CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND APRIL 26, 2018
CME Disclosures: Planning Committee And Speaker Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD
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
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
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. Ø Your 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. Ø You will not be able to receive CME credits if you leave the session early. Ø At the end of the Webinar our Training Coordinator will email a CME Evaluation Survey. Ø All participants are required to complete and return the CME Evaluation Survey at the end of each session. It may be scanned and emailed back to den_bailey@howard.edu, or faxed to: AETC-Capitol Region T elehealth Project ( FAX#: 202.667.1382 ) ATTN: Project Coordinator. Please indicate in your email or FAX if you would like to receive CMEs.
TEST YOUR KNOWLEDGE 6
TestYour Knowledge Question #1 HIV Accelerates HCV related Fibrosis: A. True B. False
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
TestYour Knowledge Question #3 HCV antibody test means the person is still infectious: A. True False B.
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
CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS
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
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
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)
RISK FACTORS FOR ACQUIRING HCV http://www.healthline.com/health/hepatitis-c/facts-statistics-infographic
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
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
CARE CASCADE IN HCV
PROGRESSION OF FIBROSIS IN HCV www.hcvonline.org
IMPACT OF HIV COINFECTION http://hivinsite.ucsf.edu/InSite?page=kb-05-03-05#S1X
HIV ACCELERATES HCV RELATED FIBROSIS Kim and Chung Gastroenterology 2009
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
MODIFIABLE RISK FACTORS FOR DISEASE PROGRESSION ¡ Diabetes/ insulin resistance ¡ Coinfection with HBV ¡ Marijuana
IMPACT OF HCV CURE
FUNDAMENTALS OF HEPATITIS C VIRUS TREATMENT
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
CURRENT ALL-ORAL THERAPIES 2 All-Oral Direct-Acting Highly effective, simple, well-tolerated Therapy Antivirals Peginterferon (DAAs) Current 2013 Sustained HCV Virologic Response (%) 100 (pegIFN) 95+ 2011 90+ Cure Rates 80 Ribavirin 2001 (RBV) 70+ Standard Interferon 1998 60 55 (IFN) 1991 42 39 40 34 16 20 6 0 IFN IFN IFN/RBV IFN/RBV PegIFN PegIFN/RBV PegIFN/ DAA + All–Oral 6 Mos 12 Mos 6 Mos 12 Mos 12 Mos 12 Mos RBV + RBV � PegIFN DAA � DAA RBV Box T, Clinical Care Options. 2017
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
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.
Child-Turcotte-Pugh Class A (score 5-6) APPROPRIATE PROVIDER BY STAGE OF LIVER DISEASE 1 ID and HCV-informed primary care providers § 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 §
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
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
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
PREPARING PATIENTS FOR TREATMENT Ø Achieve medical stability before HCV treatment ¡ HCV treatment usually not urgent ¡ Avoids confounding comorbid symptoms with treatment side effects Ø Patient 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
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
PRE-TREATMENT TESTS 1 Ø Fibrosis staging: ¡ 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
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
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