what every PCP needs to know about Hepatitis C_Dr. Paul Pinto

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Hepatitis-CWhat to Know in 2014

Clinical Presenter: Paul C. Pinto, MD

Southern Colorado GI Health and Wellness Summit & CME Event – February 22nd, 2014

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

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


Associates, PC

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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


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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)


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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


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Advice and education for the Hepatitis C-infected 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


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Copyright (c) 2014 Paul C. Pinto, MD | Peak Gastroenterology Associates, PC

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


Antiviral treatment of Hepatitis C-Historical 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%


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

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 20546533Copyright (c) 2014 Paul C. Pinto,

MD | Peak Gastroenterology Associates, PC

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


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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 65% Rash, anemia-both can be severe24-48 weeks Drug-Drug interactions extensive

Pill burden-fat required with meds

Boceprevir/PIFN/R 60% Anemia-can be severe32-48 weeks Many Drug-Drug interactions

Sofosbuvir/PIFN/R 80% Untested in previously treated patients12 weeks Low pill burden

Side effects similar to PIFN/R alone

Simeprevir/PIFN/R 70-80% Tested in previously treated patients24-48 weeks Low pill burden

Few side effects over PIFN/R alone


Associates, PC

Treatment of Genotypes 2 and 3 Hepatitis C-2014

Genotype 2: Sofosbuvir/Ribavirin for 12-16 weeks

Clinical Parameters Response Rate

Treatment naïve 97%Naive with cirrhosis 83%Non-naïve 90%Non-naive with cirrhosis 60%*

Genotype 3: Sofosbuvir/Ribavirin for 16-24 weeks

Naïve 93% Non-naïve 85%Naive with cirrhosis 92% (12 pts)Non-naive with cirrhosis 60% (24

pts)*

*may do better with a regimen that includes pegylated interferon

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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 themCopyright (c) 2014 Paul C. Pinto,

MD | Peak Gastroenterology Associates, PC

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.


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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)


Associates, PC


Thank you!

We are available to assist you!

Peak Gastroenterology Associates, PC719-636-1201

www.peakgastro.com

what every PCP needs to know about Hepatitis C_Dr. Paul Pinto

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