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題名 | A Pilot Study of Add-on Oral Hypoglycemic Agents in Treatment-Naïve Genotype-1 Chronic Hepatitis C Patients Receiving Peginterferon Alfa-2b Plus Ribavirin= |
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作者 | Hsu, Ching-sheng; Hsu, Shih-jer; Lin, Hans hsienhong; Tseng, Tai-chung; Wang, Chia-chi; Chen, Ding-shinn; Kao, Jia-horng; |
期刊 | Journal of the Formosan Medical Association |
出版日期 | 20141000 |
卷期 | 113:10 2014.10[民103.10] |
頁次 | 頁716-721 |
分類號 | 415.533 |
語文 | eng |
關鍵詞 | Hepatitis C virus; Insulin resistance; Oral hypoglycemic agents; Pegylated interferon; Randomized controlled trial; Sustained virological response; |
英文摘要 | Background/Purpose: Insulin resistance (IR) affects sustained virological response (SVR) to peginterferon alfa plus ribavirin (PR) in patients with chronic hepatitis C (CHC). Whether add-on oral hypoglycemic agents (OHAs) to PR improve SVR remains unclear; therefore, we conducted a prospective, randomized pilot trial on 23 consecutive patients with genotype 1 CHC and IR in Taiwan. Methods: Patients were randomized to receive acarbose (Arm A; n = 7) or metformin (Arm B; n = 6) or pioglitazone (Arm C; n = 5) in addition to peginterferon alfa-2b (1.5 μg/kg/week) plus ribavirin (1000–1200 mg/day) or just PR (Arm D; n = 5). The primary end point was SVR, and secondary end points were viral clearance at Weeks 17, 29, and 53. There were no differences among all arms at baseline. Results: Using intent-to-treat analysis, SVR was observed in 66.7% (4/6), 83.3% (5/6), 66.7% (4/6), and 60% (3/5) in Arms A, B, C, and D, respectively. SVR was higher in female patients receiving OHA [90% (9/10)] than in male patients [50% (4/8)]. Results of per protocol analysis showed that SVR was 80.0% (4/5) in Arm A, 100% (5/5) in Arm B, 66.7% (4/6) in Arm C, and 60% (3/5) in Arm D. Patients receiving OHA had a higher rapid virologic response: 11/18 (61%) versus 2/5 (40%). Complete early virologic response was comparable between patients receiving OHA and PR [15/18 (83%) vs. 4/5 (80%)]. Conclusion: Our preliminary data show add-on OHAs to PR might achieve better early viral kinetics and SVR. However, further larger studies are needed to confirm these findings. |
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