Perinatal HIV Transmission in the Post HAART Era

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Perinatal HIV Transmission in the Post HAART Era

• Norma Tejada RN, MSN, MPH, FNP-C
• Theresa Aldape, LMSW
• Celine Hanson, M.D.

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Pediatric HIVTransmission

• Longitudinal Pediatric
• AIDS Data

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United States Perinatal HIV infection
EpidemiologyPast to Present

• Perinatal HIV transmission can occur during
  pregnancy, labor and delivery, or with
  breastfeeding.
• In 1991 peak incidence of perinatal HIV
  transmission was 1,650 cases.
• Incidence declined to an estimated range of
  144-236 in 2002 due to
• HIV testing
• Antiretroviral use
• Avoidance of breastfeeding
• Scheduled cesarean delivery

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Pediatric HIVTransmission

• National AIDS and HIV Data
• 2006

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Pediatric HIVTransmission

• Regional Data
• Texas Childrens Hospital
• 1998 - 2008

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Texas Childrens Hospital All HIV Infected
Children
N54
N26
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Texas Childrens HospitalHIV Infected Children
Transmission Risk
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Texas Childrens HospitalPerinatal HIV
TransmissionMaternal Risk Factors
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Texas Childrens HospitalPerinatally HIV
Infected Children Race/Ethnicity
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2003-2008 Perinatal HIV Infection Case Studies

• History, Demographics,
• HIV Testing, Treatment

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Case Study 1Baby A History

• Full term female infant born to 16 year old
  Hispanic mother. Born vaginally unknown length
  of rupture of membranes.
• Mother initiated prenatal care 1 week prior to
  delivery.
• Delivered at small hospital outside of a large
  metropolitan city.
• Mother was Elisa/Western Blot positive at
  prenatal visit days prior to delivery. Lab
  results available to hospital at time of
  delivery.
• Maternal testing repeated at delivery.
• Infant/mother discharged from hospital 1 day post
  delivery before lab results were available.
• Mother attempted breastfeeding but was
  unsuccessful.

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Case Study 1Baby A Demographics

• Mother and baby are Hispanic. Both are US
  citizens.
• Mother is unemployed and high school drop out.
• Mother speaks English and Spanish, primary
  language is English.
• Mother is a teenager and has little social
  support. Her mother is in prison and her father
  is unknown to her. Has sister who is close in
  age to her and provides some support. Has
  estranged maternal grandmother that she has some
  contact with.
• Babys father was incarcerated.
• Mother/infant lived with infants paternal
  grandmother but then displaced when biologic
  father returned to his mothers home with new
  women.

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Case Study 1Baby A HIV Testing
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Case Study 1Baby A HIV Treatment
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Case Study 2Baby B History

• 37 week gestational age Hispanic female born
  vaginally with unknown length for rupture of
  membranes to a 30 year old woman.
• Unintended pregnancy. Mother considered
  termination which delayed seeking prenatal care.
  
• Pregnancy occurred 3 months after giving birth to
  previous HIV-exposed male child (maternal HIV
  diagnosis made during this pregnancy) who
  received full ARV prophylaxis.
• Mother first sought prenatal care at 5th month of
  pregnancy but started ARV treatment in 7th
  month.
• Mother had 5 prenatal visits throughout her
  pregnancy.
• Baby tested at birth, positive HIV DNA PCR.
• Mother denies breastfeeding.

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Case Study 2 Baby B Demographics

• Mother and baby are Hispanic. Both parents were
  born in El Salvador. Primary language is
  Spanish.
• Mother has high school education from country of
  origin.
• Baby lives with her mother, father and older
  toddler brother.
• Mother stays at home and cares for baby and older
  sibling. Father works as day laborer doing such
  work as painting and construction.
• Mother has 3 older children by different father
  in country of origin.

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Case Study 2 Baby B HIV Testing
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Case Study 2Baby B HIV Treatment
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Case Study 3 Baby C History

• 39 week small for gestational age Black male
  infant delivered by C-section due to breech
  presentation/nuchal cord to a 33 y/o woman.
• Unintended pregnancy. Mother did not initiate
  prenatal care until 8th month of pregnancy.
  Could not find Ob/Gyn to provide care in her
  small town.
• Mother with known positive HIV status since 1996.
  Did not initially tell local Ob/Gyn of her HIV
  status.
• HIV test performed as part of routine prenatal
  care and positive. Patient transferred to HIV Ob
  specialist in large metro area where she
  delivered.
• Baby hospitalized until 3 weeks of age for poor
  feeding and low birth weight.
• Baby tested at birth, positive HIV DNA PCR.
• Mother denies breastfeeding.

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Case Study 3 Baby C Demographics

• Mother and baby are Black.
• Mother is a US citizen.
• Mother is employed and has 3 years of college.
• Mother and baby reside in small town about 120
  miles from large Metro area. Moved to small town
  prior to pregnancy.
• Babys maternal grandmother provides support to
  baby and mother. Father of the baby is
  intermittently involved. Mother is primary care
  taker of child.
• No other pregnancies.

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Case Study 3Baby C HIV Testing
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Case Study 3 Baby C HIV Treatment
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In Utero vs Intrapartum HIV Perinatal Transmission

• In Utero Transmission
• Purported to occur in 30-40 of mother-to-child
  HIV transmission (MTCT) post HAART availability.
• Postpartum and L/D ARV prophylaxis not likely to
  impact infant HIV outcome status.
• ? Transmission of resistant virus
• Association with intermittent maternal ARV use in
  pregnancy and with previous pregnancies.
• Intrapartum Transmission
• Likely most common perinatal transmission route.
• Preventable with ARV prophylaxis
• In utero, peripartum, postpartum ZDV and other
  ARV as indicated

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In Utero vs Intrapartum HIV Transmission
Importance of Infant HIV DNA PCR Testing

• In Utero HIV Transmission
• HIV DNA PCR positive at
• 0-48 hours or birth
• 1 week of age
• Intrapartum HIV Transmission
• HIV DNA PCR negative at birth and 7 days of age
  or less
• HIV DNA PCR positive after
• 1-2 months of life

No data to support more rapid disease
progression for in utero MTCT
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Summary of Cases A-CHIV Infected Infants
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Case Management Challenges of Continued Perinatal
HIV Transmission
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Social Issues Impacting Perinatal HIV
Transmission

• Disclosure of HIV
• Significant other
• Family members
• Healthcare provider
• Denial of Diagnosis
• Inhibits access to education and treatment
• Access to Healthcare
• Continual HIV care is inadequate
• Interruption of healthcare benefits or providers
  hinders state of the art healthcare for HIV

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Social Issues Impacting Perinatal HIV
Transmission

• History of Substance Abuse
• History of Mental Health Illness
• Transient or Unstable Living Situation

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Social Issues Impacting Perinatal HIV Transmission

• CASE A
• Adolescent (16 year old/Hispanic) HIV
  mother/HIV newborn
• Access to Care
• Difficulty Keeping Appointments
• Consent for Treatment
• The CDC reports that women and young people of
  color are at an increasing risk of acquiring HIV.
  The risk increases if youth or young adults are
  exchanging sex for drugs or money.
• Immaturity
• Youth who drop out of school are at risk of
  becoming sexually active, pregnancy at an early
  age, drug use, poverty, and lack of access to
  healthcare services.
• Research has shown that a large proportion of
  young people are not concerned about becoming HIV
  positive.

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Social Issues Impacting Perinatal HIV Transmission

• CASE A
• Limited Support
• Fear of seeking health care for STDs and
  pregnancy.
• Due to lack of emotional support, adolescents are
  left to navigate the social and medical systems
  on their own.
• Nearly 1 in 5 Hispanic youth live in poverty
  leading to the lack of access to high quality
  health care
• Missed Opportunities
• Access to treatment HIV/STD testing.
• Unintended pregnancy often leads to denial and
  inadequate prenatal care
• Access to Comprehensive Medical Case Management
• Access to information and education regarding
  HIV, STDs and social services in the community
  to facilitate HIV testing, treatment and general
  well-being
• Education for physicians and healthcare staff in
  all hospitals and clinics

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Summary of Cases A-CHIV Infected Infants
Inadequate prenatal Care
No case management
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Social Issues Impacting Perinatal HIV Transmission

• CASE B
• 30 year old Hispanic HIV mother-known DX/HIV
  newborn
• Denial of HIV
• Families often require intensive medical case
  management.
• Testing, diagnosis, counseling and follow-up is
  critical throughout the helping process with
  young women and adolescents.
• Ambivalence about pregnancy
• Consider terminating the pregnancy
• Non-Compliance with Prenatal Care

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Social Issues Impacting Perinatal HIV Transmission

• CASE B
• Spiritual/Religious Considerations
• Being HIV / shame / fear/ blaming oneself
• Considering permanency planning/termination of
  pregnancy
• Missed Opportunities
• Access to healthcare services/follow-up when
  patients move or transfer to a new physician or
  healthcare setting
• Patients are in denial of their diagnosis
• Unintended pregnancy/counseling and follow-up is
  critical
• Ongoing case management services
• RAPID Testing in physicians offices

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Case Management Summary of Cases A-C
Cultural/spiritual conflicts
Lack of adherence support
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Social Issues Impacting Perinatal HIV Transmission

• CASE C
• 34 year old Black HIV mother-known DX/HIV
  newborn
• The CDC reports that women (especially women of
  color) have a higher incident of HIV.
• Immature
• Not aware of pregnancy
• Facing an unintended pregnancy and termination
• Transition
• Changes in housing and socioeconomic status,
  families may move from Houston to smaller
  rural areas.
• Interruption of HIV Care
• Changes in healthcare coverage.

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Social Issues Impacting Perinatal HIV Transmission

• CASE C
• Denial/Stigma
• Inhibits the ability and may affect the decision
  to inform the healthcare provider about their HIV
  diagnosis.
• Patient privacy is more apt to be violated in a
  small town vs. a large metropolitan area
• Missed Opportunities
• Follow-up and referrals to healthcare facilities
  in rural areas to continue treatment, adherence
  to medications and follow-up
• Counseling regarding termination and unintended
  pregnancies
• Access to education and information regarding the
  prevention of HIV from mother to baby.
• Communication must be part of the
  patient/provider relationship
• Case managers, social workers and counselors can
  be a role model and talk about different
  scenarios and ways to disclose their HIV
  diagnosis to individuals who need to know .
• Rapid testing must be available at all sites

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Case Management Summary of Cases A-C
Denial, stigma
Case management failure
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Model for Prevention of Perinatal HIV Transmission
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Perinatal HIV Prevention Cascade(CDC model,
April 2008)

• Missed Opportunities
• HIV infected women
• HIV-infected pregnant women
• Inadequate prenatal care
• No/Late HIV testing
• No/Late ARV prophylaxis
• Infected child

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Prevention Opportunities(CDC Model, April 2008)

• Missed Opportunities
• HIV women

• Prevention Options
• Primary prevention for women
• Pre-conceptual counseling and care
• Discussion of unplanned/unintended pregnancy
  with HIV women

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Prevention Opportunities(CDC Model, April 2008)

• Missed Opportunities
• HIV pregnant women

• Prevention Options
• Discussion of unplanned vs unintended pregnancy
• Continued pregnancy
• Access to obstetrical care
• Method of delivery
• ARV use, access, adherence
• Pregnancy
• Delivery
• Postpartum
• Breastfeeding counseling
• Family support during pregnancy and post partum

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Estimated Number of HIV Pregnant Women in the US

• Incident data unavailable in the US
• Unlinked anonymous sero-survey discontinued in
  the US in 1994
• Texas with no funding to support these efforts
• locally
• Ethical issues
• Estimate HIV pregnancy/year in the US
• Modeling system (last calculated in 2000, uses
  1995 data in women) predicts
• 6,075-6,422 exposed infants/year

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Estimated Number of HIV/AIDS Cases and Rates for
Female Adults and Adolescents, by Race/Ethnicity
2006-33 States
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Inadequate Prenatal Care for HIV Pregnant Women

• Prevention Options
• Enhanced medical case management
• Improved coordination and communication of
  services across all case managers during all
  stages of the HIV womans life
• Part D HRSA
• Part B HRSA
• Other funded case management
• Identification of affordable, non-judgmental
  prenatal care
• Evaluation of adequacy of local care to assist
  with prevention options
• Timely local access to ARV therapy
• Specialized HIV care

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Medical Care for Pregnant HIV-Infected Women and
Their Exposed Infants

• National surveillance data of HIV infected
  infants reports 41 of their HIV pregnant
  mothers lacked prenatal visit care.
• 8 of HIV-exposed infants in 24 sites (EPS
  includes Texas) had no prenatal care.
• All of our 3 mother/infant cases lacked access
  to optimal prenatal care.
• One mother did not know her HIV status at
  delivery.

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MTCT Cesarean Section in Pregnancy

• Scheduled C-section recommended for delivery at
  38 weeks gestation in
• HIV women with unknown HIV virologic status at
  delivery
• HIV women with HIV RNA PCR gt1,000 copies/ml
• Efficacy of C-section obviated following
  prolonged rupture of membranes (ROM).
• Unknown efficacy of C-section for HIV women on
  HAART and HIV RNA PCR lt1,000 copies/ml.
• Scheduled C-section with greater maternal/infant
  morbidity than risk of vaginal delivery BUT
  lesser morbidity than urgent/emergent C-section.

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MTCT HIV Transmission and Breastfeeding

• US recommendations are to avoid breastfeeding
• Many safe and available commercial formulas
• Existing support for acquisition of formulas
  (WIC, etc)
• Studies from Africa suggest that breastfeeding
  increases MTCT HIV by 8-14 in some settings but
  mortality risks without BF must be considered.
• CDC (Cote dIvoire)
• ZDV vs placebo study
• 26 MTCT with placebo and breastfeeding
• 16.5 MTCT with ZDV for 3 mos and breastfeeding
• Centre for HIV/AIDS Networking (South Africa)
• MTCT risk for exclusive BF, formula, mixed
  feeding and NVP at birth
• MTCT 14.1 for exclusive breastfeeding by 6 weeks
• MTCT 19.5 for exclusive breastfeeding by 6
  months
• MTCT risk accentuated with maternal CD4
  lt200cells/mm3
• Mortality risk (at 3 mos of age) for exclusive
  BF, formula, mixed feeding and NVP at birth
• Exclusive BF 6.1
• Replacement feedings 15.1

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Prevention Opportunities(CDC Model, April 2008)

• Missed Opportunities
• No/Late HIV testing during pregnancy

• Prevention Options
• Current Texas Health and Safety Code
• Mandates opt-out testing at centers (including
  L/D) providing healthcare to pregnant women
• First visit and at L/D
• Enhancing Existing Prevention What are the
  options?
• Expand opt-out testing to 2nd and/or 3rd
  trimester?
• Initiation of rapid testing at all delivering
  hospitals?
• JCAHO mandate for HIV status to be on pregnant
  woman records?
• gt95 of pregnant women deliver at Texas hospitals

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In Utero versus Intrapartum HIV Perinatal
Transmission

• In utero HIV transmission
• Increasing transmission (30-40) risk post HAART
  availability
• Postpartum and L/D ARV prophylaxis not likely to
  impact infant outcome
• ? Transmission of resistant virus
• Intermittent maternal ARV use
• Intrapartum HIV transmission
• Most common timing for perinatal HIV Transmission
  in US
• Preventable with ARV use
• WITS 1990 epidemiologic study defined MTCT risk
  with/without treatment.
• NO ARV use 20 MTCT
• ZDV use alone 10.4 MTCT
• Combination therapy (NO PI use) 3.8 MTCT
• Combination therapy with PI use 1.2 MTCT

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In Utero vs Intrapartum HIV Transmission
Importance of Infant HIV DNA PCR Testing

• In Utero Perinatal HIV Transmission
• HIV DNA PCR positive
• Birth
• 7 days of age
• Intrapartum HIV Transmission
• HIV DNA PCR negative at birth or 7 days
• HIV DNA PCR positive after 1-2 months of life

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Rapid HIV Testing for Pregnant Women

• ELISA (EIA)
• 99 sensitivity/specificity for HIV-1
• Requires confirmation with WB or IFA
• Turnaround time for test results lengthy
• 24-96 hours in some settings
• Rapid HIV Testing
• Rapid antibody testing using whole blood, oral
  secretions, plasma or serum
• All reactive tests require confirmation with
  WB/IFA
• Sensitivity/specificity for HIV-1 dependent upon
  population HIV prevalence
• Turnaround time for test results dependent upon
  location of test performance
• Bedside results can be 45 minutes
• Laboratory processing can be 3-4.5 hours

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Percent Sensitivity/Specificity of HIV Testing by
Population Prevalence
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Key Elements for Successful Implementation of
Rapid HIV Testing at Delivery

• Ensure confidentiality of testing individuals
• Standing order for HIV test result
• Mechanism to report HIV test
• Similar to RPR, rubella testing
• Opt-out rapid HIV test for women without previous
  testing or unknown HIV status
• Standardization of selected tests
• Results to patient in real or relevant time
• Impact MTCT perinatal prevention options
• Maximal success prior to delivery
• Results MUST be given prior to patient discharge
• Linkage to case management for individuals
  without known HIV status at delivery

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Resistance Testing in Pregnancy

• HIV drug resistance testing recommendations
• Pregnant women no currently receiving ARV
• Prior onset treatment or prophylaxis
• Pregnant women with prior ARV use and virologic
  failure
• Detectable HIV RNA level on treatment
• Suboptimal viral suppression following ARV use

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ARV Resistance During Pregnancy

• Factors unique to pregnancy increase risk
• ARV used intermittently for prophylaxis of
  perinatal transmission
• NVP concerns
• Pregnancy-associated nausea/vomiting may
  compromise adherence
• General population incidence of ARV resistance
• Increase in resistance
• 3.4 in 1995 12.4 in 1999
• Limited data suggest same incidence ARV
  resistance for pregnant HIV-infected women as in
  general population
• Potential for transmission of resistant virus

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Case Management Summary of Cases A-C
Unknown HIV status, inadequate hospital reporting
Unintended pregnancy
Unintended pregnancy
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Prevention Opportunities(CDC Model, April 2008)

• Missed Opportunities
• No ARV Prophylaxis

• Prevention Options
• Access to medications upon identification of
  pregnant HIV status
• Pharmacy coordination of services in rural
  locations
• Role of ADAP for rural deliveries?
• Education of case managers, nursing and medical
  staff regarding need for earliest intervention
• During pregnancy
• At L/D
• Postnatal newborn prophylaxis

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Identifying Delivery Facility Adequacy for MTCT
PreventionCHECKLIST

• Availability to provide HIV testing during labor
• Adequate EIA turnaround time (prior to
  delivery/discharge)
• Options for rapid testing
• Access to ARV in real time
• Oral dosing, IV dosing, pediatric dosing
• Access to providers versed in HIV perinatal
  prevention
• Rupture of membranes
• C-section options
• Linkage options to case management
• Breastfeeding education
• Linkage to infant care and testing
• Linkage to post partum maternal care and testing

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Prevention Opportunities(CDC Model, April 2008)

• Missed Opportunities
• HIV infected child

• Prevention Options
• Comprehensive services for infected mother
• Comprehensive services for infected child
• Evaluation of family for additional HIV infection
  (siblings, father)
• IMPORTANCE of medical case management
• Access to services
• Assistance with daily living
• Assistance with medication adherence support

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HIV-Exposed Infants Represent Family Sentinel
Event

• Testing of family imperative
• Counseling
• Linkage to case management for affected FAMILY
• Address postpartum education regarding future
  pregnancy planning
• Address other HIV risk factors
• Youth and access to care
• Drug use
• Cultural obstacles to care
• Travel needs if local facility cannot support care

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HIV-Infected Infant Represents Missed Opportunity
Sentinel Event

• Statewide review of each perinatally HIV-infected
  infant in the post HAART era
• Define missed opportunities
• Systematic approach to identify new
  intervention options
• Report of missed prevention opportunities to
  health departments, hospitals and care
  providers

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References

• Epidemiology
• 1.http//www.cdc.gov/hiv/topics/surveillance/resou
  rces/slides/pediatric/
• 2. MMWR Twenty-five Years of HIV/AIDS- United
  States, 1981-2006 June 2, 2006/Vol. 55/ No. 21
• 3. Hanson, I.C.,  Shearer, W. T. et al. (2004) 
  Lentiviruses (Human Immunodeficiency Virus Type 1
  and Acquired Immunodeficiency Symdrome), In
  Feigin et al (Ed), Textbook of Pediatric
  Infectious Diseases (pp. 2455-2481), 5th ed.
  Vol 2.  Philadelphia, Pennsylvania Saunders.

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References

• Case Management Challenges
• 1. CDC HIV/AIDS Surveillance Report, 2004. Vol.
  16, Atlanta US Department of health and Human
  Services, CDC 20051-46.
• 2. CDC. HIV Prevention in the Third Decade.
  Atlanta US Department of Health and Human
  Services, CDC2005.
• 3. CDC. Youth Risk Behavior Surveillance
  United States, 2003. MMWR 200453(SS-2)1-29.

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Missed Opportunities/ HIV Prevention References

• 1. United States Public Health Service Task
  Force Public Health Service Task Force
  recommendations for use of antiretroviral drugs
  in pregnant HIV-- infected women for maternal
  health and interventions to reduce perinatal
  HIV-1 transmission in the United States. November
  2, 2007 (cited May 20, 2008) Available from
  http//AIDS info.nih.gov.
• 2. Fleming P, et al. Estimated number of
  perinatal HIV infection, US 2000 in 14th
  International AIDS Conference, 2002 Barcelona,
  Spain.
• 3. M.M.W.R. Reduction in perinatal
  transmission of HIV infection---United States,
  1985-2005. June 2, 2006.

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Thank you for your attention!

• Questions?
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