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RJ Simonds, MD

Transferring U.S. Domestic & Global Innovations to Combat HIV/AIDS PMTCT. Turning the tide together to eliminate HIV in children. RJ Simonds, MD. July 22,2012. The success of ACTG 076 led quickly to research that adapted its findings to resource-constrained settings.

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RJ Simonds, MD

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  1. Transferring U.S. Domestic & Global Innovations to Combat HIV/AIDS PMTCT Turning the tide together to eliminate HIV in children • RJ Simonds, MD July 22,2012

  2. The success of ACTG 076 led quickly to research that adapted its findings to resource-constrained settings. ACTG 076 trial US/France 1994 Short-course AZT trial Thailand 1998 Transmission Risk by Treatment Group 22.6% Transmission Risk Single-dose NVP trial Uganda 1999 7.6% Placebo AZT

  3. Combined efforts of the U.S. and other countries optimized PMTCT interventions. Mother-Child Transmission Risk (%) 35 30 25 USA & Europe 20 Thailand 15 Africa 10 5 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Research in US/Europe on ARV prophylaxis Research in Africa and Thailand on shorter ARV prophylaxis Research in Africa on ARV prophylaxis during breastfeeding Source: adapted from N. Shaffer, WHO, 2010

  4. Key organizations have linked U.S. and global PMTCT research, programs, and advocacy. International Maternal Pediatric Adolescent AIDS Clinical Trials Group Francois-Xavier Bagnoud Center (UMDNJ) Elizabeth Glaser Pediatric AIDS Foundation

  5. Technologies developed or researched in the U.S. have been critical to PMTCT programs in resource-constrained settings.

  6. The successful national PMTCT response in the U.S. informed and encouraged national-level programs in other countries. ARV coverage for PMTCT Thailand, 2001 Sources: CDC surviellance slides; Amornwichet JAMA 2002

  7. Early U.S. PMTCT policy experience helped inform policies in other countries. HIV testing in 4 antenatal clinics using opt-in vs. opt-out testing strategies, Francistown, Botswana 2003-2004 Source: Creek et al 2007

  8. Programmatic issues emerging in the U.S. are alerting other countries to their future issues. Aging of Perinatally HIV-InfectedChildren in the United States 30 years into the perinatal HIV epidemic in the US, HIV-infected children are now aging into adolescence and adulthood. HIV has become a chronic disease with challenges such as: • adherence to therapy, psychosocial challenges • late complications from chronic HIV infection and its therapy • interaction of HIV and puberty • ARV resistance • mental health issues • sexual activity and pregnancy Dr. James Oleske and Long-Term Survivors UMDNJ Newark 2003

  9. U.S. research informs global guidance. WHO Simplified Pediatric Dosing Table Based on Modeling from PK Studies in Resource-Rich Countries

  10. U.S. researchers help develop WHO guidelines. Content experts: Elaine Abrams (The International Center for AIDS Care and Treatment Programs, Mailman School of Public Health, Columbia University, New York, USA), François Dabis, Laura A. Guay (Elizabeth Glaser Pediatric AIDS Foundation, Washington DC, USA), Louise Kuhn (Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, USA), Marc Lallemant (Programs for HIV Prevention and Treatment, Thailand), James McIntyre, Lynne M. Mofenson, Roger Shapiro (Harvard Medical School, Division of Infectious Diseases, Boston, USA) and Jeffrey S. A. Stringer (University of Alabama at Birmingham, Center for Infectious Disease Research in Zambia, Lusaka, Zambia). Slide 10

  11. Resource-constrainedcountries are researching issues no longer able to be studied in the U.S. 2010 2003 2003 Africa SIMBA: Infant ARV 2010 Malawi BAN: Infant NVP vs Maternal ARV 2009 Tanzania MITRA-plus: Maternal ARV 2010 Botswana MmaBana: Maternal ARV 2008 Ethiopia, India, Uganda SWEN: Infant NVP Clinical Trials of Prevention of Postnatal Mother-to-Child HIV Transmission via Breast Feeding 2008 Malawi PEPI-Malawi: Infant NVP

  12. A growing body of global research informs USPHS guidelines in the U.S. CHER Study in South Africa “Antiretroviral therapy (ART) should be initiated in HIV-infected infants <12 months of age, regardless of clinical status, CD4 percentage, or viral load“

  13. Continuing PMTCT effort in resource-constrained settings reminds the U.S. to remain vigilant to maintain its success. Zimbabwe U.S.A.

  14. Approaches to PMTCT in the U.S. and resource-constrained countries are coalescing. AIDS-Free Generation Treatment as Prevention Option B+

  15. Elimination of pediatric HIV infection worldwide requires continued efforts in the U.S. and in all other countries. Framework to Eliminate Mother-to-Child Transmission of HIV in the U.S. Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive

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