Download Other factors complicating treatment

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
There have been remarkable
advances in HIV treatment and yet

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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.
Only 55% of eligible patients
in US receiving ARV therapy
On ARV therapy
268,000
253,000 – 283,000
In care
340,000
320,000 – 860,000
Eligible
480,000
441,000 – 519,000
PLWHA
Teshale E, et al. 12th CROI Abstract 167.
820,000
746,000 – 894,000
Timing of AIDS Diagnosis, 2004
Data from 35 states
Within 12
Months of HIV
Diagnosis
39%
More than 12
Months from
HIV Diagnosis
61%
Source: CDC, HIV/AIDS Surveillance Report, Vol. 16, 2005.
When is Antiretroviral Therapy Started?
Median CD4 count at
start of ART, 2003–5
42 countries
176 sites
33,008 patients
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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
Egger M et al. 14th CROI; 2007; Los Angeles. Abstract 62.
Late diagnosis makes a difference
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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 HIVrelated 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.
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 preHAART
 are less likely to fully benefit from antiretroviral
treatment
Other factors complicating treatment
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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.
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.
Comments on the Adult Listings
for HIV Infection (14.08)
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.
Other bacterial infections can cause
disability
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Methicillin-resistant Staphylococcus aureus or MRSA
1
 Increasing among people with HIV/AIDS
 Requires prolonged antibiotic treatment
Clostridum Difficile (C-difficile)
 PWA increased risk for c-difficile
2
 Most common cause of bacterial diarrhea for HIV patients
 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.
Bacterial infections - terminology

Consider changing terms defining severity to better
reflect medical terminology
 replace “recurrent” with “refractory, persistent”
B. Fungal Infections
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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.
C. Protozoan or helminthic infections
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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
D. Viral Infections
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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
Consider adding hepatitis C (HCV)
to the listings
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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 antiretroviralassociated 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.
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
E. Malignant neoplams
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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
F. Conditions of the skin or mucous
membranes
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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
Other conditions less common but
still affecting some patients with
advanced HIV
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HIV Wasting (H)
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Diarrhea (I)
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Fungal sinusitis (J.6)
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What does resistant to treatment mean?
14.08 K repeated manifestations
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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
HIV and mental illnesses
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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.
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