Chi-Yi Chen1, Chung-Feng Huang2,3, Pin-Nan Cheng4, Kuo-Chih Tseng5,6, Ching-Chu Lo7, Hsing-Tao Kuo8, Yi-Hsiang Huang9,10, Chi-Ming Tai11,12, Cheng-Yuan Peng13, Ming-Jong Bair14,15, Chien-Hung Chen16, Ming-Lun Yeh3,17, Chih-Lang Lin18, Chun-Yen Lin19,20, Pei-Lun Lee21, Lee-Won Chong22,23, Chao-Hung Hung16,24, Jee-Fu Huang3,25, Chi-Chieh Yang26, Jui-Ting Hu27, Chih-Wen Lin12,28, Chun-Ting Chen29,30, Chia-Chi Wang31, Wei-Wen Su32, Tsai-Yuan Hsieh30, Chih-Lin Lin33, Wei-Lun Tsai34, Tzong-Hsi Lee35, Guei-Ying Chen36, Szu-Jen Wang37, Chun-Chao Chang38,39, Lein-Ray Mo40, Sheng-Shun Yang41, Wen-Chih Wu42, Chia-Sheng Huang43, Chou-Kwok Hsiung44, Chien-Neng Kao45, Pei-Chien Tsai2, Chen-Hua Liu46, Mei-Hsuan Lee47, Chun-Jen Liu46, Chia-Yen Dai2,3, Jia-Horng Kao46, Wan-Long Chuang2,3, Han-Chieh Lin9,10, Ming-Lung Yu2,3. 1. Division of Gastroenterology and Hepatology, Department of Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan. 2. Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 3. School of Medicine and Hepatitis Research Center, College of Medicine, and Center for Cancer Research and Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan. 4. Division of Gastroenterology and Hepatology, Department of Internal Medicine, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan. 5. Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan. 6. School of Medicine, Tzuchi University, Hualien, Taiwan. 7. Division of Gastroenterology, Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan. 8. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan. 9. Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital. 10. Institute of Clinical Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan. 11. Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan. 12. School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan. 13. Center for Digestive Medicine, Department of Internal Medicine, School of Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan. 14. Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan. 15. Mackay Medical College, New Taipei City, Taiwan. 16. Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan, Taiwan. 17. Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 18. Department of Gastroenterology and Hepatology, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan. 19. Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan. 20. Graduate Institute of Biomedical Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan. 21. Liouying Division of Gastroenterology and Hepatology, Department of Internal medicine, Chi Mei Medical Center, Tainan, Taiwan. 22. Division of Hepatology and Gastroenterology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan. 23. School of Medicine, Fu-Jen Catholic University, New Taipei City, Taiwan. 24. Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital, Puzi, Taiwan. 25. Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 26. Department of Gastroenterology, Division of Internal Medicine, Show Chwan Memorial Hospital, Changhua, Taiwan. 27. Liver Center, Cathay General Hospital, Taipei, Taiwan. 28. Division of Gastroenterology and Hepatology, E-Da Dachang Hospital, Kaohsiung, Taiwan. 29. Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital Penghu Branch, National Defense Medical Center, Taipei, Taiwan. 30. Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. 31. School of Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan. 32. Department of Gastroenterology and Hepatology, Changhua Christian Hospital, Changhua, Taiwan. 33. Department of Gastroenterology, Renai branch, Taipei City Hospital, Taipei, Taiwan. 34. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. 35. Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital, New Taipei City, Taiwan. 36. Penghu Hospital, Ministry of Health and Welfare, Taipei, Taiwan. 37. Division of Gastroenterology, Department of Internal Medicine, Yuan's General Hospital, Kaohsiung, Taiwan. 38. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan. 39. Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 40. Division of Gastroenterology, Tainan Municipal Hospital, Tainan, Taiwan. 41. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. 42. Wu Wen-Chih Clinic, Kaohsiung, Taiwan. 43. Yang Ming Hospital, Chiayi, Taiwan. 44. Chou Kwok Hsiung Clinic, Penghu, Taiwan. 45. National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan. 46. Hepatitis Research Center and Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 47. Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Abstract
BACKGROUND/AIMS: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. METHODS: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). RESULTS: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% ( adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P < .001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P = .0003 and aOR/CI: 1.55/1.05-2.29, P = .03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P < .001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P < .001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P < .001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P = .02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P < .001). CONCLUSIONS: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.
BACKGROUND/AIMS: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infectedpatients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. METHODS: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). RESULTS: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% ( adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P < .001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P = .0003 and aOR/CI: 1.55/1.05-2.29, P = .03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P < .001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P < .001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P < .001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P = .02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P < .001). CONCLUSIONS:DAAs are highly effective in treating Taiwanese HCVpatients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.
Authors: Ana Paula de Torres Santos; Vanessa Cristina Martins Silva; Maria Cássia Mendes-Corrêa; Marcilio Figueiredo Lemos; Fernanda de Mello Malta; Rúbia Anita Ferraz Santana; Gregório Tadeu Fernando Dastoli; Vanessa Fusco Duarte de Castro; João Renato Rebello Pinho; Regina Célia Moreira Journal: Rev Inst Med Trop Sao Paulo Date: 2022-09-30 Impact factor: 2.169