Transcript What’s New in the Perinatal Guidelines

U.S. Public Health Service
Perinatal Guidelines
Recommendations for Use of Antiretroviral Drugs
in Pregnant HIV-1-Infected Women for Maternal
Health and Interventions to Reduce Perinatal HIV
Transmission in the United States
July 31, 2012
About This Presentation
 These slides were developed from the July 31,
2012, revisions to the guidelines.
 The goal of the guidelines is to provide guidance
to HIV care practitioners. Because of the rapidly
changing field of HIV care, users of this slide set
are advised to check http://aidsinfor.nih.gov for
updates.
 It is intended that these slides be used as
prepared, without changes in either content or
attribution. Users are asked to honor this intent.
 AETC National Resource Center
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Table of Contents
Topic
Introduction
Lessons Learned from Clinical Trials
Pre-Conception Counseling
Antiretroviral Drugs
Antepartum Care
Intrapartum Care
Postpartum Care
Care of the Neonate
Special Considerations
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Slide Number
4
7
12
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Introduction (1)
 Providers considering the use of antiretrovirals
(ARVs) for HIV-infected women during
pregnancy must take into account:
 ARV treatment (ART) for maternal HIV infection; and
 ARV chemoprophylaxis to reduce the risk of perinatal
transmission of HIV
 With universal prenatal HIV counseling and
testing, preconception care, ARV prophylaxis,
scheduled C-section delivery (if indicated), and
avoidance of breast-feeding, perinatal HIV
infection has diminished to <2% in the United
States.
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Introduction (2)
 The members of the Panel for Use of ARV Drugs
in Pregnant HIV-1-Infected Women are experts
in the field of maternal HIV and prevention of
perinatal HIV transmission.
 Members meet monthly to review clinical trials
results and update the guidelines, which are
posted on www.aidsinfo.nih.gov.
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Introduction (3)
Strength of
Recommendation
A: Strong
B: Moderate
C: Optional
Quality of Evidence
I: One or more randomized trials
with clinical outcomes and/or
validated lab end points
II: One or more well-designed,
nonrandomized trials or
observational studies with longterm clinical outcomes
III: Expert opinion
Recommendations in these guidelines are based on scientific evidence and expert opinion. Each
recommended statement is rated with a letter of A, B, or C that represents the strength of the
recommendation and with a numeral I, II, or III, according to the quality of evidence.
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LESSONS LEARNED FROM CLINICAL
TRIALS OF ANTIRETROVIRAL
INTERVENTIONS TO REDUCE
PERINATAL TRANSMISSION OF HIV
Overview
 Pediatric AIDS Clinical Trials Group 076
 Major achievement in HIV research
 Showed administration of zidovudine (ZDV) to
pregnant women and their infants could reduce
perinatal transmission by 70%
 In addition, increased HIV testing in pregnancy
and combination ARV prophylaxis during
pregnancy has reduced perinatal transmission to
<2%.
 Every HIV-infected infant is a sentinel event
representing missed opportunities.
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ARV Prophylaxis: Mechanisms of Action
 Combined antepartum, intrapartum, and infant
ARV prophylaxis is recommended to prevent
perinatal transmission of HIV. (AI)
 ARV drugs reduce perinatal transmission by
several mechanisms, including:
 Lowering maternal antepartum viral load (VL)
 Providing infant pre- and postexposure prophylaxis
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Lessons from Trials of Short-Course ARV
Regimens
 Combination antenatal prophylaxis taken over longer
duration is more effective then a short-course, singledrug regimen in reducing perinatal transmission.
 Combination infant ARV prophylaxis is recommended in
the United States for infants whose mothers have not
received antenatal ARV drugs.
 Adding single-dose intrapartum nevirapine (NVP) is not
recommended for women in the United States who are
receiving standard recommended antenatal ARV
prophylaxis.
 Breast-feeding by HIV-infected mothers is not
recommended in the United States.
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Perinatal Transmission and HIV RNA Copy
Number
 All HIV-infected women should be counseled
about and administered ARV drugs during
pregnancy regardless of their HIV RNA levels.
(AI)
 Mother-to-child transmission has been observed at
very low or undetectable maternal HIV RNA levels.
 Discordance may occur between plasma RNA levels
and amount of cervicovaginal viral shedding.
 Particularly in the presence of genital tract coinfections
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PRECONCEPTION COUNSELING
AND CARE FOR HIV-INFECTED
WOMEN OF CHILDBEARING AGE
Preconception Counseling and Care (1)
 Preconception care is part of routine primary
care and is recommended by CDC, ACOG, and
other national organizations.
 Purpose:
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Prevention of unintended pregnancies
Optimization of maternal health prior to pregnancy
Prevention of perinatal transmission
Prevention of HIV-transmission to an uninfected
partner while trying to conceive
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Preconception Counseling and Care (2)
Recommendations
 Discuss childbearing intentions with all women of
childbearing age on an ongoing basis throughout
the course of their care. (AIII)
 Include information about effective and appropriate
contraceptive methods. (AI)
 Preconception counseling: Include information
on safer sex and elimination of alcohol, illicit
drugs, and smoking. (AII)
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Preconception Counseling and Care (3)
 Include assessment of HIV disease status and
need for ART for the health of the woman. (AII)
 Choose an ART regimen for HIV-infected women
of childbearing age based on:
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Efficacy
Hepatitis B status
Teratogenic potential
Possible adverse outcomes for mother and fetus (AII)
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Reproductive Options for HIV-Concordant
and Serodiscordant Couples (1)
All couples:
 Both partners should be screened for genital
tract infections. (AII)
 Semen analysis is recommended for HIVinfected men. HIV, and possibly ART, may be
associated with a higher prevalence of
abnormalities.
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Reproductive Options for HIV-Concordant
and Serodiscordant Couples (2)
Serodiscordant couples:
 Expert consultation is recommended. (AIII)
 No single method of safer conception is fully
protective against transmission of HIV.
 Initiation of ART for the HIV-infected partner is
recommended (AI for CD4 count ≤550 cells/µL
and BIII for CD4 count >550 cells/µL).
 Maximal viral suppression is recommended before
attempting conception. (AIII)
 HPTN 052 trial showed ART can significantly
decrease HIV transmission to uninfected partners.
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Reproductive Options for HIV-Concordant
and Serodiscordant Couples (3)
 HIV-infected female with uninfected male
partner: The safest option is artificial
insemination, including the option of selfinsemination, during the periovulatory period.
(AIII)
 HIV-infected man with uninfected female: Sperm
preparation techniques + either intrauterine
insemination or in vitro fertilization should be
considered if using donor sperm from an
uninfected male is unacceptable. (AII)
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Reproductive Options for HIV-Concordant
and Serodiscordant Couples (4)
 Periconception administration of PrEP for HIVuninfected partners may offer an additional tool
to reduce the risk of sexual transmission. (CIII)
 The utility of PrEP of the uninfected partner when the
infected partner is receiving ART has not been
studied.
 Outcome studies are needed to examine adverse
events, including risk of congenital abnormalities.
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ANTIRETROVIRAL DRUGS IN
THE PERINATAL PERIOD
Use of ARV Drugs by HIV-Infected Pregnant
Women and Their Infants
 Considerations for choice of ARV drugs for
pregnant women include:
 Possible changes in dosing requirements resulting
from physiologic changes associated with pregnancy
 Potential exacerbation of ARV drug toxicities
 Pharmacokinetics and toxicity of transplacentally
transferred drugs
 Potential short- and long-term effects of ARV drugs on
fetuses and newborns
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Combination ART and Pregnancy Outcome
 Possible small increased risk of preterm birth in
pregnant women receiving protease inhibitor
(PI)-based ART; however, given the clear
benefits, PIs should not be withheld for fear of
altering pregnancy outcome. (AII)
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Pharmacokinetic Changes
 Altered dosing during pregnancy may be
required for some protease inhibitors, such as
lopinavir/ritonavir (AII)
 Concentrations of the following drugs are reduced
during the 2nd and/or 3rd trimesters
 Lopinavir/ritonavir (LPV/r)
 Atazanavir (ATV)
 Darunavir (DRV)
 Nelfinavir (NFV)
 The need for dosage adjustment depends on the
patient’s treatment experience and use of
concomitant medications
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Teratogenicity
 Women of childbearing potential should undergo
pregnancy testing before initiating efavirenz
(EFV) and receive counseling about the potential
risk to the fetus and desirability of avoiding
pregnancy while on EFV. (AIII)
 Consider non-EFV regimens in patients who are:
(BIII)
 Planning to become pregnant
 Sexually active and not using effective contraception
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Report all cases of ARV use in pregnant women to
the Antiretroviral Pregnancy Registry:
http://www.APRegistry.com (AIII)
The registry collects observational, nonexperimental
data regarding ARV exposure during pregnancy to
assess potential teratogenicity.
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Nevirapine and Hepatic/Rash Toxicity
 Avoid initiating NVP in women with CD4 counts
>250 cells/µL unless the benefits outweigh the
risks. (AII)
 Risk of hepatotoxicity/hypersensitivity reaction
 Women who are tolerating NVP-containing
regimens and become pregnant can continue
regardless of CD4 count. (AII)
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NRTI Drugs and Mitochondrial Toxicity
 The combination of stavudine (d4T) and
didanosine (ddl) should not be prescribed during
pregnancy because of reports of lactic acidosis
and maternal/neonatal mortality with prolonged
use in pregnancy. (AII)
 Mitochondrial dysfunction should be considered
in uninfected children with perinatal exposure to
ARV drugs who present with severe clinical
findings, particularly neurological. (AII)
 Long-term clinical follow-up is recommended for
any child with in utero exposure to ARV drugs.
(AIII)
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Protease Inhibitors and Hyperglycemia
 HIV-infected women taking ARV regimens during
pregnancy should undergo standard glucose
screening at 24-28 weeks’ gestation. (AIII)
 Owing to linkage with hyperglycemia
 Consider earlier glucose screening in women
receiving PI-based regimens initiated before
pregnancy. (BIII)
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Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors (1)
Preferred Agents
Lamivudine (3TC)
Concerns during Pregnancy
Well-studied during pregnancy in combination with
ZDV; ZDV/3TC is a recommended dual-NRTI
backbone in pregnancy. PK not significantly altered.
High placental transfer. No evidence of teratogenicity.
Well tolerated. Short-term safety in mothers and infants
demonstrated.
If hepatitis B coinfected, possible hepatitis B flare if
drug is stopped postpartum.
Zidovudine (AZT,
ZDV)
PK not significantly altered. High placental transfer.
Well tolerated. Short-term safety in mothers and infants
demonstrated.
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Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors (2)
Alternative Agents
Abacavir (ABC)
Concerns during Pregnancy
PK not significantly altered. High placental transfer.
No evidence of teratogenicity.
Hypersensitivity reactions occur in 5-8% of
nonpregnant individuals; a much smaller percentage
are fatal and are usually associated with rechallenge.
Testing with HLA-B*5701 identifies patients at risk;
conduct before starting ABC and educate patients
about signs and symptoms.
Emtricitabine (FTC) Slightly lower PK levels in 3rd trimester, compared
with postpartum. No clear need to increase dosage.
High placental transfer. No evidence of teratogenicity.
If HBV coinfected, possible hepatitis flare if drug is
stopped postpartum.
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Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors (3)
Alternative Agents
Tenofovir disoproxil
fumarate (TDF)
Concerns during Pregnancy
Preferred NRTI in combination with 3TC or FTC in
women with chronic HBV infection. AUC lower in 3rd
trimester; trough levels adequate. High placental
transfer. No evidence of human teratogenicity; in
monkeys, decreased fetal growth and fetal bone
porosity.
Potential renal toxicity; renal function should be
monitored. Clinical studies in humans show bone
demineralization with chronic use; clinical
significance unknown. If HBV coinfected, possible
hepatitis flare if drug stopped postpartum.
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Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors (4)
Use in Special
Circumstances
Concerns during Pregnancy
Didanosine (ddI) PK not altered during pregnancy. Moderate placental
transfer.
Increased rate of birth defects compared with general
population noted after 1st trimester and later exposure; may
be related to maternal characteristics. No specific pattern of
defects noted and clinical relevance uncertain.
Lactic acidosis, sometimes fatal, has been reported in
pregnant women using ddI and d4T together.
Stavudine (d4T)
PK not significantly altered. High placental transfer. No
evidence of human teratogenicity.
Potential toxicities: Should be used only in special
circumstances. Do not use with ddI or ZDV.
Lactic acidosis, sometimes fatal, has been reported in
pregnant women using ddI and d4T together.
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Nonnucleoside Reverse Transcriptase
Inhibitors (NRTIs) (1)
Preferred Agents
Nevirapine (NVP)
Concerns during Pregnancy
PK not significantly altered. High placental transfer. No
evidence of human teratogenicity.
Increased risk of potentially life-threatening hepatotoxicity
(often rash-associated) in women with high CD4 count at
the time of NVP initiation. If CD4 is >250 cells/µL, start NVP
only if benefit clearly outweighs risk. Increased
transaminase levels at baseline also may increase the risk.
Women who become pregnant while on NVP and are
tolerating it well can continue, regardless of CD4 count.
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Nonnucleoside Reverse Transcriptase
Inhibitors (NRTIs) (2)
Use in Special
Circumstances
Efavirenz (EFV)
Concerns during Pregnancy
AUC decreased in 3rd trimester, but nearly all subjects
exceeded target exposure. Moderate placental transfer.
FDA Pregnancy Class D: Neural tube defects observed in
3 of 20 monkeys; 5 human case reports + 1 case report
of anophthalmia. Relative risk unclear.
• Counsel nonpregnant women on risks and conduct
pregnancy test prior to initiation of EFV.
• Consider alternative regimen in women planning to
become pregnant and those who are sexually active
and not using effective contraception, assuming
alternatives are acceptable to provider and will not
compromise health of the woman.
• Continue EFV in pregnant women receiving and EFVbased regimen who present for care in 1st trimester if
there is virologic suppression on the regimen.
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Nonnucleoside Reverse Transcriptase
Inhibitors (NRTIs) (3)
Insufficient Data to
Recommend
Concerns during Pregnancy
Etravirine (ETR)
Safety and PK data in pregnancy
insufficient; no significant changes in 4
women. Limited experience in human
pregnancy; no evidence of teratogenicity in
rats and rabbits.
Rilpivirine (RPV)
Safety and PK studies insufficient; no PK
studies in human pregnancy and placental
transfer unknown. No evidence of
teratogenicity in rats or rabbits.
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Protease Inhibitors (1)
Class concerns for PIs: hyperglycemia, diabetes, question of
increased risk of preterm delivery
Preferred Agents
Concerns during Pregnancy
Atazanavir +
ritonavir (ATV/r)
Decreased ATV plasma concentrations during
pregnancy. Use with ritonavir boosting. Serum levels
may be lower when used with TDF or H2-receptor
antagonists. Consider increased dosing during 2nd and
3rd trimesters. Theoretical concern of increased indirect
bilirubin in neonates.
Lopinavir/ritonavir
(LPV/r)
Increase dosing in 2nd and 3rd trimesters. Oral solution
not optimal in pregnancy owing to alcohol content. Use
twice-daily dosing during pregnancy.
Ritonavir (RTV)
Recommended only as PK booster for other PIs. Should
not be used alone owing to poor drug levels in pregnant
women and poor tolerance when given at full dose.
Oral solution not optimal in pregnancy owing to alcohol
content.
(When used as a
low-dose booster)
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Protease Inhibitors (2)
Alternative Agents
Concerns during Pregnancy
Darunavir (DRV/r)
Limited safety and PK data during pregnancy but some
experts recommend twice-daily dosing. Insufficient data
to assess for teratogenicity in humans.
Saquinavir (SQV/r)
PR and/or QT interval prolongations have been
observed; baseline ECG recommended before starting.
Contraindicated if cardiac conduction system disease.
Twice-daily dosing. Insufficient data to assess for
teratogenicity in humans.
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Protease Inhibitors (3)
Use in Special
Circumstances
Concerns during Pregnancy
Indinavir +
ritonavir (IDV/r)
Potential for renal stones. Theoretical concern regarding
increased indirect bilirubin levels in neonates. Monitor HIV
RNA and IDV trough levels during use in pregnancy. Twicedaily dosing.
Nelfinavir (NFV)
Lower rate of viral response compared with LPV/r or EFV
regimens. Consider in special circumstances for prophylaxis.
Twice-daily dosing.
Insufficient Data to Recommend Use
Fosamprenavir (FPV)
Tipranavir (TPV)
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Additional Recommendations by Class
Integrase Inhibitors
Use in Special
Circumstances
Concerns during
Pregnancy
Raltegravir (RAL)
Insufficient data
to assess
teratogenicity.
Variable but high
placental transfer
to fetus. Consider
if preferred and
alternative agents
cannot be used.
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Entry Inhibitors
Insufficient Data to Recommend
Use
Enfurvirtide (T20)
Maraviroc (MVC)
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ANTEPARTUM CARE
Pregnant Women Who Are ARV Naive (1)
 Pregnant women with HIV infection should
receive standard clinical, immunologic and
virologic evaluation.
 Including hepatitis C and tuberculosis screening
 All HIV-infected pregnant women should receive
a potent combination ARV regimen to reduce the
risk of perinatal transmission. (AI)
 Reducing HIV RNA to undetectable levels lowers the
risk of perinatal transmission, lessens the need for
elective C-section to reduce risk of HIV transmission,
and reduces risk of ARV drug resistance in the
mother.
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Pregnant Women Who Are ARV Naive (2)
 The choice of regimen should take into account
current adult treatment guidelines, what is known
about the use of the drugs during pregnancy,
and the risk of teratogenicity. (see Guidelines,
Table 5)
 Use a dual-NRTI backbone; 1 or more NRTIs should
have high levels of transplacental passage: (AIII)
 ZDV, 3TC, FTC, TFV, ABC
 NVP can be used as a component of the regimen in
pregnant women with CD4 counts <250 cells/µL. But
NVP should only be used if the benefit clearly
outweighs the risk of hepatic toxicity. (AII)
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Pregnant Women Who Are ARV Naive (3)
 The decision as to whether to start the regimen in the 1st
trimester vs delay until 12 weeks’ gestation will depend
on CD4 count, VL, and maternal conditions such as
nausea and vomiting. (AIII)
 Earlier initiation may be more effective in reducing risk
of transmission, but benefits must be weighed against
potential fetal effects.
 Fetuses are most susceptible to potential teratogenic effects
in the 1st trimester.
 Although most transmission occurs late in pregnancy or
during delivery, recent analyses suggest that early control of
viral replication may be important.
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Pregnant Women Who Are ARV Naive (4)
 Conduct drug resistance testing before starting
ARVs.
 However, if HIV is diagnosed or the woman presents
later in pregnancy, start the ARV regimen promptly
and adjust, as needed, after resistance testing results
are available.
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Pregnant Women Who Are ARV Naive (5)
 RAL has been suggested for women with a high
VL late in pregnancy because of its ability to
rapidly suppress VL. But the safety and efficacy
of RAL in this setting have not been evaluated.
 Use of ZDV alone for prophylaxis is not optimal,
but could be an option, combined with C-section
delivery, for women with VL <1,000 copies/mL
who wish to reduce fetal exposure to ARVs.
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Pregnant Women Who Are ARV Naive (6)
 The regimen initiated during pregnancy can be
modified after delivery to a simplified regimen
with ARVs that are not used during pregnancy
because of insufficient pregnancy safety data.
 Drugs may be stopped after delivery in women who
do not feel prepared to continue lifelong treatment.
 Consult with the HIV care provider.
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HIV-Infected Pregnant Women Who Are
Currently Receiving Antiretroviral Therapy (1)
 HIV-infected women who present for care in the
1st trimester should continue any effective ARV
regimen. (AII)
 Including:
 Effective EFV-based regimens (CIII)
 Effective NVP-based regimens (AIII)
 Resistance testing should be performed on
women with detectable viremia. (AI)
 >500-1,000 copies/mL
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HIV-Infected Pregnant Women Who Are
Currently Receiving Antiretroviral Therapy (2)
 Rationale for continuing EFV in pregnancy:
 1st trimester exposure is not associated with a large
increase in the risk of neural tube defects.
 The risk of neural tube defects is limited to the first 5-6
weeks of pregnancy, before most pregnancies are
recognized.
 Treatment changes during pregnancy increase the
risk of incomplete viral suppression at the end of
pregnancy.
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Pregnant Women Who Are ARVExperienced (1)
 Pregnant women with HIV infection who have
received ARVs previously for prevention of
perinatal transmission:
 Rates of resistance appear to be low after prophylaxis
with combination ART. But interpretation of resistance
testing after treatment discontinuation is complex;
resistance testing is most accurate if done while on
ARVs or within 4 weeks of discontinuing ARVs.
 Treatment failure has not been demonstrated with
reinitiation of ART following prophylactic use in
pregnancy.
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Pregnant Women Who Are ARVExperienced (2)
 Pregnant women with HIV infection who have
received ARVs previously for their own health:
 Choice of ARV regimen is challenging and will vary
by:
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History of ART
Indication for stopping treatment
Efficacy of previous ART
Results of past and current resistance testing
Testing for HLA-B*5701
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Pregnant Women Who Are ARVExperienced (3)
Recommendations:
 Obtain an accurate history of all prior ARV
regimens used for treatment or prevention,
including efficacy, tolerance, prior resistance
testing, and adherence. (AIII)
 Perform drug-resistance testing. (AIII)
 Initiate therapy or prophylaxis promptly (without
waiting for test results) in women who present late in
pregnancy. (BIII)
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Pregnant Women Who Are ARV
Experienced (4)
 Consult specialists about the choice of regimen
in women who previously received ART for their
own health. (AIII)
 Choose a combination ARV regimen based on
results of resistance testing and prior history of
ART. (AII)
 Avoid drugs with teratogenic potential or known
adverse potential for the mother. (AII)
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Maternal and Fetal Monitoring during
Pregnancy (1)
 More frequent VL monitoring in pregnancy is
recommended to identify women in whom the
decline in VL is slower than expected.
 Viral suppression generally achieved in 16-24 weeks
in ARV-naive adherent individuals; rare cases take
longer.
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Maternal and Fetal Monitoring during
Pregnancy (2)
 Monitor VL:
 At the initial visit (AI)
 2-4 weeks after initiating or changing ARV regimen
(BI)
 Monthly until VL is undetectable (BIII)
 At least every 3 months during pregnancy (BIII)
 At 34-36 weeks’ gestation to inform decisions about
mode of delivery (AIII)
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Maternal and Fetal Monitoring during
Pregnancy (3)
 Monitor CD4 count:
 At initial antenatal visit (AI)
 At least every 3 months during pregnancy (BIII), or
every 6 months in women on ART for more than 2-3
years who are adherent and clinically stable, and have
sustained viral suppression (CIII)
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Maternal and Fetal Monitoring during
Pregnancy (4)
 Perform genotypic drug resistance testing at
baseline if VL >500-1,000 copies/mL, whether
they are ARV naive or currently on ART. (AIII)
 Repeat testing in women who have suboptimal viral
suppression on ART or who have persistent viral
rebound to detectable levels after prior viral
suppression on an ARV regimen. (AIII)
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Maternal and Fetal Monitoring during
Pregnancy (5)
 Monitor for complications of ART based on what
is known about the adverse effects of the drugs
in the regimen. (AIII)
 Perform 1st-trimester ultrasound to confirm
gestational age and to guide timing of scheduled
C-section (if needed). (AII)
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Maternal and Fetal Monitoring during
Pregnancy (6)
 Perform amniocentesis, if indicated, only after
initiation of ART regimen and, if possible, when VL
is undetectable. (BIII)
 No perinatal transmission after amniocentesis have
been reported in women on effective ART.
 Small risk cannot be ruled out.
 In women with detectable VL in whom
amniocentesis is deemed necessary, consultation
with an expert should be considered.
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Failure of Viral Suppression (1)
 Use a 3-pronged approach for management of
suboptimal suppression of VL.
 Assess for resistant virus (AII)
 Assess adherence (AII)
 Consult an expert for consideration of modifying the
ARV regimen (AIII)
 Treatment modification has been independently
associated with HIV RNA >400 copies/mL during
late pregnancy.
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Failure of Viral Suppression (2)
 Efficacy and safety of adding RAL to an ART
regimen during late pregnancy in women with
high VL or multiple drug-resistance mutations has
not been evaluated and is not recommended.
 The addition of a single drug to a failing regimen may
further increase risk of resistance and loss of future
effectiveness of RAL.
 Cesarean delivery is recommended when RNA is
>1,000 copies/mL near the time of delivery. (AII)
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Resistance Testing during Pregnancy (1)
 Drug resistance:
 Is one of the major factors leading to treatment failure
 May limit future maternal treatment options and
decrease effectiveness of ARV prophylaxis during
current and future pregnancies
 Increased risk of resistance
 During pregnancy with:
 Nausea and vomiting
 PK changes
 Postpartum
 After simultaneous discontinuation of drugs with different
half-lives
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Resistance Testing during Pregnancy (2)
Recommendations:
 Perform drug resistance studies before starting
or modifying ART for all pregnant women with
detectable VL prior to initiation of ART (AIII) and
for those with detectable VL while on ART or
with suboptimal suppression after starting ART.
(AII)
 Start empiric ART for women who present during late
pregnancy; adjust regimen as needed when results
are available. (BIII)
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Resistance Testing during Pregnancy (3)
 Give all HIV-infected pregnant women maximally
suppressive ART. (AII)
 Provide counseling and support for adherence. (AII)
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Stopping ARVs during Pregnancy (1)
 Women who are on ART and present in the 1st
trimester should continue therapy. (AII)
 Although EFV should be avoided during the first
trimester when possible, therapy should NOT be
interrupted in women taking the drug who present in
the 1st trimester.
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Stopping ARVs during Pregnancy (2)
 Discontinuation of ART during pregnancy may
be indicated in some situations.
 If ART is stopped acutely for severe or lifethreatening toxicity, severe hyperemesis, or
other acute illness that preclude oral intake, all
ARV drugs should be stopped and reinitiated at
the same time. (AIII)
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Stopping ARVs during Pregnancy (3)
 If an NNRTI-based regimen is being stopped
electively, consider either:
 Stopping the NNRTI first and continue other ARVs for
a period; or
 Switching from an NNRTI to a PI before interruption;
continue PI-based regimen for a period.
 Optimum period of time is unknown. At least 7 days is
recommended. (CIII)
 For EFV-based regimens, some experts recommend up
to 30 days. (CIII)
 If NVP is restarted after >2 weeks, restart with the 2week half-dose escalation period. (AII)
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INTRAPARTUM CARE
Intrapartum Care (1)
 Two major studies support the use of intrapartum
ZDV:
 PACTG 076: Combination antenatal, intrapartum, and
infant prophylaxis with ZDV reduced perinatal
transmission by 66%.
 French Perinatal Cohort found that intrapartum IV
ZDV was associated with lower risk of transmission if
the maternal VL was >10,000 copies/mL but not
associated with reduced risk in women on ART with
VL <400 copies/mL.
 Limited PK data on oral vs IV ZDV during labor;
drug levels needed for prophylaxis are unknown.
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Intrapartum Care (2)
Recommendations:
 Continue ART on schedule during labor and
before scheduled C-section. (AIII)
 Give IV ZDV to women with VL ≥400 copies/mL
(or unknown VL) near delivery, regardless of
antenatal regimen or mode of delivery. (AI)
 IV ZDV not required for women on ART with VL <400
copies/mL. (BII)
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Intrapartum Care (3)
 Conduct rapid HIV antibody testing for women in
labor with unknown HIV status. (AII)
If positive:
 Perform confirmatory testing ASAP.
 Administer maternal IV ZDV and infant combination
prophylaxis pending results of confirmatory test. (AII)
 Continue infant prophylaxis for 6 weeks if confirmatory
test result is positive (AI); discontinue prophylaxis if
confirmatory test result is negative.
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Transmission and Mode of Delivery (1)
 Scheduled cesarean delivery at 38 weeks’
gestation to minimize perinatal HIV transmission
is recommended for women with HIV RNA levels
>1,000 copies/mL or unknown levels near the
time of delivery. (AII)
 Perform C-section irrespective of administration of
antepartum ARV drugs.
 IV ZDV should be administered for 3 hours total prior
to scheduled delivery.
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Transmission and Mode of Delivery (2)
 Scheduled cesarean delivery is not
recommended for prevention of perinatal
transmission in pregnant women receiving
combination ARV drugs with HIV RNA levels
<1,000 copies/mL near the time of delivery. (BIII)
 Data are insufficient to evaluate the potential benefit
 Low rates of transmission
 C-sections performed for standard obstetrical
indications should be scheduled for 39 weeks’
gestation
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Transmission and Mode of Delivery (3)
 The benefit to performing a cesarean delivery
after rupture of membranes or onset of labor is
unclear. Management should be based on:
 Duration of rupture and/or labor
 Plasma HIV RNA level
 Current ARV regimen (BII)
 If unscheduled cesarean delivery is performed
and IV ZDV administration is indicated,
consideration can be given to providing only the
loading dose.
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Transmission and Mode of Delivery (4)
 Inform pregnant women of the risks associated
with cesarean delivery. If the indication is for
prevention of perinatal transmission of HIV, the
risks should be balanced with potential benefits
expected for the neonate. (AII)
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Other Intrapartum Considerations (1)
 Avoid the following because of potential
increased risk of transmission (unless there are
clear OB indications):
 Artificial rupture of membranes (BIII)
 Routine use of fetal scalp electrodes (BIII)
 Operative delivery with forceps or vacuum extractor
and/or episiotomy (BIII)
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Other Intrapartum Considerations (2)
 When treating excessive postpartum bleeding,
consider the ARVs a woman is receiving:
 If she is receiving a cytochrome (CYP) 3A4 enzyme
inhibitor (eg, a PI), use methergine only if no
alternative treatments are available and the need for
pharmacologic treatment outweighs the risks. (BIII)
 If she is receiving a CYP3A4 enzyme inducer such as
NVP, EFV, or etravirine, additional uterotonic agents
may be needed because of the potential for
decreased methergine levels and inadequate
treatment effect.
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POSTPARTUM CARE
Postpartum Care (1)
 Contraceptive counseling should be included in
the prenatal period and immediately postpartum
as a critical aspect of postpartum care. (AIII)
 The postpartum period is a critical time to address:
 Safer sex practices
 Secondary transmission prevention
 Contraception
 Review possible drug interactions of specific ARV drugs
with hormonal contraceptives before prescribing.
 Encourage dual-protection strategy of condom use
plus a second highly effective contraceptive.
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Postpartum Care (2)
 Decision-making about continuing ARVs should
take into account current recommendations for
the initiation of ART, current and nadir CD4
counts and trajectory, HIV RNA levels,
adherence issues, whether a woman has an
HIV-uninfected sex partner, and patient
preference. (AIII)
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Postpartum Care (3)
 For women continuing ARV drugs postpartum,
arrangement for new or continued supportive
services should be made before hospital
discharge because the immediate postpartum
period poses a unique challenge to adherence.
(AII)
 Counsel women about the challenge of adherence in
the postpartum period.
 Remain vigilant for signs of depression and drug or
alcohol use.
 Consider simplifying an ART regime to improve
adherence.
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Postpartum Care (4)
 Women with a positive rapid HIV antibody test
result during labor require immediate linkage to
HIV care and comprehensive follow-up including:
(AII)





Confirmation of the diagnosis
Full health assessment
Evaluation for associated medical conditions
Counseling related to HIV diagnosis
Assessment of need for ART and opportunistic
infection prophylaxis
 Partners and children should be referred for
HIV testing.
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Postpartum Care (5)
 Breast-feeding is not recommended for HIVinfected women in the United States, including
those receiving ART. (AII)
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CARE OF THE NEONATE
Infants Born to Mothers with Unknown HIV
Infection Status (1)
Determine possible HIV exposure and need for
infant ARV prophylaxis:
 Perform rapid HIV test on infant or mother as
soon as possible after birth. (AII)
 If rapid test result is positive:
 Immediately initiate infant ARV prophylaxis (AII)
 Do not wait for confirmatory testing
 Send confirmatory test (mother or infant)
 If negative, stop infant ARV prophylaxis (AIII)
 If positive, perform an HIV DNA PCR test on the infant
(AIII)
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Infants Born to Mothers With Unknown HIV
Infection Status (2)
 If infant HIV DNA PCR is positive:
 Discontinue ARV prophylaxis
 Promptly refer to an HIV specialist for confirmation
of diagnosis and HIV treatment with standard
combination ART (AI)
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Infant Antiretroviral Prophylaxis (1)
 All HIV-exposed infants should receive a 6-week
course of ZDV prophylaxis. (AI)
 If the mother received standard antepartum and
intrapartum ARV prophylaxis with suppressed HIV
RNA, risk of HIV transmission is very low; infant ZDV
alone is recommended.
 If the mother did not receive optimal antepartum and
intrapartum prophylaxis, risk of HIV transmission is
higher, and additional infant ARVs may be
recommended.
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Infant Antiretroviral Prophylaxis (2)
Dosing for Infant Zidovudine (ZDV) HIV Prophylaxis
Age
≥35 weeks’ gestation at
birth
Zidovudine Dosage
4 mg/kg/dose PO twice daily
If unable to tolerate oral agents:
3 mg/kg/dose IV every 12 hours
≥30 to <35 weeks’ gestation 2mg/kg/dose PO every 12 hours or
1.5 mg/kg/dose IV every 12 hours
At age 15 days: increase to
3 mg/kg/dose PO every 12 hours or
2.3 mg/kg/dose IV every 12 hours
<30 weeks’ gestation
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Duration
Birth through 6
weeks
Give first dose as
close to the time of
birth as possible
(preferably within 6 to
12 hours)
2 mg/kg/dose PO every 12 hours or
1.5 mg/kg/dose IV every 12 hours
After age 4 weeks: increase to
3 mg/kg/dose PO every 12 hours or
2.3 mg/kg/dose IV every 12 hours
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Infant Antiretroviral Prophylaxis (3)
 Infants born to mothers who did not receive
antepartum ARV drugs
 Standard 6-week course of ZDV, plus
 3 doses of NVP in the first week of life (AI)
 1st dose at birth
 2nd dose 48 hours later
 3rd dose 96 hours after 2nd dose
 Begin regimen as soon as possible postdelivery
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Infant Antiretroviral Prophylaxis (4)
Weight Band Dosing for Infant Nevirapine (NVP) HIV
Prophylaxis
Weight Band
Nevirapine Dosage
Birth weight: 1.5-2 kg 8 mg TOTAL for each
dose
Birth weight: >2 kg
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Timing and Duration
3 doses in the first week of
life:
1st dose as soon as
possible postdelivery and
within 48 hours of birth
2nd dose 48 hours after
the 1st dose
3rd dose 96 hours after
2nd dose
12 mg TOTAL for each Same
dose
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Infant Antiretroviral Prophylaxis (5)
 For complex scenarios, eg:
 Infant born to a mother who received antepartum/
intrapartum ARV drugs but has suboptimal viral
suppression at delivery
 Infant born to a mother with ARV drug-resistant virus
 Consult a pediatric HIV specialist for guidance
on combination prophylaxis
 Preferably before delivery
 Counsel about risks and benefits (BIII)
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Infant Antiretroviral Prophylaxis (6)
 Management of breast-feeding infants of mothers
diagnosed with HIV-infection postpartum
 Stop breast-feeding
 Consult a pediatric HIV specialist
 Postexposure prophylaxis vs preemptive therapy
 Perform virologic testing in infants <18 months of age
 At baseline; 4-6 weeks; 3 months; and 6 months
postdiagnosis of maternal infection
 HIV DNA PCR is the preferred test for infants receiving
combination prophylaxis or preemptive therapy
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Infant Antiretroviral Prophylaxis (7)
Safety considerations
 Limited data on most ARVs in infants, particularly if given
in combination
 NRTIs:
 ZDV generally safe, may cause transient anemia
 3TC + ZDV may increase hematologic toxicity
 NVP: rare cases of severe rash and hepatotoxicity;
resistance may occur in infants who become HIV infected
 Protease inhibitors not recommended for neonates
 No PK data for most
 LPV/r: possible cardiac and other toxicity
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Infant Antiretroviral Prophylaxis (8)
 In premature infants
 Dosing information is available for:
 ZDV
 NVP
 Use of other ARV drugs cannot be
recommended because of lack of dosing and
safety data. (BIII)
 Consult a pediatric HIV specialist for cases in
which there is high risk of perinatal transmission
in a premature infant.
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Infant Antiretroviral Prophylaxis (9)
The National Perinatal HIV Hotline
1-888-448-8765
Free clinical consultation on
all aspects of perinatal HIV
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Initial Postnatal Management of the HIVExposed Neonate (1)
 Obtain a CBC with differential before initiation of
ARV prophylaxis. (BIII)
 Frequency of monitoring blood levels is based
on: (CIII)






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Gestational age and clinical condition of infant
Baseline values
ZDV dosage administered
Receipt of other ARV drugs
Concomitant medications
Maternal ARV regimen
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Initial Postnatal Management of the HIVExposed Neonate (2)
 Intensive monitoring may be considered for
infants exposed to combination ARV regimes in
utero or neonatally, including: (CIII)




Hematologic monitoring
Serum chemistry
Liver function
Bilirubin levels (ATV exposure)
 Monitoring can coincide with timing for HIV
diagnostic lab work. (CIII)
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Initial Postnatal Management of the HIVExposed Neonate (3)
 For infants receiving combination ZDV/3TCcontaining ARV prophylaxis: (AI)
 Recheck hemoglobin and neutrophil count 4 weeks
after ARV initiation and/or at the time HIV diagnostic
testing is performed.
 Consider for infants receiving ZDV 4 mg/kg twice-daily dosing
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Initial Postnatal Management of the HIVExposed Neonate (4)
 Routine measurement of serum lactate is not
recommended unless infant develops severe
clinical symptoms. (CIII)
 Especially neurologic symptoms
 In symptomatic infants with significantly
abnormal serum lactate levels (>5 mmol/L):
 Discontinue ARV prophylaxis
 Consult a pediatric HIV specialist for alternative
prophylaxis
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Initial Postnatal Management of the HIVExposed Neonate (5)
 If hematological abnormalities are identified,
considerations about continuing ARV prophylaxis
include: (CIII)





Extent of abnormality
Related symptoms
Duration of prophylaxis
Risk of HIV infection
Availability of alternative interventions
 May consider reducing therapy to 4 weeks.
 Consult a pediatric HIV specialist.
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Initial Postnatal Management of the HIVExposed Neonate (6)
 Diagnostic HIV tests for infants: (AII)
 HIV DNA PCR
 Optimal test for diagnosis in the neonatal period
 HIV RNA
 Standard antibody tests cannot be used to
diagnose HIV infection in infants
 Detect maternal HIV antibodies up to 18 months
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Initial Postnatal Management of the HIVExposed Neonate (7)
 Virologic tests should be performed at: (AII)
 14-21 days,
 1 to 2 months, and
 4 to 6 months
 Virologic tests at birth may be performed:
 If mother did not have good virologic control during
pregnancy
 If adequate follow-up cannot be assured
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Initial Postnatal Management of the HIVExposed Neonate (8)
 HIV infection in an infant is diagnosed by two
positive virologic tests on separate specimens.
 HIV infection is excluded:
 Presumptively by two negative virologic tests, one at
age ≥14 days and one at age ≥1 month
 Definitively (in non-breast-fed infants) by two negative
virologic tests, one at age ≥1 month or older and one at
age ≥4 months
 Negative status may be confirmed by antibody testing at
age 12-18 months
 See guidelines for diagnosis of non-subtype-B
HIV.
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Initial Postnatal Management of the HIVExposed Neonate (9)
 PCP prophylaxis should begin at age 4-6 weeks,
after completion of ARV prophylaxis. (AII)
 Unless HIV infection can be presumptively excluded
 Evaluate and treat infants as indicated for
transmittable maternal coinfections identified
through history or physical evaluation.
 HIV-exposed infants should follow the routine
immunization schedule
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Initial Postnatal Management of the HIVExposed Neonate (10)
 Preventing HIV transmission to infants:
 HIV-positive women should not breast-feed
 Transmission of HIV in infancy may occur owing to the
practice of premasticating foods
 Health providers should: (AII)



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Inquire about premastication with patients
Instruct HIV-infected caregivers to avoid the practice
Advise on safer feeding options
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Long-Term Follow-Up of Infants Exposed to
ARVs
 Long-term data from infants exposed to ARVs in
utero are insufficient.
 Children with in utero/neonatal exposure to
ARVs who develop significant organ system
abnormalities of unknown etiology, particularly
the nervous system or heart, should be
evaluated or mitochondrial dysfunction. (CIII)
 Follow-up of children with exposure should continue to
adulthood because of theoretical concerns for
carcinogenicity of nucleoside analogues. (CIII)
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SPECIAL CONSIDERATIONS
Acute HIV Infection (1)
 Primary or acute HIV infection in pregnancy or
during breast-feeding is associated with
increased risk of transmission.
 Counsel all pregnant or breast-feeding women
about prevention of HIV. Reinforce importance of
using condoms.
 Maintain a high level of suspicion for acute HIV
in women who have a compatible clinical
syndrome, even if high-risk behaviors are not
reported.
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Acute HIV Infection (2)
 When acute HIV is suspected, obtain a plasma
RNA and an HIV antibody test. (AII)
 Repeat antibody testing in 3rd trimester for all
women with an initial negative antibody:
 Who are known to be at risk of HIV, and
 Who are receiving care where incidence in pregnant
women is at least 1 per 1,000 per year; and for
 Women who are incarcerated or reside in jurisdictions
with elevated HIV incidence (AII)
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Acute HIV Infection (3)
 All pregnant women with acute or recent HIV
infection should start an ARV drug regimen as
soon as possible, with the goal of complete
suppression of VL. (AI)
 Use an RTV-based PI regimen. (AIII)
 Perform baseline genotyping; adjust regimen if
necessary to optimize response. (AIII)
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Hepatitis B and HIV Coinfection (1)
 Screen all HIV-infected pregnant women who
have not been screened in the current
pregnancy for hepatitis A, B, and C. (AII)
 Administer HBV vaccine series to pregnant
women who screen negative for HBV. (AII)
 Consult with an expert in HIV and HBV for
management of coinfection during pregnancy.
(AIII)
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Hepatitis B and HIV Coinfection (2)
 Screen pregnant women with chronic HBV
infection for antibodies to HAV; if negative,
administer HAV vaccine series. (AII)
 Interferon not recommended during pregnancy.
(AIII)
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Hepatitis B and HIV Coinfection (3)
 ART is recommended for all.
 ART should include a dual-NRTI/NtRTI
backbone with 2 drugs active against both HIV
and HBV. (AII)
 TDF + 3TC or FTC preferred (A1)
 Initiation of an ARV regimen that does not include
anti-HBV drugs may be associated with reactivation of
HBV and development of IRIS
 Counsel on signs and symptoms of liver toxicity
and assess LFTs 1 month after initiation of
treatment then every 3 months at least. (BIII)
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Hepatitis B and HIV Coinfection (4)
 If ART is discontinued postpartum, monitor LFTs
frequently and reinitiate treatment for HIV and
HBV if a flare is suspected. (BIII)
 Give HBV immune globulin and the 1st dose of
HBV vaccine series to infants within 12 hours of
birth. Give 2nd and 3rd doses at ages 1 month
and 6 months. (AI)
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Hepatitis C and HIV Coinfection (1)
 Screen for HCV in all pregnant women who have
not been screened during the current pregnancy.
(AIII)
 Recommendations for ARV use during
pregnancy are the same as those for pregnant
women without HCV. (BIII)
 Interferon is not recommended; ribavirin is
contraindicated for use during pregnancy. (AIII)
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Hepatitis C and HIV Coinfection (2)
 Screen women with HCV for HAV and HBV.
 If negative for HAV IgG, give HAV vaccine series. (AIII)
 If not infected with HBV, give HBV vaccine series. (AIII)
 Counsel women about symptoms of liver toxicity;
check LFTs 1 month after initiation of ART, then at
least every 3 months thereafter. (BIII)
 Make decisions about mode of delivery based on
standard OB and HIV-related indications alone. (BIII)
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HIV-2 Infection and Pregnancy (1)
 In the United States, 166 cases met CDC criteria
for HIV-2 diagnosis between 1998 and 2010.
 HIV-2 is endemic in West African countries and
occurs in France and Portugal.
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HIV-2 Infection and Pregnancy (2)
 Most HIV screening tests detect HIV-2 but do not
distinguish between HIV-1 and HIV-2.
 Bio-Rad Laboratories Multispot HIV-1/HIV-2 test is the
exception and should be used if HIV-2 is suspected.
 Available HIV-2 supplemental tests are not FDA
approved.
 Available HIV-2 VL assays are not FDA approved.
 State or local health departments can arrange for
additional testing by the CDC.
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HIV-2 Infection and Pregnancy (3)
Recommendations:
 Suspect HIV-2 in pregnant women who are from
or have partners from countries where HIV-2 is
endemic, who are HIV positive on initial ELISA
and who have repeatedly indeterminate results
on HIV WB along with VL at or below the limit of
detection. (BII)
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HIV-2 Infection and Pregnancy (4)
 Treat women who require treatment for their own
health with 2 NNRTIs and a boosted PI. (AIII)
 ZDV/3TC + LPV/r is preferred (AIII). TDF + 3TC or
FTC + LPV/r can be an alternative. (BIII)
 Optimal perinatal prophylaxis is not defined.
Experts recommend:
 Boosted-PI regimen (2 NRTIs + LPV/r, with drugs
stopped postpartum (BIII); or
 ZDV prophylaxis alone during pregnancy and
intrapartum (BIII)
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HIV-2 Infection and Pregnancy (5)
 NNRTIs and enfuvirtide are not active against
HIV-2 and should not be used. (AIII)
 Give HIV-2-exposed infants the standard 6-week
ZDV prophylactic regimen. (BIII)
 Breast-feeding is not recommended. (AIII)
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About This Slide Set
 This presentation was prepared by Mary Jo
Hoyt, RN, MSN; and Joanne Phillips, RN, MS;
and was reviewed by Susa Coffey, MD, for the
AETC National Resource Center, August 2012.
 See the AETC National Resource Center
website for the most current version of this
presentation http://www.aidsetc.org
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