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A Medical Review of the HIV Disability Criteria

A Medical Review of the HIV Disability Criteria

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A Medical Review of the HIV Disability Criteria

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  1. A Medical Review of the HIV Disability Criteria Judith A. Aberg, MD HIVMA SSA Disability Working Group Member Principal Investigator, AIDS Clinical Trials Unit Director of Virology, Bellevue Hospital Center Associate Professor of Medicine New York University School of Medicine

  2. There have been remarkable advances in HIV treatment and yet • Only 50 to 60% of people respond to antiretroviral therapy • Many people with HIV/AIDS in the US still diagnosed late in the disease process • IOM estimates that nearly 50% of people with HIV/AIDS in need of antiretroviral treatment not receiving it1 1Institute of Medicine of the National Academies. Public Financing and Delivery of HIV/AIDS Care: Securing the Legacy of Ryan White. 2005: National Academy of Sciences.

  3. Only 55% of eligible patients in US receiving ARV therapy 268,000253,000 – 283,000 On ARV therapy In care Eligible PLWHA 340,000320,000 – 860,000 480,000441,000 – 519,000 820,000746,000 – 894,000 Teshale E, et al. 12th CROI Abstract 167.

  4. Timing of AIDS Diagnosis, 2004 Data from 35 states Source: CDC, HIV/AIDS Surveillance Report, Vol. 16, 2005.

  5. When is Antiretroviral Therapy Started? Review of data from 42 countries, 176 sites; n=33,008 Since 2000, CD4+ cell count at initiation in developed countries remained stable at ~150–200 cells/mm3, increasing in Sub-Saharan Africa from 50 to 100 cells/mm3 Median CD4 count at start of ART, 2003–5 42 countries 176 sites 33,008 patients Egger M et al. 14th CROI; 2007; Los Angeles. Abstract 62.

  6. Late diagnosis makes a difference • South Carolina Health Department study of 2001 to 2005 HIV cases: • 41% progressed to AIDS within one year of an AIDS diagnosis1 • New York City Department of Health and Mental Hygiene Study: • patients diagnosed with AIDS at time of initial presentation 55% more likely to die of an HIV-related cause • more than 50% of the deaths occurred within four months of diagnosis2 1CDC. Missed Opportunities for Earlier Diagnosis of HIV Infection—South Carolina, 1997—2005. MMWR. 55(47)1267-1271. 2Hanna D, Pfeiffer M, Torian L, Sackoff J. Concurrent HIV/AIDS diagnosis increases the risk of short-term HIV-related death among persons newly diagnosed with AIDS, 2002-2005.  AIDS Patient Care and STDs. 2008. 22: 17-28.

  7. HIV listings (14.08) reflect state of HIV disease in the US People diagnosed late with HIV… • are more difficult to treat • experience the disease course similar to pre-HAART • are less likely to fully benefit from antiretroviral treatment

  8. Other factors complicating treatment • As many as 76 to 90% of patients in treatment resistant to at least one drug1 • Effective suppression of HIV requires strict adherence (90%) to potent medications with serious side effects • Immune Reconstitution Inflammatory Syndrome (IRIS) severely complicates treatment 1Hirsch MS, Huldrych GF, Schapiro JM, Brun-Vézinet F, Clotet B, Hammer SM, Johnson VA et al. Antiretroviral drug resistance testing in adult HIV-1 infection: 2008 recommendations of an International AIDS Society-USA Panel. Clin Infect Dis. 2008;47(2):266-85.

  9. Immune reconstitution inflammatory syndrome (IRIS) • Refers to a pathogen-specific inflammatory response that may be triggered after initiation, re-initiation, or change to more active ART which usually results in a rising CD4 cell count. The inflammatory response may cause an unmasking or worsening of symptoms which were previously quiescent or mild. Depending on the circumstances, IRIS may be mild or severe, or even result in death.

  10. Comments on the Adult Listings for HIV Infection (14.08)

  11. A. Bacterial Infections: Tuberculosis • HIV patients with TB five times more likely to die during anti-TB treatment than those not HIV-infected1 • Weakened immune systems leave patients at increased risk for TB • Optimal treatment for TB/HIV co-infection still not identified • Considerations include drug-drug interactions, drug resistance and tolerability 1CDC. Reported HIV Status of Tuberculosis Patients --- United States, 1993—2005. MMWR. 2007;56(42):1103-1106.

  12. Other bacterial infections can cause disability • Methicillin-resistant Staphylococcus aureus or MRSA • Increasing among people with HIV/AIDS1 • Requires prolonged antibiotic treatment • Clostridum Difficile (C-difficile) • PWA increased risk for c-difficile • Most common cause of bacterial diarrhea for HIV patients2 • More difficult to treat for HIV patient 1Crum-Cianflone NG, Burgi AA, Hale BR. Increasing rates of community-acquired methicillin-resistant Staphylococcus aureus among HIV-infected patients. Int J Std AIDS. 2007 Aug;18(8):521-6. 2Sanchez TH, Brooks JT, Sullivan PS, Juhasz M, Mintz E, Dworkin MS, et al. Bacterial diarrhea in persons with HIV infection, United States, 1992-2002. Clin Infect Dis. 2005 Dec 1;41(11):1621-7.

  13. Bacterial infections - terminology • Consider changing terms defining severity to better reflect medical terminology • replace “recurrent” with “refractory, persistent”

  14. B. Fungal Infections • Less common but still see in patients with advanced HIV • Affected patients as ill as pre-HAART • PCP still most common opportunistic infection1 • 70 to 80% of patients respond to treatment but unable to predict response and outcomes 1Morris A, Lundgren JD, Masur H, Walzer PD, Hanson DL. Current epidemiology of pneumocystis pneumonia. Emerging Infectious Diseases. CDC. 2004; 10 (10):1713-1730.

  15. C. Protozoan or helminthic infections • Weakened immune systems leave patients with HIV more susceptible to parasites that are benign to others, e.g., giardia • Unable to control for some patients with current treatment options • Unable to predict who responds to treatment

  16. D. Viral Infections • Herpes can still be disabling • Superimposed bacterial infections • Acyclovir-resistant • Progressive multifocal leukoencephalopathy (JC Virus) lethal if patient unresponsive to antiretrovirals (e.g. PML IRIS) • Hepatitis C is the major viral infection affecting people with HIV. Significant cause of ESLD. Many patients not eligible for HCV treatment

  17. Consider adding hepatitis C (HCV) to the listings • 25 to 30% of patients co-infected with HIV and HCV • Prognosis poor for HIV/HCV patients • Rate of progression to cirrhosis with HIV/HCV threefold higher1 • Also increased risk for antiretroviral-associated hepatoxicity1 1Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 29, 2008; 1-128.

  18. Trends in Standardized Incidence Rates of AIDS-Defining and Non-AIDS-Defining Types of Cancer among Persons with HIV Patel, P. et. al. Ann Intern Med 2008;148:728-736

  19. E. Malignant neoplams • Non-HIV related malignancies increasing (e.g. lung) • HPV related cancers and side effects of radiation • Seen more with advancing HIV disease and ? IRIS • Questionable association with CCR5 inhibitors vs immune activation

  20. F. Conditions of the skin or mucous membranes • Still see in patients with advanced disease and for some symptoms persist even with treatment • Particularly intrusive if occur in genital, hands and rectal areas • At risk for recurrent cellulitis and bacteremia

  21. Other conditions less common but still affecting some patients with advanced HIV • HIV Wasting (H) • Diarrhea (I) • Fungal sinusitis (J.6) • What does resistant to treatment mean?

  22. 14.08 K repeated manifestations • Impact of HIV disease on functioning is unique to each patient (e.g. malaise, fatigue, metabolic syndrome, DSPN) • Recognize the validity of the HIV treating physician’s objective evaluation of the patient’s ability to perform sustainable gainful employment due to manifestations of HIV disease

  23. HIV and mental illnesses • Around 50% of my HIV patients have a mental illness or substance use disorder • Complicates treatment and adherence • Data suggests affects disease course1 1Leserman J. Role of depression, stress, and trauma in HIV disease progression. Psychsom Med. 2008. Jun;70(5):539-45.

  24. Identify qualified medical experts to review HIV disability cases • HIVMA defines “experienced HIV medical providers” as those that (1) provide continuous and direct medical care to at least 20 patients with HIV over the past two years and (2) complete at least 30 hours of HIV-related continuing medical education over the past two years