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David Bernstein MD:
The preparation of a patient for treatment for chronic hepatitis C is
a long process. It begins with education, explaining to the patient how
this disease is transmitted, what the long-term progression may be and
then a long discussion about the risk-benefits of liver biopsy.
Rajender Reddy MD:
There are some basic, fundamental tests that we need to do prior to initiating
therapy. One is, we would get a CBC with platelet count. We would get
a liver profile. You would want to make sure that you have a baseline
thyroid function test, because some of the patients may have thyroid abnormalities
on therapy, so you would need to monitor those with investigations. You
would like to have a quantitative HCV-RNA and an HCV genotype in these
patients.
Robert Brown MD:
Liver biopsy is not mandatory prior to antiviral therapy. But I think
it's strongly recommended for two reasons. One is this is a liver disease
and it's important to stage the liver disease and to define the prognosis
for the patient for purely medical grounds. Second, we have a treatment
strategy that does not work in all of the patients. It actually works
in only about half the patients. And it has side-effects that are not
insignificant. So in defining the risks and benefits of therapy, the benefits
are proportional to how severe the liver disease is. If we had a treatment
that you took for two weeks, like penicillin, we wouldn't need a liver
biopsy. But I think until we get to better therapies with fewer side-effects,
we do need to have a liver biopsy.
Rajender Reddy MD:
One could make an argument to treat a patient without a liver biopsy if
indeed your philosophy is that this is an infections disease and not a
liver disease alone.
So I would say that the role of liver biopsy at this time point is controversial.
One could make an argument for treating patients without a liver biopsy
and if they do respond and go on to have a sustained biologic response,
of course you have eliminated the need for a liver biopsy in those patients.
If they do not respond to therapy, you could consider doing a liver biopsy
to assess the severity of liver disease in those patients, and over time
plan their therapies with newer therapies coming down the road. For genotypes
2 and 3 patients, where the response rates are very high, you could clearly
make an argument for treating those patients without the need for a liver
biopsy.
David Bernstein MD:
A discussion is then had with the patient and his or her family
about treatment. That discussion includes what to expect from the treatment
as far as response rates. That discussion includes what to expect side-effect-wise
and also includes, most importantly, how the patient and/or their family
can get a hold of the physician or medical care provider in case there's
a problem.
Robert Brown MD:
The goals of antiviral therapy for hepatitis C primarily is to eliminate
the virus, the thought being no virus, no progression of the liver disease.
However, we have secondary goals of therapy.
Rajender Reddy MD:
By eradicating hepatitis C infection, one would hope that you would favorably
influence the natural history of chronic C hepatitis and that you would
prevent or slow down the progression of chronic C hepatitis. By doing
so, over the long run you hopefully prevent the dreaded complication of
cirrhosis and its complications and also decrease the frequency of development
of hepatocellular carcinoma.
What patients with hepatitis C are candidates for medical therapy?
Rajender Reddy MD:
The ideal candidate for therapy is someone who has chronic C hepatitis
as defined by a positive hepatitis C viral RNA and abnormal ALT, and has
histologic evidence of chronic hepatitis, and does not have decompensated
liver disease. Apart from the disease definition, one has to carefully
assess the patient for the presence of any comorbid conditions that might
contraindicate therapy. A history of depression has to be carefully assessed
before deciding on whether we should pursue therapy.
There are, however, some exceptions to the well-defined case of chronic
C hepatitis where treatment is still indicated. Let us take the example
of a patient with a normal ALT, particularly persistently normal ALT.
In these patients, one may consider doing a liver biopsy and if there
is severe histologic disease, treatment can be recommended, even if they
have a normal ALT. We however recognize that patients who have a persistently
normal ALT often have relatively mild disease and thus these patients
may not be in need of therapy particularly on an urgent basis.
Another example where therapy is indicated, regardless of the severity
of liver disease, is a patient who is in the health care environment where
there is a concern of transmission of infection in that environment. Regardless
of the severity of liver disease, such patients can be considered for
therapy, in fact, should be considered for therapy.
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