An intensive initial course of interferon therapy
provides the best clearance of hepatitis C virus from the blood in
patients with chronic infection. In a study of different doses and
schedules of administration of interferon alfacon-1 (Infergen,
Amgen), "induction therapy" with 15 mcg daily provided the greatest
reduction in virus at week 4. Patients with either high or low
baseline viral titers benefited.
No ideal treatment yet exists for chronic HCV infection, and
treatment failure is a common outcome. While longer duration and
combination therapy including ribavirin have helped to some degree,
better treatment options are needed, especially to improve the
initial response rates.
At the November meeting of the American Association for the
Study of Liver Diseases, Paul Pockros, M.D., head of the
Gastroenterology Division at Scripps Clinic in La Jolla, California
presented early results on 169 patients in his ongoing multi-center
trial to see if induction therapy could improve the early virologic
response without causing substantial side effects.
These treatment-naïve patients were stratified into two
groups according to baseline HCV RNA levels: less than or equal to
106 copies/ml, and greater than 106 copies/ml. They received one of
five, 4-week interferon alfacon-1 dosing regimens: 7.5 mcg twice a
day; 15 mcg once daily; 15 mcg three times a week; 9 mcg once
daily; and 9 mcg three times a week. After the 4-week induction
period at one of these doses, all patients received 44 weeks of 9
mcg interferon alfacon-1 three times a week, followed by 24 weeks
The greatest reduction in HCV RNA levels at the end of the
four-week induction period occurred in the patients who received 15
mcg daily, for patients with high or low baseline viral levels.
At week 4, once or twice daily induction therapy, as well as 15
mcg TIW, resulted in undetectable HCV RNA in 25-29% of patients who
started out with high baseline viral titers. For patients with low
baseline titers, once or twice daily induction therapy produced
undetectable virus in 64-78% of the patients in the groups at week
A twice daily dose of 7.5 mcg appeared to produce less viral
suppression than did 15 mcg once a day when measured at the end of
the induction period for the high viral baseline patients. However,
this difference was not statistically significant.
Patients tolerated induction with 15 mcg once a day well. But
7.5 mcg twice daily caused almost three times the need for dose
reductions and twice the number of drug discontinuations during the
induction period compared to 15 mcg once a day. The reason for this
finding was not apparent, considering the total daily dose is the
Induction dosing with 15 mcg of interferon alfacon-1 once a day
appeared to be best at reducing viral levels, according to the
interim results of this study. "I think this was a well tolerated
regimen," Dr. Pockros said. "I think the key take home lesson here
is that patients can handle the daily dosing. It's a reasonable
approach to treatment."
Looking ahead, the study suggests that combining strategies to
treat HCV infection may prove useful. "I think the real clinical
implication will be that induction dosing may be the correct
strategy when you combine this drug with ribavirin," Dr. Pockros
suggested. "And that trial is being initiated right now, where
we're using induction dosing at 9 mcg daily plus ribavirin." His
thought is that ribavirin may help reduce the rate of relapse when
added to an induction regimen using interferon alfacon-1.
Reports of Dr. Pockros' study and several others from the AASLD
meeting are available at Med Onscene at http://www.medonscene.com.
The site offers health professionals the opportunity to earn
continuing medical, nursing, or pharmacy education credits by
completing the educational activity in liver disease.
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