CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS

Transcription

1 CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND APRIL 26, 2018

2 CME Disclosures: Planning Committee And Speaker Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD

3 Howard University CME Accreditation Sponsor Accreditation: Howard University College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credits for Physicians: Howard University College of Medicine, Office of Continuing Medical Education, designates this live activity for a maximum of 1.0 AMA PRA Category I Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Goulda A. Downer, PHD, RD, LN, CNS Principal Investigator/Project Director

4 CME Disclosures: Planning Committee And Speaker AETC-Capitol Region Telehealth Project Planning Committee: The following committee members have nothing to disclose in relation to this activity: Goulda A. Downer, PhD, RD, LN, CNS John I. McNeil, MD John Richards, MA-AITP Denise Bailey, MED Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD

5 Howard University CME Accreditation Requirements For Internet Viewers Intended Audience: Health service providers: Physicians, Physician Assistants, Nurse Practitioners, Pharmacists, Dentists, Nurses, Social Workers, Case Managers and other Clinical Personnel. Webinar Requirements: A computer, phone, etc., with internet accessibility and a telephone line. ØYour presence on the call must be acknowledged at the start of each session. Please log in for the session announce your name loud and clear at the beginning of the session. ØYou will not be able to receive CME credits if you leave the session early. ØAt the end of the Webinar our Training Coordinator will a CME Evaluation Survey. ØAll participants are required to complete and return the CME Evaluation Survey at the end of each session. It may be scanned and ed back to den_bailey@howard.edu, or faxed to: AETC-Capitol Region Telehealth Project (FAX#: ) ATTN: Project Coordinator. Please indicate in your or FAX if you would like to receive CMEs.

6 TEST YOUR KNOWLEDGE 6

7 TestYour Knowledge Question #1 HIV Accelerates HCV related Fibrosis: A.True B. False

8 TestYour Knowledge Question #2 The following factors are associated with HIV/HCV Fibrosis Progression: A. Alcohol Consumption B. Male Gender C. Age D. Multiple Transfusions

9 TestYour Knowledge Question #3 HCV antibody test means the person is still infectious: A. True B. False

10 TestYour Knowledge Question #4 Which of the following is true about Hepatitis C? A. Cure protects for a life time B. Cannot be treated while treating HIV C. Cannot be treated in someone with cirrhosis D. Can be cured in as little as 8 weeks

11 CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS

12 LEARNING OBJECTIVES 1. Describe the epidemiology of HCV 2. Describe progression of liver disease in the setting of HIV/hepatitis C virus (HCV) coinfection 3. Understand the Fundamentals of HCV treatment 4. Describe barriers to treatment, including drug-drug interactions

13 EPIDEMIOLOGY Ø Five major types, maybe six minor types Ø Estimated 3.5 million people in the US have chronic HCV Ø Yearly, 17,000 get infected Ø Long-term incubation can eventually result in liver failure, liver cancer Ø Every year approximately 12, 000 die from HCV related liver disease

14 WHERE DOES IT COME FROM? Ø It is typically spread when blood from a person infected with the hepatitis C virus enters the blood stream of a non-infected person. Ø Yes, and sex Ø Transfusions (before 1982)

15 RISK FACTORS FOR ACQUIRING HCV

16 SYMPTOMS Ø Silent for years Ø Signs of eventual liver damage o Fever o Fatigue o Jaundice o Dark urine o Grey colored stools o Joint pain

17 HIV/HCV COINFECTION Ø Compared to HCV monoinfection o Higher rates of susceptibility to mucosal transmission o Higher rates of persistence o Faster rates of fibrosis o Higher rate of cirrhosis o Increased liver related mortality

18 CARE CASCADE IN HCV

19 PROGRESSION OF FIBROSIS IN HCV

20 IMPACT OF HIV COINFECTION

21 HIV ACCELERATES HCV RELATED FIBROSIS Kim and Chung Gastroenterology 2009

22 FACTORS ASSOCIATED WITH HIV/HCV FIBROSIS PROGRESSION Ø CD4 count less than 200 cells/mm 3 Ø Alcohol consumption Ø Older age at time of HCV acquisition Di Martino et al Hepatology 2001

23 MODIFIABLE RISK FACTORS FOR DISEASE PROGRESSION Diabetes/ insulin resistance Coinfection with HBV Marijuana

24 IMPACT OF HCV CURE

25 FUNDAMENTALS OF HEPATITIS C VIRUS TREATMENT

26 GOAL OF TREATMENT The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response. 1 AASLD-IDSA

27 CURRENT ALL-ORAL THERAPIES 2 Sustained HCV Virologic Response (%) Highly effective, simple, well-tolerated Standard Interferon (IFN) 1991 Ribavirin (RBV) Peginterferon (pegifn) Cure Rates Direct-Acting Antivirals (DAAs) All-Oral Therapy Current IFN 6 Mos IFN 12 Mos IFN/RBV 6 Mos IFN/RBV 12 Mos PegIFN 12 Mos PegIFN/RBV 12 Mos PegIFN/ RBV + DAA DAA + RBV PegIFN All Oral DAA RBV Box T, Clinical Care Options. 2017

28 THEN (PRE-2013) AND NOW Ø Cure rates are much higher today, in some populations close to 100% Ø There is far less medication toxicity Ø Length of treatment is shorter Ø Treatment is much more expensive Ø Treatments are now more complex and depend on genotype, degree of liver damage, and history of previous treatment failure

29 APPROPRIATE HCV PROVIDERS Ø All persons with current active HCV infection should be linked to a practitioner who is prepared to provide comprehensive management. 3 Ø New potent and well-tolerated hepatitis C treatments present an opportunity to expand the number of advanced practice practitioners and primary care physicians trained in the management and treatment of HCV infection.

30 Child-Turcotte-Pugh Class A (score 5-6) APPROPRIATE ID and HCV-informed PROVIDER BY primary STAGE care OF providers LIVER DISEASE 1 Child-Turcotte-Pugh Class B (score 7-9) Hepatologists ID and HCV-informed primary care providers in close communication with a supporting hepatologist Child-Turcotte-Pugh Class C (score 10) Hepatologists

31 HELP PATIENTS SUCCEED Use nurse or medical assistant-based medical case management to: Ø Schedule patient intakes Ø Submit and track prior authorizations Ø Resolve pharmacy and medication delivery issues Ø Make reminder calls for patient visits and labs Ø Field patient questions

32 APPROPRIATE PATIENTS FOR TREATMENT 1 Ø Review who and when to treat Ø Goal should be to treat whenever possible to reduce HCV transmission and HCV-related morbidity and mortality Ø Treatment may not be of sufficient benefit to justify the cost if life expectancy is <12 months

33 PREPARING FOR TREATMENT Ø Approval for treatment varies by insurer. Factors may include: Fibrosis stage Sobriety requirements Prescriber type: Hepatology, ID, primary care Ø Some states provide and require a certification process to prescribe HCV medications

34 PREPARING PATIENTS FOR TREATMENT ØAchieve medical stability before HCV treatment HCV treatment usually not urgent Avoids confounding comorbid symptoms with treatment side effects ØPatient must be able to understand and adhere to care plan HCV medications are expensive use resources wisely by working aggressively to resolve barriers to success before treating

35 PRETREATMENT EVALUATION HISTORY AND EXAM: Ø Evaluate symptoms and medical comorbidities Ø Ask about alcohol and drug use that may impact treatment Ø Elicit information about housing or food insecurity that may impact treatment Ø Reconcile medication list Ø Look for stigmata of liver disease

36 Ø Fibrosis staging: PRE-TREATMENT TESTS 1 AASLD-IDSA recommends combining a serum biomarker assay (such as FibroSURE, FIBROSpect II) and elastography (vibration-controlled transient liver elastography, MR elastography, acoustic radiation force impulse) Liver biopsy is reserved for situations in which discordance between serum and elastography tests will impact clinical decisions Individuals with clinically evident cirrhosis do not require additional staging (biopsy or noninvasive assessment) Ø Liver ultrasound

37 PRE-TREATMENT LABS 4 Ø Any time prior to treatment: HCV genotype and VL (but insurers often require a VL within 6 months of treatment) Ø Labs <12 weeks prior to treatment: HIV 4 th -generation test preferred (if not already known to be HIV infected) HAV Ab and HBV cab, sab, sag (vaccinate if not immune) LFTs, INR needed to calculate Child-Turcotte-Pugh score CBC (for platelets) and BMP creatinine/egfr TSH if IFN to be used

38 INFLUENCES ON HCV REGIMEN SELECTION 5 Ø Prior treatment history, whether with IFN or DAAs Ø HCV genotype Ø Presence or absence of cirrhosis Ø If cirrhotic: compensated vs. decompensated Ø Renal impairment Ø Other comorbid conditions and medication interactions

39 HCV TREATMENT IN PREGNANCY 4 Ø No DAAs are approved for use during pregnancy Ø Ribavirin is highly teratogenic Women of childbearing age need dependable contraception when taking ribavirin and for 6 months thereafter Men taking ribavirin should avoid close contact with pregnant women during treatment and for 6 months thereafter Ø See Guidelines for full review of HCV management in pregnant women Ø Bottom line: do not treat HCV during pregnancy

40 HCV MEDICATION CLASSES 4 Ø Protease inhibitors: previr e.g., simeprevir, paritaprevir Ø NS5A inhibitors: asvir e.g., elbasvir, ombitasvir Ø NS5B nucleotide polymerase inhibitors: buvir e.g., sofosbuvir, dasabuvir Ø Ribavirin

41 RESISTANCE 4 Ø There is no cross-resistance between classes Ø Recommendations include discussion of how to screen for resistance if necessary before treatment

42 LABORATORY MONITORING DURING TREATMENT 4 Ø 4-week HCV VL, egfr, LFTs for all regimens Plus other labs for some specific regimens see guidelines HCV VL check is recommended by AASLD-IDSA and required by some insurers, but treatment should not be stopped if the HCV VL is not done Consult guidelines for stopping treatment based on side effects or lab abnormalities Ø If 4-week HCV VL undetectable, continue treatment and consider rechecking at end of treatment (recommendations are not firm) Ø If 4-week HCV VL detectable, recheck at 6 weeks Stop treatment if 6-week HCV VL has increased 10-fold from 4-week level Some experts recommend stopping treatment if 6-week HCV VL is higher than 4-week HCV VL, even if not 10-fold higher

43 Ø 12-week post-treatment HCV VL: MONITORING AFTER TREATMENT 4 if undetectable = SVR = 99% chance of durable cure Ø 24-week post-treatment HCV VL is optional; order if risk is higher, such as: Viremia present on 4-week HCV VL check Adherence problems identified Patients who have received a liver transplant Ø If viremia reappears at 12 or 24 weeks, consider rechecking HCV genotype to see if patient may have been dually infected with a different minority genotype

44 ADDITIONAL MONITORING POST-TREATMENT Ø HCC screening with every 6-month liver ultrasound if F3-F4 fibrosis or cirrhosis Ø Also includes: Counseling to prevent reinfection Screening for reinfection Behavior modifications See Lesson 2.4 (preventing reinfection) for additional information

45 CHRONIC HBV/HCV CO-INFECTED PATIENTS REQUIRE EXTRA MONITORING 4 Ø HCV can suppress HBV in vivo, so HBV may flare when HCV is treated More common in HBV sag+ patients, but also can occur in isolated HBV cab+ patients from latent cccdna Risk is much lower in HIV co-infected patients who are on tenofovir, lamivudine, or emtricitabine Ø Stage chronic HBV patients with eag/eab/alt/vl before treatment for HCV (along with the fibrosis assessment), then check ALT and HBV VL during and immediately after HCV treatment Ø Treat if HBV treatment criteria are met (see Resources)

46 IF TREATMENT IS DEFERRED 1 Ø Annual assessment of fibrosis progression labs and vibration-controlled transient elastography or equivalent testing Ø HCC screening with liver ultrasound every 6 months in patients with advanced fibrosis (METAVIR F3 or F4) Ø Work to resolve barriers to treatment

47 WHEN TREATMENT FAILS Ø DAA resistance and re-treatment strategies are areas of ongoing research; consult AASLD- IDSA guidelines 7 Ø General approach do two of the following if cirrhosis is not present 8: Switch regimen Add ribavirin Lengthen treatment Ø With all patients, assess adherence and work to resolve adherence barriers Ø May also wait for new therapies if re-treatment is not urgent

48 KEY POINTS Ø Non-hepatologists can and should provide HCV treatment to confront the HCV epidemic Ø The AASLD-IDSA HCV Guideline website is the definitive source for treatment recommendations Ø Other websites provide helpful clinical tools and opportunity to practice and reinforce knowledge Ø The main challenge in HIV/HCV co-infection treatment is managing drug interactions

49 REFERENCES 1. AASLD-IDSA. When and in whom to initiate HCV therapy. Recommendations for testing, managing, and treating hepatitis C. Accessed April 17, Box TD. Hepatitis C Update for Primary Care. Clinical Care Options. February 21, Accessed July 7, 2017 at 3. AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. Accessed April 17, AASLD-IDSA. Monitoring patients who are starting hepatitis C treatment, are on treatment, or have completed therapy. Recommendations for testing, managing, and treating hepatitis C. Accessed April 17, AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. July 7, AASLD-IDSA. Retreatment of Persons in whom prior therapy has failed. Recommendations for testing, managing, and treating hepatitis C. Accessed April 17, Feld JJ. How I manage patients with HCV after DAA treatment failure. Clinical Care Options Hepatitis. Posted 11/19/2016. Accessed April 17, 2017.

50 ACKNOWLEDGMENTS Ø A portion of this presentation are from slides prepared by Philip J. Bolduc, MD (New England AETC) for the AETC National Coordinating Resource Center in July Ø Dr. Bolduc s presentation is part of a curriculum developed by the AETC Program for the project: Jurisdictional Approach to Curing Hepatitis C among HIV/HCV Co-infected People of Color (HRSA ), funded by the Secretary's Minority AIDS Initiative through the Health Resources and Services Administration HIV/AIDS Bureau.

51 TEST YOUR KNOWLEDGE 51

52 TestYour Knowledge Question #5 HIV Accelerates HCV related Fibrosis: A.True B. False

53 TestYour Knowledge Question #6 The following factors are associated with HIV/HCV Fibrosis Progression: A. Alcohol Consumption B. Male Gender C. Age D. Multiple Transfusions

54 TestYour Knowledge Question #7 HCV antibody test means the person is still infectious: A. True B. False

55 TestYour Knowledge Question #8 Which of the following is true about Hepatitis C? A. Cure protects for a life time B. Cannot be treated while treating HIV C. Cannot be treated in someone with cirrhosis D. Can be cured in as little as 8 weeks

56 Howard University HURB th Street NW, 2 nd Floor Washington, DC (Office) (Fax) As a Reminder: At the end of the Webinar, All participants are required to complete and return the CME Evaluation Survey. It may be scanned and ed back to den_bailey@howard.edu, or faxed to: AETC-Capitol Region Telehealth Center (FAX#: ) ATTN: Training Coordinator. Please indicate in your or FAX if you would like to receive CMEs.