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Preventing and Treating Hep C among People who use Drugs

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Prevention and Treatment of Hepatitis C Infection Among People Who Use Drugs Jocelyn James, MD Assistant Professor Division of General Internal Medicine University of Washington School of Medicine April 6, 2021 Panel Discussants James Darnton, MD Clinical Instructor Division of General Internal Medicine University of Washington School of Medicine Jared Klein, MD, MPH Assistant Professor Division of General Internal Medicine University of Washington School of Medicine Slides adapted from talk developed by Dr. James and Dr. Judith Tsui in collaboration with the Washington State Department of Health. Session Objectives Describe epidemic of hepatitis C (HCV) infection among people who use drugs and importance of treating this population in order to eliminate hepatitis C as a public health threat Address common myths about HCV treatment among people use drugs Describe key features of a typical treatment course for HCV infection Outline Background Changing epidemiology of HCV associated with opioid use epidemic Health consequences of chronic HCV Health benefits of cure of HCV Treatment as prevention for people who use substances Basics of HCV treatment Screening and prevention of HCV Administrator Counselor / case worker / social worker Nurse Physician or other prescribing provider Other Which of the following best describes your professional role? Patient Case 51 yo woman with opioid use disorder on methadone maintenance, chronic hepatitis C, tobacco use, presenting to establish care. Due to severe L hip pain, her substance use has escalated in the last month. She now muscles heroin and smokes methamphetamine daily. She has heard there are great medications for hepatitis C now, but her priority is to get control over her heroin use. How would you approach the topic of hepatitis C treatment? What would you recommend? What other information would you most want to know? Background and Epidemiology of HCV RNA virus identified in 1988 Most common blood-borne infection in US: 2.4 million chronically infected1 56% aware of infection2 Not vaccine preventable Most people exposed to hepatitis C virus will develop chronic infection 1Hofmeister MG et al, Hepatology 2018; 2Kim HS et al, J Viral Hepat 2019 May; 26(5): 596-602 HCV in the US: Routes of Transmission Injection drug use: 60% of cases Blood transfusion prior to 7/1992 Receipt of solid organ transplantation or factor concentrates made before 1987 Male-to-male sex Body tattoos Intranasal cocaine use Highest risk: sharing needles and syringes Can also occur with sharing injection paraphernalia such as water, cookers, and cotton filters IDU accounts for 70% of new infections Opioid Epidemic and HCV Emerging epidemic of HCV infections among young people who inject drugs Closely related to opioid epidemic Rates of reported acute hepatitis C by age group, US, 2002-2017 (CDC Viral Hepatitis Surveillance Data) Figure source: modified from hepatitisc.uw.edu from Klevens et al, Am J Public Health 2014 Opioid Epidemic and HCV Figure source: modified from hepatitisc.uw.edu from Klevens et al, Am J Public Health 2014. 1 Centers for Disease Control Reported acute infections are only the tip of the iceberg 3,621 acute cases reported in U.S. in 2018 1 Estimated 50,300 actual new cases1 Example from Washington State Source: Washington State Department of Health As throughout US, there are now two epidemics: baby boomers and young people who inject drugs In 2018 there were 118 new reports of acute HCV, the highest in 20 years Chronic HCV in WA State 2018 2007 Health Consequences of Chronic HCV 15-30% of those with chronic HCV will develop cirrhosis, which can lead to Liver failure Hepatocellular carcinoma: 3-5% per year Death: since 2017, deaths from HCV > deaths from HIV Alcohol use increases each of these risks AND affects transplant candidacy Figure: Hepatitisc.uw.edu, illustration by David Spach, MD Worse Outcomes in People Co-infected with HIV and HCV Image from Hepatitis C Online (hepatitisc.uw.ed). Di Martino et al, Hepatology. 2001;34:1193-9 Image credit: Hepatitis C Online: hepatitisc.uw.edu Definitions Cure of HCV = SVR 12 No detectable HCV virus (HCV RNA) at 12 or more weeks after completion of treatment DAA= direct-acting antiviral medication (to treat hepatitis C infection) Add pictures Benefits of Cure of HCV Reduced all-cause mortality Positive psychosocial effects and improved quality of life Reduction in liver fibrosis and liver complications Decreased inflammation and non-hepatic comorbidities Reduced transmission to others Reduced incidence of liver cancer Psychosocial Benefits Improved self-efficacy and empowerment Relief from stigma and illness-related uncertainty/stress Positive impacts on substance use "Clearing HCV will help in defeating the bigger problems, because it's like trying to get up when you've got 100 bricks on ya. But then if I took half the bricks off from the Hep C, then now I've got a bit more movement and I can start taking the bricks off." 1 "Everything changed. I stopped drug use. I stopped everything because I said if I beat the Hep C, I could beat that too. Praise God up to today, I feel so good." 2 1Goutzamanis et al, BMC Infectious Diseases 2018; 2Batchelder et al, Drug and Alcohol Depend 2015 Which People with HCV Should Be Treated? HCVguidelines.org (IDSA/AASLD) Nearly everyone: What about people who use drugs? Treating people who use drugs is critical to achieving elimination of HCV IDSA/AASLD Guideline Update Treatment as Prevention in HCV Treating populations that actively transmit HCV Reduces new infections Reduces prevalence over time Common Myths #1 People who use substances can't be effectively treated / cured #2 People who use substances are likely to get reinfected anyway Though previously assumed true and incorporated into guidelines and coverage requirements, these myths have been debunked Countering Myth #1 Studies from various settings show good adherence and high cure rates among people who use drugs, including those with injection drug use There are NO data to support pretreatment screening for illicit drug or alcohol use to select a population more likely to be successful with hepatitis C treatment HCVguidelines.org Randomized, double-blind, placebo-controlled trial of elbasvir/grazoprevir for treatment-nave patients with genotype 1, 4, or 6 enrolled in opioid agonist treatment Participants had to be at least 80% adherent to OAT visits Primary outcome: proportion of patients with SVR12 Results: 301 patients, 76% men, 80% white, 7% coinfected with HIV, >46% with positive urine screens 91.5% had SVR 12 1Dore G Ann Int Med 2016 eligible patients had been in tx at least 3 months; randomized 2:1 to immediate vs delayed treatment; ~80% methadone, 20% buprenorphine; frequent monitoring, adherence support not described; 7% coinfected with HIV; mostly men, mostly white, mostly between 35-64; 25% IDU within prior 6 months Open-label international trial of sofosbuvir/velpatasvir among people with hepatitis C, genotypes 1-6, and with injection drug use within 6 months Therapy was given in one-week electronic blister packs Primary outcome: proportion of patients with SVR12 Results: 103 patients, mostly male, 59% of whom were receiving opioid agonist treatment, 74% of whom had injected in last month 97% completed treatment, 94% had SVR 12, drug use did not affect SVR Grebely Lancet Gastroenterol Hepat 2018 Self-reported IDU w/in 6 months; recruited from drug tx clinics, hospital clinics, community clinics, etc; HIV excluded Attended 4 visits during treatment, plus weekly to pick up blister packs There is also real-world data with comparable outcomes Countering Myth #2 Rate of reinfection among people who use drugs is low Compared to rates of first infection: hepatitis C treatment has been associated with reduced needle sharing Rates of reinfection are decreased When people receive medications for opioid use disorder When people use syringe service programs Some degree of reinfection suggests you are treating the right population Add references Meta-Analysis of Rate of HCV Reinfection Population # Studies Rates of reinfection per 100 person-years Any drug use 33 5.9 (95% CI 4.1-8.5) Injecting drug use 31 6.2 (95% CI 4.3-9.0) Opioid agonist treatment 25 3.8 (95% CI 2.5-5.8) Studied 1) people who recently used drugs, and 2) those on opioid agonist treatment 36 studies; 6,311 person-years follow up 19 studies were DAA The Future of HCV 2016: the World Health Organization announces plan for elimination of HCV by 2030 80% reduction in incidence 65% reduction in mortality 2018: Gov. Inslee announces first state initiative to eliminate HCV: "Hep C Free WA" Identifies people who inject drugs as priority population for treatment Removes prescriber restrictions HCV Restrictions/Requirements https://stateofhepc.org/report/ Prescriber restrictions: decompensated cirrhosis -->specialist None Consider SUD in adherence counseling Screening and referral if active alcohol or substance use Screening and counseling for alcohol and drug use Drug screening within 30 days of treatment How Are We Doing? Corcorran et al, Drug and Alcohol Dependence, Volume 220, 2021 There is still a large cliff from screening to treatment among people who inject drugs This 2018 Seattle, WA, data from National HIV Behavioral Surveillance Survey mirrors the region and nation Interest in HCV Treatment is High in PWID Alcohol and Drug Abuse Institute (ADAI): https://adai.uw.edu/wa-state-syringe-exchange-health-survey-2019-results 58% of respondents to a state syringe exchange survey from 2019 reported HCV testing in the last year Of those diagnosed with HCV, 28% had received any treatment 68% reported interest in treatment Photo: Hepatitis Education Project Hepatitis C Treatment: The Big Picture In most patients with hepatitis C, treatment is straight-forward and simple and can be done by PCPs/pharmacists In people with advanced liver disease or certain other conditions (transplant, liver cancer), treatment is more complicated and should be done by or in consultation with specialists Distinguishing these two groups is an important task and starts with a good clinical history Direct-Acting Antivirals (DAAs) for HCV HCVguildelines.org Typical treatment duration 8-12 weeks Usual pill burden 1-3 pills taken once daily Tolerability Very well-tolerated overall Headache, fatigue, and nausea are relatively common but rarely interfere with treatment course Effectiveness >95% rate of cure Comparable effectiveness in those with substance use Examples (pan-genotypic) Glecaprevir/pibrentasvir (Mavyret) Sofosbuvir/velpatasvir (Epclusa) Pretreatment Assessment HCVguidelines.org Required *Complete blood count (CBC), *Comprehensive metabolic panel (CMP), HCV RNA, HIV, HBsAg Consider based on level of clinical concern for cirrhosis, based on Review of existing data (likely) duration of infection cumulative alcohol exposure signs/symptoms of cirrhosis International normalized ratio (INR) FibroTest/FibroSure, ActiTest Transient elastography (FibroScan) Abdominal ultrasound Treat as cirrhosis if any of the following FIB-4 > 3.25 Platelet count < 150,000/mm3 FibroScan > 12.5 kPa Liver nodularity and/or splenomegaly on imaging Prior liver biopsy showing cirrhosis Know When to Refer HCVguidelines.org Definite: Decompensated cirrhosis Hepatocellular carcinoma Post-transplant Relative: Hepatitis B and/or HIV Prior treatment with DAAs Image credit: Hepatitis C Online: hepatitisc.uw.edu Image credit: Mayo Clinic Simplified HCV Treatment: No Cirrhosis Hcvguidelines.org Key Steps: Review medications, drug-drug interactions Update labs Educate re: medication administration, adherence, and preventing reinfection Treatment: Glecapresvir/pibrentasvir for 8 wks (3 pills daily), or Sofosbuvir/velpatasvir for 12 wks (1 pill daily) Monitoring: No lab monitoring required Offer visits for support, assessment of symptoms Treating Patients with Compensated Cirrhosis *If treating with sofosbuvir/velpatasvir. **Hepatic panel every 4 weeks; monitor for jaundice, ascites, encephalopathy. There is also a simplified algorithm, with some key differences: Check liver ultrasound to exclude liver cancer prior to treatment Check genotype* Basic labs within 3 months Monitor for decompensation** Avoid excessive alcohol Cure does not prevent reinfection: screen annually if ongoing risk factors If elevated despite undetectable RNA, assess for other causes of liver disease Post-Treatment HCVguidelines.org If RNA detectable, refer to specialist for retreatment Test for cure! Check HCV RNA 12 or more weeks after completing treatment Check AST and ALT Provide Counseling Patients with Cirrhosis Require Follow Up Images: Mayo Clinic Coinfection with HCV and HIV HCVguidelines.org Co-infection leads to accelerated rates of fibrosis Rates of cure are comparable in those with coinfection vs monoinfection Treatment regimens are generally equivalent, though in some circumstances, 8-week regimens should be extended to 12 weeks Drug-drug interactions are key IDSA/AASLD guideline provides examples of HIV and hepatitis C medications that can be used together If considering other combinations, expert consultation is needed Resources: hcvguidelines.org, https://aidsinfo.nih.gov/guidelines, www.hep-druginteractions.org For persons with HIV-HCV coinfection who are not on antiretroviral therapy and have a CD4 cell count less than 200 cells/mm3, it may be advisable to initiate HIV antiretroviral therapy first and defer HCV treatment until undetectable HIV RNA levels have been obtained. DAAs and Antiretroviral Medications HCVguidelines.org New Recommendation for Universal Screening New USPSTF recommendation to screen all asymptomatic adults age 18-79 for hepatitis C Those at high risk should be periodically rescreened Consider screening those younger than 18 and older than 79 HCV Prevention Treatment as prevention Education/harm reduction Medications for opioid use disorder Syringe service programs Patient Case: Considerations How concerned are you for advanced fibrosis? Duration infection, alcohol history, symptoms and data How relevant is the public health argument to treat ASAP to reduce transmission? How does hepatitis C treatment fit with her goals? It may improve quality of life/symptoms It may increase self-efficacy, reduce risk behavior, improve SUD Important to treat when she feels she can be successful, but also keep in mind, DAAs are forgiving of imperfect adherence Key Resources HCVguidelines.org: IDSA/AASLD guideline Hepatitisc.uw.edu: excellent free online training Project ECHO, weekly videoconferences : contact Pam Landinez at [email protected] UCSF phone consultation, 9 am-8 pm ET: (844) HEP-INFO or (844) 437-4636 U. of Liverpool medication interaction checker: hep-druginteractions.org Panel Discussion What do you find most rewarding about providing hepatitis C treatment? What challenges have you encountered while treating hepatitis C among people who use drugs? What advice would you offer others interested in treating hepatitis C?