SOGC CLINICAL PRACTICE GUIDELINE

No. 310, August 2014

Guidelines for the Care of Pregnant Women

Living With HIV and Interventions to Reduce
Perinatal Transmission: Executive Summary
This clinical practice guideline has been prepared by the
Infectious Diseases Committee, reviewed by Family Physician
Advisory Committee and the Aboriginal Health Initiative
Committee and approved by Executive and Council of the
Society of Obstetricians and Gynaecologists of Canada.
PRINCIPAL AUTHORS
Deborah Money, MD, Vancouver BC
Karen Tulloch, BScPharm, Vancouver BC
Isabelle Boucoiran, MD, Montreal QC
Sheila Caddy, MD, Edmonton AB
INFECTIOUS DISEASES COMMITTEE
Mark H. Yudin, MD (Chair), Toronto ON
Victoria Allen, MD, Halifax NS
Celine Bouchard, MD, Quebec QC
Marc Boucher, MD, Montreal QC
Isabelle Boucoiran, MD, Montreal QC
Sheila Caddy, MD, Calgary AB
Eliana Castillo, MD, Calgary AB
Heather Gottlieb, MD, Calgary AB
V. Logan Kennedy, RN, Toronto ON
Deborah Money, MD, Vancouver BC

Abstract
Objective: This guideline reviews the evidence relating to the
care of pregnant women living with HIV and the prevention
of perinatal HIV transmission. Prenatal care of pregnancies
complicated by HIV infection should include monitoring by a
multidisciplinary team with experts in this area.
Outcomes: Outcomes evaluated include the impact of HIV
on pregnancy outcome and the efficacy and safety of
antiretroviral therapy and other measures to decrease the risk
of vertical transmission.
Evidence: Published literature was retrieved through
searches of PubMed and The Cochrane Library in 2012
and 2013 using appropriate controlled vocabulary (HIV,
anti-retroviral agents, pregnancy, delivery) and key words
(HIV, pregnancy, antiretroviral agents, vertical transmission,
perinatal transmission). Results were restricted to systematic
reviews, randomized control trials/controlled clinical trials,
and observational studies published in English or French.
There were no date restrictions. Searches were updated on
a regular basis and incorporated in the guideline to June
2013. Grey (unpublished) literature was identified through
searching the websites of health technology assessment
and health technology-related agencies, clinical practice
guideline collections, clinical trial registries, and national and
international medical specialty societies.
Values: The quality of evidence in this document was rated using
the criteria described in the Report of the Canadian Task
Force on Preventive Health Care (Table 1).

Kellie Murphy, MD, Toronto ON

Gina Ogilvie, MD, Vancouver BC
Caroline Paquet, RM, Trois-Rivieres QC
Julie van Schalkwyk, MD, Vancouver BC
SPECIAL CONTRIBUTORS
Ariane Alimenti, MD, Vancouver BC

Key Words: HIV, pregnancy, antiretroviral agents, vertical

transmission, perinatal transmission

Neora Pick, MD, Vancouver BC

Disclosure statements have been received from all contributors.

J Obstet Gynaecol Can 2014;36(8):721734

This document reflects emerging clinical and scientific advances on the date issued, and is subject to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate
amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be
reproduced in any form without prior written permission of the SOGC.

AUGUST JOGC AOT 2014 l 721

SOGC CLINICAL PRACTICE GUIDELINE

Table 1. Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force
on Preventive Health Care
Quality of evidence assessment*

Classification of recommendations

I:

A. There is good evidence to recommend the clinical preventive action

Evidence obtained from at least one properly randomized

controlled trial

II-1: Evidence from well-designed controlled trials without

randomization

B. There is fair evidence to recommend the clinical preventive action

II-2: Evidence from well-designed cohort (prospective or

retrospective) or casecontrol studies, preferably from
more than one centre or research group

C. The existing evidence is conflicting and does not allow to make a

recommendation for or against use of the clinical preventive action;
however, other factors may influence decision-making

II-3: Evidence obtained from comparisons between times or

places with or without the intervention. Dramatic results in
uncontrolled experiments (such as the results of treatment with
penicillin in the 1940s) could also be included in this category

D. There is fair evidence to recommend against the clinical preventive action

III:

Opinions of respected authorities, based on clinical experience,

descriptive studies, or reports of expert committees

E. There is good evidence to recommend against the clinical preventive

action
L. There is insufficient evidence (in quantity or quality) to make
a recommendation; however, other factors may influence
decision-making

*The quality of evidence reported in these guidelines has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on
Preventive Health Care.69
Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force
on Preventive Health Care.69

Recommendations
1. All women living with HIV who are planning a pregnancy or
who become pregnant should have their individual situations
discussed with experts in the area, with referral to both HIV
treatment programs and obstetrical care providers, and an overall
plan should be made for their pregnancy care. (II-2A)
2. All pregnant women should be offered HIV testing, with
appropriate pre- and post-test counselling, as part of their routine
prenatal care in each pregnancy. This testing should be repeated
in each trimester in women who are recognized to be at high and
ongoing risk for HIV infection. (II-2A)
3. Pregnant women living with HIV should be made aware that
with the consistent use of combination antiretroviral therapy and
abstinence from breastfeeding, the risk of perinatal transmission
is < 1%. (I-A)
4. All pregnant women living with HIV should be treated with
combination antiretroviral therapy regardless of baseline CD4 and
viral load. (II-2A)
5. Antiretroviral therapy should not be discontinued during the
first trimester for obstetrical reasons, but if the woman is not on
therapy and there is no urgent medical indication for combination
antiretroviral therapy, it can be delayed until after 14 weeks
gestation. (III-B)
6. All women living with HIV (both those who still have a detectable
viral load after exposure to antiretroviral therapy and those who
are antiretroviral-naive) should have their virus genotyped and, if
possible, tested for phenotypic resistance to assist in optimizing
antiretroviral therapy. It is advisable to discuss the interpretation
of the genotype testing and any changes to the antiretroviral
therapy with experienced clinicians. Testing for HLA-B*5701, if
not done previously, is recommended in case abacavir might be
required. (II-2B).
7. A combination antiretroviral therapy regimen including a dual
nucleoside reverse transcriptase inhibitor (NRTI) backbone
that includes one or more NRTIs and a boosted protease
inhibitor should be favoured because there is higher confidence

722 l AUGUST JOGC AOT 2014

in its safety and efficacy in pregnancy. Whenever possible,

antiretrovirals known to cross the placenta to the fetal
compartment should be used. (II-2B)
8. Whenever possible drugs with no safety data should be avoided
during the period of organogenesis. Efavirenz should not be
prescribed in the first trimester of pregnancy because of its
possible teratogenicity; however, if exposure has occurred
and the neural tube has closed, efavirenz can be continued.
Nevirapine should not be started in pregnancy, unless indicated
by the womans resistance patterns, because it is associated
with a high rate of serious adverse outcomes in this situation;
however ongoing, pre-pregnancy treatment with nevirapine can
be continued through pregnancy if tolerance and efficacy are
established. (II-3D)
9. If antiretroviral therapy is discontinued for any reason during
pregnancy, all drugs should be discontinued at once (unless the
woman is on non-nucleoside reverse transcriptase inhibitors; in
that case a tail of 2 nucleoside reverse transcriptase inhibitors
is recommended for 1 week), and all drugs should be resumed
simultaneously to minimize the risk of viral resistance developing
during therapy. Antiretroviral therapy should be resumed as
quickly as possible after discontinuance to minimize the risk of
rebound viremia and the potentially increased risk of vertical
transmission. (II-1A)
10. If a pregnant woman has significant nausea of pregnancy, do
not begin antiretroviral therapy until her nausea is adequately
controlled. Most antinauseants used in pregnancy can be coadministered with antiretrovirals. If the woman is already on
antiretrovirals and has hyperemesis of pregnancy, discontinue
all antiretrovirals at once, and then reinstate all at once, when
nausea and vomiting are controlled (unless the woman is on
non-nucleoside reverse transcriptase inhibitors [NNRTIs],
in which case a tail of 2 nucleoside reverse transcriptase
inhibitors is recommended for 1 week to prevent future NNRTI
resistance). (II-2B)
11. Therapy should be individualized to maximize adherence to the
prescribed antiretroviral regimen. (III-A)

Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission: Executive Summary

12. Routine dose adjustment of the combination antiretroviral therapy

is not recommended in pregnancy. (III-D)

21. HIV-exposed newborns should receive antiretroviral therapy for 6

weeks to prevent vertical transmission of HIV. (I-A)

13. The womans clinical, virological, and immunological statuses

should be assessed every 4 to 8 weeks during pregnancy, and
again 6 weeks postpartum. Routine criteria should be used to
assess the womans response to, and the possible failure of,
antiretroviral therapy. The toxicity of the antiretrovirals should
also be monitored at these times. Specific testing should
be individualized for the known toxicities of the womans
antiretroviral therapy regimen. (III-B)

22. Health care practitioners who care for HIV-exposed newborns

should provide timely diagnostic HIV testing: HIV polymerase
chain reaction at birth, 1 month, and 3 to 4 months and HIV
serology at 18 months (II-A), and they should monitor both shortand long-term outcomes, including screening for adverse effects
of antiretroviral therapy and for developmental delay. (III-A).

14. As for all pregnant women, all those living with HIV, regardless
of age, should be offered, through an informed consent process,
dating ultrasound and non-invasive prenatal genetic screening for
the most common clinically significant fetal aneuploidies. (III-A)
15. A detailed obstetrical ultrasound at 19 to 20 weeks gestation
is recommended. Additional ultrasounds, for fetal growth and
amniotic fluid volume, are recommended at least each trimester,
or as guided by obstetrical indications. (II-3B)

23. Breast-feeding is not recommended regardless of plasma HIV

viral load and use of antiretroviral therapy. (I-E)
24. The pregnancy should be registered with surveillance programs
to allow the collection of provincial and national data to guide
future pregnancy policies. Women undergoing antiretroviral
therapy in pregnancy should also be offered inclusion in
appropriate studies. (III-B)
The full text of this document
is available online at:
http://www.sogc.org and http://www.jogc.com.

16. As for all pregnant women, those living with HIV should be
screened periodically for substance use, and drug addiction
should be addressed as needed in conjunction with HIV
management. (III-A)
17. Mode of delivery should be discussed in detail with all women:
a. Women on optimal antiretroviral therapy with acceptable
plasma viral load suppression (less than 1000 c/mL) over the
last 4 weeks prior to delivery are recommended to have a
vaginal delivery in the absence of other obstetrical indications
for Caesarean section. If Caesarian section is recommended
for obstetrical indications, it can be conducted at 39 weeks, as
usual for those indications. (I-A)
b. Women not on optimal antiretroviral therapy (i.e., no
antiretroviral therapy, monotherapy only, or with an
incompletely suppressed viral load) should be offered a
scheduled pre-labour Caesarian section at approximately 38
weeks gestation. (II-2A)
18. Intravenous zidovudine should be initiated as soon as labour
onset until delivery, in combination with an oral combination
antiretroviral regimen, regardless of mode of delivery, current
antiretroviral regimen, or viral load. (III-B)
19. Intrapartum, a single dose of oral nevirapine (200 mg) remains
an option in the unusual circumstance of a woman living with
HIV who has not received antenatal antiretroviral therapy in
pregnancy. (I-B)
20. Plans for ongoing HIV care should be established prenatally, and
unless otherwise indicated, maternal antiretroviral therapy should
be continued after delivery and reassessed for ongoing therapy
by providers of adult HIV care. (II-1A)

INTRODUCTION

upportive non-directive counselling regarding

reproductive choices, high-risk prenatal care, modified
management of labour and delivery, and postpartum
and infant care are all important components in the
comprehensive care of the woman living with HIV and her
infant. The provision of pregnancy and reproductive health
care in women living with HIV should involve collaboration
with individuals experienced in the management of highrisk pregnancy and HIV care of women and infants.
In Canada, several clinics provide multidisciplinary care and
guidance for this population of adults and children living
with and exposed to HIV, in coordination with provincial
authorities. Longitudinal surveillance on pregnancy outcomes
in women living with HIV are tracked by the Canadian
Perinatal HIV Surveillance Program through information
provided by clinicians who care for pregnant women living
with HIV and their infants. This is vital for the continuous
quality improvement of antiretroviral prescribing in pregnancy.
BACKGROUND

ABBREVIATIONS
ALT

alanine aminotransferase

AST

aspartate aminotransferase

cART

combination antiretroviral therapy

EIA

enzyme immunoassay

IV

intravenous

NIH

National Institutes of Health

PCR

polymerase chain reaction

RNA

ribonucleic acid

ZDV zidovudine

Scope

The guideline summarized here primarily addresses the

management of HIV during pregnancy and does not
comprehensively address pre-pregnancy planning issues.
Canadian HIV pregnancy planning guidelines are available
elsewhere,1 as are guidelines addressing the HIV care
of non-pregnant women,2 which is not discussed in this
document. Management of HIV in pregnant women with
co-morbidities is addressed in brief; readers are referred to
available guidelines for detailed discussion.3
AUGUST JOGC AOT 2014 l 723

SOGC CLINICAL PRACTICE GUIDELINE

Epidemiology of Perinatal HIV

In 2011, the Joint United Nations Programme on HIV/AIDS

and the World Health Organization (WHO) estimated that
a total of 34 million people worldwide were living with HIV,
approximately half of whom were women.4 The number of
people living with HIV in Canada continues to rise, from an
estimated 64000 in 2008 to 71300 in 2011.5 The estimated
prevalence in Canada in 2011 was 208.0 per 100000 (range:
171.0 to 245.1), 23% to 28% of whom were women.5
Combination antiretroviral therapy has been demonstrated
to prolong the lives of people living with HIV,6 and has also
significantly reduced the rate of vertical transmission of
HIV from a baseline risk of 25% without intervention to
less than 2% in the context of comprehensive pregnancy
care and cART administered antenatally, intrapartum, and
to the infant in the early neonatal period.7,8 Overall, the
HIV vertical transmission rate in women who received at
least 4 weeks of cART before delivery is 0.4% in Canada.9
As a result of these factors, more women living with HIV
are considering their reproductive options and choosing
to become pregnant,1 and the incidence of pregnancies
in women living with HIV in Canada has been gradually
increasing.9 However, the vertical transmission of HIV
remains a great concern globally as an estimated 26% of
women living with HIV remain unaware of their HIV
status,10 and the majority of childhood HIV infections are
acquired in this manner.3
PRE-CONCEPTION PLANNING

Detailed information and recommendations regarding preconception planning for people with HIV is beyond the scope
of this document. These issues are addressed in detail in the
Canadian HIV pregnancy planning guidelines1 and in the
NIH perinatal guidelines.3 In brief, the following important
clinical issues need to be considered with respect to pregnancy
planning and counselling in individuals living with HIV:
1. use of effective methods of birth control for those
who do not wish to become pregnant;
2. pre-conceptional health, including the intake of folic
acid;
3. transmission between partners during conception; and
4. antiretroviral and other drugs in pregnancy planning.
Recommendation

1. All women living with HIV who are planning a

pregnancy or who become pregnant should have their
individual situations discussed with experts in the area,
with referral to both HIV treatment programs and
obstetrical care providers, and an overall plan should be
made for their pregnancy care. (II-2A)

724 l AUGUST JOGC AOT 2014

NEW DIAGNOSIS OF HIV IN A PREGNANT WOMAN

All pregnant women should be offered HIV testing, with

appropriate pre- and post-test counselling as part of their
routine prenatal care in each pregnancy.11 Some provinces
have managed this through opt-in testing and others
through opt-out testing. Women involved in ongoing highrisk HIV transmission activities who are HIV negative
on initial testing should be retested each trimester, and if
possible again near term. Testing women for the first time
during labour and delivery is not optimal, and HIV issues
should be addressed as early as possible in the pregnancy to
optimize the health outcomes of both the woman and her
infant. Rapid HIV antibody testing (also known as pointof-care HIV testing) in the labour and delivery setting is
now available in some facilities and should be used as an
important last opportunity to identify women living with
HIV before delivery and to provide emergency prophylaxis
to decrease the risk of vertical transmission.1113
A clinician who is familiar with HIV management in
pregnancy should evaluate every pregnant woman who is
newly diagnosed with HIV. Women should be informed
about their HIV diagnosis in person and support and
counselling should be provided for the woman and her
family. Women should be made aware of the improved
natural history of HIV, specifically that with adherence to
care and therapy, individuals living with HIV now experience
an improved quality of life and prolonged life expectancy.14
Immediate assessment of risk transmission to others is
important, and the woman should be counselled regarding
the need for safe sexual practices. All previous children
that may have been exposed in the past and all sexual or
drug-use partners should be offered testing. Public health
consultation should be sought to adhere to provincial
regulations on reportable diseases. Disclosure to family and
friends not at risk of HIV is not required and should be
considered carefully in light of the unfortunate persistence
of stigmatization.
Recommendation

2. All pregnant women should be offered HIV testing,

with appropriate pre- and post-test counselling, as
part of their routine prenatal care in each pregnancy.
This testing should be repeated in each trimester
in women who are recognized to be at high and
ongoing risk for HIV infection. (II-2A)
NEW DIAGNOSIS OF PREGNANCY
IN A WOMAN LIVING WITH HIV

A clinician familiar with HIV management should evaluate

each HIV positive woman who becomes pregnant. Medical

Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission: Executive Summary

care recommendations for the pregnant woman living

with HIV will depend on the womans wish to continue or
end the pregnancy, her HIV disease status, and her cART
medication history.
In the event that the woman does not wish to continue
the pregnancy, access to termination of pregnancy services
should be facilitated. Health care providers should use
this opportunity to continue to engage in and optimize
HIV care and to provide reproductive health counselling,
including contraception, to reduce the future occurrence
of an unintended pregnancy. The HIV status of the
exposed sexual or drug use partner should also be verified.
Recommendation

3. Pregnant women living with HIV should be made

aware that with the consistent use of combination
antiretroviral therapy and abstinence from
breastfeeding, the risk of perinatal transmission is
<1%. (I-A)
ANTIRETROVIRAL DRUG THERAPY
DURING PREGNANCY

Antiretroviral drug therapy is indicated for all pregnant

women living with HIV, regardless of their HIV viral load
or CD4-cell count, for the womans own health, for the
prevention of HIV transmission to a partner, and for the
prevention of vertical transmission.3,9,15,16 Antiretroviral
agents reduce the risk of vertical transmission through a
number of mechanisms, including:
1. lowering maternal viral load using antenatal cART,
2. providing infant pre-exposure prophylaxis using
intrapartum antiretroviral therapy that rapidly crosses
the placenta in order to achieve adequate systemic drug
levels in the infant, and
3. providing infant post-exposure prophylaxis.3
It is important to note that cART is effective even in women
with low viral loads. Among women with baseline viral loads
less than 1000 copies/mL, those who received antenatal
antiretroviral therapy demonstrated a lower HIV vertical
transmission rate than those who did not (1.0% vs. 9.8%;
P<0.001).16
The benefit of preventing the vertical transmission of HIV
is considered to outweigh the potential risks associated
with antiretroviral medications, provided these agents are
administered per treatment recommendations and with
close monitoring and follow-up by experts in the area of
HIV and obstetrics. If a woman is already receiving cART,
the current regimen should in most cases be continued if
the regimen is effective in suppressing HIV viral load and

is tolerated by the woman. There are situations, however,

as specified in the recommendations below, when changing
antiretroviral medications should be considered. Readers are
referred to the comprehensive guideline for discussion of
the benefits and potential risks associated with the use of
each antiretroviral drug in pregnancy.
If a woman is not already on cART therapy, plans for a cART
regimen should be made immediately; the timing of initiation
will depend on her HIV disease status (i.e., CD4-cell count
and HIV viral load), but cART should generally be initiated
before weeks 14 to 20. Selection of a specific antiretroviral
drug therapy regimen in an pregnant woman living with HIV
must take into account the interrelated issues of:
1. the stage of pregnancy,
2. the current and co-morbid health status of the woman,
3. her HIV-resistance profile,
4. what is currently known about the use of specific drugs
in pregnancy and the risk of teratogenicity,
5. unique pharmacokinetic considerations, including altered
kinetics in pregnancy and issues of placental passage of
medications,
6. the womans social status and intravenous drug use, and
7. the ability of the woman to cope with the antiretroviral
drug therapy pill burden.
All women should be counselled about the importance of
adhering to the regimen and should be recommended to
continue therapy after delivery.
Recommendations

4. All pregnant women living with HIV should be

treated with combination antiretroviral therapy
regardless of baseline CD4 and viral load. (II-2A)
5. Antiretroviral therapy should not be discontinued
during the first trimester for obstetrical reasons,
but if the woman is not on therapy and there is
no urgent medical indication for combination
antiretroviral therapy, it can be delayed until after 14
weeks gestation. (III-B)
6. All women living with HIV (both those who still have
a detectable viral load after exposure to antiretroviral
therapy and those who are antiretroviral-naive) should
have their virus genotyped and, if possible, tested
for phenotypic resistance to assist in optimizing
antiretroviral therapy. It is advisable to discuss the
interpretation of the genotype testing and any
changes to the antiretroviral therapy with experienced
clinicians. Testing for HLA-B*5701, if not done
previously, is recommended in case abacavir might be
required. (II-2B).
AUGUST JOGC AOT 2014 l 725

SOGC CLINICAL PRACTICE GUIDELINE

7. A combination antiretroviral therapy regimen

including a dual nucleoside reverse transcriptase
inhibitor (NRTI) backbone that includes one or more
NRTIs and a boosted protease inhibitor should be
favoured because there is higher confidence in its
safety and efficacy in pregnancy. Whenever possible,
antiretrovirals known to cross the placenta to the fetal
compartment should be used. (II-2B)
8. Whenever possible drugs with no safety data should
be avoided during the period of organogenesis.
Efavirenz should not be prescribed in the first
trimester of pregnancy because of its possible
teratogenicity; however, if exposure has occurred and
the neural tube has closed, efavirenz can be continued.
Nevirapine should not be started in pregnancy, unless
indicated by the womans resistance patterns, because
it is associated with a high rate of serious adverse
outcomes in this situation; however ongoing,
pre-pregnancy treatment with nevirapine can be
continued through pregnancy if tolerance and efficacy
are established. (II-3D)
9. If antiretroviral therapy is discontinued for any reason
during pregnancy, all drugs should be discontinued
at once (unless the woman is on non-nucleoside
reverse transcriptase inhibitors; in that case a tail
of 2 nucleoside reverse transcriptase inhibitors is
recommended for 1 week), and all drugs should be
resumed simultaneously to minimize the risk of viral
resistance developing during therapy. Antiretroviral
therapy should be resumed as quickly as possible
after discontinuance to minimize the risk of rebound
viremia and the potentially increased risk of vertical
transmission. (II-1A)
10. If a pregnant woman has significant nausea of
pregnancy, do not begin antiretroviral therapy until her
nausea is adequately controlled. Most antinauseants
used in pregnancy can be co-administered
with antiretrovirals. If the woman is already on
antiretrovirals and has hyperemesis of pregnancy,
discontinue all antiretrovirals at once, and then
reinstate all at once, when nausea and vomiting are
controlled (unless the woman is on non-nucleoside
reverse transcriptase inhibitors [NNRTIs], in which
case a tail of 2 nucleoside reverse transcriptase
inhibitors is recommended for 1 week to prevent
future NNRTI resistance). (II-2B)
11. Therapy should be individualized to maximize
adherence to the prescribed antiretroviral
regimen. (III-A)
12. Routine dose adjustment of the combination
antiretroviral therapy is not recommended in
pregnancy. (III-D)

726 l AUGUST JOGC AOT 2014

ANTEPARTUM MANAGEMENT
General considerations

It is important to consider the broad context of a

womans life when managing her HIV and prenatal care.
Considerations include:
Providing empathetic, nonjudgemental care to women
living with HIV and their children in the spirit of
professionalism.17
Addressing early and systematically the need for social
support, with at least one interview with a social
worker.9,15 The aim of the comprehensive assessment
by a social worker is to determine the womans needs
and to propose culturally relevant support and followup if required.
Maintaining confidentiality, including with relatives.17
Encouraging the testing of partners and previous
children if their HIV status is unknown.18 The medical
and psychological needs of the fathers should be
addressed, and the men referred to other health care
providers if necessary.19
Advising on the use of, and facilitating access
to, condoms for the purpose of preventing the
transmission of HIV and other sexually transmitted
infections.20 If both members of the couple are living
with HIV, they should be informed of the possible risk
of superinfection associated with unprotected sex.21
Respecting the wishes of a mother who refuses
antenatal cART after being fully informed and
counselled. A plan for the care of the newborn should
be prepared prior to delivery.17
Pregnant women living with HIV should be considered
to have high-risk pregnancies. Their medical therapy
requires coordination and communication between HIV
specialists and obstetrical providers. Virtual or telephone
communication between health care providers should be
considered if women in remote settings are unable to
attend for specialist consultations.
First Trimester (Weeks 0 to 13)

Early pregnancy offers the opportunity for complete HIV and

obstetrical laboratory tests and investigations, and permits
planning for prenatal genetic screening. Recommended tests
and blood work are summarized in Table 2.
All pregnant women living with HIV, regardless of age,
should be offered, through an informed consent process,
dating ultrasound and prenatal genetic screening for the
most common clinically significant fetal aneuploidies. First
trimester biochemical screening and nuchal translucency

Urinalysis & urine culture

Toxoplasma IgG

Syphilis (RPR)

Varicella IgG

HAV IgG

HBsAg, anti-HBs, anti-HBc

HCV IgG

Pap smear

HSV history#

GBS screen anorectal swab**

Cervix chlamydia & gonorrhea

NAAT

uE3, hCG, AFP, inhibin A

1113+6
NT
1520+6

opt

opt

opt

opt

opt

opt

1517
weeks

detailed

opt

1920
weeks

opt
growth

opt

opt

opt

opt

opt

opt

2426
weeks

growth

68

2830
weeks

opt
growth

opt

3236
weeks

Delivery

*Integrate initial visit laboratory tests and investigations (as indicated) with all others if the visit occurs later than 10 weeks gestation.

**Group B streptococcus ano-rectal swab recommended at 35 to 37 weeks, or sooner if delivery within 5 weeks is anticipated.

#If there is a positive genital herpes history, recommend starting prophylactic treatment (e.g., valacyclovir 500 mg orally twice daily) at 34 to 36 weeks to prevent recurrent HSV at delivery

Confirm a positive result for HCV antibodies with HCV PCR

Screen for gestational diabetes using 50 g glucose challenge test (1 h plasma glucose [PG]) or 75 g oral glucose tolerance test (fasting PG, 1 h PG, 2 h PG).68 If a woman is receiving a protease inhibitor-based
regimen, particularly if initiated before pregnancy, consideration can be given to performing this screening test earlier.

Phosphatemia should be monitored in women receiving tenofovir-based regimens because it is a potential cause of tubular toxicity.3,66,67

HLA-B*5701 testing is recommended at baseline, or if not previously performed, before starting therapy with abacavir.

HIV genotypic drug testing recommended at time of first HIV plasma viral load, at the time of initiation of antiretrovirals, and in the case of treatment failure or incomplete viral load suppression (>250 HIV copies/mL).

46
weeks

opt: optional; CBC: complete blood count; AST: aspartate aminotransferase; ALT: alanine aminotransferase; LDH: lactate dehydrogenase; BUN: blood urea nitrogen; CMV: cytomegalovirus; HAV: hepatitis A virus;
HCV: hepatitis C virus; NT: nuchal translucency; PAPP-A: pregnancy associated plasma protein A; uE3: unconjugated estriol; hCG: human chorionic gonadotropin; AFP: alpha-fetoprotein;
NAAT: nucleic acid amplification test; HSV: Herpes simplex virus; GBS: group B streptococcus.

Sexually transmitted & other

infections

PAPP-A

dating

Rubella IgG

Ultrasound

CMV IgG

Ultrasound & prenatal screening

Blood type

Serology

Gestational diabetes screen

Fasting glucose

Blood type

Blood glucose

opt

Phosphatemia

opt

Creatinine, BUN

Renal function

opt

AST, ALT, LDH, bilirubin

Liver function tests

opt

CBC with differential

HLA-B*5701

Hematologic assessment

HIV genotypic drug resistance

opt

Drug resistance & abacavir

hypersensitivity testing

opt

HIV viral load

HIV plasma viral load

CD4

Immunologic assessment

1013+6
weeks

Initial
visit*

Table 2. Recommended laboratory tests and investigations for pregnant women living with HIV by visit and gestational age
Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission: Executive Summary

AUGUST JOGC AOT 2014 l 727

SOGC CLINICAL PRACTICE GUIDELINE

measurements should be obtained to integrate with second

trimester biochemical screening, and these results should be
used to inform the need for invasive testing.22 If integrated
prenatal screening is not accessible, then pregnant women
living with HIV should be offered the available non-invasive
option for screening for aneuploidy in the region based on
gestational age.
Nausea and vomiting can be a significant issue for all
pregnant women, and in women living with HIV, it may
affect their ability to adhere to the prescribed antiretroviral
regimen. Evaluation of nausea and vomiting of pregnancy
should be conducted and aggressive management of this
condition, starting with a prescription for doxylaminepyridoxine as needed,23 is necessary to facilitate the initiation
and/or continuation of antiretroviral medications. Women
should be counselled on all relevant aspects of ensuring
a healthy pregnancy, including maintaining a healthy diet
and lifestyle. Women should start or ideally continue taking
folic acid 1 mg daily for at least the first 3 months of their
pregnancy. In cases of food insecurity, resources should
be offered to improve nutrition. Within a harm reduction
model, women should be encouraged to stop smoking,
drinking alcohol, and using recreational drugs, and they
should be referred for appropriate counselling support
and/or treatment.1,24,25 Other harm reduction strategies that
can be offered if appropriate include nicotine replacement
treatment and opiate harm reduction measures such as
methadone and/or buprenorphine programs.
Second Trimester (Weeks 14 to 27)

Assessment of the status of the womans HIV, review of

laboratory investigations from the first trimester, and reevaluation of antiretroviral therapy should be completed
during the second trimester. The womens clinical,
virological, and immunological status should be assessed
every 4 to 8 weeks throughout the pregnancy (see Table2).
Because co-morbidities affect many women living with
HIV, more frequent evaluations may be appropriate.
The second part of the integrated prenatal screening tests,
including a detailed ultrasound, should be performed in
the second trimester.22 If aneuploidy or any other fetal
infection or syndrome that has prenatal diagnostics is a
concern, invasive testing should be considered. Invasive
testing should only occur if the statistical risk of the
condition is higher than the risk of the procedure, taking
into consideration the biochemical, serological, and
ultrasound results.22 When amniocentesis is performed, the
woman should ideally be on cART, but the timing may not
permit full suppression of her HIV viral load prior to the
procedure. Non-invasive molecular prenatal testing should
be considered as an option to avoid invasive testing.26
728 l AUGUST JOGC AOT 2014

Third Trimester (Weeks 28 to 40)

The efficacy and toxicity of the cART regimen should

be assessed every 4 to 8 weeks (Table 2). Given the risk
of placental dysfunction associated with increased rates
of intrauterine growth restriction and oligohydramnios
in the pregnancies of women living with HIV,27 followup growth ultrasound should preferably be done monthly;
if this is not possible, a third trimester scan can assist in
determining whether there has been placental or fetal
compromise. Considering the higher rate of preterm
birth in this population,2836 close clinical follow-up is
recommended and the schedule of some obstetrical
assessments (e.g. group B streptococcus screening) and
prophylaxis (e.g. genital herpes prophylaxis) may need to
be adjusted.
Adherence to cART regimens should be emphasized at
each visit throughout the pregnancy, however, this is critical
in the third trimester because virologic suppression (HIV
viral load <50 copies/mL) should be achieved at this time.
Between 30 and 35 weeks it is important that a formulafeeding plan has been arranged for the infant. Women living
with HIV are recommended to formula-feed their infants;
to avoid the 9.3% (3.8 to 14.8%) increased risk of vertical
transmission of HIV through breast milk, breastfeeding
is not recommended.3739 The risk of disclosure that may
arise when a woman does not breastfeed may compromise
her confidentiality. Health care providers should assist
with a plan before delivery that can help women feel more
comfortable when discussing feeding with family and
friends.
Plans for ongoing HIV care for the woman should also be
established at this time.
Delivery Plans and Mode of Delivery

Planning the hospital location for delivery should take

into consideration the womans gestational history, home
location and transportability, the facilities at her regional
hospital, and the comfort and experience of the local care
providers. The care providers involved and the delivery
plan, including location of delivery, can be reviewed during
the second trimester, and should be established during the
third trimester.
Mode of delivery has been reviewed extensively in cohort
studies and a randomized controlled trial of intended
mode of delivery. The initial studies that identified
elective Caesarean section as a method to reduce vertical
transmission were in women who were not receiving any
antiretroviral drug therapy or who received monotherapy
with ZDV only. Evidence to support elective Caesarean

Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission: Executive Summary

section in the current cART era, when all women (even

with viral loads <1000 copies/mL)16 are recommended
to initiate cART in pregnancy, is absent.40,41 Therefore,
elective Caesarean section at 38 to 39 weeks gestation
is recommended only in women who have an unknown
viral load, have a viral load >1000 copies/mL, or are
not on cART, regardless of their viral load. The benefit
of Caesarean delivery shown in early studies appears
to have been found exclusively in pre-labour elective
Caesarean sections; no benefit was shown for emergency
Caesarean sections.7,42 Women who receive antepartum
cART, are adherent to therapy, and have an HIV viral
load <1000copies/mL within 4 weeks of delivery can be
delivered vaginally, reserving Caesarean section deliveries
for obstetrical indications only.
Recommendations

13. The womans clinical, virological, and

immunological statuses should be assessed every
4 to 8 weeks during pregnancy, and again 6 weeks
postpartum. Routine criteria should be used to
assess the womans response to, and the possible
failure of, antiretroviral therapy. The toxicity of the
antiretrovirals should also be monitored at these
times. Specific testing should be individualized for
the known toxicities of the womans antiretroviral
therapy regimen. (III-B)
14. As for all pregnant women, all those living with
HIV, regardless of age, should be offered, through
an informed consent process, dating ultrasound
and non-invasive prenatal genetic screening for
the most common clinically significant fetal
aneuploidies. (III-A)
15. A detailed obstetrical ultrasound at 19 to 20 weeks
gestation is recommended. Additional ultrasounds,
for fetal growth and amniotic fluid volume, are
recommended at least each trimester, or as guided
by obstetrical indications. (II-3B)
16. As for all pregnant women, those living with HIV
should be screened periodically for substance use, and
drug addiction should be addressed in conjunction with
HIV management as needed (III-A)
17. Mode of delivery should be discussed in detail with
all women:
a. Women on optimal antiretroviral therapy with
acceptable plasma viral load suppression (less
than 1000 c/mL) over the last 4 weeks prior
to delivery are recommended to have a vaginal
delivery in the absence of other obstetrical
indications for Caesarean section. If Caesarian
section is recommended for obstetrical
indications, it can be conducted at 39 weeks, as
usual for those indications. (I-A)

b. Women not on optimal antiretroviral therapy

(e.g. no antiretroviral therapy, monotherapy
only, or with incompletely suppressed viral
load) should be offered pre-labour scheduled
Caesarean section at approximately 38 weeks
completed gestation. (II-2A)
INTRAPARTUM MANAGEMENT
Intrapartum management for women
known to be living with HIV

All women known to be living with HIV should be

instructed to attend labour and delivery immediately upon
rupture of membranes or regular contractions so that
measures can be taken to decrease the risk of vertical HIV
transmission. All oral antenatal antiretroviral medications,
with the exception of stavudine (d4T), should be continued
for as long as possible during labour. Stavudine should not
be administered concomitantly with IV ZDV because of an
antagonistic drug interaction.43 There are no randomized
controlled trial data on the additional benefit of intrapartum
IV ZDV in women who have been receiving antenatal
cART. The most recent guidelines published by the NIH
in the United States endorse intrapartum IV ZDV for use
in pregnant women living with HIV only if they have had
antenatal cART and have an HIV viral load >400 copies/mL
(or unknown) near delivery.3 Canadian data show that 8.7%
of women with a previously suppressed viral load have
unpredictably elevated viral loads at time of delivery.44 On the
basis of this evidence, intrapartum IV ZDV (2mg/kg/hour
followed by 1mg/kg/hour until delivery) is recommended
for all women in Canada, regardless of mode of delivery,
current antiretroviral regimen, or viral load. Intravenous
ZDV should be administered as soon as it is determined the
woman is in active labour and/or has ruptured membranes,
or at least 2 to 3 hours prior to Caesarean section.
Women who did not receive any antiretroviral therapy
during pregnancy should also receive a single dose of oral
nevirapine (200mg) as soon as possible at the onset of
labour or at least 2 to 3 hours prior to Caesarian section.
This recommendation also differs somewhat from that in
the NIH perinatal guidelines.3 In our experience, a number
of practicalities must be considered when women present
in labour, including the frequent difficulty of obtaining
IV access, which makes the administration of IV ZDV
difficult or impossible. Because single-dose oral nevirapine
has been demonstrated to reduce vertical transmission of
HIV,45 it continues to be recommended for intrapartum
administration to women living with HIV who have not
received antenatal therapy, in addition to the administration
of combination antiretrovirals to their infants.
AUGUST JOGC AOT 2014 l 729

SOGC CLINICAL PRACTICE GUIDELINE

Data from the pre-cART era indicate that obstetrical

interventions that increase the exposure of the infant to
maternal blood, such as invasive monitoring or episiotomies,
may increase the risk of vertical transmission.4649 Extrapolating
this data into the present era of cART, it is recommended that
interventions that potentially increase fetal exposure, including
scalp electrodes, intrauterine catheters,50 prolonged rupture
of membranes, operative vaginal deliveries, and episiotomies
should be avoided if possible.
Intrapartum management for women of
unknown HIV status and/or ongoing HIV risk

Many women who are at risk for HIV infection do not

receive antenatal care and present late in their pregnancy
or in early labour with unknown HIV status. Women at
particular risk of HIV infection include those who use
injection drugs and have shared needles; have had a recent
illness suggestive of seroconversion; have had regular
unprotected sex with a partner known to be living with
HIV or at significant risk for HIV infection; or have had
a diagnosis of a sexually transmitted infection during the
pregnancy. Women who have been recently incarcerated or
who have emigrated from areas with endemic HIV are also
at increased risk if they have not been recently screened.
Women with unknown HIV status or at continued risk
of HIV infection since their last negative HIV serology
result should be offered (if available in the institution)
rapid HIV antibody testing in the labour and delivery
setting. If the test result is positive, the woman should
be informed of the result, and confirmatory HIV PCR
and antibody tests should be performed.12,13 Maternal
intrapartum antiretroviral drug therapy plus post-partum
ZDV-lamivudine and infant prophylactic cART should be
initiated pending results of the confirmatory test.
If rapid HIV antibody testing is not available within the
institution and/or delivery is imminent and HIV seropositivity
is a possibility, HIV PCR and HIV antibody tests should be
performed. Intrapartum and postpartum antiretroviral drugs
therapy should be offered to the woman, and all infants
should receive prophylactic cART pending results. If the
HIV antibody test is negative and the woman is out of the
seroconversion period (i.e., has not engaged in high risk
activities in 4 weeks) and/or HIV PCR is negative, infant and
maternal antiretroviral therapy may be discontinued.

19. Intrapartum, a single dose of oral nevirapine (200 mg)

remains an option in the unusual circumstance of
a woman living with HIV who has not received
antenatal antiretroviral therapy in pregnancy. (I-B)
POSTPARTUM MANAGEMENT

Postpartum care involves collaborative efforts between

obstetric care providers, HIV specialists, and other multi
disciplinary health care providers to ensure coordinated
HIV care for both the mother and her infant. A number
of comprehensive issues that must be addressed include
contraception, continuation of and adherence to
antiretroviral drug therapy regimens, infant feeding and
pediatric care, and the womans needs for mental health
services, social services, and/or treatment for substance use.
The use of ergotamine should be avoided because of the
risk of exaggerated vasoconstriction in women receiving
protease inhibitor therapy.51 Oxytocin, misoprostol, and
prostaglandin F2 alpha are recommended agents for
managing postpartum hemorrhage. A number of studies
have evaluated the risk of infectious morbidity following
delivery in women living with HIV.5256 Some studies report
higher rates of endometritis and pneumonia following
Caesarian section in women living with HIV than in
women without,53 but others do not.52
Women who were receiving antenatal antiretroviral therapy
should have their complete regimen resumed after delivery
as soon as oral intake is tolerated. Women who were not
receiving antenatal antiretroviral therapy but who received
single-dose nevirapine during labour should receive 7
days of ZDV-lamivudine, 1 tablet orally twice daily, to
reduce the risk of developing nevirapine resistance. ZDVlamivudine therapy can be discontinued before completion
of the 7-day treatment period if confirmatory HIV testing
results show that the woman is not infected with HIV.

Recommendations

Plans for ongoing HIV care should be established

prenatally, and unless otherwise indicated, maternal
antiretroviral therapy should be continued after delivery
and reassessed for ongoing therapy by providers of adult
HIV care. Based on future pregnancy planning and adult
HIV status, antiretroviral treatment modifications may be
appropriate. Adherence in the postpartum period can be
challenging57,58 and support is important.

18. Intravenous zidovudine should be initiated as

soon as labour onset until delivery, in combination
with an oral combination antiretroviral regimen,
regardless of mode of delivery, current
antiretroviral regimen, or viral load. (III-B)

Management of the effects of not breastfeeding should

include measures such as acetaminophen, ibuprofen, or
cold compresses to minimize pain from engorgement.
Bromocriptine and cabergoline, the classical therapies used
for lactation suppression, are ergot derivatives, whose co-

730 l AUGUST JOGC AOT 2014

Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission: Executive Summary

administration with protease inhibitors is contraindicated.

Women who test positive on rapid HIV antibody testing
or who are believed to be at high risk of HIV (when rapid
HIV antibody testing is not available) are recommended to
pump their breast milk, but they should not feed it to the
infant unless a confirmatory HIV test result is negative.
An early return to fertility can be expected as a result of not
breastfeeding. It is critical to discuss safer sex practices and
effective contraception methods with the women. Condom
use is recommended to reduce the risk of transmission
between partners; however, the contraception failure rate
with condoms as commonly used is reported to be as high
as 14%.59 Oral contraceptives may also be used by women
living with HIV, particularly with the use of condoms
as part of a dual-protection strategy. Drug interactions
between antiretroviral drugs and oral contraceptives have
been documented, therefore it is important to assess
potential interactions between specific antiretroviral agents
and oral contraceptive pill.3,60 Non-oral contraceptive
methods including Depo-Provera, contraceptive patches,
contraceptive vaginal rings, and intrauterine devices are
also options; however, there are less data available on their
use in combination with antiretroviral medications.59,61
Linkage to care is important for all women with HIV,
particularly for women who were newly diagnosed with
HIV during labour and delivery. All women should
have arrangements for follow-up care with providers
experienced in the management of HIV.
Recommendation

20. Plans for ongoing HIV care should be established

prenatally, and unless otherwise indicated, maternal
antiretroviral therapy should be continued after
delivery and reassessed for ongoing therapy by
providers of adult HIV care. (II-1A)
INFANT MANAGEMENT

All infants should be offered antiretroviral prophylaxis

regardless of maternal antenatal or intrapartum
antiretroviral therapy, viral load, or mode of delivery. The
prophylaxis should be started as soon as possible, no later
than 6 to 12 hours after birth. The recommended regimen
will depend on the presumed level of risk.
Infants born to a mother known to be living with HIV
infection and with a viral load <1000 copies/mL should
be offered prophylactic therapy with oral ZDV for 6
weeks. Infants born to a mother known to be living with
HIV infection and a known or projected viral load >1000
copies/mL or to a mother known to be living with HIV

and who did not receive any antepartum antiretroviral

therapy, should receive prophylactic antiretrovirals with a
3-drug regimen including ZDV for 6 weeks combined with
3 doses of nevirapine in the first week of life and oral
lamivudine twice daily for 2 weeks. This recommendation
is made on the basis of the HPTN040/PACTG 1043
trial in women living with HIV who were not receiving
antenatal antiretrovirals, which demonstrated that
combination regimens had better efficacy in reducing
vertical transmission to infants intrapartum (2.2%) than
ZDV alone (4.8%).62
In settings where rapid HIV antibody testing is not yet
available, the optimal management strategy for infants
born to women with unknown HIV status and considered
at high risk of HIV infection has not been established in
a randomized clinical trial. In this clinical scenario, the
potential benefit of preventing vertical transmission of
HIV is believed to outweigh the potential risks of the
infants unnecessary exposure to antiretrovirals.
It is important to discuss feeding practices with the mother
during antenatal visits, using a sensitive approach and
acknowledging the mothers cultural beliefs about infant
feeding. Because premastication by caregivers living with
HIV has been implicated as a potential route of HIV
transmission to young infants, health care practitioners
should also inquire specifically about premastication and
advise caregivers living with HIV to avoid this practice.
Infants exposed to HIV should be tested for HIV infection
by a virological test at birth, at 4 weeks, and at 3 to 4
months of age to determine HIV status. Additional testing
for infants at high risk of vertical transmission should
be discussed with a pediatric HIV specialist. HIV RNA
PCR (or nucleic acid amplification test) is the virological
test currently used for diagnostic purposes. HIV infection
can be excluded when two HIV virological tests are nonreactive, one collected after 4 weeks of age and the other at
least 4 weeks after the end of prophylactic antiretrovirals.
Serological EIA tests are not indicative of infant status due
to the presence of detectable maternal HIV antibodies in
the infant up to 18 to 24 months of age.
A confirmatory HIV EIA test is recommended to
document seroreversion after 18 months of age. If an HIV
PCR is reactive, a confirmatory RNA PCR test should be
requested immediately. When an infant is found to have
HIV, antiretroviral prophylaxis should be discontinued and
an urgent referral should be made to an HIV specialist;63
this may prevent the establishment of viral reservoirs in
the infant.64
AUGUST JOGC AOT 2014 l 731

SOGC CLINICAL PRACTICE GUIDELINE

All infants born to women living with HIV should be

referred for ongoing assessment and care to a pediatrician
with expertise in this area. Developmental follow-up is
crucial for uninfected HIV-exposed children. Factors such
as poverty, food insecurity, low literacy, inexperience in
parenting, and parental substance or alcohol use put infants
at higher risk for failure-to-thrive, developmental delay, and
behavioural disorders. Long-term follow-up of children
who were perinatally exposed to HIV and antiretrovirals is
recommended into adulthood, because there are unknown
and theoretical concerns about the potential carcinogenicity
of nucleoside analogue antiretroviral drugs and other longterm effects of antiretroviral medications.3
Recommendations

21. HIV-exposed newborns should receive

antiretroviral therapy for 6 weeks to prevent vertical
transmission of HIV. (I-A)
22. Health care practitioners who care for HIV-exposed
newborns should provide timely diagnostic HIV
testing: HIV polymerase chain reaction at birth,
1 month, and 3 to 4 months and HIV serology
alabort 18 months (II-A), and they should monitor
both short- and long-term outcomes, including
screening for adverse effects of antiretroviral
therapy and for developmental delay. (III-A).
23. Breast-feeding is not recommended regardless of
plasma HIV viral load and use of antiretroviral
therapy. (I-E)
24. The pregnancy should be registered with
surveillance programs to allow the collection
of provincial and national data to guide
future pregnancy policies. Women undergoing
antiretroviral therapy in pregnancy should also be
offered inclusion in appropriate studies. (III-B)
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