Weight-based ribavirin during pegylated interferon-alpha therapy increased the likelihood of moderate to severe depressive symptoms compared to standard dose (OR 2.7; 95% CI 1.3-5.6; P<0.01).
RCT (n=162)
Does weight-based ribavirin compared to standard dose ribavirin increase depressive symptoms in HCV-infected patients treated with pegylated IFN alpha-2b?
Weight-based ribavirin dosing and baseline depression scores predict the development of moderate to severe depressive symptoms during HCV treatment with pegylated interferon-alpha.
Odds Ratio: 2.7 (95% CI 1.3–5.6)
p-value: p=<0.01
BACKGROUND: Interferon-alpha (IFN-alpha) plus ribavirin is used to treat hepatitis C virus (HCV) infection and is associated with a high rate of depression. Newer, pegylated preparations of IFN-alpha have a longer half-life, require once-per-week dosing, and may be associated with reduced neuropsychiatric burden. Limited data exist on depression during pegylated IFN-alpha therapy. METHOD: Depressive symptoms were assessed using the Zung Self-Rating Depression Scale (SDS) in 162 HCV-infected patients at baseline and after 4, 8, 12, and 24 weeks of treatment with pegylated IFN alpha-2b (PEG IFN) plus weight-based (N = 86) versus standard dose (N = 76) ribavirin. Data were collected from March 2001 to April 2003. RESULTS: Compared with baseline, mean SDS index scores were significantly increased by week 4 and remained elevated throughout the study. Thirty-nine percent of the sample experienced moderate to severe depressive symptoms (SDS index score > or = 60) at some point during PEG IFN/ribavirin therapy. Baseline depression scores significantly predicted severity of depressive symptoms during PEG IFN/ribavirin treatment (simple regression analysis: Y = 0.55X + 32.7, p < .0001). In addition, assignment to weight-based ribavirin treatment and history of depression were associated with increased likelihood of developing moderate to severe depressive symptoms (odds ratio OR = 2.7, 95% CI = 1.3 to 5.6, p < .01, and OR = 3.3, 95% CI = 1.3 to 8.1, p < .01, respectively). CONCLUSIONS: Development of moderate to severe depressive symptoms occurred frequently during PEG IFN/ribavirin treatment and was predicted by baseline depression scores and higher doses of ribavirin. History of major depressive disorder was also a significant predictive factor, but only through association with elevated baseline depression status. All of these factors can be evaluated and addressed to limit neuropsychiatric morbidity during HCV treatment.
Raison et al. (Sat,) conducted a rct in Hepatitis C virus (HCV) infection (n=162). Weight-based ribavirin plus pegylated IFN alpha-2b vs. Standard dose ribavirin plus pegylated IFN alpha-2b was evaluated on Development of moderate to severe depressive symptoms (SDS index score ≥ 60) (OR 2.7, 95% CI 1.3-5.6, p=<0.01). Weight-based ribavirin during pegylated interferon-alpha therapy increased the likelihood of moderate to severe depressive symptoms compared to standard dose (OR 2.7; 95% CI 1.3-5.6; P<0.01).