Introduction

advertisement
HIV and Hep C testing
Ardis Moe, M.D.
UCLA CARE/NEVHC Van Nuys HIV Clinic
amoe@mednet.ucla.edu
Friday 20 June, 2014
 I do not have any financial arrangements or
affiliations with commercial sponsors which have
direct interest in the subject matter
Goals
 What types of HIV and hep C tests are available
 USPSTF Recommendations
 How to tell someone they are HIV+
 How to get HCV meds paid for.
Types of HIV tests
Clinical case
 18 year old high school senior donates blood
 Phone call from blood bank: patient has HIV. Elisa
positive, NAAT positive. No WB done
 Is he HIV+?
 How do you counsel him?
 What is NAAT?
 What is Elisa?
Audience Response Questions
33%
33%
33%
 1)I have given an HIV test result to someone
newly HIV+
 2)I have never given an HIV test result
 3)I do not give HIV test results as a scope of my
practice
 Legally, a patient is not HIV+ unless there are two
licensed rapid HIV tests --two different kits--- (mostly
used in developing countries)
 OR a repeatedly reactive Elisa test AND a
confirmatory test: Western blot or IFA.
 OR +Elisa test and HIV viral load >1,000 copies
 NAAT is a simplified HIV viral load test
 Used by blood banks to screen for HIV seroconversion
 Elisa is also a screening test; false positives occur with
pregnancy; blood transfusions, flu shots, hepatitis,
SLE, etc. there are 3rd and 4th generation tests
 Rapid blood tests for HIV
 Rapid oral tests for HIV
 3rd and 4th generation HIV tests
 3rd generation—antibody test—will miss some patients in
seroconversion “window” period”
 4th generation—combination antibody/p24 antigen—will pick
up more people in the window period (57-84%) Uptodate
2014
 What does a western blot look like?
Need for HIV testing
 Half of HIV+ patients are infected before age 25
 1/3 infected before age 20
 60% of MSM AA men will be infected with HIV by age
40 (40% of white MSM)
 Treatment of HIV+ partners decreases HIV
transmission by 96%
 Detection of HIV virus alone would reduce new HIV
infections by up to 50%
uptodate 2014
 The combination of early testing and treatment is the
most effective tool we have to prevent further
infections
 67 yo married businessman, while sitting in waiting
room for a routine cholesterol blood draw, decides to
fill in the circle on the paper lab form for an HIV test
 His HIV test comes back positive.
 He first indicates his risk factor was sex with
prostitutes
 He then recalls a blood transfusion. This is not in his
medical records
 He is then noted to flirt with the male clinic staff.
 He is turning 82 this year. Wife is still HIV negative.
 Test everyone 13- dead
 Test persons who ask for viagra for all STI’s, including
HIV.
 Persons with obvious risk factors should be tested
every 6-12 months (IDU, meth, MSM, etc)
 Pregnant women should be tested twice if possible; in
first or second trimester, and again in 3rd trimester
 Treatment of HIV during pregnancy decreases HIV
transmission to <1% of newborns
 If you are doing any other test of STI (GC/CT screen
for PAP test) order an HIV test as well.
 Early HIV mimics lupus: rash, joint aches
 AIDS mimics lymphoma or other cancers: weight loss,
night sweats, lymph nodes
 Any person under age 60 with shingles needs an HIV
test
 Anyone with hep C or ITP
 Any person under age 65 being worked up for
dementia needs an HIV test.
 If you are ordering an RPR or any other STD test (GC
etc), order an HIV test.
 What if results come back INDETERMINATE?
 Order an HIV RNA PCR (HIV viral load)
 If they are in seroconversion, the viral load will be
>1,000 copies. If undetectable, reassure the patient
they have a false-positive
 If they have an indeterminate HIV test and a positive
viral load <1,000 copies, call your ID consultant
Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement
Summary of Recommendations and Evidence
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen
adolescents and adults ages 15 to 65 years for HIV infection. Younger adolescents and older
adults who are at increased risk should also be screened. See the Clinical Considerations for
more information about screening intervals.
This is a grade A recommendation.
The USPSTF recommends that clinicians screen all pregnant women for HIV, including those
who present in labor whose HIV status is unknown.
This is a grade A recommendation.
Audience Response Question: You have a 22 yo
pregnant female who had an HIV test that came
back INDETERMINATE. What do you do?
33%
33%
33%
1)Repeat the HIV Elisa and Western blot in 3
months
 2)Repeat the HIV Elisa and Western blot
immediately
 3)Do an HIV viral load
“HIV TESTING IS ROUTINE”
 How you offer the HIV test makes a difference in how
patients will accept the test.
Opt-Out Screening
Prenatal HIV testing for pregnant women:
 RCT of 4 counseling models with opt-in consent: (formal written
consent with pre and post counseling)
 35% accepted testing
 Some women felt accepting an HIV test indicated high risk
behavior
 Testing offered as routine, opportunity to decline
 88% accepted testing
 Significantly less anxious about testing
Simpson W, et al, BMJ June,1999
California Law
 AB 682 (Berg/Garcia/Huffman) in California
Legislature to implement opt-out testing. Now law in
January 2008
 Verbal consent only needed
 If patient refuses HIV test, write in chart
 Posted signs enough for pre-counseling
Make it Easy
 Incorporate HIV test into general women’s lab form/
health panel: pap smear, mammogram,
GC/Chlamydia screen/cholesterol
 Incorporate HIV test into routine tests for cholesterol,
glucose, CBC, PSA
 Pair HIV tests with all other STD tests—no RPR, GC or
Chlamydia test should be ordered WITHOUT an HIV
test
HIV Treatment--and Training--is Available
 Ryan White funds available for indigent and/or
undocumented patients for free HIV care; many HIV
clinics have case managers who can sign up patients
for the ACA on site
 PAETC resources available to counsel patients being
deported or moving back to other countries to access
HIV treatment.
How to give HIV test results
 When you order an HIV test, schedule a followup visit
one week later.
 Positive tests should always be given face to face by
an MD, RN, or RNP.
 If the HIV test is negative, you can always cancel the
appointment and tell negative results over the phone
When your patient is HIV positive…
 Have HIV results and other paperwork ready for when
the patient shows up
 Have an HIV/ID clinic appointment available for the
patient: HMO referral sent, etc.
 Red, white and blue panic reactions.
 Say” I have important news: your blood test is
positive for the virus that causes AIDS”
 Say “important news” not bad news. Many patients
later tell me that getting HIV was the best thing that
ever happened.
Red panic
 Patient is angry, but it is a fear-type anger
 They threaten to infect others, may suddenly get
violent; they may want to sue you
 Sit with your back to the door so you can escape.
 Pay attention to what the “red panic” patient is
saying: often the HIV test results are just one more
darn thing—they are hungry, thirsty, they are broke,
the social worker has not called them back, etc.
 Red panic patients typically spew out a litany of bad
news.
 Try to identify one simple problem you can solve : get
them a drink of water
 Say “I can see that you are upset. Let me get you a
glass of water and I will be right back.”
 By stepping out you give them a chance to calm down
 By bringing them that glass of water you demonstrate
you are listening and are there to solve problems.
Blue Panic
 They cry, and cry, and cry.
 Bring tissues with you into the room.
 Assure the patient that it is normal to be upset.
 Schedule the patient for the end of the day so you
have plenty of time. Eventually they will stop crying
and will ask questions.
 Turn your pager off or mute
White Panic
 They freeze up and do not say anything or move.
 Again, schedule them for the end of the day and
mute your pager.
 Reassure them over and over again that HIV is
treatable and that all they need to do is show up for
the HIV clinic appointment that you have arranged.
 Don’t give them complicated information or
instructions.
 Wait until you are sure they understand about the
HIV clinic appointment, and that it is important to go
to the HIV clinic
 Regardless of how the patient reacted, call them that
night, and again the next day.
 Often they will have more questions and calling them
gives the patient the message that you have not
abandoned them.
What if they are married?
 Legally you are obligated to tell the patient to notify
all their sexual partners; document this in the chart.
 You can advise the patient that California has name
reporting for HIV (and hep C) and that the public
health department will be contacting him/her
 HIV Partner Notification Service, LA County Health
Department
 213 744 3367 (Frank Ramirez)
 Fax 213 749 9606
Summary of HIV testing
 HIV testing leads to decreased transmission
 Certain groups should be tested multiple times.
 Red, white and blue panic
 Use confirmatory tests and HIV viral loads before
declaring a patient to be HIV+
Hep C testing
 Who should be tested for Hep C
 Selection of who should be treated now
 What tests do you need to get HCV meds paid for
 3.2 million persons in US have hep C (CDC)
 45-85% persons with hep C are unaware of their
infection (CDC)
 Hep C leading cause of need for liver transplantation
 Int J Med Sci 2006, 3(2) 47-52
 1/3 of homeless patients
 30% of HIV+ patients
 3% of all MSM
 40% of all Egyptian adults over age 50
Types of Hep C tests
 Most hep C can be diagnosed with 3rd generation
elisa type test and hep C viral load
 Elisa detects antibodies to core antigens of hep C ,
NS3, NS4 and NS5 proteins.
 Hep C viral load detects actively growing hep C .
 RIBA (recombinant immunoblot protein)for hep C
rarely used,:
 population studies
 when hep C viral load is undetectable, Elisa + results
and Hep C infection needs to be
documented.(forensic)
 Hep C Elisa can be falsely negative in
immunocompromised persons(AIDS, transplants,
lupus, etc)
 Elevated LFT’s in those persons should be evaluated
with a hep C viral load.
 Rapid hep C tests available .
Hep C disease
Differences between HIV and hep C
 95% of persons with HIV will die of AIDS IF they do
not get treatment for HIV
 10-15% of persons with hep C will develop cirrhosis of
liver in 20 years of infection (faster with HIV and with
alcohol)
 1-4%/year of persons with cirrhosis will develop liver
cancer from hep C
• Hep C has 6 genotypes
• Hep C 1a and 1b are most common
• Hep C 2, 3 and 4 are less common
• 1/7 patients exposed to hep C will clear the hep C
virus (self cure). They will have +ab but NEGATIVE hep
C viral load
 Metavir score: F0, F1, F2, F3 and F4
 F0 normal, F4 cirrhosis
 Used to grade degree of liver damage
 Insurance companies unlikely to pay for hep C meds
unless F3 or F4.
What treatments are available now?
• Interferon-free effective treatments are here:
– IDSA recommendations: sofosbuvir and simeprevir,
12 week course for hep C genotype 1, for persons
not eligible for treatment with interferon. 90%+
cure rate Similar protocols for hep C genotype 2, 3
and 4
s
 Over $100,000 for a 12 week course
 In addition, insurance companies will not pay for
treatment with simprevir for patients with
decompensated cirrhosis (ascites, hepatic
enceophalopathy, GI bleed)
Audience Response Question: Which is true?
25%
25%
25%
25%
 1) 21% of persons with Hep C in US are
unaware of their hep C infection
 2)Hep C genotype tests detect hep C drug
resistance
 3)Most people with hep C will eventually die of
Hep C disease
 4)New hep C drugs are $1,000 a pill
Who to test and treat now?
• test all adults born 1945-1964, anyone with hx of jail,
tattoos, cocaine/meth use, or rectal intercourse for
Hep C. Immigrants from high risk countries
• If hep C ab positive, then send for hep C RNA PCR
quantitative, HIV test, and CBC with platelets and
complete metabolic panel (AST and ALT)
If hep C viral load positive and are sober x 6 months,
who have a hep C viral load >50,000 copies, and -–if
they practice rectal sex-- no new infections of GC/CT or
syphilis in past 6 months.
 If hep C viral load undetectable, reassure the patient.
No treatment needed
 If hep C viral load <50,000, then repeat hep C viral
load in 1-2 months. Patient may be undergoing self
cure.
 If patient still doing drugs , or having episodes of
STD’s from unprotected rectal sex, counsel the
patient and reevaluate.
• Fib-4 score performed: (AST x age)/ ((square root of
ALT) x platelet count.).
• If fib-4 score >3.25 =F3 or F4 on metavir score: high
risk for liver complications from hep C
• All patients counseled to avoid alcohol, limit tylenol,
and to have hep A and B vaccines updated.
Example Fib-4 score
 Age: 57
 Platelets 109
 AST 60
 ALT 75
 3420/944=3.62
 If fib-4 >3.25, patient at risk for liver cancer and other
cirrhosis complications
 Ultrasound annually
 Alfa fetoprotein annually
 If Fib 4< 3.25, order ultrasound elastography.
 If ultrasound elastography scores F3 or more, then
include that in the PA letter.
Mr. XXXXXX is my patient at UCLA. He has AIDS and hep C genotype 1A. He has current
depression and a history of IDU, so he is not a candidate for interferon. His Hep C viral load is
1,490,000 and his FIB-4 score is 12.97. This FIB score is indicative of current advanced liver
disease and fibrosis. He does not have any signs or symptoms of decompensated cirrhosis.
In addition, his AIDS diagnosis will accelerate his progression to end stage liver disease and his
hep C diagnosis will increase his risk of death from AIDS. Treatment of his hep C would increase
his life span and prevent morbidity.
His hep C viral load, genotype, CBC and chem panel accompany this letter.
Please approve him for 12 weeks of Sovaldi (sofosbuvir) at 400 mg a day and Olysio (simepravir)
at 150 mg a day for treatment of his hep C as per current guidelines from the IDSA.
If you have any questions or concerns, please don't hesitate to call.
Sincerely,
 What is ultrasound elastography?
 Counsel patient on need for adherence and close
followup for 12-24 week treatment course. Patient
needs to plan start of therapy—school, work, family
obligations
 If alfa fetoprotein elevated, send for ultrasound of
liver to r/o liver cancer
 Plan 1 month to get prior authorizations
 If not eligible for insurance, refer to USC liver clinic.
Summary of Hep C testing
 Hep C is more common than HIV
 I need to buy a new car
 Not everyone with hep C needs treatment
immediately
 Everyone with hep C should avoid alcohol and get hep
A and B vaccines
 Evaluate patients with fib-4, AFP, and ultrasound
elastography to see if they are at risk
Implementation: We can help
donohoe@ucla.edu
amoe@mednet.ucla.edu
Download