This document provides information on HIV/AIDS in India, mother-to-child transmission of HIV (MTCT), and the management of HIV-infected pregnant women. Some key points:
- An estimated 2.39 million people are living with HIV in India, with 0.9 million women infected.
- Without intervention, the rate of MTCT is 20-45%, but can be reduced to 10-1% with proper intervention.
- Triple antiretroviral therapy is recommended for all HIV-infected pregnant women in India, regardless of CD4 count, to be continued lifelong.
- Elective c-section is recommended at 38 weeks for women with high viral loads (>1000 copies/mL
2. India data:
Estimated no. of PLW HIV =2.39 million (1.93 - 3.04)
No. of women who are HIV infected =0.9 million (38%)
No. of newborns born per year = 12,900
MTCT:
Without any intervention, MTCT@ 20-45%
With intervention @10%-1%
4. In India-1/3rd of the total affected population
are rural
Classification of Indian
states
Prevalence of HIV
infection
States
High >1% in ANW Maharashtra,TN,Manipur
Karnataka,AP,Nagaland
Intermediate < 1% in ANW
>5% among HRG
Gujarat, Goa & P0ndicherry
Low < 1% in ANW
<5% among HRG
Other states
5. Timing of infection(early, late pregnancy or
labour)
Type of disease(symptomatic/asymptomatic)
Viral load,CD4 counts & immune status
Duration of ART
Genital tract infections
6. Obstetrical factors-
Prematurity, PTPROM, chorioamnionitis,
prolonged labour, operative interventions & blood
transfusion
Medical complications
Tuberculosis, Hepatitis
Route of delivery
7. Increased risk of abortion(3-6 times)
IUGR(>2times)
Preterm labour(>2times)
Still birth
Increased risk of maternal anemia & low birth
weight babies
8. HIV infection-slightly accelerated; hastens
development of AIDS
Plasma HIV1RNA-unaffected in pregnancy
but increases in postpartum period
Due to haemo-dilution, absolute CD4 count
After delivery- CD4 levels by 50-100 cells/ul
Unprotected sexual intercourse enhances the
viral load
9. Types-
a)Opt out-provider initiated counselling & testing
b)Opt in-client initiated counseling & testing
c) Pretest counselling- informed consent for testing is obtained; in case of
refusal, client is recounsiled; test report is kept confidential
d) Post test counseling-information regarding
Disease status
Therapy
Follow up
Behaviour modifications
Use of safe sex practices
Contraception
Antenatal care
Mode of delievery
Breastfeeding
10. CDC classification
- based on immunological marker
WHO classification
- based on clinical stage
11. Assesses disease severity by CD4 counts &
presence of specificAIDS related conditions
CD4 count
A
Asymp, acute
or PGL
B
Symtomatic
cond. Not A / C
C
AIDS indicator
cond
> 500 cells / micro L A 1 B 1 C 1
200-499 cells/ micro L A 2 B 2 C 2
<200 cells / micro L A 3 B 3 C 3
12. HIV-associated symptoms WHO clinical stage
Asymptomatic 1
Mild symptoms (unexpl mod wt loss, rec
URTI, rec oral ulceration)
2
Advanced symptoms(unexpl severe wt
loss, pulTB, chr diarrhoea, cervical dys, TO mass,
persistent fever,)
3
Severe symptoms (pneumocystis, CMV,
kaposi, extrapul TB, invasive Ca Cx )
4
13. Care and Assessment of HIV
Infected Pregnant Women
14. WHO clinical staging
Clinical screening forTB
Screen and treat any STIs ( Pap smear ,VDRL)
CD4 cell count (Baseline)
Additional assessments of Hb , LFTs, RFTs
should be performed when warranted by
clinical signs & symptom
Lipid profile , RBS at baseline, 6 mths & 1 yr, if
started on LPV/r based regimens
15. Avoid invasive tests(CVS, Amniocentesis)
Iron, calcium , vitamin supplementation
Folic acid intake
High protein diet
Monitor wt gain
Start on cotrimoxazole prophylactic therapy
Start on ART
17. Antenatal period- decreases maternal viral load in
blood and genital secretions
Pre exposure prophylaxis:
ARV drugs that cross the placenta from mothers to
infants and produce adequate systemic drug levels in
the infants
Post exposure prophylaxis
ARV drugs to infants after birth, provide protection
from virus that may have entered the fetal/infant
systemic circulation during labor and delivery
18. Group of ARV Name of drugs Common adverse effects
NRTI Zidovudine(ZDV)300mg od
Lamivudine(3TC) 300mg od
Tenofovir -- 300 mg od
-Nausea, vomiting, anemia
-Minimal side effects
-Nephrotoxicity
NNRTI Nevirapine(NVP)200mg od
Efavirenz(EFV) -----600 mg od
Liver dysfunction, hyp.reaction
NTDs , Neurological problems
Protease Inhibitors Lopinavir (LPV)+ Ritonavir(r)
FDC- 200mg/ 50 mg 1 tab
Dose- 2 tab bd
Hyperglycemia, diabetic
exacerbation-ketoacidosis, viral
diarrhoea, deranged liver
function- drug interactions
19. Zidovudine (300 mg) + Lamivudine (150 mg)
Tenofovir (300mg) +Lamivudine (150 mg)
Zidovudine(300 mg) +Lamivudine (150 mg)+Nevirapine
(200 mg)
Efavirenz (600 mg)
Nevirapine (200 mg)
Fixed-dose combinations (FDCs) are preferred
Easy to use
Have distribution advt (procurement and stock
management)
Better complaince & reduce drug resistance
20. NACO Dec 2013 Recommends - Lifelong
Triple drug therapy for all Pregnant and
Breastfeeding Women with HIV
irrespective of CD4 counts & clinical stage
of Disease
22. Principles for selecting the first-line
regimen
1. Choose Lamivudine in all regimens
2. Choose one NRTI Ziduvudine / Tenofovir
to combine with Lamivudine
3. Choose one NNRTI Nevirapine/ Efavirenz
23. Option B+Triple drug
therapy lifelong
Option B
ARV Prophylaxis
Triple drugs frm 14 wks
+ 1 week until BF ends
OptionA
Ziduvudine+ sd
Nevirapine+AZT& 3TC
postpartum for 1 week
24. Efavirenz has been classified as FDA Pregnancy Category D.
Because of the potential for teratogenicity, pregnancy should be avoided in women
receiving efavirenz, and treatment with efavirenz should be avoided during the first 8
weeks of pregnancy (the primary period of fetal organogenesis) whenever possible
Meta-analysis including data from 21 studies reporting on 1,437 first-trimester
exposures found no increased risk of overall birth defects in infants - giving an
incidence of 0.07% ( incidence in general US population 0.02-0.2%)
(PACTG) 219 and 219C studies -reported a higher defect rate in infants
Additional data are needed on first-trimester Efavirenz exposures to be able to more
conclusively determine if risk of neural tube defects or other malformations is
elevated.
AIDS info/ USA Guidelines march 2014
25. Until recently, most people receiving ART in resource-limited
settings have initiated NVP-based regimens
EFV has been recommended for use in pregnant women in all
trimesters of pregnancy including first trimester.
(Ford. N et. al, 2011, Ekouevi DK et.al2011, Use of Efavirenz during pregnancy: a public
health perspective, Technical update on treatment optimisation, Geneva, World Health
Organization, 2012
The use of EFV is increasing in resource-limited settings as a result
of its widespread availability as part of once-daily fixed-dose
combinations ,considerable reductions in drug price
26. Previous exposure to Single dose Nevirapine (or EFV) for
PPTCT prophylaxis in prior pregnancies, first line ART
regimen such asTDF+3TC+EFV may not be fully effective
due to development of resistance to Nevirapine/ cross
resistance with Efavirenz
Tenofovir+ Lamivudine + Efavirenz
Tenofovir+ Lamivudine + Lopinavir 2oomg / ritonavir 50 mg
27. Should continue to receive the same regimen
throughout pregnancy, labour, breast-
feeding period and thereafter life-long.
If a woman is on an EFV based regimen,
there is no need to substitute with Nevirapine
(this was done as per earlier guidelines)
28. When CD4 count is 250 cells/mm3
Continued through pregnancy, delivery and breastfeeding as per
national guidelines
Dose: Double strength tablet 1 tab daily
CPT-is helpful in reducing morbidity and mortality as it prevents
Opportunistic Infections
If CD4 count >250 for at least 6 months and If patient is on ART for
at least 6 months, is asymptomatic and well , CPT should be
stopped
Should be continued during breastfeeding when indicated
29. Labour and Delivery in the HIV
Infected Pregnant Women
30. LSCS in HIV positive pregnant women
should be performed for Obstetric
indications only
Caesarean section is not recommended for
prevention of MTCT & only if there is an
Obstetric indication for the same
NACO Dec 2013
31. Elective CS at 38 weeks gestation to minimize
perinatal transmission of HIV is recommended for
women with HIV RNA levels >1000 copies/mL or
unknown HIV levels near the time of delivery,
irrespective of administration of antepartum ART
In women with HIV RNA levels 1000 copies/mL, CS
performed for standard obstetrical indications should
be scheduled at 39 weeks gestation.
AIDS info/ USA Guidelines march 2014
32. Results from a large meta-analysis from 15
prospective cohort studies demonstrated the
benefit of Elective CS with a 50% reduction in
risk
The benefits of CS included mostly women who
were receiving either no ARVs or zidovudine
alone
Pregnant women receiving ART ( at least 3
drugs) had transmission rates of about 1%, the
benefit of is difficult to evaluate.
33. Women on life-longART should continue
their standardART regimen
In case of an emergency CS in pregnant
women who are not on ART, ensure that the
women receiveART prior to the procedure
and continues thereafter
Standard prophylactic antibiotics to be given
34. IV zidovudine should be administered to HIV-
infected women with
HIV RNA >1,000 copies/mL
Unknown HIV RNA status
Non complaince withART
IV zidovudine administration should begin 3
hours before the scheduled operative delivery
AIDS info/ USA Guidelines march 2014
35. Standard/Universal Work Precautions
ARM reserved for cases of fetal distress or delay
in progress of labour.
Minimize PVs and use aseptic techniques
Avoid invasive procedures like fetal blood
sampling, fetal scalp electrodes
Avoid instrumental delivery as much as possible
If indicated, low-cavity outlet forceps is
preferable to ventouse, as it is generally
associated with lower rates of fetal trauma than
ventouse
Avoid routine episiotomy as far as possible
36. Use of dry haemostatic techniques to minimize bleeding;
i.e. good observation and following of surgical fascial
planes during dissection, judicious use of electro-cautery
during Caesarean section etc.
Membranes are left intact until the head is delivered
through the surgical incision.
Early cord clamping
Use of round-tip blunt needles
Do not use fingers to hold the needle; Use forceps to
receive and hold
Observe good practice when transferring sharps to
surgical assistant eg. holding container for sharps the
needle
37. The decision Elective CS vsVaginal delivery must be
individualized, taking into account:
Duration of rupture or labor upon presentation( 2% risk per hour)
Plasma RNA levels
Current ARV drug regimen status
The ARV drug regimen should be continued and IV zidovudine
initiated
HIV transmission rate was similar
in women undergoing emergency
cesarean delivery and those
delivering vaginally (1.6% vs. 1.9%)
Meta-analysis of HIV-infected
women, most of whom were on
zidovudine as a single drug or
receiving no ARV medications,
demonstrated a 2% INCREASED
RISK PER HOUR
39. NACO2013
Infants should be given exclusive
breastfeeds for the first 6 mths
preferably.
Exclusive replacement feeding(ERF)
may be done only if the mother has
died or has a terminal illness or decides
not to breastfeed despite adequate
counselling
Exclusive Replacement Feeding should
be done only when AFASS criteria is
fulfilled:
A Affordable F Feasible A
Acceptable S Sustainable S Safe
In US where safe infant
feeding alternatives are
available and free for
women in need, HIV
infected women should not
breastfeed their infants.
Maternal receipt of
combination ARV regimens
is likely to reduce free virus
in the breast milk, but the
presence of cell-
associated virus
(intracellular HIV DNA)
remains unaffected and,
therefore, may continue to
pose a transmission risk
40. Risk of infant mortality due to diarrheal
and respiratory infections
Duration of maternal ART- Several weeks to months before
full viral suppression in breast milk is achieved
Reduced but potential risk of transmission of virus in breast
milk(intracellular DNA )
Development ofARV drug resistance in infants who become
infected despite prophylaxis
IN INDIA
>50 % of children <5 yr
of age Malnutrition
57 % of women of
childbearing age
Anaemia
30 % of infants being
born r underweight
41. Mixed feeding -Feeding breast-feeds and replacement feeds
simultaneously in the first 6 months is contraindicated- infant gut
mucosal injury
Mother should be receiving ART during the whole duration of
breastfeeding (ART is lifelongART for the mother)
Breast-feeding should NOT be stoppedABRUPTLY
Complementary feeding should be introduced gradually after 6 months
irrespective of whether the infant is diagnosed HIV negative or positive
BF- continued upto 1 year( Infant tested negative)
BF- continued upto 2 years ( Infant tested positive)
NACO Dec 2013
42. Infants born to HIV-infected mothers should receive NVP prophylaxis
immediately after birth(Within 1 hr of delivery)
43. It is important to do the following for infants at 6 weeks:
Do re-inforcement for EBF for the first 6 Mths (Continuation of
breastfeeds with introduction of complementary feeds thereafter)
Do Early Infant Diagnosis (EID) testing at 6 wks, 6 mths & 18 mths
Do Immunization
Do CPT initiation and continue until baby is 18 mnths old or longer
if baby is confirmed positive
Do stop NVP Prophylaxis for baby at 6 weeks (maternal ART is not
of adequate duration continue upto 12 wks)
45. Dual protection refers to simultaneous protection against both
unplanned pregnancy and STIs and HIV by using:
Condoms together with another effective method of contraception,
including emergency contraception
HIV-infected women can use all available contraceptive methods,
including hormonal contraception (e.g., pill, patch, ring, injection,
implant) and intrauterine devices (IUDs)
DMPA can be used without restriction because of its relative higher
dose and studies that have shown no significant interaction between
DMPA and ARV
Ritonavir boosted regimens- OCPs contraindicated
NVP reduces the levels of cOCPs but at present, no dosage modification
are being suggested
IUCD/ PPIUCD within 48hrs good contraceptive method
Male partner counselled for NSV( condoms to be used still)
NACO Dec 2013
46. NACO DEC 2013 AIDS info/ USA March
2014
1) When to start ART At diagnosis of HIV status
irrespective of CD4 count
Drug resistance testing
advised
If later in pregnancy ART
started promptly
2) ART Drug regimens 2NRTI-
Tenofovir+Lamivudine
1 NNRTI- Efavirenz
2 NRTI-
Tenofovir+ Lamivudine
Tenofovir+ Emtricitabine
Tenofovir+ Abacavir
PI-ritonavir boosted LPV
3) Efavirenz safety Safe
To be continued in first
trimester
Efavirenz after 8 wks
4) Mode of delivery Vaginal delivery unless
obstetrical Indication
If RNA > 1000 copies/ml
Elective CS @ 38 wks
If RNA < 1000 copies /ml
Elective CS for obs
indication only @ 39 wks
47. NACO DEC 2013 AIDS info/ USA March
2014
5) Zid0vudine during CS ---------- IV Zidovudine ( for 3 hrs)
before CS- if viral RNA
copies > 1000
6) Infant feeding EBF preferred ERF
7) Infant prophylaxis Nevirapine for 6-12 wks 4-6 weeks of zidovudine +
3 doses of nevirapine in the
first week of life
8)When to stop ART To be continued lifelong Depending upon
Pretreatment CD4 Count
RNA levels
Drug complaince
Partner status
Pt preference etc.
48. TB responsible for - 25% of all deaths among
HIV infected individuals.
Risk of activeTB - 10 times higher in HIV
ActiveTB in HIV-infected pregnant-
Risk of Maternal mortality
Prematurity
Low BirthWeight
InfantTB
Risk of HIV transmission ( MTCT) by 2.5 times
49. Evaluation forTB- History & Exam
Should be started on ART, irrespective of CD4 count
ATT should be started first, and followed by ART as soon
as feasible (usually after 2 wks)
Drug interactions:
Efavirenz preferred over Nevirapine( liver toxicity)
Those not able to tolerate EFV, a boosted PI regimen -
With Rifampicin(component of ATT) should be substituted
with Rifabutin
50. Eligibility For HIV PEP
1)Timing of initiation of prophylaxis- within 72 hrs of
exposure ( not to delayed awaiting HIV test results)
2)The persons HIV status-PEP for HIV negative individual
3) Nature and risk of exposure-mucous membrane or non
intact skin exposed to potentially infectious body fluids
4) HIV positive status of the source of potential exposure/
status not known
First line PEP:
Zidovudine( 300mg) + Lamivudine
( 150mg) (BD) for 4 wks
51. Exposure to body fluids
considered at risk
Blood
Semen
Vaginal secretions
Cerebrospinal fluid
Synovial, pleural,
peritoneal, pericardial
fluid
Amniotic fluid
Other body fluids
contaminated with visible
blood
Exposure to body fluids
considered Not at risk
(unless these secretions
contain visible blood)
Tears
sweat
Urine
faeces
saliva
52. Exposure which may place at risk of blood-borne
infection :
Percutaneous injury-needle-stick or cut with a sharp
instrument(o.3%)
Contact with the mucous membranes of the eye or mouth( 0.09%)
Contact with non-intact skin (particularly when the exposed skin is
chapped, abraded, or afflicted with dermatitis)
Contact with intact skin when the duration of contact is prolonged
(e.g. several min or more) with blood or other potentially
infectious body fluids.
53. TIMING after exposure TESTS
2-4 Weeks Hb, LFTs
6 weeks HIV antibody( ab)
3 months HIV antibody( ab)
Anti HCV
Hbsag
6 months HIV antibody( ab)
Anti HCV
Hbsag
54. PrEP- Daily- or intermittently-dosed oral or vaginally-
applied ART given to an HIV-uninfected individual in
order to prevent HIV acquisition during a high risk
sexual encounter
PrEP - More practical than post-exposure prophylaxis
(PEP) - injection drug users, commercial sex workers, or
women in serodiscordant heterosexual relationships
Microbicides- intravaginal/intrarectal topical formulations
of anti-HIV agents
Tenofovir disoproxil fumarate (or in co-formulation with
emtricitabine )