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U.S. Public Health ServiceU.S. Public Health ServicePerinatal GuidelinesPerinatal Guidelines
Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for
Maternal Health and to Reduce PerinatalHIV-1 Transmission in the United States
April 2009April 2009
April 20092 www.aidsetc.org2
About This PresentationAbout This Presentation
These slides were developed using the April 2009 guidelines. The intended audience is clinicians involved in the care of patients with HIV infection.
Users are cautioned that, because of the rapidly changing field of HIV care, this information could become out of date quickly. Finally, 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
http://www.aidsetc.org
April 20093 www.aidsetc.org
Table of ContentsTable of Contents
Topic
Lessons from Clinical Trials Preconception Counseling and Care Management of Pregnant Women with
HIV-Infected Male Partner Antepartum Management Intrapartum Management Postpartum Management Neonatal Postnatal Care
Slide Number
6
11
14
16
53
60
64
April 20094 www.aidsetc.org
IntroductionIntroduction
U.S. recommendations have evolved over 25 years
With universal prenatal HIV counseling and testing, ARV prophylaxis, scheduled cesarean section delivery, and avoidance of breast-feeding, perinatal HIV infection has diminished to <2% in the United States
The guidelines and slides update the July 8, 2008, recommendations
The most recent information is available from the AIDSinfo website: http://aidsinfo.nih.gov
April 20095 www.aidsetc.org
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)
Lessons from Clinical TrialsLessons from Clinical Trialsof ARV Interventions to Reduceof ARV Interventions to ReducePerinatal HIV TransmissionPerinatal HIV Transmission
April 20097 www.aidsetc.org
ARVs: Mechanisms of ActionARVs: Mechanisms of Action
ARVs reduce perinatal transmission by several mechanisms:
Decreasing maternal viral load Preexposure and postexposure infant prophylaxis
Combined antepartum, intrapartum, and infant ARV prophylaxis is recommended
April 20098 www.aidsetc.org
International Studies: Short-Course International Studies: Short-Course Regimens to Prevent TransmissionRegimens to Prevent Transmission
Combination ARV regimens are more effective than 1-drug therapy
Longer duration of antepartum ARV prophylaxis is more effective than shorter duration
Should start prophylaxis at least by 28 weeks
If no maternal antepartum therapy, administer ARVs during labor and delivery, and to the infant
Less effective than if antepartum ARVs also given
April 20099 www.aidsetc.org
International Studies: Short-Course International Studies: Short-Course Regimens to Prevent Transmission Regimens to Prevent Transmission (2)(2)
If no maternal therapy, give postnatal infant ARV prophylaxis with a minimum of ZDV for 6 weeks
In the United States:
Adding single-dose NVP to standard combination antepartum ARV therapy is not recommended
No additional efficacy; may cause NVP resistance
Breast-feeding is not recommended for HIV-infected women (including those receiving suppressive combination ART) Safe, affordable, and feasible alternatives are available and
culturally acceptable
April 200910 www.aidsetc.org1010
Transmission and Maternal HIV RNATransmission and Maternal HIV RNA
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
Preconception Counseling andPreconception Counseling andCare for HIV-Infected WomenCare for HIV-Infected Womenof Childbearing Ageof Childbearing Age
April 200912 www.aidsetc.org
RecommendationsRecommendations
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 200913 www.aidsetc.org
Recommendations Recommendations (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)
Management of the Pregnant Woman with an HIV-Infected Male Partner
April 200915 www.aidsetc.org
Pregnant Woman with an Pregnant Woman with an HIV-Infected Male PartnerHIV-Infected Male Partner
Test for HIV (unless patient declines) 2nd HIV test in 3rd trimester, before 36 weeks if possible
If patient presents in labor: rapid HIV test
If 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
Antepartum Care Antepartum Care for HIV-Infected Womenfor HIV-Infected Women
April 200917 www.aidsetc.org
Use of ARVs during Pregnancy: Use of ARVs during Pregnancy: General PrinciplesGeneral Principles
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 200918 www.aidsetc.org
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 200919 www.aidsetc.org
HIV-Infected Pregnant Women HIV-Infected Pregnant Women Currently on ARTCurrently on ART
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 200920 www.aidsetc.org
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 200921 www.aidsetc.org
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 200922 www.aidsetc.org
Women Not Currently on ARVs with Women Not Currently on ARVs with History of Prophylaxis or TreatmentHistory of Prophylaxis 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 200923 www.aidsetc.org
Special Considerations for ARV UseSpecial Considerations for ARV Useby Pregnant Women and Infantsby Pregnant Women and Infants
Pregnancy 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 200924 www.aidsetc.org
Special Considerations for ARV Use Special Considerations for 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 200925 www.aidsetc.org
Special ConsiderationsSpecial Considerations for ARV Use for 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 weeksConsider earlier screening if on chronic PI-based therapy
Risk of lactic acidosis/hepatic steatosis owing to NRTIs: Monitor hepatic enzymes, electrolytes monthly in 3rd
trimester; assess often for new symptoms
April 200926 www.aidsetc.org
Types of ARV RegimensTypes of ARV Regimens
NNRTI based
(1 NNRTI + 2 NRTI backbone)
PI based
(1 or 2 PIs + 2 NRTI backbone)
NRTI based
(3 NRTIs: inferior virologic efficacy; consider if NNRTI- or PI-based regimen is not appropriate)
April 200927 www.aidsetc.org
Current ARV MedicationsNRTI Abacavir (ABC) Didanosine (ddI) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4T) Tenofovir (TDF) Zidovudine (AZT, ZDV)
NNRTI Efavirenz (EFV) Delavirdine (DLV) Etravirine (ETR) Nevirapine (NVP)
PI Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Lopinavir (LPV) Nelfinavir (NFV) Ritonavir (RTV) Saquinavir (SQV) Tipranavir (TPV)
Entry Inhibitor Enfuvirtide (ENF, T-20) Maraviroc (MVC)
Integrase Inhibitor Raltegravir (RAL)
April 200928 www.aidsetc.org
Components of ART: Components of ART: Working Group CategoriesWorking Group Categories
Recommended
Alternative
Use in Special Circumstances
Insufficient Data to Recommend Use
Not Recommended
April 200929 www.aidsetc.org
ARV Recommendations: NRTIsARV Recommendations: NRTIs
Recommended Concerns in Pregnancy
3TC Extensive studies in pregnancy
ZDV Extensive studies in pregnancy
Alternative
ABC Risk of hypersensitivity reaction; test for HLA-B*5701 before starting; do not use if positive for HLA-B*5701
ddI Lactic acidosis, sometimes fatal, with ddI + d4T
FTCSlightly lower levels in 3rd trimester; no clear
need to increase dosage
d4T Same as ddI
• Class concerns for NRTIs: lactic acidosis, mitochondrial toxicity
April 200930 www.aidsetc.org
ARV Recommendations: NRTIs ARV Recommendations: NRTIs (2)(2)
Use in Special Circumstances
Concerns in Pregnancy
TDF Limited studies in pregnant women; concern for possible fetal bone effects; monitor for renal toxicity during pregnancy
• Class concerns for NRTIs: lactic acidosis, mitochondrial toxicity
April 200931 www.aidsetc.org
ARV Recommendations: NNRTIsARV Recommendations: NNRTIs
Recommended Concerns in Pregnancy
NVPIncreased risk of potentially fatal liver toxicity if initiated at CD4 counts of >250/µL
Use in Special Circumstances
EFV
FDA pregnancy class D; case reports of neural tube defects in humans with 1st trimester exposure
• Can be considered after 1st trimester• If continued postpartum, ensure adequate
contraception (concerns include drug interactions with hormonal contraceptives; risk of teratogenicity in fetus if woman becomes pregnant while taking EFV)
• Class concerns for NNRTIs: rash, hypersensitivity, hepatic toxicity
April 200932 www.aidsetc.org
ARV Recommendations: NNRTIs ARV Recommendations: NNRTIs (2)(2)
Insufficient Data to Recommend Use
Concerns in Pregnancy
ETR Insufficient data
Not RecommendedDLV Teratogenic in animals
• Class concerns for NNRTIs: rash, hypersensitivity, hepatic toxicity
April 200933 www.aidsetc.org
ARV Recommendations: PIsARV Recommendations: PIs
Recommended Concerns in PregnancyLPV/r* Optimal dosing of tablet formulation during
pregnancy is uncertain
AlternativeATV/r* Optimal dosing during pregnancy is uncertain
IDV/r* May exacerbate hyperbilirubinemia in neonate
NFV May require increased dosage in 3rd trimester
SQV/r* Limited data on hard-gel and tablet formulations
• Class concerns for PIs: hyperglycemia, diabetes, question of increased risk of preterm delivery
* r = low-dose ritonavir
April 200934 www.aidsetc.org
ARV Recommendations: PIs ARV Recommendations: PIs (2)(2)
Insufficient Data to Recommend Use Concerns in Pregnancy
DRV/r* No experience in pregnancy
FPV/r* Limited experience in pregnancy
TPV/r* No experience in pregnancy
* r = low-dose ritonavir
April 200935 www.aidsetc.org
ARV Recommendations: Entry InhibitorsARV Recommendations: Entry Inhibitors
Insufficient Data to Recommend Use
Concerns in Pregnancy
ENF Minimal data in pregnancy
MVC No experience in pregnancy
April 200936 www.aidsetc.org3636
ARV Recommendations: Integrase InhibitorsARV Recommendations: Integrase Inhibitors
Insufficient Data to Recommend Use
Concerns in Pregnancy
RAL No experience in pregnancy
April 200937 www.aidsetc.org
HIV/HBV CoinfectionHIV/HBV Coinfection
Screen for HBsAg
Interferons not recommended during pregnancy
If chronic HBV/HIV, and treatment required for either, use 3-drug regimen
Include TDF + 3TC or FTC in ARV regimen
Entecavir should not be used without fully suppressive anti-HIV ARV regimen (risk of ARV resistance)
April 200938 www.aidsetc.org
HIV/HBV CoinfectionHIV/HBV Coinfection (2)(2)
Postpartum, if treatment of HBV but not HIV indicated, consult with expert
Risk of HBV flare with discontinuation of HBV-active ARVs
Options include:
Stop ARVs and start pegylated interferon-alfa
Continue the 3-drug ARV regimen
April 200939 www.aidsetc.org
HIV/HBV CoinfectionHIV/HBV Coinfection (3)(3)
If HBV/HIV coinfected and treatment not required for either, consult with expert
Options include:
Antepartum 3-drug regimen including TDF + 3TC or FTC; discontinue postpartum (monitor closely for HBV flare)
Antepartum 3-drug regimen without TDF + 3TC or FTC; discontinue postpartum
April 200940 www.aidsetc.org
HIV/HBV CoinfectionHIV/HBV Coinfection (4)(4)
Check transaminase levels 2 weeks after ARV initiation, at least monthly thereafter
Infants: give HBIG and begin HBV vaccination series within 12 hours of birth
April 200941 www.aidsetc.org
HIV/HCV CoinfectionHIV/HCV Coinfection Screen for HCV
Interferons not recommended during pregnancy
Ribavirin contraindicated during pregnancy(teratogenic)
Coinfection increases risk of perinatal HCV transmission, and perhaps of HIV transmission
Consider combination ART for all HCV/HIVpregnant women
April 200942 www.aidsetc.org
HIV/HCV CoinfectionHIV/HCV Coinfection (2)(2)
Check transaminase levels 2 weeks after ART initiation, at least monthly thereafter
Mode of delivery based on considerations related to HIV infection alone
Evaluate infants by HCV RNA testing (at 2-6 months) and/or HCV antibody testing (after age 15 months)
April 200943 www.aidsetc.org
Stopping ART during PregnancyStopping ART during Pregnancy
Avoid interruption of ART, if possible
If discontinuation required, stop and reinitiateall drugs at the same time, except: If on NNRTI, if possible stop NNRTI first, continue others
for 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 200944 www.aidsetc.org
Failure of Viral SuppressionFailure of Viral Suppression
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 200945 www.aidsetc.org
Monitoring Woman and FetusMonitoring Woman and Fetus
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 200946 www.aidsetc.org
Monitoring Woman and FetusMonitoring Woman and Fetus (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 200947 www.aidsetc.org
ART and Pregnancy OutcomeART and Pregnancy Outcome
Conflicting data: Are ARVs associated with adverse outcomes, especially preterm delivery? – Most U.S. data do not demonstrate increased risk
Conflicting data: Does in utero ARV exposure cause mitochondrial dysfunction in neonates?– If so, appears to occur very rarely
HIV-infected women should receive combination ART according to current guidelines
April 200948 www.aidsetc.org
ARV Resistance in PregnancyARV Resistance in Pregnancy
Resistance to ARVs may:
Decrease efficacy of perinatal prophylaxis
Limit future maternal treatment options
Limit treatment options in infected infants
April 200949 www.aidsetc.org
ARV Resistance Testing during PregnancyARV Resistance Testing during Pregnancy
Recommended for:
Women not currently on ARVs – before starting treatment or prophylaxis
Women experiencing virologic failure or suboptimal VL suppression
To maximize prevention of perinatal transmission, empiric ART can be started before test results are available, with adjustments made after results are known
April 200950 www.aidsetc.org
Management of ARV Resistance Management of ARV Resistance during Pregnancyduring Pregnancy
Women with ZDV resistance should still receive IV ZDV during labor, along with their ARV regimen
Their infants should receive oral ZDV for 6 weeks
Often, only wild-type virus is transmitted
ZDV crosses placenta readily, with high levels in fetus
Reduces genital HIV VL
Consult pediatric HIV specialist
Discontinue d4T in women taking ZDV
April 200951 www.aidsetc.org
Incidence of Resistance with Incidence of Resistance with Prophylactic RegimensProphylactic Regimens
Single-dose NVP added to an ongoing ART regimen not recommended
No additional efficacy
May result in NVP drug resistance
April 200952 www.aidsetc.org
Prevention of ARV Drug ResistancePrevention of ARV Drug Resistance
Select ARVs according to ART history and resistancetest results
Maximally suppress viral replication
Counsel patient about adherence
If 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
Intrapartum Care Intrapartum Care for HIV-Infected Womenfor HIV-Infected Women
April 200954 www.aidsetc.org
Intrapartum ARV Therapy/ProphylaxisIntrapartum ARV Therapy/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 200955 www.aidsetc.org
Intrapartum ARV Therapy/Prophylaxis Intrapartum ARV 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 200956 www.aidsetc.org
Intrapartum ARV Therapy/Prophylaxis Intrapartum ARV 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 200957 www.aidsetc.org
HIV Transmission and Cesarean DeliveryHIV Transmission and Cesarean Delivery
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 membranes
or 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 200958 www.aidsetc.org
Maternal Risks by Mode of DeliveryMaternal Risks by Mode of Delivery
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 200959 www.aidsetc.org
Other Intrapartum Management IssuesOther Intrapartum Management 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
Postpartum Management Postpartum Management for HIV-Infected Womenfor HIV-Infected Women
April 200961 www.aidsetc.org
Postpartum Follow-UpPostpartum Follow-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 200962 www.aidsetc.org
Postpartum Follow-Up Postpartum Follow-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 200963 www.aidsetc.org
Postpartum Follow-UpPostpartum Follow-Up (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
Neonatal Postnatal CareNeonatal Postnatal Care
April 200965 www.aidsetc.org
Infants Born to Mothers with Unknown Infants Born to Mothers with Unknown HIV Infection StatusHIV Infection Status
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 200966 www.aidsetc.org
Infant ARV ProphylaxisInfant ARV Prophylaxis
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 200967 www.aidsetc.org
Infant ARV ProphylaxisInfant ARV Prophylaxis (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 200968 www.aidsetc.org
Infant ARV ProphylaxisInfant ARV Prophylaxis (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 200969 www.aidsetc.org
Initial Management of the Initial Management of the HIV-Exposed NeonateHIV-Exposed Neonate
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 200970 www.aidsetc.org
Initial Management of the Initial Management of the HIV-Exposed Neonate HIV-Exposed 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 200971 www.aidsetc.org
Long-Term Follow-Up of Long-Term Follow-Up of ARV-Exposed InfantsARV-Exposed Infants
Children 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 200972 www.aidsetc.org
Guidelines InformationGuidelines Information
U.S. Public Health Service Perinatal Guidelines
Working Group meets monthly, reviews clinical trials
results, and updates the guidelines
The published text is posted on www.aidsinfo.nih.gov
April 200973 www.aidsetc.org
This presentation was prepared by Susa Coffey, MD; Rebecca Fry, MSN, APN; Elaine Gross, RN, MS; Supriya Modey, MPH, MBBS; for the AETC National Resource Center in July 2008, and revised in April 2009
See the AETC National Resource Center website for the most current version of this presentation:
http://www.aidsetc.org
About This Slide SetAbout This Slide Set