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Impact of body weight reduction via diet and exercise on the anti-viral effects of pegylated interferon plus ribavirin in chronic hepatitis C patients with insulin resistance: a randomized controlled pilot trial
Iwane S, Mizuta T, Kawaguchi Y, Takahashi H, Oza N, Oeda S, Nakashita S, Kuwashiro T, Otsuka T, Kawazoe S, Eguchi Y, Anzai K, Ozaki I, Fujimoto K
Internal Medicine 2015 Dec;54(24):3113-3119
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Insulin resistance (IR) modifies the anti-viral effects of interferon (IFN) therapy in patients with chronic hepatitis C (CHC). This prospective study evaluated whether lifestyle interventions improve the antiviral response to treatment with pegylated (PEG)-IFN plus ribavirin (RBV) in patients with CHC. METHODS: The study cohort consisted of 60 patients chronically infected with a high viral load of hepatitis C virus genotype 1b and a homeostasis model assessment of IR (HOMA-IR) value above 2. The patients were divided into two groups, an intervention group (n = 26) and a control group (n = 34). The patients in the intervention group were prescribed diet and exercise treatment for 3 to 6 months to reduce their body weight by > 5% before starting treatment with PEG-IFN plus RBV. RESULTS: Diet and exercise significantly reduced the HOMA-IR values in the intervention group, from 3.4 to 2.5 (p = 0.0009), especially among the 15 patients who achieved a body weight reduction of > 5%. The viral disappearance rate at 12 weeks was significantly higher in the intervention group among the patients with a > 5% weight reduction than in the control group (53.3% versus 23.5%, p = 0.01). However, the sustained viral response (SVR) rates were similar. CONCLUSION: Improvements in IR achieved through weight reduction via lifestyle interventions may enhance the early viral response to PEG-IFN plus RBV in patients with CHC. However, this intervention program has no effect on the SVR rate.

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