HIV and Hep C testingArdis 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 StatementSummary 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 ScreeningPrenatal 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.eduamoe@mednet.ucla.edu