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Perinatal Update

Perinatal Update. It Takes An Island!. 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)

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Perinatal Update

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  1. Perinatal Update

  2. It Takes An Island!

  3. 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) www.aidsetc.org

  4. Preconception Counseling andCare for HIV-Infected Womenof Childbearing Age

  5. Recommendations • 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 www.aidsetc.org

  6. Recommendations (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) www.aidsetc.org

  7. Management of the Pregnant Woman with an HIV-Infected Male Partner

  8. Pregnant Woman with an HIV-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 www.aidsetc.org

  9. Antepartum Care for HIV-Infected Women

  10. Transmission 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 allHIV-infected women www.aidsetc.org 10 10

  11. Use of ARVs during Pregnancy: General 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 www.aidsetc.org

  12. General Principles(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 www.aidsetc.org

  13. HIV-Infected Pregnant Women Currently 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 www.aidsetc.org

  14. ARV 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 www.aidsetc.org

  15. ARV Naive (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 CD4cell count is >250 cells/µL, initiate NVP only if benefit outweighs risk (increased risk of hepatic toxicity) • Avoid EFV in 1st trimester www.aidsetc.org

  16. Women Not Currently on ARVs with History 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 www.aidsetc.org

  17. Special Considerations for ARV Useby 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 www.aidsetc.org

  18. Special Considerations for ARV Use (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 www.aidsetc.org

  19. Special Considerationsfor ARV Use (3) • Use with caution during pregnancy: • NVP: Increased risk of hepatotoxicity; do not initiate in women with CD4 counts of >250 cells/µLunless 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 www.aidsetc.org

  20. Stopping 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 othersfor approximately 7 days • NNRTIs have long half-life; optimal interval between stoppingNNRTI and other ARV drugs not known • If restarting NVP after interruption of >2 weeks,restart with standard 2-week dosage escalation www.aidsetc.org

  21. Failure 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 www.aidsetc.org

  22. Monitoring Woman and Fetus • Monitor CD4cell 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 www.aidsetc.org

  23. Monitoring Woman and Fetus(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 www.aidsetc.org

  24. ARV Resistance in Pregnancy • Resistance to ARVs may: • Decrease efficacy of perinatal prophylaxis • Limit future maternal treatment options • Limit treatment options in infected infants www.aidsetc.org

  25. Incidence of Resistance with Prophylactic Regimens • Single-dose NVP added to an ongoing ART regimen not recommended • No additional efficacy • May result in NVP drug resistance www.aidsetc.org

  26. Prevention 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 www.aidsetc.org

  27. Intrapartum Care for HIV-Infected Women

  28. Intrapartum 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 www.aidsetc.org

  29. Intrapartum ARV Therapy/Prophylaxis (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 www.aidsetc.org

  30. Intrapartum ARV Therapy/Prophylaxis (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 www.aidsetc.org

  31. HIV 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 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 www.aidsetc.org

  32. Maternal 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 www.aidsetc.org

  33. Other 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 www.aidsetc.org

  34. Postpartum Management for HIV-Infected Women

  35. Postpartum 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 www.aidsetc.org

  36. Postpartum Follow-Up (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) www.aidsetc.org

  37. Postpartum Follow-Up(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 www.aidsetc.org

  38. Neonatal Postnatal Care

  39. Infants Born to Mothers with Unknown HIV 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 www.aidsetc.org

  40. Infant 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 www.aidsetc.org

  41. Infant ARV Prophylaxis(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 www.aidsetc.org

  42. Infant ARV Prophylaxis(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 www.aidsetc.org

  43. Initial Management of the HIV-ExposedNeonate • 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 prophylaxisand consult pediatric HIV specialist www.aidsetc.org

  44. Initial Management of the HIV-Exposed Neonate (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 www.aidsetc.org

  45. Long-Term Follow-Up of ARV-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 www.aidsetc.org

  46. Infant Feeding

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