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John G. Bartlett, MD Program Chair

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  1. John G. Bartlett, MDProgram Chair Professor of MedicineJohns Hopkins University School of MedicineBaltimore, MD

  2. Educational Objectives • Discuss the epidemiology of HIV, particularly in minority populations • Identify special issues related to HIV testing and treatment • Outline the risks and benefits of earlier ART initiation and its role in reducing HIV transmission • Summarize the latest data on the newer HIV agents, including those in clinical development, and how they may fit into HIV treatment paradigms • Define the most important concerns in the long-term management of patients with HIV • Discuss critical factors for aging patients with HIV

  3. Program Agenda

  4. Program Agenda (Continued)

  5. FACULTY Program Chair John G. Bartlett, MD Professor of Medicine Johns Hopkins University School of Medicine Baltimore, MD Faculty Calvin J. Cohen, MD, MS Clinical Instructor Harvard Medical School Research Director CRI New England Boston, MA Brian G. Gazzard, MA, MD, FRCP Consultant Physician and Research Director, HIV/GUM Chelsea & Westminster Hospital London, UK Sally L. Hodder, MD Professor of Medicine New Jersey Medical School University of Medicine and Dentistry of New Jersey Newark, NJ Harold W. Jaffe, MA, MD, FFPH Professor of Public Health University of Oxford Oxford, UK Jens D. Lundgren, MD Professor, Viral Diseases University of Copenhagen Copenhagen, Denmark

  6. FACULTY (Continued) Julio Montaner, MD Professor of Medicine Chair in AIDS Research The University of British Columbia Vancouver, BC William G. Powderly, MD Dean of Medicine Head, University College Dublin School of Medicine and Medical Science Dublin, Ireland Valerie E. Stone, MD, MPH Associate Professor of Medicine Director, Women’s HIV/AIDS Program Massachusetts General Hospital Boston, MA

  7. Physician CME Information Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and HealthmattersCME. PIM is accredited by the ACCME to provide continuing medical education for physicians. Credit Designation Postgraduate Institute for Medicine designates this educational activity for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

  8. Nursing CE Information Credit Designation This educational activity for 2.0 contact hours is provided by Postgraduate Institute for Medicine (PIM). Accreditation Statements Postgraduate Institute for Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. California Board of Registered Nursing Postgraduate Institute for Medicine is approved by the California Board of Registered Nursing, Provider Number 13485, for 2.4 contact hours

  9. Program Sponsorship This activity is jointly sponsored by Postgraduate Institute for Medicine and HealthmattersCME

  10. Financial Support This activity is supported by an independent educational grant from Gilead Sciences Medical Affairs

  11. Estimated Rates for Adults and Adolescents Living With HIV Infection (not AIDS) 34 States and 5 U.S. Dependent Areas, 2007 American Samoa NorthernMarianaIslands Guam DC Estimated HIV Rateper 100,000 Confidential name-basedHIV infection reporting not implemented as of 2003 2.2 – 51.7 AK HI 51.8 – 103.8 103.9 – 170.5 Puerto Rico 170.6 – 282.0 Data classed using quartiles Total rate: 154.2 per 100,000 Note: Rates have been adjusted for reporting delays. Inset maps not to scale. HIV/AIDS Surveillance Report, 2007. Vol 19, table 11. U.S. Virgin Islands

  12. From 2004 to 2007, the estimated number of newly diagnosed HIV/AIDS cases increased 15%3 Awareness of HIV Status in the US 1CDC. HIV prevalence estimate—United States, 2006. MMWR. 2008;57(39):1073-1076. 2Hall HI, et al. Estimation of HIV incidence in the United States of America. JAMA. 2008;300:520-529. 3CDC. HIV/AIDS surveillance report—cases of HIV infection and AIDS in the United States and dependent areas, 2007;19.http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2007report/default.htm. Accessed July 23, 2009.

  13. Total US Population (2007) (N = 301.6 million)1 Estimated HIV/AIDS Prevalence by Race/Ethnicity (2006)(N = 1,106,400)2 Other<2% Other 6% Hispanic/Latino18% White 66% Black46% Black 12% US Population Demographics: Total Population and HIV/AIDS Cases by Race/Ethnicity White35% Hispanic 15% 1Kaiser Family Foundation, based on Table 3: Annual Estimates of the Population by Sex, Race and Hispanic Origin for the United States: April 1, 2000 to July 1, 2007 (NC-EST2007-03). Population Division, U.S. Census Bureau.2CDC. HIV Incidence. Available at http://www.cdc.gov/hiv/topics/surveillance/incidence.htm.

  14. HIV Testing: Efforts to Change Maryland Law and Practice Maryland Law: Teams of providers and advocates, but the main lesson is power of the anecdote Maryland Practice: Email to 155 Maryland infectious disease (ID) physicians Lectures – general ID talks Medscape Emergency room workers (0.5% test)

  15. AUDIENCE RESPONSE QUESTION

  16. Testing and Access to Care: Where Have We Been, Where Do We Need to Be, and How Can We Get There? John G. Bartlett, MD, Moderator Harold W. Jaffe, MA, MD, FFPH Valerie E. Stone, MD

  17. Faculty Disclosures John G. Bartlett, MDConsulting fees: Merck, Tibotec Harold W. Jaffe, MA, MD, FFPH Fees for non-CME services: Merck Valerie E. Stone, MD Consulting fees: Abbott, Gilead Sciences, Tibotec Fees for non-CME services: Abbott, Gilead Sciences

  18. What’s New in HIV Testing, Access and Linkage to Care? Valerie E. Stone, MD, MPH Massachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MA

  19. Case Presentation Imagine that you are a primary care provider… You are seeing a new 35-year-old female patient for her initial annual physical exam. She feels completely well and has no complaints She has a history of depression for which she has taken citalopram in the past. Denies history of other medical problems including HTN, DM, asthma, high lipids Social history is essentially unremarkable – she is an attorney, has a long-term boyfriend with whom she lives, no smoking hx, 5-7 alcoholic drinks per wk, no hx of illicit drug use. FH notable only for breast ca in her mother last year at age 65 You do a complete history and physical including pap/pelvic. Exam is completely normal except that she is a bit overweight (BMI 26.5)

  20. AUDIENCE RESPONSE QUESTION

  21. September 22, 2006 CDC Recommendations: Routine Testing for HIV ROUTINE voluntary screening for patients aged 13-64 in health care settings OPT-OUT testing NO separate consent Pretest counseling NOTrequired Goal is to make HIV testing Less exceptional Universal and routine Not based on RISK

  22. Opt-Out Testing Has Become More Feasible Legislatively Since 2006 At the time of CDC’s 2006 recommendations, 20 states had laws or regulations that required written consent for HIV testing Currently, laws in 40 states and DC are compatible with the CDC recommendations1 States that still have laws requiring signed consent are: Alabama, Hawaii, Massachusetts, Michigan, New York, Nebraska, Pennsylvania, Wisconsin, and Rhode Island 1. Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA.

  23. High Acceptance of Testing and Increasing Percentage Have Been Tested HIV testing has a high rate of acceptance in the US As of 2006 in US, 71 million reported that they had ever had an HIV test -- 40% of target population aged 13-64 Data show modest increase in number tested in 2006 compared with 20021 Most of the testing was done in physicians’ offices (53%) or hospital setting (22% ERs or hospital based clinics)1 PCPs cite many barriers to routine HIV screening2 1. Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA. 2. Bashook PG et al. Society of General Internal Medicine Annual Meeting, April 2008.

  24. Views on Routine HIV Testing HIV testing should be: 65% say treated just like routine testing for any other disease and should be included as part of regular check-ups 27% say it is different from screening for other diseases and should require written permission from the patient Don’t know Neither 27% 65% Kaiser Family Foundation. Survey of Americans on HIV/AIDS; May 8, 2006. Available at: http://www.kff.org/kaiserpolls/pomr050806pkg.cfm.

  25. Trends in HIV Testing in the US, 2002-2006 Ever tested Preceding 12 months Percent Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA.

  26. Location of HIV Testing Summary health statistics for US adults: National Health Interview Survey, 2006.

  27. Reasons for HIV Testing 100% Late (Tested <1 y before AIDS dx) Early (Tested >5 y before AIDS dx) 80% 60% 40% 20% 0% Illness Self/partner Wanted to Routine Required Other check up at risk know Supplement to HIV/AIDS Surveillance, 2000-2003.

  28. Primary Care Physicians Cite Many Barriers to Routine HIV Testing Focus groups of primary care physicians regarding routine HIV testing at SGIM Annual Meeting in 2007 Numerous perceived barriers to implementing routine HIV screening cited: State and local laws and regulations Concerns about stigma and stereotyping Belief that pre-test counseling is essential Time constraints Concerns about how and when to give results Reimbursement concerns Rapid test preferred but not available at their site Bashook PG et al. Society of General Internal Medicine Annual Meeting, April 2008.

  29. Late HIV Diagnosis Is Common In 1 state, 45% of patients diagnosed with HIV within 1 year of AIDS diagnosis (“late testers”) Late testers compared with early testers (>5 y prior to AIDS dx) are more likely to be: Younger (18-29 y) Heterosexual Less educated African American or Hispanic CDC. HIV/AIDS Surveillance, 2000-2003. MMWR Morbid Mortal Wkly Rep. 2003;52(25):581-586.

  30. Late Testing in 34 States, 1996-2005 Method: CDC review of AIDS diagnosis within 1 year of first positive test in 34 states with named reporting Results: 38% of 281,421 1996 – 43% 2001 – 36% 1998 – 42% 2003 – 38% 2000 – 40% 2005 – 36% CDC. MMWR Morbid Mortal Wkly Rep. 2009;58(24):661-665.

  31. Awareness of Serostatus Among People With HIV and Estimates of Transmission Accounting for ~25% Unaware of Infection ~54% of New Infections ~75% Aware of Infection ~46%of New Infections People Living with HIV/AIDS: ~1,000,000 New Sexual Infections Each Year: ~32,000 Marks G et al. AIDS. 2006;20(10):1447-1450.

  32. Knowledge of HIV Infection and Behavior Meta-analysis of 11 HIV risk-behavior studies: Unprotected anal/vaginal sex with HIV-negative partners was 68% lower in people aware vs unaware they were HIV positive Marks G et al. J Acquir Immune Defic Syndr. 2005;39(4):446-453.

  33. Critical Challenge: Linkage to Care Mean time from diagnosis to first HIV primary care visit 2.5 years in cohort of 203 consecutive outpatients presenting for HIV care in Boston1 HIV Cost and Services Utilization Study (HCSUS): 1/3 of people delayed >3 months before getting HIV care2 Delay more common in: African American, Latino Women (esp children at home)3 Uninsured Low trust in doctors 1Samet JH. AIDS. 2001;15(1):77-85; 2Turner BJ. Arch Intern Med. 2000;160(17):2614-2622. 3Stein MD. Am J Public Health. 2000;90(7):1138-1140.

  34. HIV Provider-Cited Challenges to Early Linkage to Care Manpower issues: number of HIV providers is insufficient and decreasing Productivity is lower in HIV-focused practices than in other primary care practices Numerous hidden costs of care that negatively impact the cost-effectiveness of HIV care All of these factors result in each additional patient who is newly “linked to care” contributing further to the challenging financial situation of HIV-focused practices Saag M, Weddle A, Carmichael JK. National Summit on HIV Diagnosis, Prevention and Access to Care; November 19-21, 2008; Arlington, VA.

  35. Interventions to Reduce Delay Rapid testing – more patients get results Case management Improve physician training in posttest counseling – Attention to social situation and need for support Immediate referral and specifics about accessible HIV providers and sites “No show” follow-up by HIV providers Address drug, alcohol use, and mood disorders

  36. Summary 3 years have passed since the “new” CDC Recommendations for HIV Testing were released There has been legislative progress; now 40 states have laws that support opt-out testing More people have been tested at least once in the US—was 40% as of 2006 Primary care physicians cite numerous barriers to enacting these guidelines Linkage to care for those found to be HIV positive is critical and remains challenging

  37. Testing and Access to Care Harold W. Jaffe, MA, MD, FFPH Professor of Public HealthUniversity of OxfordOxford, UK

  38. Overview of Talk HIV rapid tests Screening for acute infection Test and treat strategy

  39. HIV Rapid Tests Point-of-contact testing Three tests CLIA-waived in the US Whole blood (finger stick) or oral fluid (OraQuick) Results in 10 to 20 min

  40. HIV Rapid Testing of Oral Fluid Reactive Control Positive HIV-1/2 Positive Negative

  41. HIV Rapid Test Screening in Emergency Departments 1Walensky RP, et al. Ann Intern Med. 2008;149:153-160. 2Christopoulos K, et al. CROI 2009, Abstract #1040. 3Lyss SB, et al. J Acquir Immune Defic Syndr. 2007;44:435-442.

  42. Confirmation of Reactive HIV Rapid Tests: Standard Algorithm WB, Western blot; IFA, indirect fluorescent antibody; NAT, nucleic acid test. *APTIMA RNA Qualitative Assay (Gen-Probe) is only FDA-approved NAT test for confirmation of HIV infection.

  43. Confirmation of Reactive HIV Rapid Tests: Proposed Algorithms WB, Western blot; IFA, indirect fluorescent antibody; NAAT, nucleic acid amplification test. *Second manufacturer †Third manufacturer From: APHL and CDC. HIV testing algorithms: a status report. April 2009. Available at: http://www.aphl.org/aphlprograms/infectious/hiv/Pages/HIVStatusReport.aspx

  44. Screening for Early HIV Infection by Pooled NAT Testing A B C D E F G H I J 100 Individual specimens (HIV antibody negative) 10 Pools of 10 A B C D E F G H I J 1 Screening Pool

  45. Resolution Testing A Individual NAT testing on 10 specimens 10 Pools of 10 tested with NAT Screening Pools of 100 specimens tested with NAT

  46. Screening for Early HIV Infection NAT testing Detects infection as early as 10 to 12 days Increases detection rate by 2%-8% in public health settings Fourth-generation immunoassay* Simultaneous detection of antibody/p24 antigen in single sample Detects 60%-90% of EIA-/NAAT+ acute infections EIA, enzyme immunoassay; NAAT, nucleic acid amplification test. * ARCHITECT HIV Combo Assay; Abbott Laboratories.Available for sale outside of the United States only.

  47. Test and Treat Strategy “Our model suggests that massive scale-up of universal voluntary HIV testing with immediate initiation of ART could nearly stop transmission and drive HIV into an elimination phase in a high-burden setting within 1-2 years of reaching 90% of programme coverage.” Granich RM et al. Lancet. 2009;373:48-57.

  48. Obstacles to Test and Treat In sub-Saharan Africa, 60%-95% of infected persons have not been diagnosed Of ~33 million HIV-infected persons worldwide, only ~3 million receiving ART Primary infection accounts for 9%-31% of sexual transmission of HIV1 Risks and benefits of early treatment unclear 1Hollingsworth TD et al. J Infect Dis. 2008;198:687-693.