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Prenatal Care for the HIV Positive Woman

Prenatal Care for the HIV Positive Woman. Best Practices for Reducing Mother to Child HIV Transmission (MTCT). Objectives. Describe HIV epidemiology in HIV Mother to Child Transmission (MTCT) Review HIV care during pregnancy and post partum Recognize the symptoms of acute HIV

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Prenatal Care for the HIV Positive Woman

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  1. Prenatal Care for theHIV Positive Woman Best Practices for Reducing Mother to Child HIV Transmission (MTCT)

  2. Objectives Describe HIV epidemiology in HIV Mother to Child Transmission (MTCT) Review HIV care during pregnancy and post partum Recognize the symptoms of acute HIV Discuss the importance of continuity of care for the pregnant woman with HIV.

  3. Percent of Women Aware of HIV StatusPrior to Delivery in NYS, 1997-2008 Expedited testing regulations initiated August 1999 From 1997 to 2003, the percentage of women aware of their HIV status before delivery increased from 64% to 95%, and has remained at 95%. Source: Bureau of HIV/AIDS Epidemiology, NYSDOH

  4. Mother-to-Child HIV Transmission Rateby Year, NYS, 1990-2008 *1990: 1,898 known HIV (+) births in NYS; 25% transmission rate and subsequent estimate of HIV-infected newborns are based on generally-accepted medical knowledge at that time. Source: Bureau of HIV/AIDS Epidemiology, NYSDOH

  5. U.S. Population, HIV/AIDS Cases, HIV-exposed Births and HIV infected infants by Race/Ethnicity, 2005 7% 2% 2% 0% 2% *HIV/AIDS Reporting System, CDC. HIV/AIDS Surveillance Report, Vol.17, 2007 **Enhanced Perinatal Surveillance, CDC, unpublished data.

  6. HPTN 052:Study Design Delayed ART CD4 <250 cells/mm3 Randomization 1:1 Phase 3 study Americas, African, Asian sites (n=1763 couples) Stable, healthy, sexually active, serodiscordant couples CD4 350-550 cells/mm3 Similar baseline demographic characteristics and sexual history/behavior both arms and between HIV-negative partner and HIV-positive, treatment naïve index patient Early ART CD4 350 to 550 cells/mm3 Primary Endpoints • Transmission • Virologically linked transmission events • Clinical • WHO stage 4 clinical events • Pulmonary TB • Severe bacterial infection and/or death Cohen M, et al. N Engl J Med. 2011;Jul 18. [Epub ahead of print].

  7. HPTN 052:DSMB Halts Trial April 28, 2011 • Median follow-up: 1.7 years • HIV RNA <400 copies/mL • Early ART: 90% • Delayed ART: 93% • Linked HIV transmission to HIV-negative partner (n=39) • Early therapy (n=1) • 0.1 per 100 person-years • Delayed therapy (n=27) • 1.7 per 100 person-years • Early ART that suppressed HIV RNA led to a 96% reduction of sexual transmission of HIV in serodiscordant couples Linked HIV Transmission HR: 0.04 (95% CI 0.01-0.27) (P<0.001) Delayed ART Cumulative Probability Early ART 0 1 2 3 4 5 *Transmission occurred within 90 days after the index initiated antiretroviral therapy. Years Cohen M, et al. N Engl J Med. 2011;Jul 18. [Epub ahead of print]. Hosseinipour MC, et al. 6th IAS Conference. Rome, 2011. Abstract MoAX0104.

  8. Elimination of Perinatal HIV—Why? It is feasible We know how We have the tools Missed opportunities account for most remaining transmissions Cost-savings potentially $25,000,000/yr Discounted lifetime medical care cost for an HIV-infected child= $250,000 > 100 perinatal infections per year remaining

  9. Elements of preconception care:maintaining optimal health Folic acid supplementation Smoking cessation, treatment for illicit drug and alcohol use Mental health screening and referrals Normalize BMI - exercise Immunizations Dental care History – obstetrical, family, maternal age Sustained clinical and immunological stability ACOG, CDC, AI

  10. Preconception Care: ARV Use • Preconception counseling includes discussion of benefits and risks of ARV therapy. • The HIV pregnancy registry has increasing evidence for the lack of a teratogenic effect with ARVs, except for efavirenz. • Efavirenz should be avoided in women of childbearing potential who are not using effective contraception if other treatment options are available • Efavirenz and combination pills containing efavirenz are contraindicated during the first trimester of pregnancy. • If a woman receiving efavirenz is discovered to be pregnant in the second or third trimester, an alternative regimen should be offered, but the efavirenz-containing regimen can be continued if the benefits outweigh the risks.

  11. Identified Factors Contributing to Decrease of MTCT in NYS Early identification of HIV (before & during pregnancy) Streamlined Counseling and Testing At initial prenatal visit Repeat testing 34 to 36 weeks - one consent Expedited test in Labor and Delivery Antiretroviral (ARV) therapy Coordination between prenatal and HIV care providers Intrapartum and postnatal care, including avoidance of breastfeeding

  12. Acute HIV infection and MTCT Disease may be missed if woman tested negative earlier in pregnancy and was not tested again in the third trimester If diagnosis is missed, no ARV prophylaxis High viral load – no elective C/S at 38 weeks No avoidance of invasive procedures Breastfeeding increases risk Will probably be diagnosed by newborn screening unless still in window

  13. Acute HIV Infection (AHI) Occurs within first 2 weeks of HIV exposure Elevated viral load despite negative HIV antibody test HIV antibody takes 2 to 8 weeks to appear (average is 25 days) Viral load can be > 100,000 copies/ml (usually millions of viral copies/ml) Patient is highly infectious 17

  14. AHI During Pregnancy 18 AHI may not be recognized (symptoms may be attributed to other conditions such as URI, etc) Educate women during pregnancy about AHI. May occur at any time during pregnancy, even after initial NEGATIVE HIV TEST. Need information about risk behavior of partners as well as the patient Risk of MTCT higher due to high maternal VL during acute infection Consider that women who are HIV negative who breastfeed and then have acute HIV infection, may transmit HIV to their baby (30% risk if breastfeeding during AHI).

  15. AHI Clinical symptoms Fever 80-90% Fatigue 70-90% Rash 40-80% Lymphadenopathy 40-70% Pharyngitis 50-70% Myalgia/arthrlagia 50-70% 19

  16. Maculopapular rash during primary HIV infection: Trunk > Extremities.

  17. Acneiform lesions during primary HIV infection

  18. Diagnosis history High index of suspicion Be alert for complaints/symptoms of acute viral illness, presentation with STDs in prenatal clinic or ER. Symptoms are non-specific Woman may deny activity that may have placed them at risk of HIV acquisition If clinical picture is consistent with AHI, providers should test with consent

  19. Laboratory Diagnosis Immediate HIV RNA viral load testing and HIV antibody test Work closely with the HIV clinic when determined patient experiencing AHI

  20. ARV Use During Pregnancy:Goals • Goals in use of HAART during pregnancy • treatment of maternal infection • reduction in the risk of perinatal transmission • Pregnant women who meet criteria for HAART • offer standard combination ARV therapy as for other adults and adolescents • include Zidovudine (ZDV) • two nucleoside reverse transcriptase inhibitors (NRTIs) and a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) (excluding efavirenz) • Reduction of maternal viral load is key to reduction of MTCT

  21. Trends in ARV Use by HIV-Positive Pregnant Women in NYS - 1997-2007 December 2009 26 Source: Bureau of HIV/AIDS Epidemiology, NYSDOH

  22. Impact of ARV on MTCT of HIV in the US Cooper, et al, JAIDS, 2002 27

  23. MTCT of HIV: Rates Based on Viral Load (VL) at Delivery 28 Garcia,et al, NEJM, 1999

  24. ARV Use During Pregnancy:Resistance Testing Not currently receiving ARV, before starting Rx or prophylaxis Receiving antenatal ARV with persistent detectable HIV RNA levels or have sub-optimal viral suppression after starting ARV therapy Start ARV therapy even in absence of drug resistance testing; modify therapy when resistance testing is available 29

  25. Abbreviated Regimens of ZDV Prophylaxis and Perinatal Transmission of HIV *p<0.05 compared to no ZDV prophylaxis Wade et al, NEJM, 339:20, 11/12/98; 1409-1414. 30

  26. ARV Use During Pregnancy:Role of ZDV Include ZDV in all regimens of ARV therapy during pregnancy, during labor and to the newborn Important exceptions Severe toxicity to ZDV Resistance to ZDV Already on a fully suppressive regimen If ZDV toxicity precludes use during pregnancy, include IV ZDV during labor and delivery 31

  27. ARV Use During Pregnancy:Prevention of MTCT ARV RX/Prophylaxis for prevention of MTCT should be recommended for all pregnant HIV positive women regardless of HIV RNA viral load or CD4 count HIV positive pregnant women who are not on RX for their own health, should receive ARV including ZDV starting at 14 weeks unless there is severe toxicity. 32

  28. Monitoring HIV positive Pregnant Women CD4 initial and every 3 months Plasma RNA should be monitored Initially Every 2 to 4 weeks After initiating HAART With change in ARV therapy Monthly till undetectable Every 3 months At 34 to 36 weeks to plan for delivery Monitor for drug complications – CMB/CBC every trimester 33

  29. Special considerations Report to ARV pregnancy registry www.apregistry.com/ With adverse effects, alter drug regimen NVP with CD4 greater than 250/mm3 - watch for rash, hepatic toxicity Lactic acidosis/ hepatic steatosis syndrome with d4T and ddI – monthly evaluation in 3rd trimester Glucose screening Give ZDV during labor and then to newborn even if woman’s virus is resistant to ZDV 34

  30. Intrapartum care IV ZDV is recommended for ALL HIV positive pregnant women regardless of antepartum regimen For women taking d4T – discontinue d4T during labor while IV ZDV is being administered Continue combination therapy on schedule during labor and prior to scheduled C/S 35

  31. Intrapartum Care for Women with no Prenatal ARV IV ZDV during labor and 6 weeks infant ZDV Single-dose NVP associated with development of resistance but this can be managed with short course of alternate classes of ARV agents post partum If it is given in combination with ZDV, consider also giving 3TC during labor and maternal ZDV/3TC for 7 days to reduce development of NVP resistance 36

  32. Maternal Risks of Morbidity by Mode of Delivery ACOG recommends consideration of scheduled CS (CS prior to labor and rupture of membranes) for HIV-infected pregnant women with HIV viral load >1,000 copies/mL near the time of delivery. Given the low rate of MTCT in women receiving HAART with VL less than 1000 copies per ml, it is unlikely that elective C/S would further decrease risk of MTCT Collaborative decision – risk to mother balanced with potential benefits expected for the neonate. 37

  33. Other obstetrical factors Certain obstetric procedures increase the risk of fetal exposure to maternal blood Amniocentesis Fetal scalp electrodes Other modes of invasive monitoring. Operative delivery with forceps or vacuum extractor may increase the risk of transmission and should be avoided if possible. Operative delivery may be considered in selected circumstances to shorten the time to delivery 38

  34. New York State Expedited HIV Testing Regulations Effective November 1, 2003 If a pregnant woman appears in labor and delivery with no documentation of her HIV status, she will receive a recommendation to be screened for HIV. Ideally screening test result should be available in one to two hours but, by regulation must be received no later than 12 hrs after: Mother consents to testing Birth of baby All preliminary positive results must be reported to DOH (on DOH-4159) regardless of confirmatory result 39

  35. Preliminary Positive HIV test in Labor IV ZDV ASAP Consider C/S if not in active labor and no ROM Comprehensive follow up including confirmation of HIV infection Call for help – Maternal Fetal Medicine/ HIV specialist Perinatal HIV Hotline – 888-448-8765 40

  36. Residual MTCT Why do vertical HIV transmissions continue to occur? Two groups continue to have increased risk for MTCT Vulnerable populations – women often known to be HIV positive with risk factors such as homelessness, drug use, mental health issues, no prenatal care Sero-converters during pregnancy – became infected after initial negative HIV test conducted earlier in pregnancy; highlighting the importance of second HIV test during third trimester and recent sero-conversion. (NYSDOH Health Alert Feb 2007)

  37. Recommendations and Strategies for Continuity of Prenatal Care Coordinated co-managed OB and HIV care Maintenance of an electronic record accessible to HIV/ID and OB clinicians Regular, periodic interdisciplinary case conference meetings including all clinicians involved in patient’s care Comprehensive Case Management Using resources inside hospital facility or linking to external case managementresources such as COBRA Provide immediate and accessible referrals for mental health, substance use counseling and services, and entitlements

  38. Recommendations and Strategies for Continuity of Care Staff training: create an environment of sensitive, non-judgmental, and cultural competent care to combat high risk patients’ perception of disrespect, lack of confidentiality (Lindau, S.T., Jerome, J., et al., (2006). Mothers on the Margins: Implications for Eradicating Perinatal HIV) Implement quality assurance measures on continuity of care Inclusion of patient in care planning Introduction of the mother to the Pediatric HIV Team during pregnancy Provide patient education about care of the newborn, including ARV and breastfeeding recommendations. Provide prescriptions for infant ARV. Establish post-partum care linkages, including substance use and mental health services. 43

  39. Planning for Discharge and Follow-Up Care • Aggressive post-delivery case management, testing, and treatment for mother and infant • Assess need for comprehensive case management • Mother/caretaker leaves hospital with: prophylactic ARV for newborn, adequate supply of formula, referral to WIC (breastfeeding is not recommended in the US) • Opportunity to review and optimize woman’s health: screening for health, substance use and mental health, including post-partum depression; immunizations. • Multiple contact information to ensure ability to follow-up

  40. Infant Diagnostic Testing A test that detects virus (not antibodies) must be used for infant diagnosis HIV nucleic acid test (NAT) for RNA or DNA should be used to diagnose HIV infection in HIV-exposed infants NYSDOH recommends a series of tests be conducted as follows: within 48 hours, at 2 weeks, at 4-6 weeks and at 4-6 months 45

  41. Infant Diagnostic Testing A positive NAT results at any age should be confirmed by repeat testing as soon as possible on a new sample. Two independent positive NAT definitively diagnose pediatric HIV infection in HIV-exposed infants; no further testing is required. HIV infection can be ruled out if the infant has two or more negative HIV NAT, one of which is done at one month of age or older and another done at 4 months of age or older Free testing at Wadsworth Center’s Diagnostic HIV Pediatric Laboratory, 518-474-2163 46

  42. HIV Testing Timeline MOTHER: All tests require consent Repeat third trimester: identify women who seroconvert during pregnancy Expedited test if no prenatal test on record: allows for 2 of 3 part regimen Recommended testing - allows for full three part regimen 1st trimester Labor and Delivery Birth Infancy 3rd trimester Expedited test at birth ONLY if mom does not consent to her own test: allows for 3rd part of regimen Newborn Screening test at birth: results not available in time to prevent infection INFANT: Consent is NOT required Diagnostic testing for infants exposed to HIV

  43. Take home messages Preconception counseling of all HIV positive women Routine testing: HIV testing at gyn visits - MMWR no. 411, Aug 2008 HIV testing at initial prenatal visit and 34 to 36 weeks gestation Educate woman about acute HIV infection and how it is diagnosed Rapid test in labor and delivery if no prenatal test available Appropriate ARV therapy – locate HIV specialist resources Coordinate OB/HIV care for HIV positive pregnant woman and know available resources

  44. Handout References and Resources Kiarie, J.N., Carey F., et al (2006) Domestic Violence and Prevention of Mother-to Child Transmission of HIV-1, AIDS 20 (2006) 1763-1769.Lindau, S.T., Jerome, J., et al., (2006). Mothers on the Margins: Implications for Eradicating Perinatal HIV, Social Science and Medicine, 62 (2006) 59-69. Burr, C., Fry, R., Weber, S., Armas-Kolostroubis, L, Lampe, M (2009) Integrating Reproductive Health Into HIV Care of Women in the United States: It Is TimeAIDS. 2009 Sep 10;23(14):1928-30 New York State Department of Health, Health Alert: Steps to Further Reduce Mother-To-Child HIV Transmission in New York State, 2007. Patterson, K. B., Leone, P. A., et al., (2007). Frequent Detection of Acute HIV Infection in Pregnant Women, AIDS 2007, 21: 2303-2308. Reduction in Perinatal Transmission of HIV Infection: Milestones in the Reduction of Perinatal HIV Transmission, Morbidity and Mortality Weekly Report, 2006; 55(21) 597-603. 2006 Centers for Disease Control and Prevention (CDC).

  45. Intrapartum management considerations Avoid artificial ROM, invasive monitoring, episiotomy Operative delivery in select circumstances When hemorrhage occurs due to uterine atony in women getting PI, EFV, or delavirdine, methergine should only be used when: Alternative treatment for post-partum hemorrhage is not available Potential benefit outweigh risk Alternate medications: F2alpha, misoprostol, oxytocin If no alternatives are available use methergine in lowest dose and for shortest duration 51

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