Sj. Cotler et al., Pretreatment symptoms and dosing regimen predict side-effects of interferon therapy for hepatitis C, J VIRAL HEP, 7(3), 2000, pp. 211-217
We analysed data from a multicentre interferon (IFN) treatment trial to eva
luate symptoms in patients with chronic hepatitis C and to identify factors
that might predict development of debilitating IFN side-effects. Two hundr
ed and twenty-two patients (120 US, 102 French) received 3 or 5 million uni
ts (MU) of IFN-alpha three times weekly (t.i.w.) for 3 months. Those who ha
d detectable hepatitis C virus (HCV) RNA, as detected by the branched DNA s
ignal amplification (bDNA) assay, at 3 months were intensified to daily the
rapy, while patients who were bDNA negative continued t.i.w. dosing for the
subsequent 3 months of treatment. Symptoms were assessed at baseline, and
adverse effects were evaluated at 6 months of therapy. Prior to treatment,
the most common symptom that interfered with daily functioning was fatigue,
occurring in 25% of patients. The frequency of debilitating fatigue, myalg
ia, arthralgia, headache, the presence of dry eyes and dry mouth, and use o
f antidepressant medication increased significantly from baseline to 6 mont
hs of IFN therapy (all P < 0.01). In multivariate analysis, the development
of a debilitating side-effect at 6 months of treatment was associated with
the presence of that symptom prior to therapy in all cases. Symptoms and a
dverse effects varied by gender and country. Compared with patients maintai
ned on t.i.w. dosing, those who were dose intensified to daily IFN reported
more debilitating fatigue, malaise, myalgia, arthralgia, fever, nausea, an
d headache, and the presence of dry mouth (all P < 0.05). In conclusion, pa
tient characteristics, including pretreatment symptoms, gender and national
ity, as well as daily IFN dosing are associated with the development of deb
ilitating adverse effects on IFN therapy.