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Update on Hepatitis C
Sally Williams MD
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 10th leading cause of death in U.S., most are Hep C positive This should change with new medications
Hepatitis C Around the World
Risk Factors for the Acquisition of Hepatitis C
IV drug use by far the most common
Blood product transfusion prior to 1992
10% 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
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
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
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 30-40 years. Hep C is NEVER an emergency
Everything has changed with new medications, expect almost no deaths in future
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.
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.
Stages of Liver Disease
Inflammation
Fibrosis
Compensated cirrhosis (normal albumin and bilirubin)
Decompensated cirrhosis (liver failure)
Cirrhosis is stage 4, anything else is fibrosis
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.
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
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
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)
History of Hep C Treatments
1991 Alfa interferon daily
1996 3x/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 1
2013 Sofosbuvir and simeprevir approved
2014 Harvoni and Viekira approved
The breakthroughs
The new meds
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
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%)
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
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
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
Don’t forget to test for Hepatitis A and B!
