Transcript What`s New in the Perinatal Guidelines

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
viral load 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 below <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 in 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 during 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 ARVExperienced (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 during 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, 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
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 precludes 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 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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