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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
| Department of Health, Executive Yuan, R.O.C. (Taiwan) | OTHER_GOV |
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Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.
Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) RNA levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% vs. 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. We aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peg-IFN + WB RBV for 16 weeks | Active Comparator | Weight-based ribavirin (1000-1200 mg/day) from weeks 1-16 in patients with RVR |
|
| Peg-IFN + LD RBV for 16 weeks | Active Comparator | Weight-based ribavirin (1000-1200 mg/day) from weeks 1-6, and then low dose ribavirin (800 mg/day) from weeks 6-16 in patients with RVR |
|
| Peg-IFN + WB RBV for 24 weeks | Active Comparator | Weight-based ribavirin (1000-1200 mg/day) from weeks 1-24 in patients without RVR |
|
| Peg-IFN + WB RBV for 48 weeks | Active Comparator | Weight-based ribavirin (1000-1200 mg/day) from weeks 1-48 in patients without RVR |
|
| Peg-IFN + LD RBV for 24 weeks | Active Comparator | Low dose ribavirin (800 mg/day) from weeks 1-24 in patients with or without RVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-IFN + WB RBV for 16 weeks | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic response (HR) | 1.5 year | |
| Biochemical response (BR) | 1.5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jia-Horng Kao, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Ding-Shinn Chen, MD | National Taiwan University Hospital | Principal Investigator |
| Ming-Yang Lai, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Pei-Jer Chen, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Chun-Jen Liu, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Chen-Hua Liu, MD | National Taiwan University Hospital | Principal Investigator |
| Shih-Jer Hsu, MD | National Taiwan University Hospital, Yun-Lin Branch | Principal Investigator |
| Chih-Lin Lin, MD | Taipei City Hospital, Ren-Ai Branch | Principal Investigator |
| Cheng-Chao Liang, MD | Far Eastern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | Douliu | Taiwan | ||||
| Kaohsiung Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11583749 | Background | Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5. | |
| 12324553 |
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| Peg-IFN + LD RBV for 16 weeks | Drug |
|
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| Peg-IFN + WB RBV for 24 weeks | Drug |
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| Peg-IFN + WB RBV for 48 weeks | Drug |
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| Peg-IFN + LD RBV for 24 weeks | Drug |
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|
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| Ching-Sheng Hsu, MD | Buddhist Xindian Tzu Chi General Hospital | Principal Investigator |
| Sheng-Shun Yang, MD | Taichung Veterans General Hospital | Principal Investigator |
| Chia-Chi Wang, MD | Buddhist Xindian Tzu Chi General Hospital | Principal Investigator |
| Tai-Chung Tseng, MD | Buddhist Xindian Tzu Chi General Hospital | Principal Investigator |
| Ming-Lung Yu, MD, PhD | Kaohsiung Medical University | Principal Investigator |
| Wan-Long Chuang, MD, PhD | Kaohsiung Medical University | Principal Investigator |
| Chia-Yen Dai, MD, Ms | Kaohsiung Municipal Hsiao-Kang Hospital | Principal Investigator |
| Jee-Fu Huang, MD | Kaohsiung Municipal Hsiao-Kang Hospital | Principal Investigator |
| Chang-Fu Chiu, MD | Paochien Hospital | Principal Investigator |
| Kaohsiung City |
| Taiwan |
| Kaohsiung Municipal Hsiao-Kang Hospital | Kaohsiung City | Taiwan |
| Paochien Hospital | Pingtung City | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Buddhist Xindian Tzu Chi General Hospital | Taipei | Taiwan |
| Far Eastern Memorial Hospital | Taipei | Taiwan |
| Ren-Ai Branch, Taipei Municipal Hospital | Taipei | Taiwan |
| Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047. |
| 14996676 | Background | Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010. |
| 15158341 | Background | Zeuzem S, Hultcrantz R, Bourliere M, Goeser T, Marcellin P, Sanchez-Tapias J, Sarrazin C, Harvey J, Brass C, Albrecht J. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. J Hepatol. 2004 Jun;40(6):993-9. doi: 10.1016/j.jhep.2004.02.007. |
| 17625124 | Background | Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403. |
| 15057920 | Background | Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available. |
| 15558712 | Background | Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467. |
| 16083709 | Background | von Wagner M, Huber M, Berg T, Hinrichsen H, Rasenack J, Heintges T, Bergk A, Bernsmeier C, Haussinger D, Herrmann E, Zeuzem S. Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology. 2005 Aug;129(2):522-7. doi: 10.1016/j.gastro.2005.05.008. |
| 15972867 | Background | Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608. |
| 16956917 | Background | Yu ML, Dai CY, Huang JF, Hou NJ, Lee LP, Hsieh MY, Chiu CF, Lin ZY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut. 2007 Apr;56(4):553-9. doi: 10.1136/gut.2006.102558. Epub 2006 Sep 6. |
| 26130141 | Derived | Liu CH, Huang CF, Liu CJ, Dai CY, Huang JF, Lin JW, Liang CC, Yang SS, Lin CL, Su TH, Yang HC, Chen PJ, Chen DS, Chuang WL, Kao JH, Yu ML. Peginterferon plus weight-based ribavirin for treatment-naive hepatitis C virus genotype 2 patients not achieving rapid virologic response: a randomized trial. Sci Rep. 2015 Jul 1;5:11710. doi: 10.1038/srep11710. |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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