HIV and Public Health: C hallenges and Opportunities

1. HIV and Public Health: Challenges and Opportunities Joy Zeh, RN, MS, Family Nurse Practitioner VCU HIV/AIDS Center May 2013 View the slides and NOTES for more information

2. HIV and Public Health: Challenges and Opportunities Latest News! Epidemiology History and Changing Paradigms National HIV Strategy Spectrum of HIV Infection CD4 & Viral Load Principles of HIV Therapy Related Infections and Co-Morbidities HIV Testing and Prevention Resources

3. Latest News! • March 27, 2012: Treatment Guidelines recommend treating HIV with medication at any CD4 level • May 10, 2012: FDA recommends approving Truvada, HIV medication, for use in high- risk individuals for Pre-Exposure HIV Prophylaxis (PrEP) – in conjunction with condoms • May 15, 2012: FDA recommends approving OraquickHIV Test for OTC (over the counter) sale and home use – results in 20 minutes • Direct Access Home HIV Test already available, but must be mailed to lab, results in 3 to 7 days

4. Challenges and Opportunities • Increasing new cases especially in certain populations: MSM, women of color • Financial – cost of HIV medications has strained many states drug assistance programs • Financial – decreased funding for prevention efforts • Earlier testing and treatment can improve life expectancy of HIV infected people • National HIV strategy can guide prevention and treatment efforts • HIV medications can decrease risk of transmission to uninfected partners

5. Epidemiology http://apps.who.int/globalatlas/default.asp is World Health Organization HIV/AIDS database. You can look at country-specific data on incidence, risk, and treatment. www.cdc.gov/hiv/topics/surveillance/ is the Centers for Disease Control and Prevention website with HIV/AIDS statistics and surveillance information. www.vdh.virginia.gov/Epidemiology/DiseasePrevention/Programs/HIV-AIDS/index.htm is the Virginia Department of Health website with the most recent surveillance information for the state.

6. HIV - U.S. Trends August 2006 CDC revised estimated annual new HIV infections in US to 56,300 annually Since 1993, decreasing pediatric infections Decreasing AIDS deaths = increasing prevalence Minority populations disproportionately affected Increasing heterosexual transmission, increasing women especially in southeast US 10% new cases in people over age 50 Diagnosis LATE in spectrum of infection persists September 2006 CDC recommended change in testing approach with goal to decrease late diagnosis

8. Comparison of Mortality Data from AIDS Case Reports and Death Certificates in which HIV Infection was Selected as the Underlying Cause of Death, United States, 1987−2009 *For comparison with data for 1999 and later years, data in the bottom (orange) line for 1987−1998 were modified to account for ICD-10 rules instead of ICD-9 rules.

9. CDC Statistics 1985 CDC case definition for AIDS – did not include some diagnoses that women get more than males 1993 – jump in cases because CDC case definition for AIDS was revised to include more conditions that result from HIV immune compromise, including pulmonary TB and invasive cervical cancer 1996 – death rate decreasing, Prevalence or number of people living with AIDS diagnosis increasing 2010 - New cases and deaths continue to be higher in people of color

12. HIV: History and Changing Paradigms for Medical Management 1981 – First cases of Pneumocystis Pneumonia and Kaposi’s Sarcoma in young gay males identified – common factor of immune suppression identified 1985 – Test for HIV Antibody approved by FDA 1987 – Zidovudine - AZT - approved for HIV treatment 1993 – ACTG 076 Results Released early – giving pregnant women AZT decreases risk of HIV infection in the baby – becomes standard of care 1995 – Combination therapy in clinical trials improves viral suppression and improves patient outcomes, decreased opportunistic infections and decreased hospitalizations, HIV/AIDS death rate plummets, increased life expectancy

13. HIV: History and Changing Paradigms for Medical Management Prior to 1995 – only 4 medications available – gave one at a time 1995 – Protease Inhibitors available – new category of antiretroviral medications SMART Study – ended early in 2007 – group randomized to stop HIV medication had more cardiovascular adverse events than those on HIV medications

14. HIV: Changing Paradigms for Medical Management Evidence Based Practice – recommendations change as more evidence available from clinical studies 1985 – Treatment options limited, patients concerned about side effects, often avoided medications, high death rate 1993 – ACTG 076 showed benefit to baby by treating pregnant HIV+ women 1995 – Combination therapy effective, Recommendation treat all HIV+ patients early in infection 2000 – Cohort studies data: safe to wait until CD4 around 350 to treat 2012 – Guidelines recommend treatment when CD4 500 or consider when above 500

15. HIV: Changing Paradigms for Medical Management Evidence Based Practice – recommendations change as more evidence available from clinical studies SMART study – Strategic Management of AntiRetroviral Therapy – large international study, patients with CD4>350 randomized to start/ continue medications, or to stop medications. 2007 – SMART study ended early, group that stopped medications had more cardiovascular adverse events than those on medication. Analysis of metabolic parameters ongoing.

16. HIV: Changing Paradigms for Medical Management Evidence Based Practice – recommendations change as more evidence available from clinical studies 2009 – Test and treat theoretical discussion: What if everyone HIV infected immediately was put on antiretroviral medications? Granich, Reuben M, et al, Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model, January 2009, The Lancet Practical concerns: Access to care; Paying for medications; Medication adherence

17. HIV: Changing Paradigms for Medical Management Evidence Based Practice – recommendations change as more evidence available from clinical studies • National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health (NIH) issued a press release on May 12, 2011, announcing the results of HPTN 052 • “A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in SerodiscordantCouples” • Conclusion: Treating HIV-infected People with Antiretrovirals Protects Partners from Infection • Concerns: Who will pay for testing and treatment?

18. 2010: The U.S. National HIV/AIDS Strategywww.hab.hrsa.gov Goal 1 – Reduce New Infections Goal 2 – Increase Access to Care and Improving Outcomes Includes strategies to improve linkage to care, maintain patients in care, and increase number and diversity of providers Goal 3 – Reduce Disparities By end of 2011 HRSA wants to collect data to “calculate community viral load” as burden of illness Increase coordination of state and federal programs

19. HIV SPECTRUM OF INFECTION Acute Asymptomatic Early Sx AIDS 4-6 wks 10-12 years months-yrs ______/___________/________/______ Most people will have HIV infection for 10 to 12 years or longer before developing AIDS diagnosis. Goal is to have HIV-infected people enter care before they develop AIDS and get on medication to prevent AIDS and promote normal life span

20. AIDS-Defining Illnesses and Conditions Opportunistic Infections and Cancers Wasting AIDS-Related Dementia T4 (CD4) count < 200 Any HIV+ patient who does not have one of these illnesses or conditions just has HIV infection and does not have AIDS

21. Association between virologic, immunologic, and clinical events and time course of HIV infection

22. CD4 Count CD4+ T-Lymphocytes “Conductor” of the Immune System “Orchestra” Normally 600-1200 Can be lower due to illness, stress, pregnancy Gradually decrease over the course of HIV Infection Can increase with ARV therapy Usually checked every 3 months outpatient Cost around $150

23. HIV Viral Load Indirect Measure of Viral Replication in the body - lymph nodes, CNS, GI tract Higher with acute illness, immunization, also seroconversion or reinfection Higher viral load - increased risk of disease progression (>100,000) Lower viral load - decreased risk of disease progression (<100,000) Undetectable viral load - means ARV medications are working, NOT that virus is gone Usually checked every 3 months, cost about $180

24. Principles of HIV Therapy Combination therapy is better than monotherapy. HAART - Highly Active Antiretroviral Therapy - 3 or 4 drugs, usually from 2 or 3 classes of antiretrovirals. When to start therapy depends on CD4 count, HIV viral load, patient symptoms, and patient ability to be adherent to medication regimen. When resistance develops drugs should be changed or added based on HIV genotype resistance profile. Antiviral therapy ideally begun outpatient. Once started, can therapy be safely interrupted? SMART Study data: Treatment Interruption is NOT recommended

25. HIV MEDICATIONS Expensive: $600 or more per month In US only Zidovudine, Lamivudine and Didanosineare available as generics, still very expensive ADAP is AIDS Drug Assistance Program which is federally funded, administered by state Health Departments. HIV+ patients who meet income guidelines and have no insurance can receive ADAP medications at no cost

26. ADAP Crisis: states with waiting lists

27. ADAP Crisis • Go to website for National Alliance of State & Territorial AIDS Directors www.nastad.org for current ADAP Watch update • Over 8,000 patients in 13 states are on waiting lists for medication • Almost 700 in Virginia on waiting list • States have reduced number of drugs available on ADAP formulary, and decreased the income guidelines, to help control costs • Pharmaceutical company Patient Assistance Programs are helping bridge the gap

28. Other factors in HIV risks, transmission, and management

29. HIV funding is categorical medicine – funding for one condition – but HIV does not exist in a vacuum. HIV alters the immune system and the response to cancers, certain infections. We know some categories of patient are at increased risk for HIV infection HIV

30. Presence of sexually transmitted diseases increases risk of becoming infected with HIV; IN 2009-2010 many new cases of syphilis occurring in HIV+ young men who have sex with men (MSM), especially African-American men HIV Sexually Transmitted Diseases

31. STD Epidemiology Each year, there are approximately 19 million new STD infections, and almost half of them are among youth aged 15 to 24.4 In 2004, an estimated 4,883 young people aged 13-24 in the 33 states reporting to CDC were diagnosed with HIV/AIDS, representing about 13% of the persons diagnosed that year.

32. Hepatitis is not thought of as a sexually transmitted disease; however co-infection with HIV and Hep C increases risk of sexual transmission of Hep C; Sex with multiple partners and presence of STDs is risk factor for Hep C infection Hepatitis C HIV Sexually Transmitted Diseases

33. HIV infection impairs cell-mediated immunity, the type of immunity that helps the body control TB infection Tuberculosis Hepatitis C Sexually Transmitted Diseases HIV

34. Tuberculosis (TB) Infection The TB skin test, also referred to as PPD, is used to determine if a person has TB infection in the body. A person can have TB infection without having active disease – they have no symptoms, they are not sick, and cannot transmit TB to anyone else. Active TB disease can be prevented by taking prophylactic medication. HIV+ patients have increased risk of becoming infected with TB, then once infected HIV+ patients have a 1 in 8 risk every year of developing active TB infection; compare with HIV Uninfected patients who have 1 in 10 lifetime risk of developing active TB Many HIV+ patients also have other risks for TB infection including homelessness, IV drug use, incarceration

35. Substance abuse decreases inhibitions, increases risky behaviors to obtain the drug or while using the drug of choice, and increases risk of becoming infected with HIV and Hep C HIV Sexually Transmitted Diseases Tuberculosis Hepatitis C Substance Abuse

36. Incarcerated populations have higher incidence of Hepatitis C, and crowded living conditions can increase risk of TB infection. Continuity of care for HIV+ inmates on release can be challenging, especially access to HIV medications HIV Sexually Transmitted Diseases Tuberculosis Hepatitis C Substance Abuse Incarceration

37. Poverty can limit access to care and treatment. Poverty is a independent risk factor for TB, substance abuse, and incarceration. Poverty HIV Sexually Transmitted Diseases Tuberculosis Hepatitis C Substance Abuse Incarceration

38. Mental illness is another condition that can increase risky behaviors or make a person more vulnerable to circumstances that increase risk of HIV infection. Adherence to HIV medications may be affected by mental illness. Poverty Mental Illness Tuberculosis HIV Sexually Transmitted Diseases Hepatitis C Substance Abuse Incarceration

39. Homelessness makes it difficult to locate HIV+ patients, get them needed medications, and arrange follow-up. Patients may be at increased risk for homelessness because of all of the factors in the diagram. Homeless HIV+ patients may have difficulty finding a place to keep medications. Homelessness Mental Illness Poverty HIV Sexually Transmitted Diseases Tuberculosis Hepatitis C Substance Abuse Incarceration

40. HIV programs are categorical medicine, but HIV does not take place in a vacuum. HIV+ patients may have their care complicated by all the factors in the preceding diagram

41. HIV Antibody Testing Tests for presence of ANTIBODY, NOT directly for virus. Many of those infected produce detectable antibody by 28 days after infection. 95% have detectable antibody in 3 months. CDC: By 6 months after infection, it would be rare for anyone infected not to have detectable antibody.

42. HIV Antibody Testing Technology Blood Tests - “Gold Standard” “Home Access” Home Test Kit Orasure - Tests Oral Transmucosal Exudate Urine Tests - expensive Rapid Test Kits: ELISA only, positive test needs confirmation Oraquick- approved for blood and oral testing Reveal - requires whole blood sample Clearview – requires blood fingerstick

43. Testing Recommendations • THEN • 1993-2006 • *Based on RISK: • Risk & Prevalence • OPT-IN

44. CDC HIV Testing Recommendations • THEN • 1993-2006 • *Based on RISK: • Risk & Prevalence • OPT-IN NOW September 22, 2006 *ROUTINE: NOT Based on Risk Ages 13-64 OPT-OUT

45. HIV Testing and Other Routine Tests:Cost-Effectiveness Compared http://www.drugabuse.gov/NIDA_notes/NNvol20N3/Expanded.html

46. HIV Risk Reduction - Perinatal ACTG 076 (1993) demonstrated giving zidovudine to pregnant HIV+ women decreased vertical transmission to 8% (control group had 25% vertical transmission rate). Ongoing research of combination therapies for further decreased perinatal prevention. HIV testing should be OFFERED to all women seeking prenatal care.

47. Results of ACTG 076 (1993) This represents a 66% reduction in risk for transmission (P = <0.001) 30 20 22.6% Transmission Rate (%) 10 7.6% Placebo ZDV Group Efficacy was observed in all subgroups

48. Pregnant Women Since 2001: Routine, voluntary HIV testing as a part of prenatal care, as early as possible, for all pregnant women Simplified pretest counseling Flexible consent process Since 9/26/2006: Standard prenatal screening Opt OUT testing Repeat screening 3rd trimester in high HIV prevalence jurisdictions

49. HIV PREVENTION COUNSELING CDC Guidelines recommend that counseling around HIV focus on PREVENTION of new HIV infections (Primary Prevention) or PREVENTION of reinfections or transmission of HIV from someone known to be HIV infected (Secondary Prevention) through behavior change. 1993 - CDC Prevention Counseling Guidelines

50. HIV Risk Reduction Counseling Broadly covers: • Knowledge of Risk • Personal Perception of Risk • Readiness to Change • Self-Efficacy • Skill Development • Reinforcements of Behavior Change • Identification of Barriers for Risk Reduction behavior John Kelly, 1992