Update on Hepatitis C. Sally Williams MD

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1 Update on Hepatitis C Sally Williams MD

2 Hep C is Everywhere!

3 Hepatitis C Magnitude of the Infection Probably 8 to 10 million people in the U.S. are infected with Hep C 30,000 new cases are diagnosed annually; most were acquired years ago New infections are at 10-20,000 a year, most in young IV drug users Liver disease is 10 th leading cause of death in U.S., most are Hep C positive This should change with new medications

4 Hepatitis C Around the World

5 Risk Factors for the Acquisition of Hepatitis C IV drug use by far the most common Blood product transfusion prior to % risk in early 80s with single transfusion Tattoos likely if done in unlicensed setting Male-female sex transmission almost zero; condoms not recommended Male-male sex is high risk

6 Who should be tested for Hep C? Any history of IVDU (even once!) Even with no shared needles Blood or blood product transfusion from about 1965 to 1992 Hemodialysis patients Anyone with elevated transaminases, even in the absence of risk factors Gay men and HIV+ persons

7 100% of people freak out after their Hep C diagnosis

8 Natural History of Hepatitis C Infection About 70% of persons will be chronic carriers of Hep C (+ viral load) 30% of persons will eliminate the virus in the year after infection and will be immune They will be antibody + but RNA negative Presence of Hep C RNA (viral load) determines the diagnosis of active infection

9 Natural History of Progression of Hepatitis C Not that bad for most people! Lifetime risk of cirrhosis is 20-25%; risk of liver disease death or liver cancer is 5% Heavy alcohol use increases risks Average time to cirrhosis is years. Hep C is NEVER an emergency Everything has changed with new medications, expect almost no deaths in future

10 Living with Hepatitis C The vast majority of patients are asymptomatic 50% or more have clinical depression Complaints of fatigue are common and usually related to depression Rare patients have arthritis, vasculitis or renal disease; Type II diabetes is common There is a strong correlation with fibromyalgia. Also, RA test often false + with Hep C. True arthritis is rare.

11 Markers of Hep C disease There is NO correlation between a patient s symptoms, transaminase levels, Hepatitis C viral load, and the stage of liver disease found on biopsy Many persons even with cirrhosis have no symptoms Average viral load is 2-5 million, higher has no worse prognosis.

12 Stages of Liver Disease Inflammation Fibrosis Compensated cirrhosis (normal albumin and bilirubin) Decompensated cirrhosis (liver failure) Cirrhosis is stage 4, anything else is fibrosis

13 Tests Utilized with Hepatitis C Infection Transaminases do NOT correlate with stage of disease unless always normal Hep C RNA presence confirms active disease, amount usually not important Hep C genotype determines what meds will be used for treatment Liver biopsy determines stage of disease and need for treatment. Used less now, fibrosure blood test often used.

14 Progressive Liver Damage

15 Therapy for Hepatitis C Goals of treatment: Eradicate virus permanently (cure) Slow progression, stabilize disease, and decrease risk for hepatocellular cancer Improve symptoms for rare persons with vasculitis and glomerulonephritis Treatment rarely improves joint pain or fatigue symptoms

16 Therapy for Hepatitis C It s all new. Previous treatment involved interferon shots and ribavirin for 6-12 mos New treatments are all oral, short courses New medications are targeted at genotype 1 which represents about 75% of patients New meds have minimal side effects and very high cure rates Genotype 3 cirrhotics are now the most difficult to treat group

17 Responses to Treatment Transaminase response: expect enzymes to normalize during treatment Virologic response: expect negative or very low Hep C RNA during treatment **Sustained response: persistent eradication of Hep C RNA 3 months after end of tx Biopsy response: improvement in histology after treatment (research only)

18 History of Hep C Treatments 1991 Alfa interferon daily x/wk interferon 1998 ribavirin added 2001 Once weekly peg-interferon with ribavirin 2011 Telaprevir and boceprevir approved for use with peg and ribavirin for genotype Sofosbuvir and simeprevir approved 2014 Harvoni and Viekira approved

19 Targets for Hep C medications

20 The breakthroughs The new meds

21 New oral meds for Hep C 2013 Sofosbuvir (Sovaldi) NS5B polymerase inhibitor To be used with peginterferon for genotype 1, 12 week treatment, 90% cure For genotype 2: 12 weeks with ribavirin, 93% cure For genotype 3: 24 weeks with ribavirin, 84% cure Simeprevir (Olysio) NS3/4a protease inhib Almost always used with sofosbuvir for patients with cirrhosis, cure rates variable Both are priced at $1000 a pill

22 New Medications 2014 Sofosbuvir/ledipasvir (Harvoni) (Gilead) Approved for genotype 1 only, cost $1200 a pill Treatment course: 1 a day for 8 weeks if not cirrhotic, 12 weeks for cirrhosis, high viral load or previously treated with interferon Very minimal side effects, cure rates 90-95% even with cirrhosis if treatment naive Ribavirin often added for treatment experienced cirrhotics (increased cure 86% to 96%)

23 New Medications 2014 VieKira pack (AbbVie) A combination of 4 drugs: ritonavir + NS3/4a protease+ NS5a protease+cy3pa inhibitor BID dosing for 12 weeks, 4 pills a day for 1b Approved for geno 1 only, cure rates similar to Harvoni but many more pills If pt has geno 1a OR 1b with cirrhosis then ribavirin bid must be added to the regimen Cost is $1000 a day for 12 weeks

24 Treatment issues Because of cost, currently insurance is only treating patients with stage 3 fibrosis or more Abbvie drug company has negotiated an exclusive contract with Express scripts for their 25 million members. Appears cost of drug will be about $60,000 Only Viekira will be covered, not Harvoni, except for advanced cirrhosis Abbvie is promising treatment for all, remains to be seen Medicaid has had to carve out cost of drugs

25 The future of Hep C treatment Hopefully prices will drop and all with stage 2 or more will be able to get treatment No progress for the genotype 2 or 3 market. Geno 3 cirrhotics now have almost no treatment options Treatment will become so easy that all primary care providers will be prescribing meds We now can guarantee patients they will never reach cirrhosis or have complications The new influx of young heroin IVDUs could stress the treatment system

26 Don t forget to test for Hepatitis A and B!