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what every PCP needs to know about Hepatitis C_Dr. Paul Pinto
1. Copyright (c) 2014 Paul C.
Pinto, MD | Peak
Gastroenterology Associates,
PC
Hepatitis-C
What to Know in 2014
Clinical Presenter: Paul C. Pinto, MD
Southern Colorado GI Health and Wellness Summit & CME Event – February 22nd, 2014
2. Why should I care about Hepatitis C?
Hepatitis C affects 3 million Americans
It accounts for 40% of chronic liver disease in the US
HCV-cirrhosis is the leading indication for liver
transplantation
It disproportionately affects African-Americans and Latinos
We CAN cure this infection in most individuals
We will be caring for more patients cured of the infection
who have advanced fibrosis-they still need us!
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
3. Most persons infected with Hepatitis C
are Baby Boomers
75% of those infected were born between 1945 and 1965
Persons with these years of birth should be screened once for
hepatitis C with an HCV-antibody test regardless of risk
factors
Continue to screen high risk individuals
A positive antibody test usually means chronic infection
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
4. Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
5. Natural history of Hepatitis C progression
100 infections--80% (80) become chronic
25% of the 80 (20) will develop cirrhosis (tell them this)
5 will require transplant or die from liver disease
Cirrhosis may not end life due to death from other causes
Most who spontaneously clear infection do so early, leaving
them with little liver damage
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
6. Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
7. Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
8. How to test for Hepatitis C
ELISA or other test for antibodies against
Hepatitis C
• Antibody Positive---> Perform HCV-RNA
• Antibody Negative---> No further testing
required
(caveat: a negative antibody test can miss
acute infection)
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
9. What to tell a patient who is both antibody
and RNA positive
Chronic infection is likely, and it will not resolve
spontaneously (< 1%)
Blood is infectious; take steps to prevent
transmission
Tell them the infection is curable in most
persons
Help them remain positive-discuss steps to stay
healthy
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
10. Advice and education for the Hepatitis Cinfected individual
Limit alcohol consumption-it is synergistic with
hepatitis C
Achieve normal body weight and control diabetes
Limit marijuana use-it worsens hepatic fibrosis
Stop smoking-it increases risk of liver cancer
Get a HIV test done – co-infection worsens hepatitis C
outcomes
Get vaccinated against hepatitis A and B
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
11. Commonly used medications-The
relationship to Hepatitis C
Acetaminophen
limit to 2,000 mg per day
NSAIDs - avoid in advanced liver disease
idiosyncratic hepatotoxicity (uncommon)
renal dysfunction (common)
Statins - Acceptable in patients with compensated cirrhosis, and
stable liver disease-may improve response to antivirals
Opiates and sedative-hypnotics
Do not worsen liver disease, but their clearance is slowed by liver
disease-start with lower dose, increase slowly
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
12. Antiviral treatment of Hepatitis CHistorical perspective
Drug-year first in use
Response-genotype 1
Interferon alfa-1991
15%
Interferon alfa and ribavirin-1998
25%
Pegylated Interferon & Ribavirin-200
40%
PIFN/R/Telaprevir or Boceprevir-2011
60%
PIFN/R/sofosbuvir-2013
70-80%
PIFN/R/simeprevir-2013
80%
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
13. Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
14. Eradication of Hepatitis C saves lives
• Data from the HALT-C Trial-patients with advanced fibrosis*
• Followed for 7.5 years after completion of PIFN/R treatment
140 patients who cleared virus
Death or transplant in 2.2%
309 patients who did NOT clear virus
Death or transplant in 21.3%
*Morgan TR; PMID 20364351
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
15. Eradication of Hepatitis C helps prevent liver
cancer
307 French patients with advanced fibrosis treated with
PIFN/R*
Patients followed for an average of 3.5 years after treatment
completion
Incidence of Liver Cancer per 100-person years
Those cured of infection
1.24
Those NOT cured of infection
5.85
*Cardoso, et al. PMID 20546533
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
16. Treatment of Hepatitis C may help
Hepatitis C comorbidities
Fatigue - in a study of 431 patients, 59% of which had fatigue
at baseline-fatigue improved in 35% of responders, and 22%
of non-responders*
Little Data in the following conditions-consider treatment
Mixed Cryoglobulinemia - and renal disease
Porphyria Cutanea Tarda
Leucocytoclastic Vasculitis
Necrolytic Acral Erythema
*Cacoub P; J Hepatol: 2002; 36(6):812
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
17. Regimens for Genotype 1 Hepatitis C in
2014
All Regimens are given with Pegylated Interferon and Ribavirin
Regimen
Best Response
Clinical Issues
Telaprevir/PIFN/R
24-48 weeks
65%
Rash, anemia-both can be severe
Drug-Drug interactions extensive
Pill burden-fat required with meds
Boceprevir/PIFN/R
32-48 weeks
60%
Anemia-can be severe
Many Drug-Drug interactions
Sofosbuvir/PIFN/R
12 weeks
80%
Untested in previously treated patients
Low pill burden
Side effects similar to PIFN/R alone
Simeprevir/PIFN/R
24-48 weeks
70-80%
Tested in previously treated patients
Low pill burden
Few side effects over PIFN/R alone
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
18. Treatment of Genotypes 2 and 3
Hepatitis C-2014
Sofosbuvir/Ribavirin for 12-16 weeks
Clinical Parameters
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
Genotype 2:
Response Rate
Treatment naïve
Naive with cirrhosis
Non-naïve
Non-naive with cirrhosis
97%
83%
90%
60%*
Genotype 3:
Sofosbuvir/Ribavirin for 16-24 weeks
Naïve
Non-naïve
Naive with cirrhosis
Non-naive with cirrhosis
93%
85%
92% (12 pts)
60% (24 pts)*
*may do better with a regimen that includes pegylated interferon
19. How to help someone taking Hepatitis C
treatment
Fatigue-remain active both mentally and physically; consider interferon dose
decrease if severe
Anemia -do not prescribe iron or vitamins-they will not work; consider dose
modifications of ribavirin and/or interferon
Depression - treat as usual with SSRI or SNRI agents; avoid St John's Wort
If depression occurred on previous treatment, begin antidepressant with the
antiviral treatment; Involve psychiatrist if concerned
Any new medication should be reviewed for drug-drug interactions
Discuss avoidance of pregnancy in both women and men who are on treatment
Remind them to comply with laboratory tests needed on therapy-these help us
help them
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
20. Exactly what do we mean by “Cure”?
In clinical trials of hepatitis C treatment, cure means that HCV-RNA is non-
detectable in the serum when performed by an assay that can detect as few as 25
IU/ml of virus, 24 weeks after completion of treatment.
The chance that the virus will return after this is less than 1% per year.
I personally stop testing for virus recurrence after two years of treatment
completion.
Hepatitis C is the ONLY curable chronic viral infection in 2014. It is the speaker's
experience that patients will frequently refer to themselves being in "remission"
after a course of therapy, regardless of viral test results. This term should not be
used in hepatitis C-you are either cured, or not-period.
Avoiding vague terms may help those with persistent infection return for re-
treatment-speaker's opinion.
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
21. What do we do after a patient is cured of
Hepatitis C?
Test for thyroid disorders six months after treatment completion-
(hypothyroidism may occur)
Wean off antidepressants as appropriate
Repeat HCV-RNA one and two years after treatment completion
Confirm that HIV testing as well as Hepatitis A and B vaccination
are completed
Screen those with advanced fibrosis as follows:
--for esophageal varices, with every two year upper endoscopy
--for liver cancer with every six month imaging (US or TP-CT)
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC
22. Thank you!
We are available to assist you!
Peak Gastroenterology Associates, PC
719-636-1201
www.peakgastro.com
Copyright (c) 2014 Paul C. Pinto, MD | Peak
Gastroenterology Associates, PC