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Joy Zeh, RN, MS, Family Nurse Practitioner VCU HIV/AIDS Center May 2011 View the slides and NOTES for more information 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 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 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/DiseasePreve ntion/Programs/HIV-AIDS/index.htm is the Virginia Department of Health website with the most recent surveillance information for the state. 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 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 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 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 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 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. 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 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 Serodiscordant Couples” Conclusion: Treating HIV-infected People with Antiretrovirals Protects Partners from Infection Concerns: Who will pay for testing and treatment? 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 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 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 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 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 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 Expensive: $600 or more per month In US only Zidovudine, Lamivudine and Didanosine are 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 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 HIV HIV Sexually Transmitted Diseases 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. Hepatitis C HIV Sexually Transmitted Diseases Tuberculosis Hepatitis C HIV Sexually Transmitted Diseases 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 Tuberculosis HIV Hepatitis C Sexually Transmitted Diseases Substance Abuse Tuberculosis HIV Hepatitis C Incarceration Sexually Transmitted Diseases Substance Abuse Poverty Tuberculosis HIV Hepatitis C Incarceration Sexually Transmitted Diseases Substance Abuse Mental Illness Poverty Tuberculosis HIV Hepatitis C Incarceration Sexually Transmitted Diseases Substance Abuse Homelessness Mental Illness Poverty Tuberculosis HIV Sexually Transmitted Diseases Substance Abuse Incarceration Hepatitis C 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 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. 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 THEN 1993-2006 *Based on RISK: Risk & Prevalence OPT-IN THEN NOW 1993-2006 September 22, 2006 *Based on RISK: Risk & Prevalence OPT-IN *ROUTINE: NOT Based on Risk Ages 13-64 OPT-OUT TEST $/QALY* Gained HIV test: All inpatients† 38,600 HIV test every 5 years: People at high risk (3% prevalence)† 50,000 HIV test one time (1% prevalence)‡ Individual benefit only Including benefit to others 41,736 15,078 HIV test one time: U.S. general population (0.1% prevalence)† 113,000 Breast cancer test: Annual mammogram, age 50-69§ 57,500 Colon cancer test: FOBT + SIG every 5 years, age 50-85§ 57,700 Type 2 diabetes test: Fasting blood glucose, age >25§ 70,000 Hypertension testing§ 48,000 FOBT indicates fecal occult blood test; SIG, sigmoidoscopy. *In quality-adjusted life years (QALYs), which account for both longevity and health-related quality of life. †Paltiel et al. (2005); ‡Sanders et al. (2005); §Adapted from personal communication, Sanders and Paltiel, 2005. http://www.drugabuse.gov/NIDA_notes/NNvol20N3/Expanded.html u u u 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. 30 This represents a 66% reduction in risk for transmission (P = <0.001) 20 22.6 % 10 7.6 % Placebo ZDV Group Efficacy was observed in all subgroups 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 n n n 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 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 Sexual Occupational Perinatal Needle-sharing Non-AIDS-defining illness: Cardiovascular Malignancies Lower CD4 count = increased death rate from all causes “AIDS-related events are no longer the major causes of death of HIV-infected patients in the era of HAART.” Bonnet, F., et al, Causes of death among HIV-infected patients in the era of highly active antiretroviral therapy, HIV Medicine “Cigarette smoking is the most important modifiable cardiovascular risk factor among HIVinfected patients.” “Cessation of smoking is more likely to reduce cardiovascular risk than either the choice of antiretroviral therapy or the use of any lipidlowering therapy.” Greenspoon, S. Carr, A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med 2005; 352:48–62 “The incidence of many non-AIDS Defining Malignancies were significantly higher … suggesting that HIV-infected persons are at higher risk of developing certain cancers In addition to encouraging tobacco cessation, health care providers should consider enhanced monitoring for these malignancies in their HIVinfected patients.” Patel P et al. Incidence of AIDS-defining and non-AIDS defining malignancies among HIV infected persons. Conference on Retroviruses and Other Infections 2006 Kaposi’s Sarcoma Burkitt’s Lymphoma B-Cell Lymphoma Primary Lymphoma of Brain Invasive Cervical Carcinoma Cancer Diagnosis may be initial AIDS-defining illness, or may lead to HIV diagnosis in unsuspecting patient Lung Cancer – 3 times increased risk than HIV-uninfected Leukemia – 3 times increased risk than HIV-uninfected Anal Cancer Hodgkin’s Disease Liver Cancer – increased risk if HIV+ person has chronic Hep B or Hep C Testicular Cancer Melanoma Oropharyngeal Cancer No increased incidence rate for colorectal or renal cancers Decreased incidence rate breast and prostate cancer www.cdc.gov/hiv/ Centers for Disease Control www.unaids.org United Nations Programme on HIV/AIDS www.aidsinfo.nih.gov Treatment Guidelines, Drug and Clinical Trials Information from US Public Health Service and National Institutes of Health http://hab.hrsa.gov HRSA HIV/AIDS Bureau that administers Ryan White programs Virginia Department of Health HIV/STD/Viral Hepatitis Hotline 800-533-4148 VDH AIDS Drug Assistance Program http://www.vdh.state.va.us/epidemiology/Disease Prevention/Programs/ADAP/index.htm VCU HIV/AIDS Center 804-828-2210 [email protected] Please contact me with any questions.
