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Perinatal HIV Prevention: Successes and Challenges in the U.S. and Internationally

Perinatal HIV Prevention: Successes and Challenges in the U.S. and Internationally. Mary Glenn Fowler, MD, MPH Divisions of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention November 9, 2004. Overview: Perinatal HIV Prevention in U.S. and Internationally.

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Perinatal HIV Prevention: Successes and Challenges in the U.S. and Internationally

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  1. Perinatal HIV Prevention: Successes and Challenges in the U.S. and Internationally Mary Glenn Fowler, MD, MPH Divisions of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention November 9, 2004

  2. Overview: Perinatal HIV Prevention in U.S. and Internationally • U.S. Successes and Remaining Challenges • International Situation • Epidemiology • Current and Planned Research Efforts • Program Activities • Next Steps and Conclusions

  3. Update on U.S. Perinatal HIV Epidemic and Prevention • Major progress since 1994 in decreasing perinatal HIV in the U.S. • Before 1994 in the U.S. perinatal transmission rates were 20%-25% • Now rates of 2% or less can be achieved • Current estimates are that 6,000-7,000 HIV-infected women deliver each year • Status of most are known by delivery • 10%-12% receive little or no prenatal care • CDC estimates that 280-370 babies continue to be infected each year in the U.S.

  4. 40 30 24.5% 20 % Transmission 7.6% 10 5.0% 3.3% 2.0% 1.5% 0 1993: 1994: 1997: 1999: 2001: 2002: WITS PACTG PACTG WITS PACTG PACTG 076 185 247 316 Perinatal HIV Transmission Ratesin U.S. Studies from 1993-2002

  5. Transmission Rates by Type of ARV and OB Interventions • AZT alone given prenatally, intrapartum and to newborn: about 8% • Dual ARV’s • Prenatal AZT/SD NVP: 2% non BF; 6% BF • Prenatal/ Intrapartum/Post AZT/3TC: 2% • Triple ARV’s: 2% or less non BF settings • Scheduled c-section prior to labor onset decreases transmission by about 50%

  6. Number of cases 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 Year of diagnosis Note: Data adjusted for reporting delays and for estimated proportional redistribution of cases reported without a risk. Perinatally Acquired AIDS Cases by Year of Diagnosis, 1981 – 2002, United States 1000 800 600 400 200 0

  7. Current CDC Perinatal HIV Prevention Strategies in the U.S. • Increase awareness among pregnant women of the importance of HIV screening • Reduce barriers to universal prenatal HIV screening — support opt out approach • Promote rapid HIV testing at L&D for women whose status is still unknown • Integrate HIV prenatal screening with other MCH programs and services that screen for and prevent other congenital infections (syphilis, Group B Strep, Hep B)

  8. Specific CDC Perinatal HIV Prevention Projects in U.S. • Since 1999, $10M in Congressional funding per year for Perinatal Prevention goes to • 16 high-prevalence states to support perinatal prevention programs • 10 states for Perinatal HIV Surveillance Activities and assessment of states prenatal testing rates • 5 national organizations for development of training and education materials • The MIRIAD study of rapid testing at L&D

  9. General Types of Perinatal Prevention Programs in High-Prevalence States • Social marketing • Outreach • Case management high-risk women • Training of health care workers • Rapid testing at labor/delivery

  10. MIRIAD Study: Mother-Infant Rapid Intervention at Delivery • CDC supported research in 5 university sites with 15 related hospitals -- began 1999 • Objectives: • Assess feasibility of offering rapid testing at labor/delivery and intervention • Assess use of rapid test kits for sensitivity and specificity • Assess rates of seroprevalence and transmission among late presenting women of unknown HIV status • Provide linkages to comprehensive care and treatment for those women identified by rapid testing as HIV-infected, and for their infants

  11. MIRIAD Demonstrates Feasibility of Rapid Testing and Intervening at Labor/Delivery (Bulterys, et al. JAMA July 2004) • Between November 2001 – June 2003, 69,094 women were evaluated at 15 hospital L&D units • Of these, 5,374 (7.8%) women were eligible based on undocumented HIV status late in pregnancy or at labor • Uptake of rapid testing was 85% • Two thirds of HIV infected women in labor received antiretrovirals as did all their newborns • To date 52 HIV+ women have been detected by rapid testing and 4 infants are infected

  12. Follow-up Translation Efforts to Support Rapid Testing at Labor/Delivery • Recent FDA licensing of rapid tests — Oraquick and Reveal • CDC Model Protocol for implementing rapid testing at L/D • Regional trainings on rapid testing in L&D settings

  13. Conclusions: U.S. Progress in Perinatal HIV Prevention • Dramatic progress in U.S. related to • Increased uptake of prenatal testing and access to rapid testing at L&D • Availability of potent combination ARV’s and obstetrical interventions including C-section • Generally adequate public and private health care infrastructure • Feasibility of not breastfeeding in U.S. — safe water, availability of formula for low income women, lack of stigma • Elimination of any new infant infections is the current DHHS/CDC goal

  14. Remaining Challenges in the U.S. • Achieve universal prenatal HIV testing • Implement rapid HIV testing in labor/delivery settings for women whose status is still unknown • Ensure adequate follow up, comprehensive treatment for HIV-infected women • Develop mechanisms to monitor possible late adverse events among ARV-exposed infants • 70,000+ infants have now been exposed to perinatal antiretrovirals • How best to follow up these infants into adulthood for potential rare late effects of perinatal ARV exposures?

  15. International Perinatal HIV Prevention:EpidemiologyPEPFAR ActivitiesResearch Success and Plans

  16. Epidemiology of Perinatal HIV in International Settings • >95% of HIV-infected children are born in resource limited breastfeeding settings • WHO estimates >700,000 new infant infections each year • Most all due to mother-to-child transmission • Transmission rates are generally in 25%-40% range without antiretroviral interventions • With antiretroviral interventions, late transmission rates at 18-24 months are currently 15%-25% • Maternal HIV seroprevalence up to 35-40% in some settings • Adolescent females are at high risk of infection • Breastfeeding accounts for 1/3 to 1/2 of all transmissions

  17. Baseline Assessment: High Antenatal Clinic HIV Prevalence* * 14 countries in the President’s Mother and Child HIV Prevention Initiative

  18. The President’s International Mother and Child Prevention Initiative • Announced in June 2002 • $500 million Initiative jointly implemented by HHS (CDC and HRSA) and USAID • Objectives for the Initiative • Reach up to 1 million women annually • Reduce mother-to-child HIV transmission by up to 40% among women treated

  19. Overall budget for global AIDS: • $15 billion over 5 years • ($10 billion new money) The President’s Emergency Plan for AIDS Relief • Announced January 28, 2003 • Targets 15 countries • Goals: • Treat 2 million HIV-infected people • Prevent 7 million new HIV infections • Provide care for 10 million HIV-infected people and AIDS orphans • Builds upon earlier efforts including the President’s Mother and Child HIV Prevention Initiative

  20. Key Partners • Led by the Department of State Global AIDS Coordinator • Ministries of Health • Nongovermental organizations, faith-based and community-based organizations • Elizabeth Glaser Pediatric AIDS Foundation, Columbia MTCT-plus, Family Health International, et al • University partners • UNICEF/ UNAIDS/ WHO/ World Bank/ Global Fund • US government agencies: Health and Human Services, USAID, State Dept, Department of Defense, et al

  21. PMTCT: Core Strategies • Routine ANC C&T • Simplified pre-test, rapid same-day results • ARV prophylaxis (2004 WHO guidelines) • AZT + SD NVP • HAART treatment where feasible and eligible • SD NVP or short-course AZT • Screening and prophylaxis in labor • Infant feeding counseling • Program support for safe, feasible alternatives • Family planning, prevention • Links to care and treatment (e.g., PMTCT+)

  22. Key CDC Support Roles for PMTCT • Funding and support for national plans • Policy and program guidelines • Strategies / support for scale-up and link to care • PMTCT curriculum and training • WHO/CDC generic PMTCT curriculum • PMTCT monitoring system (generic, facility-based, local and national monitoring) • Training guide for routine counseling and testing • Applied infant diagnosis, program effectiveness • Program evaluation / operational research

  23. Operational Research & Program Evaluation in PMTCT • Integration with MCH programs • National scale-up and decentralization • Early infant diagnosis/ program effectiveness • Use of combination regimens • Interventions at labor for women of unknown status • NVP resistance – implications for treatment • Linkages to care and treatment (PMTCT+)

  24. Research Addressing Breastfeeding Transmission

  25. Early Postpartum (0-6 months) Late Postpartum (6-24 months) Early Antenatal (<36 wks) Labor and Delivery Late Antenatal (36 wks to labor) 0% 20% 40% 60% 80% 100% Proportion of infections Breastfeeding Postnatal Transmission:Accounts for at Least one-third of all Transmissions Among Breastfeeding Women

  26. Breastfed Formula fed Transmission Rates by Feeding Method: Nairobi Randomized Trial (Nduati et al, JAMA 2000; 283: 1167-74) 40 35 30 25 20 15 10 5 0 Birth 6 wks 14 wks 6 mos 12 mos 24 mos

  27. Timing of Breastfeeding Transmission • Several studies suggest a large proportion of breast milk transmission occurs quite early, before 1-2 month of age – as high as an absolute risk of 6%by age 2 months or 3% inmonths 1 and 2. • However, there is then a low continuous risk throughout lactation, — 0.6-0.8%/mo — into the 2nd year of breastfeeding.

  28. 4.5 4 SAINT Estimate Percent Monthly Risk 3.5 Nairobi 3 Malawi 2.5 W Africa 2 1.5 1 0.5 0 2d- 1,2-5mo 6-11mo 12-18mo 18-24mo 6,8wks Summary: Estimates of Monthly Risk of HIV Transmission While Breastfeeding Late BF Transmission Early BF Transmission

  29. Risk Factors Associated with Transmission Through Breastfeeding • HIV viral load in breast milk • “Breast pathology” – mastitis, abscess • Type of breastfeeding: mixed vs. predominant or exclusive breastfeeding (BF) • Other factors (innate immune factors, vitamin A, possibly subtype, HLA etc.)

  30. South Africa Vitamin A Trial, Transmission by Feeding Practice 40 35 30 25 Never BF 20 Excl BF 15 Mixed 10 5 0 1 day 6 mos 15 mos Infant Age

  31. Early BF Cessation Could Prevent a Sizeable Fraction of Postnatal HIV Infections 68% of all infant postnatal HIV infections occurred after 6 months: ZVITAMBO Study (N=2060) Source: Piwoz, Iliff, et al, Bangkok 2004

  32. Prevention of HIV Transmission Through Breastfeeding • WHO Guidelines for resource-limited settings: • Balances risk of HIV transmission through BF with potential increased morbidity and mortality associated with not breastfeeding • Individual counseling • When acceptable, feasible, affordable, sustainable and safe, formula should be used; • Otherwise, exclusive BF with early weaning is recommended • Individual decisions are up to mother

  33. Issues Regarding Breastfeeding and HIV in Resource Limited Settings • Breast feeding improves overall infant survival in resource limited settings • Safe, feasible and sustainable alternatives to breast feeding are not available to most HIV-infected women in international resource limited settings • To not breast feed goes against cultural norms and may stigmatize a mother or lead to disclosure of HIV status • Decisions on infant feeding are often influenced by the father and other family members • Research is being conducted to determine effective strategies that reduce transmission risk for HIV+ women in resource limited settings who choose to breastfeed

  34. Recent International Perinatal HIV Trial Results

  35. International Perinatal HIV Research Trials Following PACTG 076 • Initial focus on deliverable, prenatal short course ARV’s in resource-limited settings • Short course (begun at 36 wks) maternal ZDV regimens-Thailand and West Africa • Combination short course ZDV/3TC—PETRA multi-site trial in East Africa and South Africa • SD NVP to mother and newborn--Uganda • Current and planned trials are now addressing transmission during breast feeding • ARV’s to mother or infant during BF • Immune strategies—vaccines, HIVIG

  36. Trial Regimens Shown to Prevent MTCT AP IP PP (baby, mother or both) 14 wks 28 wks 36 wks 3d to 1 wk 6 wks 076 Thai (Harvard) Thai (Harvard) Thai (Harvard) IvC (ANRS), PETRA, Thai (Harvard) Thai (CDC), IvC (CDC) PETRA, 012, SAINT NVAZ Regimens: AZT; AZT+3TC; single dose (SD) NVP; AZT+ SD NVP

  37. International Perinatal HIV Trial Results: Early Efficacy at 6 Weeks-4 Mos

  38. Effects of Breastfeeding on Late Perinatal Transmission Rates 37% No ARV, BF 22.5% AZT AP-IP 20% 18.1% AZT/3TC IP-PP 16.5% 15.7% NVP IP-PP 14.9% AZT/3TC AP-IP-PP 11.8% 8.9% 5.7% Infant Age

  39. Latest Successful Short-Course International Trial Results • Combining ZDV in the last trimester + SD NVP at labor and to newborn appears highly efficacious • Thai CDC/TUC results— 4.6% if ZDV begun at 34 weeks + SD NVP to mother/newborn • Thai NIH results— 2% if begin ZDV at 28 weeks + SD NVP • Ditrame Plus results in BF W. Africa— 5.9%with combining ZDV from 34 wks + SD NVP • Feb 2004, WHO recommends Short Course ZDV as early as possible in the 3rd trimester followed by SD NVP regimen at labor onset

  40. Strategies of New Trials to Address Breastfeeding Transmission • Maternal HAART in last trimester and during 4-6 months of breast feeding to lower maternal viral load • Infant ARV prophylaxis during first 4-6 months of breast feeding • Exclusive breast feeding followed by early weaning at 4-6 months

  41. Challenges to Perinatal HIV Prevention: U.S. and Internationally • Increasing uptake of HIV testing among pregnant women, both prenatally and at labor/delivery • Safety monitoring of ARVs among pregnant women and ARV - exposed infants • Translating perinatal research into deliverable sustainable PMTCT programs • Integrating with other MCH programs • Using PMTCT as an opportunity gateway for ARV treatment and care for HIV affected families • Assessment of ARVs for PMTCT and their potential impact on later treatment options

  42. Summary and Conclusions • There has been major progress in perinatal HIV prevention in U.S; and international PMTCT research, but challenges remain • PMTCT activities provide a gateway for families to access HIV treatment/care

  43. Summary and Conclusions • International issues include breastfeeding transmission and health care infrastructure • Current international research focuses on reducing breast milk transmission, resistance • Primary prevention of HIV infection among adolescents and women of child-bearing age is key to reducing the perinatal HIV pandemic

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