A new study questions the current hepatitis treatment
recommendations in some cases for patients with hepatitis C.

The current standard treatment for hepatitis is a combination of
pegylated (PEG) interferon and ribavirin, an antiviral drug. While
interferon can be used alone (monotherapy), the combination therapy
is currently the treatment of choice.(1)

Hepatitis C Treatment Criteria
At present, the optimal course of treatment appears to be a 24 or 48-
week regimen, depending on the strain of virus that a particular
patient carries. For those with genotype 1, the most common strain
in the U.S., yet most difficult to treat, a 48-week course of
treatment typically results in a higher sustained virological
response (SVR). That's the medical definition for undetectable
levels of virus in your bloodstream for at least six months after
the conclusion of therapy.(2)

It's estimated that as many as 70 to 80 percent of patients with
genotypes 2 or 3 are able to clear the virus, so medical experts
recommend a 24-week course of treatment for this group, which can
generally result in a similar outcome.(2)

There has also been a consensus that doctors may discontinue therapy
at 24 weeks for patients who are not responding to treatment because
they will likely continue to be unsuccessful.(3)

Halting Treatment Earlier?
However, a recent study by a group of German doctors claims
interferon combination therapy can be discontinued as early as 12
weeks if patients are not responding.(4)

The research, headed by Thomas Berg, M.D., a professor of hepatology
and gastroenterology at Homboldt-Universitat in Berlin, analyzed
treatment outcomes in a group of 260 patients who had used standard
or pegylated interferon alfa and ribavirin for 24 or 48 weeks.

They found that a certain viral level at weeks 4 and 12 "was 100
percent predictive for virologic nonresponse in all patients."

Independent predictors of a likely SVR were patients with genotypes
2 and 3, initial low levels of a liver enzyme known as gamma-
glutamyltransferase, high initial levels of a liver enzyme known as
alanine aminotransferase (ALT), and lower levels of virus at the
start of treatment.

Higher levels of both gamma-glutamyltransferase and ALT can be
indicative of liver disease, according to experts.

"In conclusion, virologic nonresponse can be predicted early at week
12 of treatment independent from the applied therapeutic regimen" in
about half of the patients studied, wrote the German researchers. In
other words, 53 percent of patients who ended treatment at week 24
could have safely ended it at week 12 instead.

'Desirable' Treatment Strategy
In commenting on the study, Kenneth D. Flora, M.D., an associate
professor of gastroenterology at Oregon Health Sciences University
in Portland, wrote that identifying patients who are likely to be
long-term nonresponders to treatment earlier is "desirable given the
expense and serious side effects associated with this treatment
regimen."(5)

Using the Proper Diagnostic Tool
In an earlier, related study, doctors at Huntington Memorial
Hospital in Pasadena, California also concurred that therapy
nonresponders could be taken off treatment as early as week 12, but
point out that it's important to use the correct diagnostic indicator
(6).

The doctors assessed therapy outcomes in 103 patients with hepatitis
C. They found that using higher levels of ALT as a basis for non-
response to treatment at week 12 was accurate 92 percent of the
time, yet misidentified a third of those patients who had wound up
clearing the virus after 48 weeks of therapy. By contrast, using HCV
antibody levels as a diagnostic indicator of therapy non-response
over the long-term was accurate 98 percent of the time, and was
wrong for only about 6 percent of patients, the investigators wrote.

"Thus positive [viral levels] at week 12 of therapy was more
accurate in identifying eventual virological nonresponders than
measurement of ALT at this time," they explained. "Termination of
interferon therapy in patients who were HCV positive at week 12
would result in a 27 percent reduction in the direct medical costs
and keep patients from undergoing unnecessary treatment."

1. Centers for Disease Control and Prevention.

2. National Digestive Diseases Information Clearinghouse. National
Institute of Diabetes & Digestive & Kidney Diseases (NIDDK). Chronic
Hepatitis C: Disease Management.

3. Schering-Plough Corporation. Frequently Asked Questions about PEG-
Intron..]

4. Berg T et al. Prediction of treatment outcome in patients with
chronic hepatitis C: a significance of baseline parameters and viral
dynamics during therapy. Hepatology 2003 Mar;37(3):600-9.

5. Flora KD. Can outcomes of interferon therapy be predicted after
12 weeks? Journal Watch Gastroenterology. 2003 Apr 29.

6. Tong MJ et al. Prediction of response during interferon alfa-2a
therapy in chronic hepatitis C patients using viral and biochemical
characteristics: a comparison. Hepatology 1997 Dec;26(6):1640-5.