In
an effort to reduce the side effects and cost of interferon-based
therapy, researchers have explored tailored regimens of varying durations.
The standard of care for patients with chronic genotype 2 or 3 hepatitis C virus
(HCV) infection is pegylated interferon plus
ribavirin for 24 weeks. Some data, however, suggest that shorter therapy may
be adequate for certain individuals.
As reported in the January 2008 issue
of Hepatology, researchers with the Scandinavian "North-C" trial
assessed a 14-week treatment regimen for rapid responder genotype 2 or 3 patients;
interim results were previously presented at the 42nd
EASL meeting in Barcelona this past April.
In a previous small, non-randomized
pilot trial, genotype 2/3 patients who achieved rapid virological response (RVR),
or undetectable HCV RNA after 4 weeks of pegylated
interferon plus ribavirin, had a 90% sustained virological response (SVR)
rate 6 months after completion of 14 weeks of treatment.
Based on these
findings, the investigators enrolled 428 treatment-naive genotype 2/3 patients
in a larger randomized, controlled trial. Most (65%) were men, the median age
was 38 years, about 20% had genotype 2, and about 80% had genotype 3.
•
302
patients (71%) achieved RVR, and 298 of these were randomized to 14-week (n =
148) or 24-week (n = 150) continued therapy.
•
In
an intent-to-treat analysis, SVR rates were 81.1% in the 14-week group and 90.7%
in the 24-week group (difference 9.6%; 95% CI 1.7-17.7).
•
Among
the subset of patients with an available HCV RNA test result 6 months after the
end of treatment, the corresponding SVR rates were 86.3% and 93.2% (difference
6.9%; 95% CI -0.1 to +13.9).
Conclusion
In
conclusion, the study authors wrote, "We cannot formally claim that 14 weeks
of treatment is non-inferior to 24 weeks of treatment."
However, they
added, "the SVR rate after 14 weeks of treatment is high, and although longer
treatment may give slightly better SVR, we believe economical savings and fewer
side effects make it rational to treat patients with genotype 2 or 3 and RVR for
only 14 weeks."
Infectious Disease Department, Ullevål University
Hospital, Oslo, Norway; Medical Department, Rikshospitalet, Oslo, Norway; Pharmaceutical
Institute, Rigshospitalet, Copenhagen, Denmark; Department of Gastroenterology,
Malmø University Hospital, Malmø, Sweden.
1/29/08
Reference O
Dalgard, K Bjøro, H Ring-Larsen, and others. Pegylated interferon alfa-2b
and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype
2 or 3 and rapid virological response. Hepatology 47(1): 35-42. January
2008.
