HIV and Hep C testing Ardis Moe, M.D. UCLA CARE/NEVHC Van Nuys HIV Clinic 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  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 3 rd and 4 th generation tests

 Rapid blood tests for HIV  Rapid oral tests for HIV

 3 rd and 4 th generation HIV tests  3 rd generation—antibody test—will miss some patients in seroconversion “window” period”  4 th 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 3 rd 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? 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  (Frank Ramirez)  Fax

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 3 rd 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?  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 , 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 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 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