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Perinatal UpdatePerinatal Update
It Takes An Island!It Takes An Island!
April 2009 www.aidsetc.org 3
New Information New Information
Includes: Lessons Learned from Clinical Trials of ARV
Interventions to Reduce Perinatal HIV Transmission
Neonatal Postnatal Care
ARV Drug Use in Pregnant HIV-Infected Women (see Tables 1, 2, and 3 in the Perinatal Guidelines)
Safety and Toxicity of ARV Agents in Pregnancy Supplement (see Perinatal Guidelines)
New Ratings for Recommendations (see Perinatal Guidelines)
Preconception Counseling Preconception Counseling andandCare for HIV-Infected Care for HIV-Infected WomenWomenof Childbearing Ageof Childbearing Age
RecommendatiRecommendationsons
Contraception counseling to avoid unintended pregnancy is an essential part of care
Counsel on safe sexual practices, eliminating alcohol, illicit drug use, and smoking
Educate about risk factors for perinatal HIV transmission and strategies for reducing them
Encourage testing and counseling of partners
Counsel on reproductive options that prevent HIV exposure to uninfected partner
April 2009 www.aidsetc.org 5
RecommendatioRecommendations ns (2)(2)
For women of childbearing potential, consider effectiveness of ARVs as well as teratogenic effects
◦ In women who intend to become pregnant, avoid EFV
Attain a stable, maximally suppressed VL prior to conception
Breast-feeding is not recommended in the United States (risk of HIV transmission via breast milk)
April 2009 www.aidsetc.org 6
Management of the Pregnant Woman with an HIV-Infected Male Partner
Pregnant Woman with Pregnant Woman with an an HIV-Infected Male HIV-Infected Male PartnerPartnerTest for HIV (unless patient declines)
◦ 2nd HIV test in 3rd trimester, before 36 weeks if possible
If patient presents in labor: rapid HIV testIf seroconversion is suspected, do HIV
RNA and antibody test; repeat test in 4-6 weeks◦ If positive: initiate interventions to reduce
perinatal transmission risk
◦ If negative: counsel to reduce risk of transmission from partner
April 2009 www.aidsetc.org 8
Antepartum Care Antepartum Care for HIV-Infected for HIV-Infected WomenWomen
Transmission and Maternal HIV Transmission and Maternal HIV RNARNA
Risk of perinatal transmission greater with higher maternal HIV RNA viral load (VL)
However, perinatal transmission can occur even at undetectable maternal VL
◦ Plasma VL may not accurately predict transmission risk
◦ VL level should not be a determining factor in deciding whether to start ART for perinatal prophylaxis
ARV prophylaxis to prevent perinatal transmission
is recommended for all HIV-infected women
April 2009 www.aidsetc.org 101010
Use of ARVs during Use of ARVs during Pregnancy: General Pregnancy: General PrinciplesPrinciples
Initial evaluation should include:◦Assessment of HIV disease status
◦Recommendations on ART or assessment of current ARV regimen
Recommend ARV therapy/prophylaxis to ALL pregnant HIV-infected women
Discuss known benefits and potential risks ofARVs during pregnancy
April 2009 www.aidsetc.org 11
General PrinciplesGeneral Principles (2)(2)
If HIV RNA is detectable, do resistance testing before starting/modifying therapy
Individualize ART
Emphasize the importance of adherence to treatment and prophylaxis
Assure coordination of comprehensive services
April 2009 www.aidsetc.org 12
HIV-Infected Pregnant HIV-Infected Pregnant Women Currently on Women Currently on ARTART
Continue ART, if possible; avoid treatment interruption
Avoid EFV in the 1st trimester: switch to an alternative ARV, if possible
Order ARV resistance tests if detectable viremia
If on NVP with suppressed VL and tolerating it, continue NVP
Include ZDV in regimen, unless contraindicated
April 2009 www.aidsetc.org 13
ARV NaiveARV Naive If patient meets criteria for initiation of ART, start
standard potent combination therapy◦ For a patient who requires ART for her own health,
start as soon as possible, including in 1st trimester
◦ Consult data on specific ARVs in pregnancy
If patient does not require treatment for her own health: 3-drug combination ARV regimen for perinatal prophylaxis ◦ May delay until after 1st trimester
◦ ZDV monotherapy for prophylaxis not recommended, but may be considered if VL <1,000 copies/mL
April 2009 www.aidsetc.org 14
ARV Naive ARV Naive (2)(2)
Perform resistance testing before selection of ARVs
Include ZDV in ARV regimen when feasible
NVP: can be initiated for pregnant women with CD4 counts of <250 cells/µL
◦ If CD4 cell count is >250 cells/µL, initiate NVP only if benefit outweighs risk (increased risk of hepatic toxicity)
Avoid EFV in 1st trimester
April 2009 www.aidsetc.org 15
Women Not Currently on Women Not Currently on ARVs with History of ARVs with History of Prophylaxis or TreatmentProphylaxis or Treatment
Obtain history of prior ARV regimens and results of resistance testing
Perform drug resistance testing before starting ARVs ◦ Results may not be accurate; interpret with caution
Select ARVs based on ARV history and resistance testing; monitor virologic response closely◦ Avoid drugs that may harm the fetus or mother (eg,
EFV, d4T + ddI)If poor virologic response, repeat resistance
testing and consult experts
April 2009 www.aidsetc.org 16
Special Considerations for Special Considerations for ARV UseARV Useby Pregnant Women and by Pregnant Women and InfantsInfantsPregnancy may alter ARV absorption,
distribution, and metabolism
◦ARV dosing and toxicity risk may be affected
Some PIs may require altered dosing
Limited data to guide treatment in pregnant women
Report all cases of ARV drug exposure to Antiretroviral Pregnancy Registry
April 2009 www.aidsetc.org 17
Special Considerations for Special Considerations for ARV Use ARV Use (2)(2)
Potential adverse effects during pregnancy:◦EFV: Avoid during 1st trimester of
pregnancy; possible risk of neural tube defects
◦TDF: Concern for possible fetal bone effects; monitor for renal toxicity in pregnancy
◦Combination of d4T + ddI: increased risk of lactic acidosis and hepatic steatosis
April 2009 www.aidsetc.org 18
Special ConsiderationsSpecial Considerations for for ARV Use ARV Use (3)(3)
◦Use with caution during pregnancy: NVP: Increased risk of hepatotoxicity; do not initiate in women with CD4 counts of >250 cells/µL unless benefits clearly outweigh risks
◦Screen for hyperglycemia: Standard glucose loading test at 24-28 weeks Consider earlier screening if on chronic PI-based therapy
◦Risk of lactic acidosis/hepatic steatosis owing to NRTIs: Monitor hepatic enzymes, electrolytes monthly in 3rdtrimester; assess often for new symptoms
April 2009 www.aidsetc.org 19
Stopping ART during Stopping ART during PregnancyPregnancy
Avoid interruption of ART, if possibleIf discontinuation required, stop and reinitiate
all drugs at the same time, except:
◦ If on NNRTI, if possible stop NNRTI first, continue othersfor approximately 7 days NNRTIs have long half-life; optimal interval between stopping
NNRTI and other ARV drugs not known
If restarting NVP after interruption of >2 weeks,restart with standard 2-week dosage escalation
April 2009 www.aidsetc.org 20
Failure of Viral Failure of Viral SuppressionSuppression
Assess resistance, adherence, dosing, and problems with absorption
Consider modification of ARV regimen
Consult with an expert
Scheduled cesarean delivery recommended if HIV RNA >1,000 copies/mL near time of delivery
April 2009 www.aidsetc.org 21
Monitoring Woman and Monitoring Woman and FetusFetus
Monitor CD4 cell count at initial visit and every 3 months thereafter
Monitor plasma HIV RNA levels to assess rapid and sustained lowering
◦ At initial visit◦ 2-6 weeks after starting/changing ARV regimen◦ Monthly until RNA levels undetectable◦ Every 2 months during pregnancy◦ At 34-36 weeks for decision on mode of delivery
April 2009 www.aidsetc.org 22
Monitoring Woman and Monitoring Woman and FetusFetus (2)(2)
◦Perform resistance testing for women with suboptimal VL suppression or rebound
◦Monitor for ARV drug complications
◦Ultrasound recommendations:
1st trimester – confirmation of gestational age and potential timing for cesarean delivery, if needed
2nd trimester – assess fetal anatomy for women oncombination ARVs (especially EFV) during 1st trimester
April 2009 www.aidsetc.org 23
ARV Resistance in ARV Resistance in PregnancyPregnancy
Resistance to ARVs may:
◦Decrease efficacy of perinatal prophylaxis
◦Limit future maternal treatment options
◦Limit treatment options in infected infants
April 2009 www.aidsetc.org 24
Incidence of Incidence of Resistance with Resistance with Prophylactic Prophylactic RegimensRegimensSingle-dose NVP added to an ongoing
ART regimen not recommended
◦ No additional efficacy
◦ May result in NVP drug resistance
April 2009 www.aidsetc.org 25
Prevention of ARV Drug Prevention of ARV Drug ResistanceResistance
Select ARVs according to ART history and resistancetest results
Maximally suppress viral replication Counsel patient about adherenceIf stopping NVP / NNRTI-containing regimen,
consider continuing NRTIs for 7 days after stopping NNRTI ◦ NNRTIs have very long half-lives
◦ Need to “cover” period of persisting NNRTI exposure
◦ Optimal time to continue NRTIs is not known
April 2009 www.aidsetc.org 26
Intrapartum Care Intrapartum Care for HIV-Infected for HIV-Infected WomenWomen
Intrapartum ARV Intrapartum ARV Therapy/ProphylaxisTherapy/Prophylaxis
IV ZDV recommended for all HIV-positive women during labor
◦ Continue other ARVs orally on schedule, as possible
◦ When administering ZDV, discontinue d4T
If suboptimal VL suppression on ARV, single-dose intrapartum maternal + infant NVP not recommended
◦ Cesarean delivery if VL >1,000 copies/mL
April 2009 www.aidsetc.org 28
Intrapartum ARV Intrapartum ARV Therapy/Prophylaxis Therapy/Prophylaxis (2)(2)
If no antepartum ARV therapy to mother, administerIV ZDV during labor and continue 6 weeks of infant ZDV
Unknown whether additional ARVs during labor and to neonate further reduces perinatal transmission
◦Some would add single-dose intrapartum maternal + infant NVP, with oral 3TC to mother + 7 days of ZDV/3TC to mother
April 2009 www.aidsetc.org 29
Intrapartum ARV Intrapartum ARV Therapy/Prophylaxis Therapy/Prophylaxis (3)(3)
If woman’s HIV status unknown, administer rapid HIV antibody test
If test result is positive, give IV ZDV and initiate infant ZDV
Confirmatory HIV test done postpartum
If positive, give infant 6 weeks of ZDV
If negative, stop infant ZDV
April 2009 www.aidsetc.org 30
HIV Transmission and Cesarean HIV Transmission and Cesarean DeliveryDelivery
Schedule at 38 weeks to reduce risk of transmission:
◦ For women with HIV RNA levels >1,000 copies/mL(whether on ARVs or not) near time of delivery
◦ For women with unknown HIV RNA levels◦ Benefits of C/S not clear after rupture of
membranesor onset of labor: base decision on clinical factors
Benefits of C/S unclear for women with HIV RNA levels <1,000 copies/mL
◦ Scheduled C/S may not further reduce risk of transmission
April 2009 www.aidsetc.org 31
Maternal Risks by Mode of Maternal Risks by Mode of DeliveryDelivery
Counsel women about potential risks and benefits of cesarean vs vaginal delivery
C/S associated with greater risk of complications ◦ Compared with vaginal delivery in HIV-infected women
◦ Compared with C/S in HIV-uninfected women
◦ Scheduled C/S less risky than emergent C/S
Complications do not outweigh benefits of reduced HIV transmission for those at increased risk
Prophylactic narrow spectrum antibiotic generally recommended at time of C/S
April 2009 www.aidsetc.org 32
Other Intrapartum Other Intrapartum Management IssuesManagement Issues
Avoid artificial rupture of membranes or invasive monitoring unless obstetrically indicated and duration is expected to be short
Use forceps or vacuum extractor only in select circumstances
Avoid use of Methergine for postpartum hemorrhage in women receiving PIs, EFV, or DLV ◦ Risk of exaggerated vasoconstrictive response
◦ Use if no other alternative, at low dosage and for short duration
April 2009 www.aidsetc.org 33
Postpartum Postpartum Management Management for HIV-Infected Womenfor HIV-Infected Women
Postpartum Postpartum Follow-UpFollow-Up Coordinate medical services between obstetric
and HIV specialists
ART:
◦ Continuing or stopping depends on CD4 nadir, clinical symptoms, disease stage, and other factors
◦ If nadir CD4 <350 cells/µL or symptomatic, encourage continuing the regimen
◦ If started ART with nadir of CD4 >350 cells/µL, consult the provider on whether to continue therapy
◦ If no indication for therapy, stop ARVs after delivery
Adherence may be challenging in postpartum period
April 2009 www.aidsetc.org 35
Postpartum Follow-Postpartum Follow-Up Up (2)(2)
Women with positive rapid HIV test result in labor ◦ Confirmation of HIV infection
◦ Counseling and comprehensive medical assessment
◦ Assessment of need for ART
◦ Supportive services to be assured prior to discharge
Breast-feeding not recommended (risk of HIV transmission via breast milk)
April 2009 www.aidsetc.org 36
Postpartum Follow-Postpartum Follow-UpUp (3)(3)
Contraceptive counseling is critical
◦ Condom use important for prevention of HIV and STD transmission
◦ Unintended pregnancy rate is high with condom use alone
◦ Drug interactions between oral contraceptives and many PIs and NNRTIs
◦ For women who are certain they do not wish future childbearing: thorough counseling and discussion about permanent contraceptive methods
April 2009 www.aidsetc.org 37
Neonatal Postnatal Neonatal Postnatal CareCare
Infants Born to Mothers with Infants Born to Mothers with Unknown HIV Infection Unknown HIV Infection StatusStatus
Rapid HIV antibody testing of mother or infant recommended◦ If positive:
Initiate ARV prophylaxis for infant immediately Perform confirmatory test (eg, Western blot) Positive infant antibody test cannot distinguish
maternal from infant infection – requires HIV virologic test
If confirmatory test is negative (in mother or infant), discontinue ARV prophylaxis
April 2009 www.aidsetc.org 39
Infant ARV Infant ARV ProphylaxisProphylaxis
6-week ZDV chemoprophylaxis advised for all HIV-exposed neonates
◦Should be initiated within 6-12 hours of delivery
◦ If concerns about adherence or toxicity, may consider reducing infant prophylaxis from 6 to 4 weeks
◦Dosage is different for premature infants; consultwith pediatric HIV specialist
April 2009 www.aidsetc.org 40
Infant ARV Infant ARV ProphylaxisProphylaxis (2)(2)
Combination therapy: ZDV + additional ARVs
◦Additional efficacy in prevention of infant infection not proven
◦Consult with a pediatric HIV specialist if considering additional ARVs in situations of increased transmission risk
April 2009 www.aidsetc.org 41
Infant ARV Infant ARV ProphylaxisProphylaxis (3)(3)
Use of additional drugs will depend on: ◦ Maternal HIV RNA level near delivery
◦ Mode of delivery
◦ Gestational age at delivery
◦ Availability of drug formulation
◦ Dosing information for neonates (known for few ARVs)
Risks of toxicity in neonates are unclear◦ Limited data on most ARVs
April 2009 www.aidsetc.org 42
Initial Management Initial Management of the HIV-of the HIV-ExposedNeonateExposedNeonate
Monitoring ARV effects◦CBC and differential before starting ZDV
Follow-up of hematologic monitoring varies by baseline results, clinical factors
If hematologic abnormalities identified, consult pediatric HIV specialist
◦LFTs may be required for infants exposed tocombination ARV therapy in utero or after birth
◦Serum lactate: recommended if infant develops severe clinical symptoms of unknown etiology If severely abnormal (>5 mmol/L), discontinue ARV prophylaxis
and consult pediatric HIV specialist
April 2009 www.aidsetc.org 43
Initial Management Initial Management of the of the HIV-Exposed HIV-Exposed Neonate Neonate (2)(2)
Begin PCP prophylaxis (TMP-SMX) at 6 weeks,after completion of ZDV regimen, unless HIVhas been ruled out
Diagnosis of HIV infection in neonates: virologictests (HIV DNA or RNA)◦ Age 14-21 days,◦ 1-2 months, and◦ 4-6 months◦ Some experts test at birth
April 2009 www.aidsetc.org 44
Long-Term Long-Term Follow-Up of Follow-Up of ARV-Exposed ARV-Exposed InfantsInfantsChildren with significant organ system
abnormalities of unknown etiology: evaluate for mitochondrialdysfunction
Other possible early and late effects of in utero ARV exposure are not fully known
Follow-up should continue into adulthood
◦ Should include yearly physical examination
◦ For adolescent females, should include gynecologicevaluation with Pap tests
April 2009 www.aidsetc.org 45
Infant FeedingInfant Feeding
It Takes An Island!It Takes An Island!
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