the use of EFV in the first
trimester and use NVP instead.
4. What ARV prophylaxis to give infants of HIV-infected women receiving
ART
All HIV exposed infants (regardless of whether breastfeeding or receiving
only replacement feeding) should be given daily NVP from birth or as soon
as feasible thereafter until 6 weeks of age.

11. 1. Pregnant Women Eligible for ART (CD4<350)
Should be initiated on lifelong ART as soon as possible
ART Regimens
1st Line
Preferred AZT 300 mg BD+3TC 150 mg BD +NVP 200 BD (or
EFV 600 mg OD)
Alternative TDF 300 mg OD +3TC 150 mg BD+NVP 200 mg
BD(or EFV 600 mg OD)
If anemic (Hb<8 Gm/L), replace the AZT-containing regimen with TDF (10%
cases) .
If 1st trimester, do not use EFV-containing regimen: Use NVP
Baby receives daily NVP for 6 weeks after birth

12. 2. ARV Prophylaxis to PW (CD4 > 350)
Option-B WHO PMTCT Guideline of adapted by NACO
ARV Prophylaxis Ante-partum Intra-partum Post-partum
and dosing
TDF 300mg once Start at 14 Continue • Continue triple ARV
daily + weeks or as triple ARV prophylaxis until 1
3TC 300 mg once soon as prophylaxis week after all infant
daily + possible exposure to breast
EFV 600mg once thereafter milk has ended
daily

13. Infant ARV Prophylaxis with NVP
• 15 mg once daily (if birth weight
>2500 g) or
• 10mg once daily (if birth weight
≤2500 g) from birth until 4 to 6
weeks of age

14. ARV prophylaxis for women presenting directly in labour
• Start Triple ARV Prophylaxis (same as option
B) to all HIV positive PW presenting directly in
labour
• Continue prophylaxis postpartum throughout
breast feeding until 1 week after BF is
stopped
• Do CD4 count at the earliest to assess
eligibility for lifelong treatment
• Infant is given NVP once daily for 6 weeks.

15. Increased NVP Hepatotoxicity in
women with higher CD4 counts
1. CD4 > 350- NVP is not recommended in such
women
2. CD4 250-350: There may or may not be an
increased risk of hepatotoxicity, benefits of
using NVP outweigh the risks of not initiating
ART, Close clinical /Lab monitoring during
the first 12 weeks of therapy in women with a
CD4 cell count of 250 to 350 cells/mm

16. Potential Teratogenicity of EFV-
EFV rarely can cause neural tube defects.
Potential risk (probably <1%) of neural tube defect with
use of EFV in first month of pregnancy (before 6 weeks of
gestation)
Neural tube closure occurs by approximately 28 days of
gestation and very few pregnancies are recognized by this
time, the potential risk with the use of EFV is primarily in
women who become pregnant while already receiving the
drug.
EFV should not be initiated in the first trimester of
pregnancy but may be initiated in the second and third
trimesters.

17. Toxicity of TDF
• Risk of Nephro-toxicity with use of TDF
• Limited data available on potential for
maternal and infant bone toxicity

18. PI Inhibitors in cases of Sd NVP
Exposure
LPV/r-based regimen is recommended
for women who require ART for their
own health who have received SdNVP
within 12 months of initiating ART.
This regimen is available only at COE,
MAMC.

19. Women receiving ART
and planning to become pregnant
• Fully suppressive ART before conception and
that it be maintained during pregnancy, labour,
delivery and breastfeeding.
• Preferred ART regimens in such situations
should have minimal teratogenic potentials for
infants (does not include EFV in first 28 days of
gestation)
• For women receiving an EFV-based regimen and
who plan to become pregnant, substitution of
NVP in the place of EFV for at least the peri-
conception period

20. Women receiving ART who become
pregnant
• If a Woman receiving EFV is recognized as
pregnant before 28 days of gestation, EFV
should be stopped and substituted with NVP
or a PI.
• If a woman is diagnosed as pregnant after 28
days of gestation, EFV should be continued.
• There is no indication for abortion in women
exposed to EFV in the first trimester of
pregnancy

21. Clinical and laboratory monitoring of pregnant women receiving
ARV
prophylaxis and their infants
• CD4 cell counts X every 6 months
• Clinical and laboratory monitoring of adverse
reactions related to the antiretroviral drugs
should be based on the potential adverse
reactions of the drugs use

22. Women with HIV-2 infection
• Testing for both HIV-1 and HIV-2 before initiating a PMTCT ARV intervention.
• HIV-2 may also progress to AIDS, although progression is generally much
slower
• HIV-2 has the same modes of transmission as HIV-1 but has been shown to
be much less transmissible from mother to child (transmission risk 0−4%).
• NNRTI drugs, such as NVP and EFV are not effective against HIV-2
• First-line ART regimen for women who are infected with HIV-2 alone-and
eligible for treatment (based on the same eligibility criteria as for HIV-1)- AZT
+ 3TC + ABC)
• ARV Prophylaxis- Pregnant women living with HIV-2 alone who are not
eligible for treatment for their own health should receive an ARV prophylaxis
intervention consisting of AZT from 14 weeks of pregnancy (or as soon
thereafter as possible) and continuing during labour and delivery. This
maternal intervention should be coupled with twice-daily AZT given to infants
from birth until 4 to 6 weeks of age. In

23. Women with active tuberculosis
• HIV-infected pregnant women with active TB should start
ART, irrespective of the CD4 cell count.
• The TB treatment should be started first, and followed by
ART as soon as clinically possible ( between rifampicin and
some of the antiretroviral drugs (i.e. the boosted protease
inhibitors)
• As for all adults, EFV is the preferred NNRTI for HIV/TB co-
infected pregnant women (starting after the first trimester).
• For those HIV/TB coinfected women not able to tolerate EFV,
an NVP-based regimen or a triple NRTI regimen (e.g. AZT +
3TC + ABC or AZT + 3TC + TDF) can be used.

24. Adverse Effects
• Nevirapine- Nevirapine is associated with
systemic symptoms (e.g. nausea, vomiting,
malaise, fatigue, anorexia, jaundice, liver
tenderness and hepatomegaly) ,increases in
hepatic transaminase enzymes and skin rash,
mainly in the first 18 weeks after starting
treatment.
NVP-related rash and hepatotoxicity can be life-
threatening, particularly among pregnant women
with CD4 counts of >250 cells/mm

25. • Efavirenz: EFV is primarily associated with toxicities
related to the central nervous system (CNS), rash and
possible Teratogenicity (if taken during the first
trimester of pregnancy). The rash is generally mild and
self-resolving and usually does not require
discontinuation of therapy.
The CNS symptoms are common. While they typically
resolve after 2 to 4 weeks, they can persist for months
and require discontinuation of the drug.
EFV should be avoided in
(i) Patients with a history of psychiatric illness,
(ii) When there is a potential for pregnancy (unless
effective contraception can be assured) and
(iii) During the first trimester of pregnancy

26. • LPV/r- The most frequent side-effects of LPV/r
consist of
- Weakness, headache and moderate digestive-
disorders (diarrhoea, nausea, abdominal pain,
vomiting),
- Fat mal-distribution and Dyslipidaemia
- Pancreatitis, Hepatotoxicity
• TDF- Nephrotoxicity, Fetal Bone defect and
LBW

27. The counseling messages given to mothers
during antenatal changes with the new
guidelines
In the new guidelines (2010):
HIV+ mothers are strongly encouraged to breastfeed their
exposed infants for 12 months while on ARV’s
Exclusive BF until 6 months, complementary from 6-12 months
Breastfeeding is no longer Just “necessary” but “critical”
because of the nutritional need and because ARV prophylaxis
now limits the risk of transmission
However, if the mother still prefers to replacement feed after
counseling, she can do so if AFASS criteria is met

28. Implementation Challenges
Successful implementation of the new guidelines depends on:
• Scale up HIV testing and counseling for pregnant women
• Availability of CD4 testing and ARVs at ANC/ICTC/PPTCT level
• Integration of PMTCT and MCH; PMTCT and ART
• Improved follow-up of pregnant women antenatally and of
mothers and HIV-exposed infants after birth
• Ability to provide prophylaxis to the mother or baby throughout
breastfeeding
• Health systems strengthening
• Enhanced M&E, including impact assessment

29. Existing facilities in Delhi
• ANC Testing Sites (PPTCTs/ICTCs)- 46
• CD4 Testing labs- 5 (NICD, AIIMS, SJH, MAMC,
RML)
• ART centres-9 (8 for PPTCT programme, except
ARTC LRS Institute)
• EID Test Lab for DNA-PCR testing-1 (AIIMS, New
Delhi)
• EID sample collection sites- 27 ICTCs
• Whole Blood Collection for DNA-PCR sites (ART
centers)- 7
Dr.A.K.Gupta,New Delhi

30. Profile of Existing ANC Testing Sites as per HIV Positive
ANC Client Load/ Annuum
• >20 - 4 sites (BSAH, LHMC, SJH, SGMH )
• 10-19- 8 sites (GTBH, SDNH, Kasturba, DDU,LBS,
LNH, RML,BJRM)
• 5-9- 13 sites (AIIMS, GGSH, Hindu Rao, DHAS, Rest
all- 5 clients: JPCH, BMH, PMM Malviya Ngr, Rao
Tularam, SGMH, SRHC Narela, MCWC Madipur, DAD
Ashok Vihar, DAD Khajuri Khas)
• 1-<5 – 26 sites
• 0 -22 sites
Dr.A.K.Gupta,New Delhi

31. Setting up F-ICTCs at 50 ANC
sites through ANMs
DSACS trained 572 ANMs in Feb- March 12 on whole blood single prick test
for screening of Pregnant women, for tracking of HIV positive women and
HIV exposed infants.
In Nov’12, 74 ANMs were given refresher hands on training on WB HIV
screening test and provided test kits and reporting formats and IEC
material.
These FICTCs are placed in Govt. dispensaries where no ICTC center was
functioning nearby.
After screening, the suspected HIV positive ANC will be linked to nearest
ICTC for confirmatory testing.
It is expected that these centers will cover an additional number of 11000
ANC per year besides improving referral linkages of ICTCs with ARTCs.
In addition to above 50 FICTs, one at Naraina Maternity Home is also doing
HIV screening of ANC.

32. CD4 Testing –Revised Strategy
CD4 sample is now drawn at ICTC/PPTCTC for testing
directly at NCDC (except ICTC/PPTCTCs with CD4 Labs
who will send sample to their labs)
No prior ART registration is done to:
1. Save time &
2. Segregate HIV positive ANC with CD4 < 350 & > 350
to prioritize further action of ART or ARV prophylaxis.
ART will be started at nearest ART centre &
ARV prophylaxis will be given at PPTCTC/ICTC.

33. PMTCT software
PPTCT software has been installed at all
45 ICTC/ PPTCT centers catering to ANC
which will be useful to track mother and
her baby till EID enrollment & up to 18
months.

35. Mainstreaming Pvt. Sector
Assessment of 100 leading Private hospital
on PMTCT Programme through survey is
being undertaken in March-April 2013 to
help in mainstreaming National PMTCT
Protocol in Pvt Sector of Delhi during 2013-
14 and setting up PPP ICTCs.

36. ANC Target 2013-14
• 2,75,000 ANC to be counseled &
tested
• 500 ANC HIV +ve expected
• ANC Expected ARV Prophylaxis
(Option B) - 60% with CD4 Count >
350= 300
• ANC expected eligible for ART-40%=
200
Dr.A.K.Gupta,New Delhi

37. Sites of Emergency Labour Room Testing-75
sites
• Hospitals – 37 (Delhi Govt- 21,
DGHS/GOI Hospitals-3, AIIMS, ESI-4, Rly-
2, Army-3, MCD -4)- ICTC services
available in all hospitals
• Maternity homes- 37 (33-MCD, 2-
NDMC, CGHS-2)- ICTC services available
in 11/37.
• RHTC, Nazafgarh- ICTC services
available.
Dr.A.K.Gupta,New Delhi

38. Nominations TOT for Master Trainers
• 4 days training programme by NACO in Delhi
in April-May 2013
• Regional TOT Master Trainers (PPTCT)
(a) Doctors (O&G )-30
(b) Paramedical staff (ANMs, Counselors, Staff nurses)-
30
• Slot for 10 O&G M.O./ specialists available
Dr.A.K.Gupta,New Delhi