Treatment
with Low-dose Pegylated Interferon Alfa-2b (PegIntron) Did Not Adversely Affect
Quality of Life over a 2-year Period in Patients Staying on Therapy: The COPILOT
Trial Quality of life (QOL) is critical for
the utilization of long-term maintenance therapies. The aims of the current study,
presented at the 58th Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD) in Boston,
were to evaluate baseline QOL in patients with advanced liver fibrosis and changes
with pegylated interferon versus colchicine. Given the side effects associated with
standard doses of pegylated interferon, it is unclear
whether lower-dose maintenance therapy would improve or impair QOL. 475 non-responder patients with advanced
chronic hepatitis C refractory to treatment with conventional
interferon with or without ribavirin were randomized
to receive 0.5 mcg/kg once-weekly pegylated interferon
alfa 2b (PegIntron) or 0.6
mg twice-daily oral colchicine. QOL was assessed by
administering the Medical Outcome Trust’s
SF-36 survey annually throughout the study. Responses were scored using the norm-based
scoring approach, where 50 is the mean for the general population and 10 is the
standard deviation. All demographic variables including
age, sex, duration of disease, liver histology, HCV viral load, biochemical tests,
and Child Pugh classification were comparable
between the 2 groups. Mental Component Summary (MCS) scores and Physical Component
Summary (PCS) scores were calculated for each of the 2 groups at baseline, 48
weeks, and 96 weeks. Mean MCS and PCS scores were not significantly different
between the study groups at baseline. Results
- QOL was relatively stable in the 2 groups, with
no statistically significant change between baseline and week 96.
- Mixed procedure analysis revealed a statistically
significant effect of treatment assignment only on MCS score (P = 0.02) at week
48 in the colchicine group; however, values returned
to baseline by week 96.
- The actual difference in score was a modest 4-point
reduction in MCS.
- There was no significant effect of treatment assignment
on PCS over time in either group (P = 0.16).
Conclusion In conclusion, the investigators wrote,
“Surprisingly, cirrhotic patients were not more than 1 standard deviation below
the normal population in either MCS or PCS at baseline.” “Treatment with low-dose pegylated interferon did not adversely affect QOL over a 2-year
period in patients staying on therapy, suggesting that it can be tolerated as
a maintenance therapy.” Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston,
MA; Division of Digestive and Liver Diseases, Columbia-Presbyterian Medical Center,
New York, NY; SUNY Upstate Medical University, Syracuse, NY; Kansas City Gastroenterology,
Kansas City, MO. 11/16/07 Reference
MB Shah, RS Brown, T Barski, and others. Tolerability of Low-Dose Peginterferon
alfa-2b in Hepatitis C Patients with Cirrhosis: Results from the COPILOT Trial.
58th Annual Meeting of the American Association for the Study
of Liver Diseases. Boston.
November 2-6, 2007. Abstract (poster) 1322. | 
