2/24/2017 Disclosures • I have nothing to disclose. Updates in the Care of Hepatitis C in Underserved Populations Kelly Eagen, MD San Francisco Department of Public Health UCSF Department of Family and Community Medicine Title Subtitle 1 “Guess what Doc! I repotted all my bonsai plants and finally moved my couch this weekend. Answer… I haven’t had energy for those things in years!” Hepatitis C Treatment Question… ? What medical intervention has the remarkable effect of allowing for bonsai repotting and * Disclaimer: HCV treatment is not guaranteed to furniture rearranging? provide boundless energy for gardening but will have a significant effect on one’s health nonetheless. 1
2/24/2017 Joy in Practice Objectives To review: Pearl… • The impact of HCV on vulnerable and underserved Adding Hepatitis C Treatment to populations your practice as a caregiver • The evidence supporting the benefits of HCV cure for underserved and vulnerable populations • The elements of primary care-based HCV treatment will bring joy to your practice. • Current HCV treatments • Effective care delivery in marginalized populations HCV Cascade of Care HCV in vulnerable populations 2000-2013 • NHANES estimate Prevent • 2.7 million cases with HCV viremia in the US reinfection Ensure our patients are • May be a gross underestimate due to exclusion of tested (and retested) underserved populations: • More realistic estimate > 4.6 million cases • Disproportionate impact on vulnerable populations • HIV infected: ~ 25-30% HCV co-infection (in the US) • Past/present injection drug use: ~ 50-90% • Homeless: ~ 7.5-50% NHANES, CDC 2014, Edlin Hepatology 2015 Yehia PLOS One 2014 2
2/24/2017 Meet Mr. Jones Assessing Treatment Readiness • 42 yo male, tested HCV Ab+ in jail a few years ago Sample Checklist: • PMHx: HTN, DM, depression, opioid dependence � Patient wants hepatitis C treatment . • Meds: benazepril, metformin, sertraline, methadone maintenance (NKDA) � Patient generally keeps scheduled medical appointments . • Social Hx: • � Patient has a reasonably stable social situation. Active injection heroin use • Alcohol - few beers/day, binge drinks on occasion � Patient takes currently prescribed medications , and has relatively good control over • Sexually active with men other chronic diseases (HIV, HTN, diabetes, etc). • Lives in SRO � Patient can articulate a plan to avoid hepatitis C reinfection after treatment. � Clinic/pharmacy staff can contact patient by phone or have another reliable way to reach “Nice to meet you doc. I’m a less-is-more-kinda-guy and don’t need patient. Consider case managers, family/friends or other support people. much but I figured I should get a doctor because it’s time to do something about this hepatitis before it gets the best of me. � If patient has active substance use and/or mental health issues, these conditions are relatively stable and do not prohibit engagement in general medical care. A guy I know at methadone clinic is on that drug from TV and he feels like a million bucks. Do you think I can be treated?” � Liver toxins (i.e. alcohol, high-dose acetaminophen) are minimized , and ideally eliminated. HCV Genotype Additional Work-Up • Confirm infection with HCV RNA (if HCV Ab positive) • Check HCV Genotype • Screen for HAV, HBV, HIV (vaccinate if indicated) • Perform fibrosis assessment : • Serum calculations (APRI or FIB4) • Imaging (ultrasound) • GT can impact disease progression • Biomarker test: Fibrosure ($$$) • GT 3: associated with steatohepatitis • Degree of fibrosis dictates: • Impacts selection and response to therapy • Decision to screen for HCC and varices • • Choice and duration of therapy Easiest to Cure: 2 > 4 ≥ 1 (1b > 1a) > 3 • Treatment response • GT 1: most common in US (70% 3
2/24/2017 Mr. Jones (cont) For the audience.. • HCV RNA: 3,000,000 IU/ml Would you offer HCV treatment to this marginally • Genotype 1b housed non-cirrhotic patient with active substance use? • APRI= 0.4 (does not suggest advanced fibrosis) a) No, I would not treat until evidence of advanced fibrosis or frank cirrhosis as no benefit now • AST 35/ALT 33, Platelets 210, Alb 3.9, INR 1.1 b) No, I am worried about reinfection • HIV negative c) Yes, I would pursue treatment now if he is motivated • HAV/HBV immune to be treated d) Yes, but only if he demonstrates 6 months of sobriety • Ultrasound: no evidence of cirrhosis High Priority • Advanced fibrosis or compensated cirrhosis • Cryoglobulinemia with end organ manifestations • Renal complications of HCV infection • HIV or HBV coinfection • Other liver disease (eg. NASH) • Insulin resistance • Debilitating fatigue resultant from HCV • High transmission risk (includes IDU, MSM, vertical transmission) (Patients who ASK about treatment are excellent candidates!) www.hcvguidelines.org 4
2/24/2017 HCV treatment as prevention Benefits of HCV Cure • Hepatic: • Reduce hepatic decompensation, liver transplant and HCC • Avert FUTURE liver disease complication in those with LESS fibrosis Base Case : • Non-Hepatic: - Risk based & Baby boomer screening • - Treatment with DAA Renal disease (Chen 2014) • Lymphoproliferative disease (Feld 2013) • Insulin resistance • Vascular disease (CAD & CVA) (Maria 2014) Ideal • - Universal Screening Cognitive impairment • Bone Disease & Fracture (Lo Re 2014) - Treatment capacity • Skin disease including porphyria cutanea tarda unlimited HCV cure reduces all cause mortality Kabiri AIM 2014 Aug 5;161(3):170-80 Active Substance Users Treating PWID More effective when paired with opioid substitution therapy and syringe exchange Dore AASLD 2015, AIM 2016 Despite substantial drug use during REINFECTION: treatment, 96.5% of patients missed • 6 reinfections through week 24 Martin Hepatology 2013, ≤ 3 doses during 12 weeks. • 4.6 reinfections/100py Martin 2013 5
2/24/2017 What about the COST?!? What about alcohol? • Current oral medications remain • Alcohol and HCV are negatively synergistic extraordinarily expensive • Despite the cost, many models find • Data support successful interferon-based HCV treatment universal HCV treatment cost effective in active drinkers • Cost effective ≠ cheap • Pearl: Successful HCV cure can be a springboard for other positive health changes. Counsel regarding alcohol reduction but don’t withhold treatment due to alcohol use alone. Chalal JAMA 2016 Drug procurement • Limited access to expensive HCV drugs has impacted direct acting agents (DAAs) • Progress towards improved access • Medi-Cal (7/2015): Expanded access to include ≥ F2, those at risk for transmission, HIV co-infection, insulin resistance, and more • Worldwide: scale up of generic production • Continued advocacy for lower pricing • New agents brings some competitive pricing 6
2/24/2017 Patient Assistance Programs • Uninsured patients with low income qualify for Patient Assistance Programs. • Choose a regimen. • Contact the appropriate PAP to obtain HCV medications. • Underinsured coverage under PAP varies (by pharmaceutical company) but can be an option. Direct Acting Agents (DAA) NS5a Inhibitors Protease Inhibitors NS5b Inhibitors � Target viral � Target viral protease � Target viral RNA assembly and The HCV Arsenal � “-previr” polymerase release Simeprevir � “-buvir” & � “-asvir” Paritaprevir Ledipasvir Grazoprevir NS5b Nucleotide Principals of therapy Velpatasvir Sofosbuvir Ombitasvir NS5b Non-nucleotide “P”= Previr Daclatasvir Dasabuvir Elbasvir “B”= Buvir “A”= Asvir >90-95% cure rate for most patients 7
2/24/2017 Current DAA combinations Current DAA combinations • NS5b Nucleotide based therapy • NS5b Nucleotide based therapy One drug from 2 nd class One drug from 2 nd class NS5b Nuke Backbone NS5b Nuke Backbone NS5a NS5a Sofosbuvir SOFOSBUVIR SOFOSBUVIR +Ledipasivir Protease inhibitor Protease inhibitor Ribavirin Ribavirin • Triple therapy without a NS5b Nuke • Triple therapy without a NS5b Nuke NS5a NS5b Non-Nuke Protease inhibitor NS5a NS5b Non-Nuke Protease inhibitor • HCV protease inhibitor + NS5a • HCV protease inhibitor + NS5a Protease inhibitor NS5a Protease inhibitor NS5a Current DAA combinations Current DAA combinations • NS5b Nucleotide based therapy • NS5b Nucleotide based therapy One drug from 2 nd class One drug from 2 nd class NS5b Nuke Backbone NS5b Nuke Backbone Sofosbuvir NS5a NS5a Sofosbuvir +Velpatasvir SOFOSBUVIR SOFOSBUVIR +Daclatasvir pangenotypic Protease inhibitor Protease inhibitor Ribavirin Ribavirin • Triple therapy without a NS5b Nuke • Triple therapy without a NS5b Nuke NS5a NS5b Non-Nuke Protease inhibitor NS5a NS5b Non-Nuke Protease inhibitor • HCV protease inhibitor + NS5a • HCV protease inhibitor + NS5a Protease inhibitor Protease inhibitor NS5a NS5a 8
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