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HIV, Women, & Pregnancy Facts, Myths, and Management Nina K. Sublette, PhD, ACRN, AACRN, FNP University of Tennessee Department of Obstetrics and Gynecology St. Jude Children s Research Hospital Department of Infectious Diseases Presented on November 11, 2010 at MCRH s Parallel Paths Lunch and Learn for HIV/AIDS Providers Supported through a generous grant from the MAC AIDS Fund

Parallel Paths Project A series of training sessions on topics of reproductive health for HIV/AIDS social and medical service providers Find more and updated information at: http://mcrh-tn.org/outreach_parallel_paths.asp Funding for this project provided by the MAC AIDS Fund.

Disclosures Definitions Statistics (HIV Epidemiology) HIV Testing Guidelines MTCT Statistics OBSC Infant Follow-up Acknowledgements/References Questions? Anytime!

Definitions HIV Human Immunodeficiency Virus AIDS Acquired Immunodeficiency Syndrome MTCT Mother to Child Transmission HAART Highly Active Antiretroviral Therapy

Incidence & Prevalence Incidence: the number of new cases of a specific disorder occurring within a given population during a certain period of time Prevalence: The total numbers of cases of a specific disorder that exist at any given time

Prevalence: Total numbers

AIDS Diagnosis

HIV and Race HIV disproportionately affects minorities in US African Americans: 12% of the population, yet make up over 50% of the new infections in US Hispanics: 13% of the population, yet make up 19% of AIDS cases CDC, 2006

HIV and Race: Women

Cause of Death US 2000-2007 AIDS is the leading cause of death among AA females aged 25-34 AIDS is the 3 rd leading cause of death among AA women 35-44 AIDS is the 4th leading cause of death for AA women aged 45 54 CDC: Cause of Death 2000-2007

Cause of Death TN: 2007 AIDS was the #1 cause of death among AA females in TN aged 25-34 AIDS is the 4th leading cause of death among AA women in TN aged 35-44 CDC: Cause of Death by state 2007

Race for the Cure 2010 Commercial Appeal

HIV and Women Biologic Vulnerability: A woman is approximately twice as likely as a man to contract HIV infection during vaginal intercourse European Study Group on Heterosexual Transmission of HIV. Comparison of female to male and male to female transmission of HIV in 563 stable couples. British Medical Journal 1992;304:809 813.

HIV and Women Women ~ 25% of new HIV infections (US) Women ~ 25% of new AIDS cases (US) 1992: 13.8% of AIDS cases were women 2001: 21% 2004: 27% 2008: 26% Sexual contact accounts for 80% of HIV infections in women

HIV Testing and Clinical Care HIV Testing: Pregnant and Non-pregnant Clinical Care: OBSC OBSC Prenatal Care Plan for Delivery Follow-up for Mom and Infant

CDC says Test everybody! Call for Routine HIV Testing on 25th Anniversary of U.S. AIDS Epidemic May 5, 2006 - The CDC recommended at least one HIV test for everyone aged 13 to 64 who visits a doctor, followed by annual testing (Implemented September 2006)* Routine HIV tests in doctors' offices and clinics will no longer require the pretest counseling now a part of all HIV testing. * Varies according to exposure

CDC says, Test everybody! "Most HIV is transmitted by the 25% of infected people who do not even realize they are infected. We need to dramatically expand access to HIV testing by making it a routine aspect of clinical care. Kevin Fenton, MD, PhD, director of CDC's National Center for HIV, STD, and TB Prevention.

HIV Testing in Pregnancy Laws regarding HIV testing in pregnancy varies from state to state. In the state of Tennessee, HIV counseling and testing should be offered to all pregnant women. Women have the right to refuse testing. (Opt out approach)

CDC (September 2006) National Recommendations HIV Testing in Pregnancy Prenatal: Routine HIV screening for all pregnant women REPEAT HIV TESTING in 3 rd trimester (certain regions, including Memphis/Shelby County) Labor and delivery: Routine rapid testing for women whose HIV status is unknown Postnatal: Rapid testing for all infants whose mother s status unknown

Diagnosing HIV Testing Methods Serum testing: ELISA/Western Blot ELISA (an antibody test, screening purposes) Positive: Repeat, then confirmatory test (WB) Negative: HIV-negative at the time of testing. Needs no further testing unless they report an exposure Indeterminate 1) Pt in process of seroconversion 2) Pregnancy 3) Medications Western Blot: an antibody test, confirmatory Saliva testing: (antibody testing) Positive: Need confirmatory

Timing of Perinatal HIV Transmission Cases documented: Antepartum 25% 40% of cases Intrapartum 60% 75% of cases Postpartum Breastfeeding, premastication

Factors Influencing Perinatal Transmission Maternal Factors HIV-1 RNA levels Low CD4 lymphocyte count Other infections (hep C, CMV, BV) Maternal injection drug use Lack of HAART during pregnancy Obstetrical Factors Length of ruptured membranes/ chorioamnionitis Vaginal delivery Invasive procedures Infant Factors Prematurity Twins, 1 st born

Post-Partum HIV Transmission Breastfeeding & Premastication HIV transmission has occurred through breastfeeding. Formula feeding encouraged for HIV+ women in US All women considering breastfeeding should know their HIV status Premastication education for HIV+ women

Perinatal HIV Transmission MTCT (Mother to Child Transmission) Pre 1994: USA /Europe: ~ 25% (no Antiretrovirals) 1994: Results of 076 study changed practices (AZT) recommendation during pregnancy 1995: down to 11% after implementation Today, risk of MTCT can be <2% with Effective multi-drug antiretroviral therapy (HAART) Elective C/S when appropriate Exclusive formula feeding Elimination of premastication

Landmark Study: ACTG 076 AIDS Clinical Trials Group A phase III randomized placebo-controlled trial of zidovudine (ZDV/AZT) for the PMTCT of HIV (1992-1994) Sponsor: NIH Branch: NIAID ACTG sites nationwide (Adult & Pediatric) Memphis: Pediatric site SJCRH The Med: Subsite of St Jude

ACTG 076 Antepartum : PO AZT/placebo 100 mg AZT/placebo po 5x day started at 14-34 weeks gestation Intrapartum: IV AZT/placebo 2 mg/kg IV bolus, followed by continuous infusion 1 mg/kg/hr until cord clamp Infant regimen: PO AZT/placebo liquid 2 mg/kg po q 6 hr for 6 weeks, start 8-12 hours after birth

Results of ACTG 076 (Interim Analysis: Unblinded Early!) 30 20 10 22.6% 66% reduction in risk for transmission (p = <0.001) Efficacy observed in all subgroups Placebo 7.6% ZDV Group

Why Continued Perinatal Transmission in the United States? Women unaware of HIV status Lack of universal screening Up to 15% diagnosed in labor Lack of prenatal care Increasing rates of HIV infection among women of childbearing age

Why Continued Perinatal Transmission in the United States? Suboptimal management (need for expert care) Perinatal transmission despite optimal management Result: ~200 new pediatric cases each year in US Dr. Lynne Mofenson, chief of pediatric, adolescent and maternal AIDS at the National Institute of Child Health and Human Development, said that despite H.I.V. babies increased survival, their mortality is still thirtyfold higher than similarly aged children. New York Times 11-8-2010

High-Risk Pregnancies HIV: High risk? Expert care needed Perinatally infected becoming pregnant

High Risk Pregnancies Hypertension Diabetes Multiples Previous C-Section Genetic Anomalies Maternal Age (very young/very old) Social, economic challenges, MSA Who gets to be the decider?

Is Pregnancy bad for HIV? Immunological changes in pregnancy Even in HIV-negative women HIV+ men/women Immunologic differences

Preconceptual Counseling Ideal for any women contemplating pregnancy HIV+ Women: Current health status (CD4, VL) PNV, Iron (anemia R/T disease, diet, HAART) Current HAART (contraindicated? Most damage done early) Immunizations Partner status Discordant couple + partner, his HAART? Resistance?

OBSC OB Special Care Clinic UTMG Obstetrics and Gynecology 880 Madison Suite 3E01 (Medplex) Multidisciplinary Team

OBSC Team Edwin M. Thorpe, Jr., MD Medical Director, Ob-GYN Nina K. Sublette, PhD, FNP HIV Research Practitioner Katrina Shields, LPN OBSC Clinic Coordinator

OBSC TEAM Multidisciplinary Social Workers Dawn Herring Tiombe Plair Consumer Advocates Keshia Rainey Theresa Williams

OBSC: Prenatal Visits Labs: CD4, VL (q month) HAART adherence Side effect assessment HIV/AIDS symptom assessment Fetal assessment Disclosure counseling, MSCHD Long range planning: ID referral, Birth Control

HAART in Pregnancy Offer treatment based on lab values Treatment is voluntary Treatment cannot be mandated Honesty Problems with adherence Swallowing pills Don t want people to see me taking pills Side effects

Lab OBSC HIV-1 RNA VL (measures viral load or burden) Goal is to keep this number low Range: 0-millions ACOG guidelines <1000 copies CD4: (measures amount of CD4 lymphocytes, damage to immune system) Goal is to keep this number high Range 600-1200 CD4 < 200 is an AIDS diagnosis

OBSC: Delivery Plan C-Section should not be done universally: Transmission already very low with HAART, low viral loads any added benefit? Complications increased risk with HIV, particularly with advanced disease C-Section is most effective plan for 38 wks Viral load > 1000 Present late in pregnancy No maternal ART Honor mother s choice Educate, risk/benefit

OBSC Post-Partum 2 week and 6 week visits Ob/GYN and family planning services Mental health screening and referral Coordination of care: ID follow-up for mom and baby

Infant Follow-up AZT/ZDV prophylaxis for 6 weeks HIV diagnostic testing Referral to an HIV specialist LeBonheur ID Clinic/St Jude ID Long-term follow-up of HIV and ARV-exposed infants Support services for the family

Is my baby HIV positive? Babies need serial testing with DNA-PCR Traditional HIV testing not useful Diagnose usually by 4 months, continue testing until 18 months Significance of in utero v. intrapartum acquisition

Acknowledgements Edwin M. Thorpe, MD Patricia M. Flynn, MD Katherine Knapp, MD Nehali Patel, MD AETC National Resource Center, UMDNJ, Newark, NJ

References www.aidsinfo.nih.gov www.aidsetc.org www.cdcnpin.org/scripts/hiv/hiv.asp