Transcript HIV/AIDS Testing and Its Impact on Treatment

Understanding HIV/AIDS Testing
and Its Impact on Treatment
Sponsored for CME credit by
Rush University Medical Center
Supported by an independent educational
grant from Gilead Sciences Medical Affairs
CPT CODES FOR HIV TESTING
AMA and AAHIVM Guidelines for
Coding Routine HIV Testing:
http://www.aahivm.org/codingguide
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Educator
Derrick Butler, MD, MPH
Associate Medical Director
T.H.E. Clinic, Inc
Los Angeles, CA
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Disclosure Information:
Educator
● Derrick Butler, MD,MPH
- Consultant
•
Tibotec Therapuetics
- Speakers’ Bureau
•
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Gilead Sciences
Quiz
1) Magic Johnson tested positive for HIV in 1992
and is now cured of the virus.
a) True, he is rich and can afford the
best medicine.
b) False, he is still infected, but is
controlled on medication.
c) Don’t know, I don’t follow football.
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New Sign-In Process
● Please clearly print all information on the sign-in sheet
● You must indicate your NAME, DEGREE, MAILING
ADDRESS, EMAIL and SIGNATURE (NAPB #
pharmacists only) in order to attend this lecture
● Completion is required for all healthcare providers
● Failure to provide complete information will result in
removal from attending future lectures
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Accreditation and Designation
Rush University Medical Center is accredited by the Accreditation Council for Continuing
Medical Education to provide continuing medical education for physicians. Rush
University Medical Center designates this live activity for a maximum of 1 AMA PRA
Category 1 Credit™. Physicians should claim only credit commensurate with the extent
of their participation in the activity.
ANAC is an approved provider of continuing nursing education (CNE) by the Virginia
Nurses Association, an accredited approver by the American Nurses Credentialing
Center’s Commission on Accreditation.
This activity is approved for 1.0 contact hour by the Association of Nurses in AIDS Care.
The University of Florida College of Pharmacy is accredited by the Accreditation Council
for Pharmacy Education as a provider of continuing pharmacy education
(UAN #0012-9999-13-034-L02-P). This activity is accredited for 1 hour of continuing
pharmacy education (CPE) credit. The University of Florida College of Pharmacy will
report all credit to CPE Monitor within 30 working days after receiving evidence of
successful completion of the course. Successful completion means that you must attend
the entire program and complete an evaluation form.
Commission for Case
Manager Certification
(CCMC)
This program (Understanding HIV/AIDS Testing and Its Impact on Treatment) has been
pre-approved by the Commission for Case Manager Certification to provide continuing
education credit to Certified Case Managers (CCMs). Approved for 1.0 CEUs.
Approval number: 20131552. Activity Code: S0001105.
Supported by an independent educational grant from Gilead Sciences Medical Affairs.
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Faculty
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CME Course Director
Harold A. Kessler, MD
Content Development and Training
Kenneth H. Mayer, MD
Professor of Medicine and
Immunology/Microbiology
Associate Director,
Section of Infectious Diseases
Rush University Medical Center
Chicago, Illinois
Professor of Medicine
Harvard Medical School
Director, HIV Prevention Research
Beth Israel Deaconess Medical Center
Medical Research Director
The Fenway Institute, Fenway Health
Boston, Massachusetts
CME Reviewer
David M. Simon, MD, PhD
CNE Reviewer
Allison R. Webel, RN, PhD
Associate Professor of Medicine
Section of Infectious Diseases
Rush University Medical Center
Chicago, Illinois
Instructor and KL2 Clinical
Research Scholar
Frances Payne Bolton School of Nursing
Case Western Reserve University
Cleveland, Ohio
Faculty Disclosures
CME Course Director:
Harold A. Kessler, MD
Content Development and Training:
Kenneth H. Mayer, MD
Grants/research
support
None
Bristol-Myers Squibb, Gilead
Sciences, Merck
Consultant
None
None
Speakers’ bureau
None
None
AbbVie,
GlaxoSmithKline, Merck
None
None
None
Stock
shareholder
Other financial or
material support
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Faculty Disclosures
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CME Reviewer:
David M. Simon, MD, PhD
CNE Reviewer:
Allison R. Webel, RN, PhD
Medical Editor:
Peter Pinkowish
Grants/research
support
None
None
None
Consultant
None
None
None
Speakers’
bureau
None
None
None
Stock
shareholder
None
None
None
Other financial
or material
support
None
None
None
Opinions and Off-Label Discussions
The opinions or views expressed in this educational program are those
of the participants and do not necessarily reflect the opinions or
recommendations of Gilead Sciences Medical Affairs,
Rush University Medical Center, the Association of Nurses in AIDS
Care, the University of Florida College of Pharmacy, or the
Commission for Case Manager Certification
The faculty may have included discussion on unlabeled uses
of a commercial product or an investigational use of a
product not yet approved for this purpose
Please consult the full prescribing information before using
any medication mentioned in this program
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New Electronic Evaluation Process
● You will receive an electronic evaluation to the email
address provided within 1 business day
● Reminder email communications will be sent up to
5 days post lecture until the evaluation is completed
● Completion Is Required for CME/CNE/CPE credit and
future attendance
● Incomplete evaluations will preclude attendees from
receiving their CME/CNE/CPE certificate & future
communications about lectures in your area
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Learning Objectives
(CME/CNE and CPE)
CPE
CME/CNE
●
Upon completion of this activity, the
participant intends to incorporate the
following objectives into their practice
of medicine and/or advance practice
nursing:
- Screen and test my patients for HIV
infection based on the
recommendations from the Centers for
Disease Control and Prevention
- Counsel my HIV-infected patients on
the benefits and risks associated with
antiretroviral therapy
- Appropriately select antiretroviral
therapy for my HIV-infected patients
according to the guideline
recommendations by the Department of
Health and Human Services
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●
Upon completion of this activity, the
pharmacist should be able to:
- Describe the screening and testing
processes for patients for HIV infection
based on the recommendations from
the Centers for Disease Control and
Prevention
- Counsel my HIV-infected patients on
the benefits and risks associated with
antiretroviral therapy
- Recommend antiretroviral therapy for
my HIV-infected patients according to
the guideline recommendations by the
Department of Health and Human
Services
We’ve Come a Long Way, Baby
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Yes, We Have….
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Evidence for Revising
Recommendations
● Many HIV-infected persons access health care but are
not tested for HIV until symptomatic
● Routine HIV screening is cost effective, and effective
treatment is available
● Opt-out screening increases testing rates
● Awareness of HIV infection leads to substantial
reductions in high-risk sexual behavior
● Inconclusive evidence about prevention benefits from
typical counseling for persons who test negative
● Great deal of experience with HIV testing, including rapid
tests
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
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General Population and HIV Cases:
Race/Ethnicity in 40 States (2009)
General Population
HIV Cases
(n=241,832,054)
(n=42,011)
Hispanic/
Latino
18%
White
68%
Hispanic/
Latino
13%
Black
52%
White
28%
Black
13%
Native Hawaiian/
Other Pacific Islander
<1%
Asian 3%
American Indian/
Native Alaska
1%
Asian 1%
American Indian/
Native Alaska
1%
Native Hawaiian/
Other Pacific Islander
<1%
CDC. HIV Surveillance Report, 2009.
Available at: http://www.cdc.gov/hiv/surveillance/resources/reports/2009report/.
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HIV in Houston
● Houston ranks 8th nationally in the number of total reported AIDS cases
● African American and Hispanic women together represent less than 25%
of all U.S. women, yet they account for more than 78% of AIDS cases
reported to date among women.
● Today, 40 million people worldwide are estimated to be living with
HIV/AIDS
● AIDS is the leading cause of death among African-American women
ages 25 to 34 and African-American men ages 35 to 44
● CDC estimates that over a million Americans are currently living with HIV.
● 40,000 Americans are newly infected with HIV each year.
● 6 out of every 10 diagnosed HIV infections in the Houston/Harris County
are African American.
● An estimated 1 in 90 Houstonians is living with HIV/AIDS.
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HIV in Houston
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Electron micrographic picture
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Viral Load
Viral load = the amount of HIV in a sample of blood
High
>100,000 copies/mL
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Low to Moderate
400-100,000 copies/mL
Undetectable
<400 copies/mL
or <50 copies/mL
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T-Cell Count1,2
T-cell count shows how well someone’s immune system is working
500 cells/mm3 or more
Normal immune system
200-499 cells/mm3
Weakened immune
system
Less than 200 cells/mm3
Severely weakened immune
system (high risk for
infection)
References: 1. Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and
expanded surveillance case definition for AIDS among adolescents and adults. MMWR, December 18, 1992; 41(RR-17).
Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm. Accessed June 12, 2008. 2. AIDSinfo: A
Service of the U.S. Department of Health and Human Services. HIV and its treatment: what you should know. February
2008. Available at: http://www.aidsinfo.nih.gov/contentfiles/HIVandItsTreatment_cbrochure_en.pdf. Accessed June 12,
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2008.
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Estimated Number of AIDS Cases and Deaths
Among US Adults and Adolescents (1985-2010)
AIDS
Prevalence
80
70
60
450
400
AIDS
Cases
350
300
50
250
40
200
30
150
20
10
0
AIDS
Deaths
85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10
Year of Diagnosis or Death
CDC. HIV Surveillance Report, 2010.
Available at: http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/index.htm.
25
500
100
50
0
AIDS Prevalence (x1000)
Number of AIDS Cases and Deaths (x1000)
90
Chronic HIV in the US:
Underdiagnosed and Undertreated
Number (in ‘000s)
1,106,4001,200,000
~80%
Diagnosed
874,056960,000
~40%
Treated
437,028489,600
~20% of All
HIV-Infected
Are HIV RNA
<50 copies/mL
209,773376,992
Prevalence
Diagnosed
Smith MK, et al. PLoS One. 2012;9:e1001260.
Gardner EM, et al. Clin Infect Dis. 2011;52:793-800.
Burns DN, et al. Clin Infect Dis. 2010;51:725-731.
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Treated
Viral Suppression
Chronic HIV in the US: New Infections
and Awareness of HIV Serostatus
~54% of New Infections
1,106,4001,200,000
Number (in ‘000s)
~20 Unaware
of Infection
~80%
Diagnosed
Prevalence
Smith MK, et al. PLoS One. 2012;9:e1001260.
Gardner EM, et al. Clin Infect Dis. 2011;52:793-800.
Burns DN, et al. Clin Infect Dis. 2010;51:725-731.
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~46% of New Infections
874,056960,000
Diagnosed
Estimated New HIV Infections: Most Affected
Populations in the United States (2011)
New HIV Infections (Number)
11,810
Total Estimated
New HIV Infections
in 2011 (n=50,007)
10,375
7266
5882
3124
1325
White
Black
MSM
Hispanic
Black
Women
Black
Men
White Hispanic
Women Women
Heterosexual
CDC. HIV Surveillance Report, 2011;vol 23. Published February 2013.
http://www.cdc.gov/hiv/library/reports/surveillance/2011/surveillance_Report_vol_23.html.
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1522
1087
Black
Male
716
Black
Female
IDUs
CDC: HIV Awareness and
Higher Sexual Risk Among MSM
● 16 US cities (2006-2007)
-
Anonymous survey, all offered HIV
testing
40
Previously aware of HIV status
(n=882)
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Not aware of HIV status (n=680)
● HIV-infected MSM who were
unaware of their HIV status
-
More likely to engage in
unprotected UAI with a discordant
partner versus MSMs aware of their
HIV status
Incidence (%)
-
Discordant UAI
30%
20
16%
10
0
Unaware
Aware
Awareness of HIV status
UAI: unprotected anal intercourse.
Heffelfinger JD, et al. 19th CROI. Seattle, 2012. Abstract 1091.
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Reduction in Risk Behaviors
Once Seropositive Status Is Known
Reduction in Prevalence (%)
Reduction in Prevalence of Unprotected Intercourse
Relative to HIV-Positive Persons Unaware of Serostatus
0
-20
-40
-60
-53%
-68%
-80
HIV-Positive Persons Aware
of Their Own Serostatus
Marks G, et al. JAIDS. 2005;39:446-453.
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HIV-Positive Persons Aware
of Their Own Serostatus
and HIV-Negative Partner
“Late Testers” Account for
Approximately 32% of HIV Diagnoses (2008)
Males
Females
Early tester
Late tester
80
60
69%
42%
60%
39% 40%
40
31%
70%
61%
58%
31%
20
0
MSM
IDU
71%
MSM Hetero- Other
+ IDU sexual
63%
HIV Diagnosis (%)
HIV Diagnosis (%)
69%
Early tester
Late tester
80
60
40
37%
30%
29%
20
0
IDU
Heterosexual
CDC. HIV Surveillance Report, 2008.
Available at: http://www.cdc.gov/hiv/surveillance/resources/reports/2008report/index.htm.
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Other
National HIV Behavioral Surveillance: HIV
Prevalence and Awareness of Infection
● Venue-based, time-space sampling
of MSMs (2008, 2011)
20-city data collection system
HIV prevalence
• 2008 (n=7847): 19%
• 2011 (n=8423): 18%
-
Awareness of infection
• 2008 (n=1520): 56%
• 2011 (n=1032): 66%
● HIV prevalence and awareness of
infection increased with age
-
31% increase in MSM <25 years of
age
-
Blacks
• Highest HIV prevalence: 30%
• Lowest awareness: 54%
Wejnert C, et al. 20th CROI. Atlanta, 2013. Abstract 90.
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100
HIV prevalence
Aware of being infected
80
Participants (%)
-
HIV Prevalence and Awareness
76%
67%
60
57%
49%
40
26%
20
15%
12%
0
18-24
25-29
19%
30-39
Age Group (years)
>40
Prevention Success:
Perinatally Acquired AIDS Cases 1985-2010
1000
PACTG 076 & USPHS ZDV Recs
Number of AIDS Cases
900
CDC HIV Screening Recs
800
700
600
500
400
300
200
~95%
Reduction
100
0 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10
Year of Diagnosis or Death
CDC. HIV Surveillance Report, 2010.
Available at: http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/index.htm.
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HIV Screening:
Guidelines From Other Organizations
● US Preventive Services Task Force (2007)
-
Strongly recommends clinicians screen for HIV in all adolescents and
adults at increased risk
•
-
No recommendation for or against routinely screening for HIV adolescents
and adults who are not at increased risk for HIV infection
Recommends clinicians screen all pregnant women for HIV
● American College of Physicians (2008)
(endorsed by the HIV Medicine Association)
-
Recommends clinicians adopt routine screening for HIV and encourage
patients to be tested
•
-
Regardless of whether HIV risk factors are present
Recommends clinicians determine the need for repeated screening on
an individual basis
US Preventive Services Task Force. AHRQ publication number 07-0597-EF-2. April 2, 2007.
Qaseem A, et al. Ann Intern Med. 2009;150:1-8.
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Revised CDC Recommendations for
HIV Testing in Healthcare Settings
● Routine voluntary testing for
patients ages 13 to 64 years in
healthcare settings
-
Not based on patient risk
● Opt-out testing
● No separate consent for HIV
● Pretest counseling not
required
● Repeat HIV testing left to
discretion of provider
-
Based on patient risk
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
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New AIDS Cases
by Age at Diagnosis (2010)
9000
Number of AIDS Cases
8000
7000
6000
5000
4000
3000
2000
1000
0
<13
13-14
15-19
20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 >65
Age (years)
CDC. HIV Surveillance Report, 2010.
Available at: http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/.
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Opt-Out Versus Opt-In Screening
Opt-Out Screening
● Implies all patients are
considered candidates for
screening
● Testing is part of standard
panel of tests
● Patients can decline test, but
test is performed unless
patient specifically refuses
Opt-In Screening
● Requires providers to
specifically recommend HIV
testing and for patients to
specifically agree to testing
● May assume that clinicians
assess which patient is at-risk
for infection
● Greater reluctance on part of
patient
● Requires more staff time
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
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HIV Outpatient Study:
Mortality and HAART Use (1999-2004)
90
80
7
Patients
on HAART
6
60
5
50
4
40
3
30
2
20
Deaths
10
1
0
1996
1997
1998
1999
2000
Time
Palella FJ, et al. JAIDS. 2006;43:27-34.
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70
2001
2002
2003
0
2004
Patients on HAART (%)
HIV Mortality
(Deaths per 100 patient-years)
8
Adults and Adolescents:
Recommendations for HIV-Screening Location
● All primary care settings
● Emergency departments, in-patient services, and urgent
care clinics
● Public health settings
- Tuberculosis clinics
- Sexually transmitted diseases clinics
- Substance abuse treatment centers
- Correctional facility treatment centers
● Screening may be discontinued in low-prevalence
communities with demonstrated yield <1:1000
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
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American College of Emergency
Physicians Policy Statement
● Early HIV diagnosis and treatment
-
Prolong life, reduce transmission, and a cost-effective public health intervention
● HIV testing in the ED
-
Should be available in an expeditious and efficient fashion similar to testing and
results for other conditions
● HIV screening when deemed appropriate by the ED physician
-
Must be practical and feasible for emergency settings
-
Should be integrated with the resources of the entire health care system
-
All local and state requirements must be met
Cannot interfere with the primary acute care mission of ED
Should be offered based on the local prevalence and medical needs of the
community
Policies and procedures must adequately address patient confidentiality,
informed consent (state dependent), provider training, significant need for pre
and post-test counseling, and linkage to care
ACEP Board of Directors. Ann Emerg Med. 2007;50:209.
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CDC Revised HIV Screening
Recommendations for Pregnant Women
● Universal opt-out screening
-
Included in routine panel of prenatal screening tests
Notification and option to decline
● Second test in third trimester for women who are
-
Known to be at risk for HIV
In communities with elevated HIV incidence
In high-prevalence health care facilities
● Labor and delivery opt-out rapid testing for women with
undocumented HIV status
-
Initiate antiretroviral prophylaxis on basis of test result
● Rapid testing of newborn if mother’s status unknown at delivery
-
Initiate antiretroviral prophylaxis within 12 hours of birth on basis of
rapid test result
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
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HIV Screening in Women: American College
of Obstetricians and Gynecologists
● Recommends routine HIV screening for women aged 19 to 64 years
-
Recommends targeted screening for women with risk factors outside
this age range
● Supports opt-out HIV screening
-
Should be aware of and comply with legal requirements regarding HIV
testing in their jurisdiction
● Recommends annually review patient’s risk factors for HIV and
assess the need for retesting
-
Repeat HIV testing should be offered at least annually
•
-
IDUs, sex partners who are IDUs or HIV infected, exchange sex for drugs or
money, STD, >1 sex partner since last HIV test
Encourage women and prospective sex partner to be tested before
initiating a new sexual relationship,
ACOG Committee Opinion Number 411. Obstet Gynecol. 2008;114:401-403.
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Types of HIV Screening Tests
Available to Primary Care Providers
● Six rapid HIV tests available
● Results available within 15 to 30 minutes
● 4 are CLIA-waived
- OraQuick Advance Rapid HIV-1/2
- Uni-Gold Recombigen HIV
- Clearview HIV 1/2 Stat-Pak
- Clearview Complete HIV 1/2
FDA Center for Devices and Radiological Health. Available at:
http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed January 7, 2013.
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Clinical Laboratory Improvements
Amendments (CLIA) Program
● All laboratories (ie, any facility that performs examinations on
human specimens) must be certified under the CLIA program
-
Administered by the Centers for Medicare and Medicaid Services
•
•
Provides oversight of clinical laboratories
Issues waiver certificates
● CLIA waiver
-
Laboratories that perform only tests that are "simple" and that have an
"insignificant risk of an erroneous result" must obtain a certificate of
waiver before accepting materials derived from the human body for
laboratory tests
The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that
have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and
procedures that have an insignificant risk of an erroneous result, including those that -- (A) employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if
Performed incorrectly.
CDC. Available at: http://www.cdc.gov/hiv/topics/testing/resources/reports/labtest_clia.htm.
FDA Center for Devices and Radiological Health. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm.
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CLIA-Waived Rapid HIV Antibody Tests:
Sensitivity and Specificity
OraQuick Advance Rapid HIV 1/2 (Orasure)*
Oral fluid
Whole blood
Plasma†
Uni-Gold Recombigen HIV (Trinity)‡
Whole blood
Serum and plasma†
Sensitivity
(95% CI)
Specificity
(95% CI)
99.3
99.8
(98.4-99.7)
(99.6-99.9)
99.6
100
(98.5-99.9)
(99.7-100)
99.6
99.9
(98.9-99.8)
(99.6-99.9)
100
99.7
(99.5-100)
(99.0-100)
100
99.8
(99.5-100)
(99.3-100)
*FDA-approved for detection of HIV-2.
†Moderate complexity, non-CLIA waived.
‡Not FDA-approved for detection of HIV-2.
FDA Center for Devices and Radiological Health. Available at:
http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed January 7, 2013.
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CLIA-Waived Rapid HIV Antibody Tests:
Sensitivity and Specificity
Sensitivity
(95% CI)
Specificity
(95% CI)
99.7
99.9
(98.9-100)
(99.6-100)
99.7
99.9
(98.9-99.8)
(99.6-99.9)
99.7
99.9
(98.9-100)
(99.6-100)
99.7
99.9
(99.9-100)
(99.6-100)
Clearview HIV 1/2 Stat-Pak*
(Inverness Medical)
Whole blood
Serum or plasma†
Clearview Complete HIV 1/2*
(Inverness Medical)
Whole blood
Serum and plasma†
*FDA-approved for detection of HIV-2.
†Non-CLIA waived.
FDA Center for Devices and Radiological Health. Available at:
http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed January 7, 2013.
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Non-CLIA-Waived Rapid HIV Antibody
Tests: Sensitivity and Specificity
Sensitivity
(95% CI)
Specificity
(95% CI)
99.8
99.1
(99.2-100)
(98.8-99.4)
99.8
98.6
(99.0-100)
(98.4-98.8)
100
99.93
(99.94-100)
(99.79-100)
100
99.91
(99.94-100)
(99.77-100)
Reveal G-3 Rapid HIV-1 (Medmira)*
Serum
Plasma
Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad)†
Serum
Plasma
*Not FDA-approved for detection of HIV-2.
†FDA-approved for detection of HIV-2 and can differentiate HIV-1 from HIV-2.
FDA Center for Devices and Radiological Health. Available at:
http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm. Accessed January 7, 2013.
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Home HIV Testing
OraQuick In-Home HIV Test
Source: OraSure Technologies: FDA Briefing Materials: May 15, 2012.
Patient Acceptance of Rapid Testing
● Rapid testing versus “traditional” HIV screening
-
Tested at anonymous HIV testing site and STD clinic
88% of previously tested preferred rapid results
● Results
-
Anonymous testing site
• 4% increase in uninfected and 16% increase in HIV-infected
individuals learning of their serostatus
-
STD Clinic
• 210% increase in uninfected and 23% increase in HIV-infected
individuals learning of their serostatus
Kassler WJ, et al. AIDS. 1997;11:1045-1051.
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Rapid Testing in a Large Urban
Emergency Department
● Rapid HIV test offered to patients seen in the ED (n=1348)
● Opted out (n=348)
-
Common reasons: recent negative test (46%), low risk (19%)
No reason given (27%)
● Opted in (n=1000)
-
Positive test (n=12)
Negative test (n=988)
•
●
Never tested before (33%), rest had a previous negative test
Conclusions
-
High acceptance of rapid testing
Rapid HIV test performed well (no false positive results)
Seroprevalence rate meets CDC criteria for routine universal testing
Lowman E, et al. 5th IAS Conference. Cape Town, 2009. Abstract MoPEB012.
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Impact of Expanded HIV Testing
on Entry into Care in Washington DC
Washington DC DOH expanded HIV
testing initiative initiated in 2006
●
New HIV/AIDS diagnoses (2004 to 2007)
- Increased by 17%
●
Median CD4 count among newly
diagnosed cases increased by 57%
(P<0.001)
●
Proportion of late testers decreased from
66% in 2004 to 57% in 2008 (P=0.0018)
●
Conclusions
- Expanded routine HIV testing increased
identification of HIV/AIDS cases, more
rapid entry into care, and earlier diagnosis
CD4 Count at Diagnosis
400
CD4 Cell Count (cells/mL)
●
impact on clinical outcomes and reduced
HIV transmission
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2007
2008
275
216
200
100
2004
2005
2006
P<0.001 for trend from 2004 to 2008.
Castel A, et al. 17th CROI. San Francisco, 2010. Abstract 34.
343
296
300
0
- Further study needed to determine the
336
HIV Prevalence Among Patients
Who Decline Rapid HIV Testing
● Routine “opt-out” HIV testing program at the emergency Department at
George Washington University
-
Approximately 44% of persons approached opted out or declined testing
Discarded blood samples were tested for HIV
• Ora-Quick rapid HIV test, positive results underwent Western Blot confirmation
● Results
-
Opt-out versus opt-in positives: 2% versus 0.7% (P=0.0038)
Demographics of opt-out positives
• Women: 67% (P=0.0014)
• African Americans: 83.3%
• Uninsured: 40%
-
Most common complaint: abdominal pain
Most common reason for declining: patients believed they were not at risk
● Interventions are needed to decrease the opt-out rate
Czarnogorski M, et al. AIDS Res Treat. 2011;2011:879065. Epub 2011.
53
Adolescents:
Special Considerations for HIV Screening
● HIV screening
- Discuss with all adolescents and encourage HIV testing for
those who are sexually active
● Laws concerning HIV testing and confidentiality differ
among states
● Laws and legal precedents allow for evaluation and
treatment of minors for STDs without parental
knowledge or consent
- Not every state has defined HIV infection explicitly as a condition
for which testing or treatment may proceed without parental
consent
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
54
Confirmatory Tests for
Patients Who Test HIV Positive
● Positive rapid antibody tests are considered
preliminary
● Confirmatory testing is needed to diagnose HIV
infection
-
ELISA and Western blot test
● HIV-positive test results
-
Communicated confidentially through personal
contact by a clinician, nurse, mid-level practitioner,
counselor, or other skilled staff
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
55
National Survey of Family Growth (2002):
Adolescents Who Had Vaginal Sex
80
77%
Adolescents Who
Had Vaginal Sex (%)
Females
69%
60
Males
40
20
0
12
15
16
Age (years)
Mosher WD, et al. National Center for Health Statistics. 2005.
56
17
18
HIV-Negative Persons:
Prevention Services
● Risk screening
-
Assessment of risk for infection with HIV and other
STDs and provision of prevention information should
be incorporated into routine primary care of all
sexually active persons
-
Refer at-risk patients to appropriate risk-reduction
services (drug treatment, STD counseling)
● Prevention counseling
-
Does not need to be linked to HIV screening
Should be offered or made available in facilities that
service high-risk populations
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
57
Public Health Issues:
HIV/AIDS Surveillance
● Risk factor assessment
-
Recommended in order to target community-wide
prevention efforts
● HIV/AIDS case reporting
-
Mandatory reporting of AIDS cases and HIV infection
diagnoses required by all states
● Pediatric exposure reporting
-
Recommended by the CDC
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
58
Partner Counseling and Referral
● Encourage patients who test positive for HIV to
notify current and prior sex partners
● Local health departments can make notification
without disclosing patient’s identity
● Providers should notify patients they may be
approached by local health departments for
voluntary interviews regarding partner
notification
Branson BM, et al. MMWR Recomm Rep. 2006;55(RR-14):1-17.
59
Impact of New Guidelines
on the Health Care System
● Implementation of routine testing
- Dramatically increase funding needs of screening programs,
including the cost of the test itself (conventional or rapid HIV
tests)
● Effective HIV screening programs
- Need to effectively link patients to competent and appropriate
care and prevention services
● Approximately 50% of HIV-positive patients have no
health insurance
- Increased demand on public funding to support the cost of care
and medications
60
When to Start Treatment
2/2013
DHHS
Guidelines
2012
IAS-USA
Guidelines
CD4 Count
HIV RNA
Clinical Category
(cells/mm3)
(copies/mL)
AIDS-defining illness or severe
symptoms
Any value
Any value
Treat
<500
Any value
Treat
>500*
Any value
Treat
Pregnant women
Any value
Any value
Treat
HIV-associated nephropathy
Any value
Any value
Treat
HIV/HBV coinfection when HBV
treatment is indicated
Any value
Any value
Treat
Asymptomatic
*Consideration of transmission risk and willingness to adhere to early therapy are considerations in when to start.
The IAS-USA guidelines also recommends initiating antiretroviral therapy in HIV-infected patients with active hepatitis C
virus infection, active or high risk for cardiovascular disease, and symptomatic primary HIV infection.
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 12, 2013; Thompson MA, et al. JAMA. 2012;308:387-402.
61
Current ARV Medications
NRTI
● Abacavir (ABC)
● Didanosine (ddI)
● Emtricitabine (FTC)
PI
● Lamivudine (3TC)
● Atazanavir (ATV)
● Stavudine (d4T)
● Darunavir (DRV)
CCR5 Antagonist
● Tenofovir (TDF)
● Fosamprenavir (FPV)
● Maraviroc (MVC)
● Zidovudine (AZT,
ZDV)
● Indinavir (IDV)
● Lopinavir (LPV)
Integrase Inhibitor
NNRTI
● Nelfinavir (NFV)
● Raltegravir (RAL)
● Delavirdine (DLV)
● Ritonavir (RTV)
●Elvitagravir (EVG)
● Efavirenz (EFV)
● Saquinavir (SQV)
● Etravirine (ETR)
● Tipranavir (TPV)
● Nevirapine (NVP)
62
Fusion Inhibitor
●Rilpivirine (RPV)
● Enfuvirtide (ENF, T-20)
HIV replication cycle and sites of drug activity
NRTIs
AZT (Zidovudine-Retrovir)
ddI (Didanosine-Videx)
ddC (Zalcitabine-Hivid)
d4T (Stavudine-Zerit)
3TC (Lamivudine-Epivir)
ABC(Abacavir-Ziagen)
FTC (Emtricitabine, Emtriva)
NNRTIs
Efavirenz (Sustiva)
Delavirdine (Rescriptor)
Nevirapine (Viramune)
Etravirine (Intelense)
nRTI
Cellular DNA
Tenofovir DF
(Viread)
Nucleus
Protease Inhibitors
Indinavir (Crixivan)
Ritonavir (Norvir)
Saquinavir (Fortovase)
Nelfinavir (Viracept)
Lopinavir/ritonavir (Kaletra)
Atazanavir (Reyataz)
Fos Amprenavir (Lexiva)
Tipranavir (Aptivus)
Darunavir (Prezista)
HIV Virions
New HIV
particles
Reverse
Integrase
Transcriptase
Protease
Capsid
proteins
and viral
RNA
CD4
Receptor
Fusion Inhibitor
T-20
(Enfuvirtide,
Fuzeon)
Viral RNA
Integrated
Integrase Inhibitor viral DNA
Raltegravir (Isentress)
CCR5 Antagonist
Maraviroc (Celsentri)
1
Attachment
63
Unintegrated
double stranded
Viral DNA
3
2
Uncoating
Reverse
Transcription
Integration
Viral
mRNA
4
Transcription
gag-pol
polyprotein
5
Translation
6
Assembly and
Release
What Is HAART?
• HAART stands for Highly Active Antiretroviral Therapy
• HAART combines drugs from different classes, slowing HIV replication
•
down at different stages
HAART is also called combination therapy, a “cocktail,” or a “regimen”
Examples of HAART regimens:
NNRTI
NRTI
NRTI
+
or
PI
Reference: AIDSinfo: A Service of the U.S. Department of Health and Human Services. HIV and its treatment: what you
should know. February 2008. Available at:
http://www.aidsinfo.nih.gov/contentfiles/HIVandItsTreatment_cbrochure_en.pdf.
64
64
Therapy is Easier, More Potent, and
Less Toxic in Single-Tablet Regimens
65
DHHS Guidelines:
Preferred Regimens
NNRTI
PI
Efavirenz1/emtricitabine2/tenofovir DF3
Atazanavir4 + ritonavir + emtricitabine2/tenofovir DF3
Darunavir + ritonavir (qd) + emtricitabine2/tenofovir DF3
INSTI
Raltegravir + emtricitabine2/tenofovir DF3
Pregnant Lopinavir/r bid + zidovudine/lamivudine2
women
INSTI: Integrase strand transfer inhibitors.
1Efavirenz should not be used during the first trimester of pregnancy or in women trying to conceive or not using effective and
consistent contraception.
2Lamivudine may substitute for emtricitabine or visa versa.
3Tenofovir DF should be used with caution in patients with renal insufficiency.
4Atazanavir + RTV should not be used in patients who require >20 mg omeprazole equivalent/day.
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 12, 2013.
66
DHHS Guidelines:
Alternative Regimens
NNRTI
Efavirenz + (abacavir1 or zidovudine)/lamivudine2
Rilpivirine3/emtricitabine2/tenofovir DF
Rilpivirine3 + abacavir/lamivudine2
PI
Atazanavir + ritonavir + abacavir/lamivudine2
Darunavir + ritonavir + abacavir/lamivudine2
Fosamprenavir + ritonavir (qd or bid) +
abacavir/lamivudine2 or emtricitabine2/tenofovir DF
Lopinavir/r4 (qd or bid) +
abacavir/lamivudine2 or emtricitabine2/tenofovir DF
INSTI
Raltegravir + abacavir/lamivudine2
Elvitegravir/cobicistat/emtricitabine/tenofovir DF5
1Abacavir
should not be used in patients who test positive for HLA-B*5701. Use abacavir with caution in patients with
high risk of cardiovascular disease or pretreatment HIV RNA >100,000 copies/mL.
2Lamivudine may substitute for emtricitabine or visa versa.
3Use rilpivirine with caution in patients with pretreatment HIV RNA >100,000 copies/mL.
4Once-daily lopinavir/r is not recommended in pregnant women.
5Patients with creatinine clearance >70 mL/min.
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 12, 2013.
67
IAS-USA Guidelines:
Preferred Regimens
NNRTI
PI
INSTI
Efavirenz/emtricitabine/tenofovir DF
Efavirenz + abacavir/lamivudine1-3
Atazanavir + ritonavir + emtricitabine/tenofovir DF
Atazanavir + ritonavir + abacavir/lamivudine3,4
Darunavir + ritonavir (qd) + emtricitabine/tenofovir DF
Raltegravir + emtricitabine/tenofovir DF
INSTI: Integrase strand transfer inhibitors.
1HLA-B*5701-negative patients with baseline plasma HIV RNA <100,000 copies/mL.
2Avoiding the use of abacavir or lopinavir/ritonavir might be considered for patients with or at high risk of cardiovascular
disease.
3HLA-B*5701 screening is recommended before abacavir administration to reduce the risk of hypersensitivity reaction.
4Patients with baseline plasma HIV RNA <100,000 copies/mL.
Thompson MA, et al. JAMA. 2012;308:387-402.
68
IAS-USA Guidelines:
Alternative Regimens1
NNRTI
Nevirapine + emtricitabine/tenofovir or abacavir/zidovudine2
Rilpivirine/emtricitabine/tenofovir DF
Rilpivirine + abacavir/lamivudine2
PI
Darunavir + ritonavir + abacavir/lamivudine2
Lopinavir/r3 (qd or bid) +
abacavir/lamivudine or emtricitabine/tenofovir DF
INSTI
Raltegravir + abacavir/lamivudine2
Elvitegravir/cobicistat/emtricitabine/tenofovir DF
INSTI: Integrase strand transfer inhibitors.
1Zidovudine/lamivudine is an alternative NRTI component of NNRTI-, PI/r-, and raltegravir-based regimens, but the toxicity
profile of zidovudine reduces its utility.
2HLA-B*5701 screening is recommended before abacavir administration to reduce the risk of hypersensitivity reaction.
3Avoiding the use of abacavir or lopinavir/ritonavir might be considered for patients with or at high risk of cardiovascular
disease.
Thompson MA, et al. JAMA. 2012;308:387-402.
69
Importance of
HIV Expertise in Clinical Care
● Multiple studies show expertise in HIV care
improves
-
Survival
Rate of hospitalizations
Compliance with guidelines
Adherence to medications
● DHHS panel recommendation
-
HIV primary care by a clinician with at least 20, and
preferably 50, HIV-infected patients
DHHS. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
Revision February 12, 2013.
70
AIDS Education Training Centers
● Network of Training Centers
-
11 Regional Centers with more than 130 local sites
serving healthcare providers nationwide
-
4 National Centers provide support services to the
AETC network
● National Resource Center
- Provides virtual library of online training resources
for adaptation to meet local training needs
AETC. Available at: http://www.aids-ed.org.
71
National HIV Consultation Service
(Warmline) for Healthcare Professionals
● 1-800-933-3413
● Provides information and individual case
consultation
● Service is offered free of charge to healthcare
professionals
● Staffed 6 am to 5 pm Pacific time
National HIV/AIDS Clinicians' Consultation Center.
Available at: http://www.nccc.ucsf.edu/. Accessed January 7, 2013.
72
Summary
● There is a need to increase the proportion of persons
who are aware of their HIV-infection status
- Routine, voluntary, opt-out screening in health care settings is
needed
● Rapid HIV tests
- Provide clinicians with preliminary results in 15 to 30 minutes
● Patients at high-risk for HIV
- Should be counseled on risk reduction strategies
● Treatment and referral services for those who test HIV
positive will benefit patients and society
- Prolong life of HIV-infected individuals
- Likely reduce risk of transmission
73
HIV: A Disease of the Poor
*census tract where ≥20% of residents
had household incomes below the U.S.
poverty level
*
74
Source: Denning at el., AIDS 2010 Conference, Vienna Austria, July 2010, Abstract WEPDD101
STIGMA
Church sign in Birmingham, Alabama
75
Additional Resources
● CDC
- http://www.cdc.gov/hiv/topics/testing/healthcare/index.htm
● HIVInsite
- http://hivinsite.ucsf.edu/
● AIDS Education Training Centers
- www.aids-ed.org
76
New Electronic Evaluation Process
● You will receive an electronic evaluation to the email
address provided within 1 business day
● Reminder email communications will be sent up to
5 days post lecture until the evaluation is completed
● Completion Is Required for CME/CNE/CPE credit and
future attendance
● Incomplete evaluations will preclude attendees from
receiving their CME/CNE/CPE certificate & future
communications about lectures in your area
77
Outcomes Measurement Reminder
● We are required to assess “changes in learners’
competence, performance or patient outcomes achieved
as a result of their participation in a CME/CNE/CPE
sponsored educational activity”
● As a result of this requirement you will receive a short
survey via email 8 to 12 weeks after completing this
course
- We consider the survey to be an additional component of your
overall participation in this educational activity and would urge
you to reflect on what you learned in the activity and then
complete this survey
78