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  1. HIV 2007: What’s New? Donna E. Sweet, MD, MACP Professor of Medicine The University of Kansas School of Medicine - Wichita

  2. Epidemiology • Prevention • Testing • Treatment • Economics

  3. A global view of HIV infection 2006 39.5 living with HIV 2.4

  4. Newly Infected with HIV - 2006

  5. Global Estimates: End of 2006 • 39.5 million people are living with HIV • 17.7 million women • 2.3 million children under age 15 • 2.9 million AIDS deaths • 3.8 million were newly infected Source - http://www.avert.org/worldstats.htm

  6. HIV 2006 • 7.1 million people in developing or transitional countries need drugs. • Only 2.015 (28%) million are receiving the drugs • The estimated lifetime medical costs are an average of $200,655. • Each new infection results in a loss of approximately 23.9 quality-adjusted life years.

  7. Epidemiology of HIV in US • 17% increase in prevalence 2001-2004 • Main risk factor: Sexual contact for both men and women • Women: 71% heterosexual; 27% IDU • Disproportionate impact on Blacks & Hispanics • 48% of HIV+; 13% of US Black population • Hispanics slightly over 4 times higher then whites Campsmith M, et al. XVI IAC Toronto, Canada, Aug. 13-18, 2006; Abst. MOPE0551

  8. Missouri Cumulative AIDS Casesas of 2005

  9. Missouri Cumulative HIV and AIDS Cases by Genderas of 2005 HIV / AIDS Cases by Gender Cumulative AIDS Cases N % 2339 87.9 Male Female 322 12.1

  10. Missouri Deaths Among HIV / AIDS Cases by Exposure Categoryas of 2005

  11. N % 13-18 56 6.9 19-24 169 20.8 25-44 508 62.4 45-64 75 9.2 65+ 6 0.7 Missouri Living HIV Cases in Heterosexual Contact by Ageas of 2005 Total 814 100%

  12. Missouri Newly Diagnosed / Living with HIV / AIDS Cases by Raceas of 2005

  13. “My daughter is not ready yet. Would you like to join me in watching a Short video on AIDS?”

  14. April 14, 2007 WASHINGTON (Reuters) -Abstinence-only education programs meant to teach children to avoid sex until marriage failed to control their sexual behavior, according to a U.S. government report. Abstinence-Only Does Not Work

  15. HIV Prevention Efforts Abstain, Be faithful, Condoms, Counseling & testing ABC I Immunization C Circumcision HSV-2 suppressive treatment H D Diaphragms Genital tract infection control G E F Exposure prophylaxis (MTCT, PEP, PrEP) Female-controlled microbicides Ramjee G. XVI IAC; 2006 Toronto. Abstract TUPL02

  16. Late HIV Testing is CommonSupplement to HIV/AIDS Surveillance, 2000-2003 • Among 4,127 persons with AIDS*, 45% were first diagnosed HIV-positive within 12 months of AIDS diagnosis (“late testers”) • Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be: • Younger (18-29 yrs) • Heterosexual • Less educated • African American or Hispanic *16 states MMWR June 27, 2003

  17. Source: study by researchers at Duke and Stanford Universities and the Veterans Affairs Palo Alto Health Care System Routine Testing Routine one-time testing of everyone would cut new infections each year by just over 20%Every HIV-infected patient identified would gain an average of 1 ½ years of life.

  18. More is Better • Earlier access to available medications • resulting in increased length of life • Those who know they are positive tend to take more precautions to protect others • On a population wide basis, such screening could reduce spread • because medications suppress viral load and reduce the chance of transmission

  19. Revised Recommendations for HIV Screening in Health-Care Settings in the U.S. September, 2006

  20. New Guidelines for HIV Screening • HIV screening is recommended in all health care settings, after notifying the patient that testing will be done. • Separate written consent for HIV testing is not required. • Prevention counseling is not recommended as part of routine HIV screening programs in health care settings. • HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.

  21. CDC Recommendation for HIV Screening Opt-out HIV screening and HIV diagnostic testing should be a part of routine clinical care in all health-care settings. This information is based on: Centers for Disease Control and Prevention (CDC). (2006, September 22). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. Information take from: http://www.cdc.gov/hiv/topics/testing/healthcare September 22, 2006

  22. The CDC recommends that HIV screening be a routine part of health care for all: • Individuals in the U.S. between the ages of 13 and 64 • Patients receiving care for tuberculosis (TB) • Patients in care for other sexually transmitted diseases (STDs) • Women who are considering conception and pregnancy • Women who are pregnant • Women in delivery who have undocumented HIV status at the onset of labor • Infants born to mothers with undocumented HIV status.

  23. Rapid HIV Testing: The “Waive” of the Future

  24. Available HIV Rapid Tests in the United States Six rapid HIV tests approved by the U.S. Food and Drug Administration (FDA) are commercially available for use in the United States (listed in chronological order of their FDA approval dates): • OraQuick Rapid HIV – 1 / 2 Antibody Test • Reveal G2 Rapid HIV - 1 Antibody Test • Uni-Gold Recombigen HIV Test - 1 • Multispot HIV-1 / HIV-2 Rapid Test • Clearview HIV 1 / 2 Stat Pak • Clearview Complete HIV 1 / 2

  25. OraQuick Advance Uni-Gold™ Recombigen® HIV Assay

  26. When Is A Rapid Test Indicated? • Obstetric admissions • Healthcare worker occupational exposures • Urgent care clinics and Emergency departments • Public health settings • Developing countries • The primary Care office

  27. Prenatal HIV Screening Based on information presented in the MMWR – Both “opt-out” and prenatal maternal screening andmandatory newborn screening achieve higher maternal screening rates than “opt-in” prenatal screening CDC recommends that clinicians routinely screen all pregnant women for HIV infection using an “opt-out” approach

  28. Number of cases

  29. HIV Status Known at Delivery2006

  30. HIV Status Known at Deliver2007

  31. HIV Replication Cycle and Sites of Drug Activity Protease New HIV particles Capsid proteins and viral RNA CD4 Receptor Viral RNA Reverse Transcription Attachment Translation Uncoating Integration Transcription • NRTIs • NNRTIs Attachment Inhibitors • Protease Inhibitors Cellular DNA Nucleus HIV Virions Reverse Transcriptase Integrase Unintegrated double stranded Viral DNA gag-pol polyprotein Integrated viral DNA Viral mRNA CCR5 or CXCR4 co-receptor 1 3 4 5 2 6 Assembly and Release Adapted:Levy JA. HIV and the Pathogenesis of AIDS. 2nd ed. Washington, DC: American Society for Microbiology; 1998:9-11 .

  32. Course of HIV Disease Progression as it Relates to CD4 Lymphocyte Count Bacterial skin infection Herpes simplex, zoster Oral, skin fungal infections 800 CD4 cell count / mm3 600 Thrombocytopenia Lymphadenopathy Kaposi’s sarcoma 500 300 400 400 200 Hairy leukoplakia Tuberculosis Lymphoma 200 PCP Cryptococcosis Toxoplasmosis CMV 100 MAC 0 Months Years

  33. 1987: zidovudine (Retrovir) 1988: 1989: 1990: 1991: didanosine (Videx) 1992: zalcitabine (Hivid) 1993: 1994: stavudine (Zerit) 1995: lamivudine (Epivir) saquinavir (Invirase) 1996: ritonavir (Norvir) indinavir (Crixivan) nevirapine (Viramune) 1997: nelfinavir (Viracept) delavirdine (Rescriptor) 1998: efavirenz (Sustiva) abacavir (Ziagen) 1999: amprenavir (Agenerase) 2000: lopinavir/ritonavir (Kaletra) 2001: tenofovir (Viread) 2003: enfuvirtide (Fuzeon) 6/03: atazanavir (Reyataz) 7/03: emtricitabine (Emtriva) *8/04: lamivudine/abacavir sulfate (Epzicom) emtricitabine/tenofovir disoproxil fumarate (Truvada) 6/05: tipranavir (Aptivus) 6/06 darunavir (Prezista) *7/06: efavirenz/emtricitabine, tenofovir DF (Atripla) 8/07 maraviroc (Selzentry) Licensure of Antiretroviral Agents by Year * Fixed dose combinations of existing drugs

  34. Indications for Initiation of Therapy: Chronic Infection

  35. Indications for Initiation of Therapy: Chronic Infection

  36. Recommended Agents for Initial Antiretroviral Therapy August 2006

  37. Recommended ART for perinatal use:DHHS October 2006 *ZDV and 3TC are included as a fixed-dose combination in Combivir®; ZDV, 3TC, and ABC are included as a fixed-dose combination in Trizivir® Available at: http://aidsinfo.nih.gov/guidelines. Revision: October 10, 2006

  38. The Move Toward Lower Pill Burdens Retrovir/Epivir/Sustiva 5 pills, BID 3 pills, BID Combivir (AZT/3TC)/EFV Viread/ Emtriva/Sustiva 3 pills, QD Truvada/Sustiva 2 pills, QD Regimen Dosing Daily pill burden 1996 Zerit/Epivir/Crixivan 10 pills, Q8H 1998 2002 2003 2004

  39. The Move Toward Lower Pill Burdens Regimen Dosing Daily pill burden 2006 Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) 1 pill QD

  40. “Did you say one a day or two a day?”

  41. Investigational drugs

  42. Each healthy year gained by newly diagnosed HIV patients and their partners would still cost less than $50,000 Even in areas with an undiagnosed HIV infection rate of only 1 in 2,000 the rate in the general population.

  43. Cost –Effective Treatment A cost of less than $50,000 is the threshold at which health economists generally consider treatments to be cost-effective

  44. “Using the current CDC estimate of 40,000 new HIV infections per year, the potential to prevent half to two thirds of these infections, and the current average lifetime cost of care for a patient with HIV infection of $200,000, more effective epidemic control would save between $4 billion and $5.4 billion per year.” - Frieden, Das-Douglas, Kellerman, and Henning in The New England Journal of Medicine, Vol. 353; No. 22, December 1, 2005