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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* |
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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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