The changing landscape of hepatitis infection Michael E. Herman D.O.

What’s New? For Primary Care Providers For HCV Treaters For everyone Importance of diagnosing HCV For HCV Treaters How can we improve current therapies? For everyone What’s in the horizon

Hepatitis C Infection is CURABLE! We can cure the majority of treated patients 75% of infected individuals have not been diagnosed Largely asymptomatic in first 2-4 decades Most diagnosed patients have not been treated (~75% - 80%) Toxicity of current medications

Who is Infected? Moorman AC, et al. JCI 2013;56:40-50 Pyenson B, et al. Milliman Inc, 2009

Who Cares? Most common indication for liver transplantation 33% undiagnosed baby-boomers have advanced fibrosis/cirrhosis Most common indication for liver transplantation Accounts for ½ of the 3-fold increase in hepatocellular carcinoma McGarry LJ, et al. Hepatology 2012;55:1344-1355 Davis G, et al. Gastroenterology. 2010;138(2):513-521.

USPSTF* Birth Cohort Screening Recommendations One-time screening of ALL adults born between 1945-1965 Screening of people at high risk including: Intranasal drug use Current or past IVDU Born to a mother with HCV Incarceration Getting an unregulated tattoo *US Preventive Services Task Force Moyer VA and USPSTF. Ann Intern Med 2013

Public Awareness Campaign

Benefits of Diagnosis Risk for progression, need for monitoring Lifestyle modifications Alcohol abstinence Risk to others Opportunity for treatment Possible cure Modification of natural history of the disease

HCV Cure Improves Prognosis International study, n=530, median age 48, HCV with advanced fibrosis SVR = cure Van der Meer AJ, et al. JAMA 2012;308:2584-2593

HCV Therapy Saves Lives VA Study, n=16,864, all genotypes, all stages. Backus LI et al. Clin Gastroenterolo Hepatol 2011;9:509-516

You Can Make a Difference! Screen and diagnose HCV infection

What can we offer today? “Triple Therapy” Telaprevir or Boceprevir Pegylated interferon Ribavirin 1st Generation protease inhibitor Telaprevir or Boceprevir

What can we offer today? PEG + ribavirin + sofosbuvir Genotypes 1, 4, 5 & 6, naïve Non responders ??? 12 weeks, 16-24 weeks?? Interferon free sofosbuvir + ribavirin Genotypes 2 & 3 PEG + ribavirin + simeprevir Genotype 1, naïve and non-responders 24/48 weeks response guided therapy

Interferon-free Regimens 96-97% SVR Harvoni (ledipasvir (NS5A inhibitor) / sofosbuvir (nucleotide analog NS5B polymerase inhibitor) or Viekira Pak (protease inhibitor ABT-450, a 100 mg boosting dose of ritonavir, and the NS5A inhibitor ombitasvir) for treatment.

Predicting the Future

Many Unknowns Remain….. Cost? Regimen approved? Payor “interference” 4, 6, 8, 12, 16, 24 weeks? Payor “interference” Step up therapy? Restricted access? Excessive copays? Ability to mix and match?

How Long Are You Going to Wait? There will always be something better coming down the pipeline….

Take Home Points HCV Therapy has “taken off” We can cure most patients if They are diagnosed They can afford and tolerate the drugs Research is advancing rapidly