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| Name | Class |
|---|---|
| Seoul National University Boramae Hospital | OTHER |
| Severance Hospital | OTHER |
| Inha University Hospital | OTHER |
| Korea University |
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A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection
The measurement of liver stiffness by transient elastography (TE) has been shown to correlate with the hepatic fibrosis stage and to have considerable accuracy for the diagnosis of cirrhosis in patients with chronic hepatitis C. Previous studied reported that liver stiffness is significantly reduced in SVR patients with pegylated interferon (IFN) and ribavirin treatment. Once a patient achieve sustained virological response (SVR), and resultingly lower liver stiffness score than baseline value, it is believed that he will have a better long-term outcome due to the improvement of liver fibrosis.
Daclatasvir(DCV) and Asunaprevir(ASV) combined treatment showed a greater SVR rate in CHC compared to IFN based therapy. The investigators hypothesize that DCV and ASV combined treatment may achieve the improvement of liver stiffness measured by TE and a more favorable clinical outcomes in patients with advanced liver fibrosis. The investigators will also compare the change of fibrosis stage assessed by TE between this study subjects and those treated with other DAA agents during same observational period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir plus Asunaprevir treatment | Among patients taking Daclatasvir and Asunaprevir combined treatment and having advanced liver fibrosis assessed by transient elastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir and Asunaprevir | Drug | Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir | To compare the change of liver fibrosis stage (defined as F3, ≥8; F4, ≥12) assessed by transient elastography between baseline and 48 weeks in advanced fibrotic/cirrhotic Chronic Hepatitis C patients who achieved sustained virological response with Daclatasvir and Asunaprevir combined treatment | baseline to 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who were treated with Daclatasvir and Asunaprevir achieved SVR12 assessed by HCV RNA | baseline to 36 weeks | |
| Proportion of patients who maintained sustained virologic response at SVR24, SVR72, SVR120, SVR168, and SVR216. | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Genotype 1b, advanced fibrotic/cirrhotic Korean patients with chronic hepatitis C aged over 18, without baseline NS5A RAVs (Y93 and/or L31)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Gyune Kim, Professor | Contact | 82-32-621-5071 | mcnulty@schmc.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang Gyune Kim, Professor | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Cheonan Hospital | Cheonan | Chungcheongnam-do | 31151 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15690481 | Background | Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506. | |
| 21752038 | Background |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
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| OTHER |
| Gachon University Gil Medical Center | OTHER |
| Hanyang University Seoul Hospital | OTHER |
| Ewha Womans University Mokdong Hospital | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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8cc serum sample for the evaluation of direct liver fibrosis marker
|
| The change of liver fibrosis stage assessed by transient elastography at 96weeks, 144weeks, 192weeks, 240weeks in patients treated with Daclatasvir and Asunaprevir | baseline to 96weeks, 144weeks, 192weeks, 240weeks |
| The change of AST to Platelet Ratio Index | APRI = [(AST/upper limit of normal)/platelet count]x100 | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
| The change of Fibrosis 4 (Fib-4) index | FIB-4 = age (years) × AST [IU/L] / [platelet count × sqr(ALT [IU/L])] | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
| Comparison of change of liver fibrosis stage assessed by transient elastography between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment | Comparison of change of liver fibrosis stage assessed by transient elastography at 48weeks, 96weeks, 144weeks, 192weeks, 240weeks between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment during same observational period | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
| Comparison of the incidence of hepatocellular carcinoma or liver cirrhosis complications between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment | Compare the incidence of hepatocellular carcinoma or liver cirrhosis complications at 48weeks, 96weeks, 144weeks, 192weeks, 240weeks between Daclatasvir and Asunaprevir combined treatment versus other Direct antiviral agents during same observational period | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
| The change of Fibrometer score | alpha2 macroglobulin, GGT, AST, ALT, prothrombin index, urea, platelet count | baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks |
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 15355 | South Korea |
|
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
|
| Inha University Hospital | Jung-gu | Incheon | 22332 | South Korea |
|
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
|
| Severance hospital | Seoul | 03722 | South Korea |
|
| Soonchunhyang University Hospital | Seoul | 04401 | South Korea |
|
| Hanyang university hospital | Seoul | 04763 | South Korea |
|
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
|
| Wonju severance christian hospital | Wŏnju | 26426 | South Korea |
|
| Hezode C, Castera L, Roudot-Thoraval F, Bouvier-Alias M, Rosa I, Roulot D, Leroy V, Mallat A, Pawlotsky JM. Liver stiffness diminishes with antiviral response in chronic hepatitis C. Aliment Pharmacol Ther. 2011 Sep;34(6):656-63. doi: 10.1111/j.1365-2036.2011.04765.x. Epub 2011 Jul 13. |
| 20236358 | Background | Arima Y, Kawabe N, Hashimoto S, Harata M, Nitta Y, Murao M, Nakano T, Shimazaki H, Kobayashi K, Ichino N, Osakabe K, Nishikawa T, Okumura A, Ishikawa T, Yoshioka K. Reduction of liver stiffness by interferon treatment in the patients with chronic hepatitis C. Hepatol Res. 2010 Apr;40(4):383-92. doi: 10.1111/j.1872-034X.2009.00618.x. Epub 2010 Mar 4. |
| 20546451 | Background | Wang JH, Changchien CS, Hung CH, Tung WC, Kee KM, Chen CH, Hu TH, Lee CM, Lu SN. Liver stiffness decrease after effective antiviral therapy in patients with chronic hepatitis C: Longitudinal study using FibroScan. J Gastroenterol Hepatol. 2010 May;25(5):964-9. doi: 10.1111/j.1440-1746.2009.06194.x. |
| 23256120 | Background | Crisan D, Radu C, Grigorescu MD, Lupsor M, Feier D, Grigorescu M. Prospective non-invasive follow-up of liver fibrosis in patients with chronic hepatitis C. J Gastrointestin Liver Dis. 2012 Dec;21(4):375-82. |
| Background | Bourliere, Marc, et al. |
| 34996920 | Derived | Yoo HW, Park JY, Kim SG, Jung YK, Lee SH, Kim MY, Jun DW, Jang JY, Lee JW, Kwon OS. Regression of liver fibrosis and hepatocellular carcinoma development after HCV eradication with oral antiviral agents. Sci Rep. 2022 Jan 7;12(1):193. doi: 10.1038/s41598-021-03272-1. |
| 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 |