HIV and Public Health: C hallenges and Opportunities

HIV and Public Health:

Challenges and Opportunities

Joy Zeh, RN, MS, Family Nurse PractitionerVCU HIV/AIDS Center

View the slides and NOTES for more information

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

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 Oraquick HIV 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

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

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.

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 2014, CDC Latest recommendations on use of

PrEP Prevention ( see link on web page)

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

HIV: History and Changing Paradigms for Medical Management1981 – 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 FDA1987 – Zidovudine - AZT - approved for HIV treatment1993 – 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

2010 New focus on prevention of HIV among high risk individuals (The PrEP program)

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

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

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.

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 Serodiscordant Couples”

Conclusion: Treating HIV-infected People with Antiretrovirals Protects Partners from Infection

Concerns: Who will pay for testing and treatment?

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

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

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

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

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

HIV MEDICATIONS 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

ADAP Crisis: states with waiting lists

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

ADAP Crisis

Other factors in HIV risks, transmission, and management

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

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

HIVSexually

Transmitted Diseases

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.  

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

HIVSexually

Transmitted Diseases

Hepatitis C

HIV infection impairs cell-mediated immunity, the type of immunity that helps the body control TB infection

HIV

Sexually Transmitted

Diseases

Hepatitis C

Tuberculosis

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

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

Hepatitis C

Tuberculosis

Substance Abuse

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

Hepatitis C

Tuberculosis

Substance Abuse

Incarceration

Poverty can limit access to care and treatment. Poverty is a independent risk factor for TB, substance abuse, and incarceration.

HIV

Sexually Transmitted

Diseases

Hepatitis C

Tuberculosis

Substance Abuse

Incarceration

Poverty

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.

HIV

Sexually Transmitted

DiseasesHepatitis C

Tuberculosis

Substance Abuse

Incarceration

Poverty Mental Illness

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.

HIV

Sexually Transmitted

Diseases

Hepatitis C

Tuberculosis

Substance Abuse

Incarceration

PovertyMental Illness

Homelessness

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

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.

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

THEN1993-2006

*Based on RISK:Risk & Prevalence

OPT-IN

Testing Recommendations

NOW September 22, 2006

*ROUTINE: NOT Based on Risk Ages 13-64

OPT-OUT

THEN1993-2006

*Based on RISK:Risk & Prevalence

OPT-IN

CDC HIV Testing Recommendations

HIV Testing and Other Routine Tests:Cost-Effectiveness Compared

TEST $/QALY* GainedHIV test: All inpatients† 38,600

HIV test every 5 years: People at highrisk (3% prevalence)† 50,000

HIV test one time (1% prevalence)‡   Individual benefit only  Including benefit to others

41,73615,078

HIV test one time: U.S. generalpopulation (0.1% prevalence)† 113,000

Breast cancer test: Annualmammogram, age 50-69§ 57,500

Colon cancer test: FOBT + SIG every5 years, age 50-85§ 57,700

Type 2 diabetes test: Fasting bloodglucose, age >25§ 70,000

Hypertension testing§ 48,000FOBT 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

Pregnant WomenSince 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

1993 - CDC Prevention Counseling Guidelines

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.

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

HIV Risk Reduction Counseling Sexual Occupational Perinatal Needle-sharing

Causes of death for HIV+ patients

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

AIDS-Defining Malignancies

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

Non-AIDS Defining Malignancies 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

OnlineWeb Resources 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

Resources Virginia Department of Health HIV/STD/Viral

Hepatitis Hotline 800-533-4148

VDH AIDS Drug Assistance Program http://www.vdh.state.va.us/epidemiology/

DiseasePrevention/Programs/ADAP/index.htm VCU HIV/AIDS Center 804-828-2210

[email protected] Please contact me with any questions.