Fatigue Adversely Affects Virologic Response to Peginterferon Plus Ribavirin

Researchers at Emory University in Atlanta, GA, King’s College London and Weill Medical College of Cornell in New York City evaluated fatigue and other factors relevant to treatment outcome in 98 HCV patients undergoing therapy with pegylated IFN-alfa-2b (PEG IFN) [PegIntron] plus ribavirin.

Results

• PEG IFN plus ribavirin resulted in severe and persistent fatigue as assessed by the Chalder Fatigue Questionnaire (CFQ).
• Sixty-five percent of patients exhibited a moderate to severe increase in fatigue (as defined by a ¡Ý5 point increase in the CFQ) during treatment.
• Patients who exhibited a ¡Ý3 g/dl decrease in hemoglobin (Hb) concentration were significantly more likely to experience a moderate or severe increase in fatigue and were significantly more likely to undergo ribavirin dosage reduction.
• At study conclusion, 59% of the patients were HCV RNA negative.
• Increasing fatigue was associated with reduced rates of being HCV RNA negative after 24 weeks of treatment.
• Mild, moderate and severe increases in CFQ scores were respectively associated with a 79%, 56% and 40% rate of being HCV RNA negative at 24 weeks.
• A moderate or severe increase in fatigue was associated with a greater likelihood of being HCV RNA positive after 24 weeks of treatment, even after controlling for other factors that predicted 24 week HCV RNA status, including viral genotype, PEG IFN and/or ribavirin dosage reduction, and race.
• Moreover, patients who were HCV RNA positive after 24 weeks of treatment had significantly greater increases in fatigue during therapy than patients who were HCV RNA negative. This represents a 40% greater delta CFQ score in HCV RNA positive patients than in patients who were HCV RNA negative at 24 weeks.
• HCV RNA positive patients also had a higher mean maximum CFQ score during treatment than patients who cleared virus.
• No relationship was observed between baseline (pre-treatment) fatigue and HCV RNA status at 24 weeks.

In conclusion, the study authors write, “The development of fatigue is common during IFN-alfa therapy and is related in part to decreases in Hb concentration.”

“In addition, fatigue appears to have an independent relationship with HCV RNA status at 24 weeks, suggesting a shared pathophysiologic pathway between the development of fatigue and treatment on response.”

11/21/05

Reference
C  L Raison and others. The association of fatigue with poor virologic response in patients receiving interferon alpha plus ribavirin for the treatment of hepatitis C. Abstract 1216. Abstracts of the 56^th annual meeting of the American Association for the Study of Liver Diseases (56^th AASLD). November 11-15, 2005. San Francisco, CA.