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Ask the Experts: What is your approach to the treatment-naive hepatitis C patient with high viral load and persistently normal ALT levels for 9 years?

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  • claudine intexas
    From Medscape/Gastroenterology Ask the Experts on . . . What Is Your Approach to the Treatment-Naive Hepatitis C Patient With High Viral Load and Persistently
    Message 1 of 1 , Dec 4, 2000
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      From Medscape/Gastroenterology

      Ask the Experts on . . .
      What Is Your Approach to the Treatment-Naive Hepatitis
      C Patient With High
      Viral Load and Persistently Normal ALT Levels for 9
      Years?
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      Question
      A 47-year-old white woman has had hepatitis C with
      persistently normal
      alanine aminotransferase (ALT) levels for 9 years. She
      is treatment-naive and
      has a viral load of 11,680,000. Hepatitis C virus
      genotype is unknown. The
      patient was an alcoholic until 1 year ago. What is the
      best way to proceed:
      (1) liver biopsy; (2) combination therapy with
      interferon plus ribavirin; or
      (3) employ watchful waiting?

      Response
      from Luis Balart, MD, 11/28/00
      A patient with persistently normal ALT levels
      (arbitrarily defined as normal
      levels on at least 3 separate occasions, 6 weeks
      apart, for a period of 6
      months) presents a difficult challenge, that at
      present, does not have an
      easy answer.
      First, to address the specifics of this case:

      The patient is said to be an alcoholic, and this would
      make it less likely --
      but not impossible -- that she would have persistently
      normal ALT levels,
      because it is well known that those who drink
      excessively have more active
      enzymes and frequently normalize enzymes if abstinent.
      Alcohol is also known
      to be associated with higher viral loads, and this is
      the case with this
      patient, who has a high viral load at 11 million.
      Excessive alcohol intake
      over more than 5 years has also been shown to lead to
      cirrhosis 3 times more
      frequently than in patients who do not drink or who
      drink modestly. The time
      to develop cirrhosis in excessive drinkers is also
      markedly less, averaging
      12-13 years, compared with 22-25 years in those who do
      not drink or who have
      moderate alcohol intake.

      In our own study of over 300 patients, we found that
      approximately 17% met
      criteria for persistently normal ALT. The overwhelming
      majority of these
      patients were women who did not drink and who were
      otherwise well. Most of
      these patients, when biopsied, had mild histology
      (grade 1 or 2 inflammation;
      stage 0 or 1 fibrosis), but a few had more advanced
      disease, and some were
      even found to have cirrhosis. Therefore, one cannot
      dismiss these patients as
      mild without some thought being given to the situation
      and perhaps even doing
      a liver biopsy, depending on the circumstances.

      In our experience as well as others, patients with
      persistently normal ALT
      levels seem to respond less well to interferon
      monotherapy. Thus, the
      majority of these patients are not routinely treated.
      With the advent of
      combination therapy, initial unpublished reports have
      shown that these
      patients respond in a manner similar to patients with
      elevated ALT levels,
      and this finding has once again rekindled the interest
      in treating this
      population. Many believe that these patients are no
      different than any other
      patient who has chronic hepatitis C and that the
      reason their ALT levels are
      normal is because most of this population are women
      whose ALT normal values
      should be lower anyway. In fact, there is at least one
      publication showing
      that if these patients are followed long enough, ALT
      levels will eventually
      become abnormal in a high proportion of cases.

      My approach to this patient group, as it would be for
      any patient with
      chronic hepatitis C, is to individualize the strategy.
      Some of these patients
      are young, well informed, and strongly desire
      treatment, and should be given
      the chance to cure their infection (particularly if
      they are infected with
      genotype non-1 virus). Others may understand their
      problem well, but choose
      to delay therapy until more effective or easier
      regimens are available. This
      option is acceptable if the histology is mild and the
      patient understands and
      accepts the need for long-term follow-up, including
      the need for repeat liver
      biopsy.

      In the specific case at hand, I would recommend first
      to do genotype
      determination and a liver biopsy. I would be concerned
      that, because of the
      history of excessive alcohol use, there may be more
      severe fibrosis --
      perhaps even cirrhosis -- already present. Second, I
      would make sure that the
      patient is truly abstinent and require either her
      attendance at a support
      group or other proof of this.

      If the histology proved to be mild, I would present
      the facts to the patient,
      weigh the pros and cons of therapy, and allow the
      patient to play a large
      role in the decision of whether to treat or not to
      treat. If the patient had
      a non-1 genotype infection, this may persuade me to
      recommend treatment, even
      in the face of mild histology. On the other hand, if
      the histology proved to
      be more severe with stage 3 or 4 fibrosis, I would
      strongly advise treatment
      as soon as possible, regardless of genotype.


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