Transcript Slide 1

HIV, conception,
pregnancy and
contraception
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Contents
Introduction
Un/planned pregnancy
Vertical transmission (MTCT)
Treatment and care during pregnancy and after childbirth
Routine testing during pregnancy
The need for further research
Case studies
2
Introduction
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Women with HIV are an important
but under recognised group
• In 2009 an estimated 33.3 million people were living
with HIV
• 16.5 million of these were women
• Most of these are of childbearing potential
• Over 3.28 million women with HIV give birth each
year
• An estimated 370,000 children were infected with
HIV in 2009 - most through vertical transmission
4
UNAIDS, 2010
Prevalence of HIV among pregnant
women in Europe and North America
Country
Prevalence (%)
Estonia1
0.48
Ukraine1
0.34
Ireland1
0.31
Belarus, Latvia, Romania, Russian
Federation, Spain, UK1
0.1–0.22
Germany, Italy, Sweden, Poland, Norway1
Canada2,3
<0.1
0.033–0.037
Bulgaria, Czech Republic, Finland, Lithuania,
Serbia and Montenegro, Slovakia, Slovenia1
<0.03
Higher pockets of HIV prevalence among pregnant women have been reported in several
countries e.g. in parts of Ukraine and in and around London in the UK
5
1. Downs et al. IAS 2006;
2. Jayaraman et al. Can Med Assoc J 2003;
3. Remis et al. Can J Infect Dis 2003
Pregnancy – planned and unplanned
•
Preparing for the possibility of pregnancy,
whether planned or unplanned, is an
important component of care
•
With access to optimal management, giving
birth to a healthy, HIV negative baby is
possible for the vast majority of women of
childbearing age
6
Planning for pregnancy:
Considerations
What happens if my baby is HIV+? When will I know?
How do I get pregnant without infecting my partner?
Will my healthcare workers treat me differently?
What is the risk that I will infect my partner?
?
What is the risk of my baby being infected?
Will I survive to see my children grow up?
Will the treatment harm me or my baby?
Should I bottle-or breastfeed my baby?
Will pregnancy make my HIV worse?
Do I have to have a caesarean?
7
Un/planned pregnancy
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Unplanned pregnancy
•
Up to 85% of pregnancies in HIV+ women
reported as ‘unplanned’1,2
•
Risk factors for unplanned pregnancy
similar to those for HIV3:
~
~
~
~
substance abuse (the woman or her partner)
mental illness
domestic violence
frequent unstable sexual relationships and
unsafe sexual practices in adolescents
9
1. Loutfy et al. HIV Med 2012;
2. Sutton et al. CROI 2012;
3. Koenig et al. Am J Obstet Gynecol 2007
Planning for unplanned pregnancies
Anticipate the possibility of
pregnancy in all HIV+
women of childbearing
potential
Consult guidelines and
consider effective ART
regimens that need
minimal modification if
pregnancy occurs
10
Pregnancy intention and desire
•
Research has shown that people living with HIV
face 3 key decisions – disclosure, adherence to
ART and desire for parenthood1
•
Factors positively influencing the desire and
intention to have children include:2,3
~
~
~
~
~
~
~
Younger age
Previous children and number of living children
Access to PMTCT and ART programs
Individual perception of current health status
Spousal, family’s and society’s expectations
Fear of stigmatisation
Ethnicity
11
1. Bravo et al. AIDS Rev 2010;
2. Nattabi et al. AIDS Behav 2009;
3. Loutfy et al. PLoS ONE 2009
Routine reproductive counselling for
women with HIV is important
•
In a survey of 700 women with HIV, 22%
became pregnant after HIV diagnosis
~ 58% of these never discussed pregnancy or
treatment options before pregnancy
~ 42% had limited/no knowledge of ART options
during early pregnancy
•
Among women considering pregnancy, or
pregnant at the time of HIV diagnosis
~ 48% were never asked by a HCP if they had or
were considering having children
12
Squires et al. AIDS Patient Care & STDs 2011
Routine reproductive counselling for
women with HIV is important
•
In a cross-sectional survey of 181 women living
with HIV age (15-44 years) and receiving
clinical care at two urban health clinics (USA)
~ 67% reported a general discussion about pregnancy
and HIV1
~ 31% reported a personalised discussion about future
childbearing plans with their provider, of which 64%
were patient initiated1
~ Unmet reproductive counselling needs were higher
for personalised discussions about future
pregnancies (56%) than general discussions about
HIV and pregnancy (23%)1
~ Accurate knowledge of vertical transmission (MTCT)
was low (15%)2
13
1. Finocchario-Kessler et al. AIDS Patient Care STDS. 2010;
2. Finocchario-Kessler et al. AIDS Behav 2010
What is reproductive counselling?
Advice, education, and discussion on:
•
Effective contraception
•
•
Maternal reproductive health
issues
Long-term health of mother and
ability to care for children
•
Healthy pre-conception planning to
reduce horizontal transmission
Importance of early and intense
antenatal care
•
Use of ARTs and other drugs in
pregnancy
•
Stigma and fears
•
Mental health preparation
•
Psychosocial issues, postpartum
impact on adherence and
outpatient visits
•
Other STIs
•
•
Safe conception
•
Reproductive options – risks,
costs and success rates
•
Impact of HIV on pregnancy
•
Impact of pregnancy on HIV
•
Vertical transmission
•
Should involve a two way interaction to explore coping, decisionmaking, emotional reactions and to plan/prepare
•
Should involve partners and be culturally relevant
14
Pre-conception counselling: a risk
reduction strategy
•
Optimise HIV management
•
Choice of ART
•
•
•
•
Stop unprotected sex as soon
as pregnant
•
Screen for and treat
sexually transmitted
infections
Avoid genital tract irritant
•
Reproductive options –
risks, costs and success
rates
Refer for assessment if
unsuccessful after 3-12
months (earlier if >35 years)
•
Possibility of treatment failure
and ability to care for child
•
Encourage sexual partners to
receive HIV testing,
counselling and care
Sex only when woman is in
fertile period of her cycle
15
The importance of the patient–HCP
relationship
Help women
to cope with HIVrelated
challenges
Empower women
to be active partners
in their own healthcare
\
Support
Positive relationship
between patient and HCP
Open, two-way,
effective
communication
Trust
Respect
Compassion
16
The role of a partner
•
•
Seroconversion in pregnant women due to
transmission from HIV positive male partners
remains a risk1
In men diagnosed with HIV, the desire to have a
family is high2,3
~ Despite this, interventions aimed at involving males in
family planning are often limited, with little planning and
provision for male treatment and care2
•
The support of a partner during pregnancy and in
the postpartum period may improve health
outcomes for mothers and children4
~ However, this must be assessed on an individual basis
17
1. Dhairyawan et al. Sex Transm Infect 2012;
2. Sherr & Croome J Int AIDS Soc 2012;
3. Sherr J Int AIDS Soc 2010;
4. Maman et al. J Midwifery Womens Health 2011
Conception planning: Prevention of
horizontal transmission
•
Different clinical scenarios
~ HIV+ man and HIV- woman (serodifferent)
~ HIV+ woman with HIV- man (serodifferent) or who is single or
in same sex relationship
~ HIV+ man and HIV+ woman
•
Different scenarios have different risk and require
different strategies to prevent horizontal transmission
18
Reproductive options
HIV+ man & HIV- woman
•
•
•
•
•
IUI, IVF or ICSI following sperm washing
Natural conception (if effective viral suppression)
Insemination of donor sperm at ovulation
Pre-Exposure Prophylaxis (PrEP)
Adoption
HIV+ woman & HIV- man
• Insemination of partner’s sperm at ovulation (if not on ART / detectable
viral load)
• Natural conception (if effective viral suppression)
• Assisted reproduction in case of fertility disorders
• Adoption
HIV+ man & woman
• Insemination of donor sperm or sperm washing to prevent
superinfection
• Natural conception
• Assisted reproduction in case of
19 fertility disorders
Pre-Exposure Prophylaxis (PrEP)
•
•
•
Pre-exposure prophylaxis (PrEP) aims to prevent transmission of
HIV through use of ART before potential exposure to HIV
Several clinical trials of topical1,2 and oral PrEP2-4 in
serodiscordant couples (where the partner with HIV is not
receiving ART) have been completed ,with other trials underway
PrEP may have the potential to contribute to effective and safe
HIV prevention if it is:
• targeted to a population at high risk of HIV
• delivered as part of a comprehensive set of prevention services, including riskreduction strategies and medication adherence counselling, access to
condoms, and treatment of STIs
• accompanied by regular monitoring of HIV status, side effects, adherence, and
risk behaviours
1. Abdool-Karim et al. Science 2010; 2. VOICE, Available at:
http://www.mtnstopshiv.org/news/studies/mtn003;
3. Baeten & Celum IAS 2011; 4. Thigpen et al. IAS 2011
Pre-Exposure Prophylaxis (PrEP)
•
A body of evidence suggests that fully suppressive
HAART has virtually eliminated the risk of sexual
transmission of HIV1
~ No cases of transmission under stable HAART have been
published2,3
~ Despite this, serodiscordant couples often strongly
overestimate the risk of transmission4
•
Risk reduction using timed intercourse and PrEP
have been shown to be effective in reducing the
already very low residual risk of transmission4
21
1. Vernazza et al. Bull Med Suisses 2008;
2. Stürmer et al. Antivir Ther 2008;
3. Vernazza et al. Antivir Ther 2008;
4. Vernazza et al. AIDS 2011
HIV and fertility
•
Evidence that women with HIV have higher
incidence of fertility disorders
• Fertility assistance has important ethical
and practical implications for patients and
professionals
• Fertility treatment options
~ IUI (+/- sperm washing)
~ Donor insemination
•
~ IVF
~ ICSI
Limited data on IVF/ICSI success
~ Pregnancy rate substantially lower in HIV+
women
IUI=intra-uterine insemination; IVF=in vitro fertilisation;
ICSI=intracytoplasmic sperm injection
22
Access to assisted reproduction
options in HIV
Privately / self
funded
Publically funded
Is adoption an
option?
Guidelines?
Yes
Available in a limited
number of centres
Yes, challenging

Available across the
country
Available in a limited
number of centres
Yes, challenging

Since Jan 2011
Available prior to 2011
Not permitted

Available
Available in some areas
Yes, challenging

Offered by few
clinics, private only
Not available
Yes, challenging

Not available
Available but not in all
clinics
Yes

Germany
50% covered by
health insurance
Yes, ~20 clinics
Yes, challenging

Italy
In a few centres
Available in a few centres
Yes

70% covered by IVF
Fund
Yes
Yes

Portugal
Spain
Denmark
UK
Romania
France
Austria
The ideal contraceptive
•
Reliable
•
Safe
•
Convenient
•
Reversible
•
Prevent transmission of HIV
•
Not interfere with HAART
•
Affordable
. . . . currently means it must involve condoms
24
Contraception options in HIV
Method
Condoms
(male and female)
Advantages
• STI/HIV protection
• Pregnancy prevention = 85%
male; 79% female
OCPs
• Effective
• Less blood loss
• Pregnancy prevention = 92%
Patch, ring,
combo injectable
• Effective
• Less blood loss
• Pregnancy prevention = 92%
DMPA
• Low maintenance
• Effective
• Pregnancy prevention = 97%
IUD
• Low maintenance
• Effective
• Pregnancy prevention = 99.2%
Cervical barrier
• Reusable/low cost
• Pregnancy prevention = 84%
Sterilisation
• Low maintenance
• Effective
• Pregnancy prevention = 99.5%
Disadvantages
• Cooperation needed
• Correct technique
• Inconvenient / may interfere
with sexual intercourse
• Drug-drug interactions
• Possibly  viral shedding
• No STI/HIV protection
• Drug-drug interactions?
• Lack of data
•  shedding?
• No STI/HIV protection
• Possible increased risk of HIV
acquisition
• No STI/HIV protection
• Blood loss with Copper T
• Possible  risk of HIV
acquisition
•  pelvic infection
• No STI/HIV protection
•  Urinary tract infections
• Requires correct technique
• Unproven HIV/STI protection
• Irreversible, invasive
• Cost
• No STI/HIV protection
1. Mostad et al. Lancet 1997; 2. Trussell, Contraceptive Technology 2007; 3. Wang et al. AIDS 2004
Hormonal contraception and HIV
acquisition
•
It has been suggested that women using
progesterone-only injectable contraception
may be at increased risk of HIV acquisition
• WHO (2012) highlight that due to the
inconclusive nature of these studies women
should always use dual protection with
a condom
• Further research is required in this area
26
WHO, 2012
Vertical transmission
(MTCT)
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Vertical transmission (MTCT)
•
HIV can be transmitted from mother to child
at various stages of pregnancy and
motherhood:
During gestation1
During labour and delivery2-5
Breast-feeding6-9
1. Connor et al. N Engl J Med 1994; 2. Kind et al. AIDS 1998;
3. Read et al. N Engl J Med 1999; 4. Parazzini et al. Lancet 1999;
5. Shapiro et al. CROI 2002; 6. Dunn et al. Lancet 1992;
7. Nduati et al. JAMA 2000; 8. Coutsoudis et al. JID 2004; 9. Coutsoudis et al. Lancet 1999
Minimising the risk of MTCT
Without optimal therapy and prevention the risk of
transmitting HIV from a mother to a baby ranges
from about 12-45%, depending on the setting and
individual circumstances
The risk of vertical transmission drops to less than
1% with optimal intervention
29
Trends in reduction of vertical
transmission
% mother-to-child-transmission
35
30
25
20
15
10
5
0
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
USA and Europe
Thailand
Africa
30
McIntyre et al. CROI 2005
Factors influencing perinatal vertical
transmission
Maternal factors
Obstetric factors
• Lack of awareness of HIV status
• HIV-1 RNA levels
• Low CD4 lymphocyte count
• Other infections e.g. hepatitis C,
CMV, bacterial vaginosis
• Maternal injection drug use
• Length of ruptured foetal
membranes (ROM)
• Chorio-amnionitis
• Vaginal delivery
• Invasive procedures
• No or inadequate antenatal care
• Lack of ART prophylaxis
• Non-adherence to ART
Infant factors
• Prematurity
• Sex of infant?
• Low birthweight
31
Reducing vertical transmission:
Issues to address
•
HIV infection among women of childbearing
potential
•
Unplanned pregnancy among women with
HIV
•
Transmission during pregnancy, labour and
delivery, and breastfeeding
32
Interventions to reduce vertical
transmission
Exclusive
formula
feeding
Caesarean
section
ARTs
Antenatal HIV
testing and
counselling
Avoid
procedures
during
delivery
Antenatal care
Reduced
MTCT
33
Infection
prevention
practices
The Mma Bana Study: Background
•
•
The Mma Bana study examined the efficacy of
different HAART regimens for prevention of
MTCT during pregnancy and breastfeeding
Study participants were randomised to one of
two treatment groups:
~ Abacavir / zidovudine / lamivudine (NRTI group)
~ Lopinavir/ritonavir plus zidovudine/lamivudine
(PI- group)
•
•
The control group received
zidovudine/lamivudine plus nevirapine
Treatment lasted from 26 to 34 weeks’
gestation through to 6 months post partum
34
Shapiro et al. N Engl J Med 2010
The Mma Bana Study: Low rate of
MTCT with HAART
HIV Infections
among live-born
1% overall
infants, n (%)
NRTI group
(ZDV/3TC/ABC)
PI group
Control group
(ZDV/3TC +
(ZDV/3TC +
transmission through
6
months
LPV/r)
NVP)
~ 95% CI for overall
MTCT rate
0.5% to 2.0%
[n = 283]
[n = 270]
[n = 156]
3 (1.1)*§
1 (0.4)
1 (0.6)
0
0
0
Breastfeeding
2 (0.7%)
0
0
Total at 6 months
5 (1.8)*
1 (0.4)
1 (0.6)
In utero
Intrapartum
•
•
•
All regimens of HAART from pregnancy through 6 months post partum
resulted in high rates of virologic suppression
No significant difference in the likelihood of MTCT between treatments
The overall rate of MTCT was just 1.1%
*P = NS for difference in between randomised arms; §Result doesn’t include in an infant
35
who died without a confirmed AIDS-defining cause after a positive PCR result at birth;
Shapiro et al. N Engl J Med 2010
Treatment and care
during pregnancy and
childbirth
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Individualising care
Socio-economic
class
Age
Family issues
Sexual issues
Medical history
Pregnancy
Stage of
HIV journey
HIV care should vary
Support
depending on the unique needs
and personal circumstances
of each woman . . .
Immigration
Violence
or sexual abuse
Culture
or religion
Child-bearing
potential
Acceptance
of diagnosis
37
Co-morbid problems
(e.g. alcoholism, drug use,
depression)
Language and
understanding
Individualising care
. . . and consider women in their
social context
e.g. as a mother, a partner,
a daughter, a caregiver
38
Antenatal care and HIV
Offer essential
health advice
about nutrition
and the
dangers of
substance use
Counsel
pregnant
women about
HIV risk
Offer
continued
advice about
safe sex
Antenatal
care
provides an
opportunity
to...
Provide
information on
peer support
networks
Offer HIV
testing
Advise about
other STIs and
general sexual
and
reproductive
health
WHO, 1998
Tests in pregnancy
Other infectious
diseases
HIV related
• Plasma HIV RNA viral load
• Biochemistry and complete
blood count (CD4 cell
count)
• Antiviral drug resistance
testing
• Therapeutic drug
monitoring (Physiological
changes during pregnancy
can affect drug
pharmacokinetics)
•
•
•
•
Tuberculin test
Hepatitis B testing
Hepatitis C testing
PAP smear and HPV
screening
• Urine and vaginal cultures
• Pregnancy diabetes
screening
• TORCH
40
HIV drug resistance testing is
recommended
•
HIV drug-resistance studies should be performed
before starting or modifying ARV regimens in:
~ All pregnant women whose HIV RNA levels are above the
threshold for resistance testing (that is >500–1,000
copies/mL) prior to initiation of ARVs
~ For those entering pregnancy with detectable HIV RNA
levels while receiving ARV therapy, or who have
suboptimal viral suppression after starting ARVs during
pregnancy
•
In order to prevent perinatal transmission, and
ensure maternal health, women who present late in
pregnancy should initiate empiric ARV without
waiting for the results of resistance testing and
adjust as needed after test results are available
41
DHHS, 2012
Goals of treatment in pregnancy
Optimal
maternal
health
Minimise
maternal
sideeffects
Reduce the risk
of vertical
transmission
Minimise
risk to the
infant
42
What do the treatment guidelines
recommend?
•
Summary of UK (BHIVA), WHO and USA (DHHS)
guidelines for initiating therapy in women who wish
to become pregnant:
•
Boosted protease inhibitors
are preferred
•
Nevirapine
as an alternative
•
Efavirenz
not preferred during preconception or for
first 6 weeks of pregnancy
European (EACS) guidelines for
ART-naïve individuals
•
ART regimen used in pregnant women
starting ART is the same as in nonpregnant women, except:
~ Avoid EFV, ddI + d4T and triple NRTI
combinations
~ NVP not to be initiated (continuation possible if
started before pregnancy)
~ Use LPVr or SQV/r as preferred PI/r
~ ZDV should be part of the regimen if possible
~ Little data are available for RAL and DRV/r in
pregnancy
44
EACS, 2011
General guidelines: HIV treatment in
pregnancy
Pregnancy Scenario
EACS1
DHHS2
1. Women becoming pregnant
while already on ART
Maintain ART but switch drugs that are potentially
teratogenic
2. Women becoming pregnant
while treatment naïve and
who fulfill the criteria (CD4)
for initiation of ART
Start ART - at start of 2nd
trimester is optimal
Start ART
3. Women becoming pregnant
while treatment naïve and
who do not fulfill the criteria
(CD4) for initiation of ART
Start ART at start of W28 of
pregnancy (at the latest 12
weeks before delivery); start
earlier if high plasma viral load
or risk of prematurity
Start ART – may
delay depending on
CD4-cell count, HIV
RNA levels and
maternal conditions
such as nausea and
vomiting, but must
start no later than
12 weeks
4. Women whose follow up
starts after W28 of
pregnancy
Start ART immediately
All cases of antiretroviral drug exposure during pregnancy should be reported to the
45
Antiretroviral Pregnancy Registry (see details at http://www.APRegistry.com)
1. EACS, 2011; 2. DHHS, 2012
US guideline recommendation
categories: Perinatal antiretroviral use
Recommended
Alternative
Insufficient data to
recommend useª
PIs
NNRTIs
NRTIs
Lopinavir/r
Nevirapine
Zidovudine*
Lamivudine*
Atazanavir
Ritonavir
Saquinavir
Indinavir**
Nelfinavir+
Efavirenz§
Abacavir#
Didanosine
Emtricitabine
Stavudine†
Tenofovir DF‡
Fosamprenavir
Darunavir
Tipranavir
Etravirine
Rilpivirine
4
Entry
Inhibitors
Integrase
Inhibitors
Enfuvirtide
Maraviroc
Raltegravir
*Combination of Zidovudine and lamivudine is recommended as dual-NRTI backbone for pregnant women
# Triple-NRTI regimens including abacavir have been less potent virologically compared with PI-based combination ARV drug
regimens.
Triple-NRTI regimens should be used only when an NNRTI- or PI-based combination regimen cannot be used, such as
because of significant drug interactions
† Should not be used with didanosine or zidovudine
‡ Preferred NRTI in combination with lamivudine or emtricitabine in women with chronic HBV infection. Monitor renal function
§ Avoid in first trimester. Use after first trimester can be considered if this is the best choice for specific women. Counsel re
teratogenic potential
** Only use when preferred and alternative agents can’t be used. Must give as low-dose RTV boosted regimen
+ Consider in special circumstances for prophylaxis of transmission in whom therapy might not otherwise be indicated when
alternative agents are not tolerated
ª Safety and pharmacokinetic data in pregnancy are limited; can
be considered for use in special circumstances when
46
preferred and alternative agents cannot be used
DHHS, 2012
BHIVA recommendations on mode
of delivery
•
•
•
•
•
For women taking HAART, a decision regarding recommended
mode of delivery should be made after review of plasma viral
load results at 36 weeks
Decisions about mode of delivery should take into account :
• adherence issues
actual viral load
• obstetric factors
trajectory of the viral load
• the woman’s views
length of time on treatment
Viral load (VL) at gestational week 36
Recommended mode
of delivery
<50 HIV RNA copies/mL and absence of
obstetric contraindications
Vaginal delivery
50–399 HIV RNA copies/mL
Consider caesarean section*
≥400 HIV RNA copies/mL
Scheduled caesarean section
*Taking the factors above into account
47
BHIVA, 2012
Post-exposure prophylaxis (PEP) for
infants
Monotherapy1
Dual therapy1
For infants born to:
For most infants:
• ZDV monotherapy
BID for 6 weeks
(4 weeks in UK2)
OR
or
• Alternative suitable
ART monotherapy if
maternal therapy does
not include ZDV
• untreated mothers
• mothers with
detectable viral RNA
despite combination
therapy
add
• NVP - 3 doses over the
first week of life
48
1. DHHS, 2012; 2. BHIVA, 2012
Hepatitis B Virus Coinfection
•
Screening for hepatitis B surface antigen
• Interferon-based therapies and ribavirin are not
recommended during pregnancy
• Treatment should include tenofovir plus 3TC or
emtricitabine (FTC)
• Hepatic toxicity should be carefully monitored
• Infants born to women with hepatitis B infection
should receive hepatitis B immunoglobulin (HBIG)
and the first dose of the HBV vaccine series within
12 hours of birth and the 2nd and 3rd doses of the
HBV vaccine at 1 and 6 months
49
DHHS, 2012
Vertical transmission of HIV when
•
Vertical transmission is possible, although extremely
unlikely, when maternal viral load (VL) is <50 copies/ml
~ In a UK and Ireland study of 2,309 mothers with an
undetectable VL at or near the time of delivery, three vertical
transmissions were reported (transmission rate=0.1%)1
~ In a French study of among 5,271 mothers who received
ART during pregnancy, vertical transmission occurred in five
cases, despite VL <50 copies/ml (transmission rate=0.4%)2
•
In both cases the rate of vertical transmission was
significantly higher in those mothers with detectable viral
loads upon delivery, highlighting the importance of
sustained viral suppression pre-delivery
50
1. Townsend et al. AIDS 2012;
2. Warszawski et al. AIDS 2008
Hepatitis C Virus Coinfection
•
Screening for hepatitis C virus (HCV) infection is
recommended
• Interferon-base therapies and ribavirin are not
recommended during pregnancy
• Hepatic toxicity should be carefully monitored
• Mode of delivery should be based on HIV infection
alone
• Infants should be screened for HCV infection by
HCV RNA testing between 3 and 6 months of age
and/or HCV antibody testing after 18 months of age
51
DHHS, 2012
Psychosocial, mental health and
emotional well being
•
•
•
Elevated perinatal depressive symptoms (i.e. during
pregnancy and post-partum) are common among
HIV-positive and women at risk of acquiring HIV1
Substance abuse during pregnancy and a past
history of psychiatric illness are predictors of
perinatal depression1,2
Clinicians caring for women living with HIV should be
aware of this risk and consider screening women
routinely for depression, both antenatally and
postpartum2
52
1. Rubin et al. J Womens Health 2011;
2. Kapetanovic et al. AIDS Patient Care STDS 2009
Post-partum care
•
Decisions about continuing ART post-partum
should take into account:
~
~
~
~
~
~
•
•
current recommendations for initiation of ART
current and nadir CD4 cell counts and HIV RNA levels
adherence
whether the woman has an HIV-partner
patient preference
breastfeeding
Contraceptive counselling should be included
For women continuing ARV drugs post-partum,
arrangements for new or continued supportive
services should be made before hospital discharge
because the immediate postpartum period may
pose a challenge to adherence
53
DHHS, 2012
Infant feeding for mothers living with HIV
Guidelines
Recommendations
•
WHO1
(and other UN
agencies)
•
•
•
BHIVA2
•
If infants and young children are known to be HIV-positive, mothers are
encouraged to exclusively breastfeed for the first six months and continue
breastfeeding up to two years or beyond
Mothers known to be HIV-positive (and whose infants are HIV-negative or of
unknown HIV status) should exclusively breastfeed their infants for the first 6
months of life, introducing appropriate complementary foods thereafter, and
continue breastfeeding for the first 12 months of life
Mothers living with HIV, regardless of maternal viral load and ART, should
refrain from breastfeeding from birth
Mothers should be provided access to infant formula milk and appropriate
equipment (including sterilisers and bottles)
Under exceptional circumstances, and after seeking expert professional
advice a highly informed and motivated mother might be assisted to
breastfeed
54
1. WHO, 2012; 2. BHIVA, 2012
Routine testing during
pregnancy
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
To reduce the likelihood of transmitting
HIV to her infant, a woman must first
know her HIV status
56
HIV testing routinely available in
pregnancy
Austria

Bulgaria

Byelorussia

Canada

Czech Republic

Denmark
Estonia

France

Germany

Moldova, Republic of

Netherlands

Norway

Poland

Portugal

Russian Federation

Slovakia

Slovenia
Spain

Greece
Switzerland

Hungary
Ukraine

Italy
UK

Malta

57
Adapted from Mounier-Jack et al. HIV Med 2008
Testing recommendations
•
HIV test offered to all women in early pregnancy, or
as soon as possible if late presentation for
antenatal care
• Repeat testing during pregnancy for women with
ongoing HIV risk
• Rapid HIV testing for women presenting for labour
• Test results available to appropriate staff on labour
wards
• To offer HIV test to sexual partners of pregnant
women
58
BHIVA, 2012
The need for further
research
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Pregnancy and HIV: More clinical
data and further study needed
•
Data on children exposed to ART in utero is
sparse
~ difficult to conduct studies in this area
•
Findings based on small studies – clinical
implications unclear
~ Some data show gender differences in MTCT
and in infant resistance
~ But data in pre-adolescents is rarely
disaggregated according to gender
Alternatives needed to address lack of data and
to clarify clinical significance of findings
60
Antiretroviral Pregnancy Register
•
•
•
•
•
Only project to evaluate first trimester (and
later) prenatal exposures to ART
Gathers anonymous data on foetal/maternal
outcomes
Provides important information to complement
clinical trial data
Data will assist clinicians/patients in weighing
potential risks and benefits of treatment
Pregnant women on ART should be
encouraged to participate in registry
www.apregistry.com
61
Rate of birth defects in live born infants
Prospective cases with known trimester exposure
to LPV/r and complete follow up data
Overall (%)
Number of live births*
[95% CI]
955
Number of outcomes with at least one defect**
23 (2.4%)
[1.5% - 3.6%]
1st trimester
5/267 (1.9%)
[0.6%-4.3%]
2nd/3rd trimester
18/688 (2.6%)
[1.6%-4.1%]
Any trimester
23/955 (2.4%)
[1.5% - 3.6%]
0.72
(0.27, 1.91)
Exact 95% CI for prevalence of birth defects
for exposures in:
Exact 95% CI for risk of birth defects for 1st trimester
exposure relative to 2nd/3rd trimester exposures
*Excludes 1 singleton live birth with no defects due to unspecified trimester of exposure. Includes
920 singleton and 35 multiple live birth outcomes.
** Defects meeting the CDC criteria only. Excludes reported defects in pregnancy losses <20
weeks. An outcome is defined as a live or stillborn infant, or a spontaneous or induced pregnancy
loss ≥20 weeks gestation.
The overall prevalence of birth defects of 2.4% in LPV/r exposed pregnancies is lower
than the CDC’s Registry overall prevalence of 2.67%
62
Robert et al. J Acquir Immune Defic Syndr 2009
Future research and specific clinical
questions and needs
•
•
•
•
•
•
•
•
Evaluation of drug safety and pharmacokinetics
Optimising neonatal regimens for perinatal assessment
of drug resistance
Risk of breastfeeding when viral load is undetectable
Stopping antiretroviral therapy
Optimising adherence
Role of caesarean delivery among women with
undetectable viral load or with short duration of ruptured
membranes
Offering rapid testing at delivery to late-presenting
women
Hormonal contraception and HIV progression
63
Case studies
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories
Case study: Former IV drug user
•
25 year old female, HIV+
• 8 weeks pregnant
• Former IV drug user
~ Relatively stable on methadone
maintenance
•
Hep C positive (antibody and PCR)
As well as managing her treatment and
delivery with respect to her HIV/co-infections
what other issues should be considered?
65
Issues to consider
Mental health and emotional well being
• Women are more likely to be diagnosed with
mental health and emotional problems than men
• Pregnancy and substance use problems increase
the risk of emotional or family problems women
with HIV
• HIV diagnoses made during pregnancy are
associated with a higher incidence of mental health
issues, (e.g. postpartum depression) than nonpregnancy diagnoses
• Not all HIV clinics have good access to perinatal
psychiatric services
• Peer support and mentoring can help
66
Issues to consider
Disclosure
• Disclosure to partners is encouraged
• HIV testing of other children is recommended
• Pregnancy is key window for disclosure
• A woman is more likely to disclose during
pregnancy, but if she doesn’t disclose then she is
likely to do so postpartum
• Disclosure may occasionally have unwanted
consequences
Adherence
• Enrol in adherence support programme/workshop
• Adherence and follow-up
67
Issues to consider
Post-pregnancy contraception
• Still no ideal contraceptive available
• If partner is HIV negative – condoms
recommended
• In cases of full viral suppression, stable
partnerships and no other STDs, there is minimal
risk of transmission. How should questions about
this be handled?
• Many ARVs interact with contraceptives
68
Case study: Discordant HIV test
result
•
33 year old woman and male partner undertake
HIV screening before stopping condoms and
planning a family
•
Woman screens HIV+ while
partner screens HIV-
•
Woman refuses to inform partner of her HIV+ result
for fear of abandonment
As well as managing her diagnosis and potential
pregnancy, what other issues should be
considered?
69
Issues to consider
Disclosure and doctor-patient confidentiality
• Many national guidelines preserve confidentiality to
patients except in special circumstances
• Pre- and post-test counselling should openly
discuss HIV+ outcome and propose how to prepare
for ‘bad news’
• Cases of prosecution for the transmission of HIV,
as well as doctors being criminally liable for nondisclosure
• Disclosure without the woman’s consent may be
mandatory but will also have consequences for
trust within the doctor-patient relationship
70
Prosecution for the transmission of HIV
•
In many jurisdictions the law is unclear in this area, varying
widely from country to country
•
It is unlikely that a person could be successfully and ethically
prosecuted for unintentional HIV transmission
•
Some convictions in Europe have occurred in rare cases
where individuals were aware of their status, for example:
~ Scotland
Stephen Kelly case (Glenochil judgement) – March 2001
(Scottish Common Law)
•
Convicted of ‘recklessly injuring’ his former partner
~ England
•
Mohammed Dica, November 2003
• Grievous bodily harm for knowingly infecting two women with HIV
• Conviction upheld at retrial in March 2005
71
Case study: Refusal to refrain from
breast feeding
•
African migrant living in Europe
• Stable on ART
• Living in shared state-provided
accommodation
• Gave birth to HIV- boy, but planned to
breastfeed while refusing to
administer ART
• Believed that “God would look after
him”
As well as managing her treatment, what
alternatives should be considered?
72
Issues to consider
Social support, duty of care to mother and baby
• Address patient’s housing situation so that she no
longer shares a room. This may change her
opinion about treating her baby
• Seek community support, e.g. community faith
leaders
• Encourage use of peer support networks
• Faith leaders can also help to encourage
adherence and issues related to stigma
• Guidelines needed on how to advise on the risks of
breastfeeding in light of the Swiss statement
• Prosecution for HIV transmission through
breastfeeding?
73
Beliefs
•
Beliefs are important
for many women with
HIV
•
Wherever possible it is
more effective to work
‘with’ beliefs, not
‘against’ them
•
Use of faith leaders
and ‘stories’ can
improve engagement
74
Thank you for your
attention
Any questions?
Women for Positive Action is an educational program
funded and initiated by Abbott Laboratories