the case for routine screening for hiv douglas k. owens, md, ms va palo alto health care system,...
TRANSCRIPT
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The Case for Routine Screening for HIV
Douglas K. Owens, MD, MS
VA Palo Alto Health Care System, Palo Alto, CA USA
Stanford University, Stanford CA, USA
June 2007
Supported by the Department of Veterans Affairs, the VA HIV QUERI, and the National Institute on Drug
Abuse
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Should voluntary HIV screening be expanded in the U.S?
• Background
• Burden of HIV in health-care settings»Are at risk patients being tested?
»What is the prevalence of undocumented HIV disease?
• What are the costs and benefits of HIV screening?»Benefit to a person identified as having HIV
»Benefit from reduced transmission of HIV
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Identification early in the course of HIV disease is critically important
• Access to highly active anti-retroviral treatment (HAART)
• Prophylaxis for opportunistic infections
• Counseling to reduce HIV transmission
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But, HIV infection is often diagnosed late in the course of disease
• CDC Surveillance: 41% of patients develop AIDS within a year of diagnosis with HIV
• VA: 40% have CD4 count < 200 at diagnosis
• Up to 20,000 new infections in the U.S from people unaware they are infected (CDC)
The system for detecting HIV in the U.S. is inadequate
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CDC and US Preventive Service Task Force Recommend Screening
• CDC, prior to September 2006: » Assess risk behaviors; screen high risk
» Routine voluntary screening if prevalence is 1% or greater
• CDC, current» Routine screening all health care settings (prevalence over 0.1%)
• USPSTF: Screen high risk people and pregnant women» Consider prevalence in determining policy
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Two approaches to screening: targeted or routine screening
• Targeted screening: assess risk behaviors, screen if high risk» MSM» IDU» Multiple partners» Exchange sex for money or drugs or have partners who do» Past or present partners HIV-infected, bisexual, or IDU» History of STD» Blood transfusion between 1978-1985» Requests testing
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Routine screening offers screening to all people in a specified clinical setting
• Defined by type of setting» STD clinics
»Homeless shelters
» TB clinics
»Clinics serving MSM
• Defined by prevalence»CDC: 1% prevalence (early 90’s)
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Targeted screening: Why not just assess risk behaviors?
• 10% to 25% of people testing positive report no risk behaviors1
• Prospective study2 in STD clinic: testing only those with reported risk behaviors missed 75% of HIV diagnoses
• Risk assessment likely less reliable in high risk populations
1Chou et al, Ann Intern Med 2005; 143:55-73; 2Chen et al. Sex Trans Dis 1998; 25:539-43
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Routine screening: Why not screen everyone?
• Potential disadvantages:»Medical harms: false-positive test result
»Cost
»Competing health care priorities
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Summary: We are failing to identify people with HIV early in disease.
• They lose opportunity for maximum benefit from ARV
• Increased ongoing transmission
• Targeted or routine screening?
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Should voluntary HIV screening be expanded in the U.S?
• Background
• Burden of HIV in health-care settings»Are at risk patients being tested?
»What is the prevalence of undocumented HIV disease?
• What are the costs and benefits of HIV screening?»Benefit to a person identified as having HIV
»Benefit from reduced transmission of HIV
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Are at risk patients being tested?
• Used VA National Patient Care database to identify cohort seen at 4 VA medical centers from October 1, 1998 to September 30, 1999
• At risk defined as documentation of ICD9 codes for substance use, STD or hepatitis
• HIV testing information from October 1, 1995 to September 30, 2000 obtained for cohort
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Have at-risk patients been tested for HIV?
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Site 1 Site 2 Site 3 Site 4 Multi-siteVA Healthcare System
Per
cen
t Not tested
Tested
Positive
Among at-risk patients, 36% had been tested for HIV
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Are primary care patients at risk?
• Randomized trial of screening in primary care
• Reviewed charts of 750 UNTESTED patients
• 25% had HIV risk behaviors
• Of patients with risk behaviors, only 15% had risk assessment
Many patients were at risk, few had risk assessment, none were tested.
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Should voluntary HIV screening be expanded in the U.S?
• Background
• Burden of HIV in health-care settings»Are at risk patients being tested?
»What is the prevalence of undocumented HIV disease?
• What are the costs and benefits of HIV screening?»Benefit to a person identified as having HIV
»Benefit from reduced transmission of HIV
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The prevalence of HIV infection determines the yield of screening.
• Prevalence of unknown HIV infection is the critical determinant of yield of screening
• Total prevalence may be a reasonable marker for prevalence of unknown HIV infection
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A blinded serologic survey can determine the prevalence of undocumented HIV infection
• Blinded, anonymous serologic survey
• Randomly sampled age-stratified blood specimens drawn for other purposes
• Unique patient specimens for inpatients and outpatients
• Collected data on demographics, comorbid conditions and prior HIV status
• HIV testing done using standard testing protocols after removing all identifiers
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HIV Prevalence: Inpatients
0
1
2
3
4
5
6
7
8
9
10
Site A Site B Site C Site D Site E Site F
Site
Per
cen
t
HIV prevalence
Undocumented prevalence
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HIV Prevalence: Outpatients
0
1
2
3
4
5
6
7
8
9
10
Site A Site B Site C Site D Site E Site F
Site
Per
cen
tHIV prevalence
Undocumented prevalence
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Results: HIV Prevalence
Site 1 Site 2 Site 3 Site 4 Site 5 Site 6
HIV PrevalenceInpatient 1.20% 4.40% 3.00% 6.91% 2.40% 0.79%Outpatient 2.27% 4.13% 8.00% 8.93% 1.60% 0.93%Total 1.73% 4.26% 4.70% 7.97% 2.00% 0.87%
Undocumented PrevalenceInpatient 0.00% 0.14% 0.00% 1.70% 1.08% 0.16%Outpatient 0.27% 0.28% 0.29% 2.89% 0.67% 0.13%Total 0.14% 0.21% 0.15% 2.33% 0.88% 0.15%
Proportion Unidentified 0.08 0.05 0.03 0.29 0.44 0.17Prevalence
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What is the Prevalence of HIV Among Older Patients?
Outpatient Inpatient Outpatient InpatientAge group 25-44 11.4 (9.3-13.7) 5.9 (4.2-8.1) 1.6 (0.8-2.7) 0.8 (0.3-2.0) 45-54 5.6 (4.4-7.2) 5.2 (4.0-6.6) 0.9 (0.4-1.6) 0.6 (0.3-1.3) 55-64 3.5 (2.3-5.2) 2.8 (1.7-4.3) 0.7 (0.2-1.7) 0.9 (0.3-1.9) 65-74 0.8 (0.4-1.6) 1.3 (0.6-2.3) 0.5 (0.2-1.2) 0.4 (0.1-1.0) >= 75 0.1 (0.0-0.6) 0.2 (0.0-0.9) 0.1 (0.0-0.6) 0.0 (0.0-0.4)
HIV Prevalence
% (95% CI) % (95% CI)(total)
HIV Prevalence (previously unknown)
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Lessons from the serologic survey
• HIV prevalence at all our sites was substantially higher than the 0.1% prevalence recommended for routine screening by CDC currently
• From 3% to 44% of HIV infections were undocumented and probably unknown.
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Providers aren’t aware their patients are at risk.
• Providers felt testing was not a high priority» Population not at risk
• One quarter of primary care patients DID have risk behaviors, none were tested
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Should voluntary HIV screening be expanded in the U.S?
• Background
• Burden of HIV in health-care settings»Are at risk patients being tested?
»What is the prevalence of undocumented HIV disease?
• What are the costs and benefits of HIV screening?»Benefit to a person identified as having HIV
»Benefit from reduced transmission of HIV
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Cost effectiveness analysis
• Compares two or more strategies
• Assesses the incremental benefit and incremental cost of one strategy versus another
• Calculate the incremental cost-effectiveness ratio:
Costs with screening – Costs without screening
Benefits with screening – Benefits without screening
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Measuring health outcomes: the quality-adjusted life years (QALYs)
Time spent in a reduced state of health is equivalent to some shorter period of time in good health.
Moderate angina
No angina
0 10 yrs8 yrs
10 years with moderate angina = 8 years with good health, or 8 “quality-adjusted” years of life.
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Interpreting the incremental cost-effectiveness ratio
• Less than $50,000 per QALY gained – usually considered good value
• $50,000 to $100,000 per QALY gained – sometimes considered good value
• Greater than $100,000 per QALY gained – often considered expensive
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We evaluated the costs and benefits of screening*
• Potential benefits» For HIV+: increased length and quality of life
» For community: decreased transmission
• Costs» Screening and counseling costs
»Costs of treatment (HAART, prophylaxis for opportunistic infections)
* Sanders et al. NEJM 2005; 352:570-85
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Screening strategies
• No screening» Testing for HIV only from case finding for
symptomatic patients
• HIV screening» Symptom-based case finding AND
»One-time or recurrent screening
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Methods: A mathematical model of screening
• Mathematical model (Markov model) follows screened and unscreened cohort
• Perspective: societal
• Time horizon: lifetime
• Health benefit: quality-adjusted years
• Costs: U.S. testing and treatment costs
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Case Finding Only
Screening andCase Finding
Markov Model
HIVAsymptomatic
HIVSymptomatic
AIDS
Uninfected
Death
HIVon HAART
AIDSon HAART
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Costs
• Testing and counseling costs
• Cost of HAART
• Other medical costs of HIV care
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Costs and Benefits of Screening
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What is the benefit to the person identified as having HIV?
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
30 40 50 60 70 80 90
Age, years
Incr
ease
in L
ife
Exp
ecta
ncy
Du
e to
S
cree
nin
g, y
ears
Life Expectancy Quality Adjusted Life Expectancy
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Lifetime costs and benefits, cost effectiveness, 1% Prevalence, ignoring transmission
Strategy Cost Incremental Cost
QALYs Incremental QALYs
CE
$/QALY
No Screening
$51,517 --- 18.626 ---
Screening $51,850 $333 18.634 2.9 days $41,700
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Lifetime costs and benefits, cost effectiveness, 1% prevalence, including transmission
Strategy Cost Incremental Cost
QALYs Incremental QALYs
CE
$/QALY
No Screening
$52,623 --- 18.576 ---
Screening $52,816 $194 18.589 4.7 days $15,000
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0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
200,000
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
Prevalence (%)
Incr
emen
tal C
ost
Eff
ecti
vene
ss o
f Sc
reen
ing
($/Q
AL
Y)
Transmission Included No Transmission
Effect of prevalence on cost effectiveness of screening
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Screening is cost effective even at low prevalence
• Including transmission, screening is cost effective when prevalence is above 0.05%
• Implication: screening is cost effective in all sites we surveyed, and likely in all but the lowest risk health-care settings
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Screening guidelines revisited
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Evidence for routine screening is compelling, but how should it be done?
• Addressed in a HIV QUERI randomized control trial»Doctor initiated, traditional testing and counseling
»Nurse initiated, traditional testing and counseling
»Nurse initiated, streamlined counseling, rapid testing
• Conducted by Steve Asch, Henry Anaya, Matt Goetz, and colleagues from the HIV QUERI
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Nurse-based screening with rapid testing and counseling out performs other strategies
MD, traditional
Nurse, traditional
Nurse, streamlined counseling, rapid testing
% Tested % Received Result
40% 15%
85% 31%
89% 80%
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Summary
• With our current approach to identification of HIV, almost half of people identified late in disease
• Many at-risk patients are seen in health-care settings
• Many are NOT tested
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Summary
• Screening in the US provides substantial health benefit:» To the HIV+ individual
» To the community – reduced transmission
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HIV Screening programs should be expanded in the U.S
• Screening is cost effective at a prevalence 20 times lower than that previously recommended by the CDC
• Routine screening would be cost effective in most health-care settings
• CDC guidelines for screening in the U.S now recommend screening in all health care settings
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Thanks to the VA HIV Quality Enhancment Research Initiative (QUERI)
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In collaboration with...VA Palo Alto/Stanford: Gillian Sanders, Ahmed Bayoumi, Vandana Sundaram, S. Pinar Bilir,
Christopher P. Neukermans, Chara E. Rydzak, Lena Douglass, Patricia Tempio, Dan Margolis, Laura Lazzeroni, and Mark Holodniy
VA San Francisco/UCSF: Peter Jensen, Vera Shadle, Diane Gyuricza
VA San Diego/UCSD:Valerie C. McWhorter, Teodora Agoncillo, Paula Paulk, Sam Bozzette
VA New York: Noreen Haren, Mark Tuen, Anne Dwyer, Mike Simberkoff
VA Greater Los Angeles/UCLA: Steve Asch, Henry Anaya, Matthew Goetz
VA New England: Allen Gifford
VA Memphis: Dennis Dietzen
VA North Chicago: Jill Nyland, Walid Khayr
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References
• US Preventive Services Task Force. Screening for HIV: Recommendation Statement. Ann Intern Med 2005; 143:32-37.
• Chou et. al., Screening for HIV: A review of the evidence for the US Preventive Services Task Force. Ann Intern Med 2005; 143:55-73.
• Chou et. al., Prenatal Screening for HIV: A review of the evidence for the US Preventive Services Task Force. Ann Intern Med 2005; 143:38-54.
• Sanders GD, et. al., Cost effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med 2005; 352:570-85.
• Paltiel AD, et. al., Expanded screening for HIV in the United States—an analysis of cost effectiveness. N Engl J Med 2005; 352:586-95.
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Demographic Characteristics of At-risk Cohort
Site 1 Site 2 Site 3 Site 4 Multi-site n=4239 n=3016 n=3227 n=3192 n=317
Male 97% 98% 97% 98% 97%
Mean age 51 (23-92) 51 (21-91) 49 (20-87) 50 (22-94) 48 (27-76)
White 52% 41% 55% 30% 50%Black 14% 22% 13% 33% 36%Hispanic 8% 4% 6% 13% 7%Asian 1% 1% 1% <1% 2%Am. Indian 1% <1% 1% <1% 0Unknown 25% 31% 25% 24% 6%
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Predictors of HIV Testing
Risk factor adj OR 95% CI
30-39 vs > 70 years 4.7 3.7-5.9
Black vs. White 1.21 1.1-1.34
Hispanic vs. White 1.17 1.01-1.3
Hepatitis C 2.39 2.16-2.67
Hepatitis B 1.83 1.36-2.47
Hepatitis B & C vs. neither 2.5 1.9-3.18
Cocaine Use 1.6 1.4-1.8
Opiate Use 1.6 1.4-1.8
STD 1.6 1.3-1.9
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Logistic regression model
• Outcome: HIV infection
• Predictors included in the model were» Age» Race/Ethnicity» Site» Patient group: Inpatient/Outpatient» Hepatitis C» Hepatitis B» Comorbid conditions: Alzheimer’s, Liver disease, COPD, Pneumonia,
Septicemia, Malignant Neoplasms, STDs, Psychiatric conditions, Heart disease, CVD, Diabetes
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HIV screening program description
• Voluntary
• Informed consent, pre- and post-test counseling
• Healthcare settings
• Counseling to reduce risk behaviors
• Referral to comprehensive care including HAART
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Intolerance
Inefficacy
Non-Suppressive Therapy
Suppressive Therapy
AlternativeFirst
Regimen (2)
AlternativeFirst
Regimen (1)
AlternativeSecond
Regimen
FirstRegimen
SecondRegimen
ThirdRegimen
AlternativeFirst
Regimen (2)
AlternativeFirst
Regimen (1)
AlternativeSecond
Regimen
AlternativeFirst
Regimen (1)
AlternativeSecond
Regimen
FirstRegimen
SecondRegimen
ThirdRegimen
FirstRegimen
SecondRegimen
ThirdRegimen
SecondRegimen
ThirdRegimen
Treatment Model
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Model description
• Health states were characterized by»Whether HIV was identified»Disease state (HIV or AIDS)»Antiretroviral therapy (suppressive or non-suppressive
therapy)»Viral load and CD4 count
• Rates of progression from HIV to AIDS and AIDS to death dependent on CD4 and viral load
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Base-case population
• Prevalence = 1%
• Gender- and age-specific incidence
0.E+00
2.E-04
4.E-04
6.E-04
8.E-04
0 20 40 60 80
Age
Ann
ual I
ncid
ence
0.E+00
2.E-04
4.E-04
6.E-04
8.E-04
0 20 40 60 80
AgeA
nnua
l Inc
iden
ce
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Sexual transmission of HIV
• Depended on:»Number of sexual partners at risk
» Type of sexual acts
»HIV+ person’s viral load– 1 log increase in viral load increased HIV transmission by
2.45 times
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Effect of knowledge of HIV status
• Identified person reduces risk behavior
• Partners of identified HIV+ person will also be identified and begin treatment when appropriate
• Partner of unidentified HIV+ person identified through symptom-based case finding
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Treatment assumptions
• Identified patients begin HAART when:» CD4 count = 350 cells/uL
» Viral load = 4.6 log copies/mL
• HAART treatment:
1st 2nd 3rd
Virologic suppression, % 80 65 30
2-yr virologic rebound, % 15 x 2 x 2
Intolerance, % 25 x 1 x 1.4
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What is the effect on HIV transmission?
Strategy Annual Transmission Rate
MSM Heterosexual
No screening 2.80% 2.09%
One-time screening
2.22% 1.66%
Relative reduction
21% 21%
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HIV Prevalence: Total
0
1
2
3
4
5
6
7
8
9
10
Site A Site B Site C Site D Site E Site F
Site
Per
cen
t
HIV prevalence
Undocumented prevalence
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Screening every 5 years can be cost effective, but depends on incidence
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
200,000
One-time screening 5-yr 3-yr Annual
Screening Frequency
Incr
emen
tal C
ost
Eff
ecti
ven
ess
of
Rec
urr
ent
Scr
een
ing
($/Q
AL
Y)
Baseline Incidence 2x Incidence 3x Incidence
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Screening guidelines revisited
• Old CDC: 1% threshold» Too high
• USPSTF: recommends screening high risk
• Does not recommend for or against routine screening
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Predictors of HIV infection
Risk factor adj OR 95% CI
Age (increasing risk with lower age) -- p<0.01Site -- p<0.01Inpatient vs. Outpatient 0.72 0.56-0.93Black vs. White 1.83 1.38-2.43History of Hepatitis C 1.89 1.40-2.55History of Hepatitis B 1.76 1.05-2.95History of Pneumonia 4.83 3.39-6.88History of STD 6.07 4.23-8.72