Comparison of Glecaprevir/Pibrentasvir and Sofosbuvir/Ledipasvir in Patients with Hepatitis C Virus Genotype 1 and 2 in South Korea

被引:0
作者
Shin, Hyun Deok [1 ]
Song, Il Han [1 ]
Lee, Sae Hwan [2 ]
Kim, Hong Soo [2 ]
Lee, Tae Hee [3 ]
Eun, Hyuk Soo [4 ]
Kim, Seok Hyun [4 ]
Lee, Byung Seok [4 ]
Chae, Hee Bok [5 ]
Kim, Seok Hwan [6 ]
Song, Myung Joon [6 ]
Ko, Soon Yeong [7 ]
Kim, Suk Bae [1 ]
机构
[1] Dankook Univ, Dept Gastroenterol, Coll Med, 119 Dandae Ro, Cheonan 31116, South Korea
[2] Soonchunhyang Univ, Dept Gastroenterol, Coll Med, Cheonan, South Korea
[3] Konyang Univ, Coll Med, Dept Gastroenterol, Daejeon, South Korea
[4] Chungnam Natl Univ, Coll Med, Dept Gastroenterol, Daejeon, South Korea
[5] Chungbuk Univ, Dept Gastroenterol, Coll Med, Cheongju, South Korea
[6] Catholic Univ Korea, Dept Gastroenterol, Coll Med, Daejeon, South Korea
[7] Konkuk Univ, Dept Gastroenterol, Coll Med, Chungju, South Korea
关键词
Glecaprevir; Pibrentasvir; Harvoni; Chronic hepatitis C; Korea; FIXED-DOSE COMBINATION; GLOBAL EPIDEMIOLOGY; OPEN-LABEL; SOFOSBUVIR; LEDIPASVIR; INFECTION; EFFICACY; LEDIPASVIR/SOFOSBUVIR; TABLET; PIBRENTASVIR;
D O I
10.4166/kjg.2023.141
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background/Aims: This study compared the effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/ledipasvir (SOF/LDV) in real-life clinical practice. Methods: The data from genotype 1 or 2 chronic hepatitis C patients treated with GLE/PIB or sofosbuvir + ribavirin or SOF/LDV in South Korea were collected retrospectively. The analysis included the treatment completion rate, sustained virologic response at 12 weeks (SVR12) test rate, treatment effectiveness, and adverse events. Results: Seven hundred and eighty-two patients with genotype 1 or 2 chronic hepatitis C who were treated with GLE/PIB (n=575) or SOF/LDV (n=207) were included in this retrospective study. The baseline demographic and clinical characteristics revealed significant statistical differences in age, genotype, ascites, liver cirrhosis, and hepatocellular carcinoma between the GLE/PIB and SOF/LDV groups. Twenty-two patients did not complete the treatment protocol. The treatment completion rate was high for both regimens without statistical significance (97.7% vs. 95.7%, p=0.08). The overall SVR12 of intention-to-treat analysis was 81.2% vs. 80.7% without statistical significance (p=0.87). The overall SVR12 of per protocol analysis was 98.7% vs. 100% without statistical significance (p= 0.14). Six patients treated with GLE/PIB experienced treatment failure. They were all male, genotype 2, and showed a negative hepatitis C virus RNA level at the end of treatment. Two patients treated with GLE/PIB stopped medication because of fever and abdominal discomfort. Conclusions: Both regimens had similar treatment completion rates, effectiveness, and safety profiles. Therefore, the SOF/LDV regimen can also be considered a viable DAA for the treatment of patients with genotype 1 or 2 chronic hepatitis C.
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页码:111 / 118
页数:8
相关论文
共 22 条
[1]   Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection [J].
Afdhal, Nezam ;
Zeuzem, Stefan ;
Kwo, Paul ;
Chojkier, Mario ;
Gitlin, Norman ;
Puoti, Massimo ;
Romero-Gomez, Manuel ;
Zarski, Jean-Pierre ;
Agarwal, Kosh ;
Buggisch, Peter ;
Foster, Graham R. ;
Braeu, Norbert ;
Buti, Maria ;
Jacobson, Ira M. ;
Subramanian, G. Mani ;
Ding, Xiao ;
Mo, Hongmei ;
Yang, Jenny C. ;
Pang, Phillip S. ;
Symonds, William T. ;
McHutchison, John G. ;
Muir, Andrew J. ;
Mangia, Alessandra ;
Marcellin, Patrick .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (20) :1889-1898
[2]   Ledipasvir-sofosbuvir for treating Japanese patients with chronic hepatitis C virus genotype 2 infection [J].
Asahina, Yasuhiro ;
Itoh, Yoshito ;
Ueno, Yoshiyuki ;
Matsuzaki, Yasushi ;
Takikawa, Yasuhiro ;
Yatsuhashi, Hiroshi ;
Genda, Takuya ;
Ikeda, Fusao ;
Matsuda, Takuma ;
Dvory-Sobol, Hadas ;
Jiang, Deyuan ;
Massetto, Benedetta ;
Osinusi, Anu O. ;
Brainard, Diana M. ;
McHutchison, John G. ;
Kawada, Norifumi ;
Enomoto, Nobuyuki .
LIVER INTERNATIONAL, 2018, 38 (09) :1552-1561
[3]   JS']JSH Guidelines for the Management of Hepatitis C Virus Infection: A 2016 update for genotype 1 and 2 [J].
Asahina, Yasuhiro ;
Izumi, Namiki ;
Hiromitsu, Kumada ;
Kurosaki, Masayuki ;
Koike, Kazuhiko ;
Suzuki, Fumitaka ;
Takikawa, Hajime ;
Tanaka, Atsushi ;
Tanaka, Eiji ;
Tanaka, Yasuhito ;
Tsubouchi, Hirohito ;
Hayashi, Norio ;
Hiramatsu, Naoki ;
Yotsuyanagi, Hiroshi .
HEPATOLOGY RESEARCH, 2016, 46 (02) :129-165
[4]   Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus [J].
Chuang, Wan-Long ;
Chien, Rong-Nan ;
Peng, Cheng-Yuan ;
Chang, Ting-Tsung ;
Lo, Gin-Ho ;
Sheen, I-Shyan ;
Wang, Horng-Yuan ;
Chen, Jyh-Jou ;
Yang, Jenny C. ;
Knox, Steven J. ;
Gao, Bing ;
Garrison, Kimberly L. ;
Mo, Hongmei ;
Pang, Phillip S. ;
Hsu, Yu-Chun ;
Hu, Tsung-Hui ;
Chu, Chi-Jen ;
Kao, Jia-Horng .
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 2016, 31 (07) :1323-1329
[5]   Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection [J].
Chung, Raymond T. ;
Ghany, Marc G. ;
Kim, Arthur Y. ;
Marks, Kristen M. ;
Naggie, Susanna ;
Vargas, Hugo E. ;
Aronsohn, Andrew I. ;
Bhattacharya, Debika ;
Broder, Tina ;
Falade-Nwulia, O. ;
Fontana, Robert J. ;
Gordon, Stuart C. ;
Heller, Theo ;
Holmberg, Scott D. ;
Jhaveri, Ravi ;
Jonas, Maureen M. ;
Kiser, Jennifer J. ;
Linas, Benjamin P. ;
Lo Re, Vincent, III ;
Morgan, Timothy R. ;
Nahass, Ronald G. ;
Peters, Marion G. ;
Reddy, K. Rajender ;
Reynolds, Andrew ;
Scott, John D. ;
Searson, Gloria ;
Swan, Tracy ;
Terrault, Norah A. ;
Trooskin, Stacey B. ;
Wong, John B. ;
Workowski, Kimberly A. .
CLINICAL INFECTIOUS DISEASES, 2018, 67 (10) :1477-1492
[6]   EASL Recommendations on Treatment of Hepatitis C 2018 [J].
Pawlotsky J.-M. ;
Negro F. ;
Aghemo A. ;
Berenguer M. ;
Dalgard O. ;
Dusheiko G. ;
Marra F. ;
Puoti M. ;
Wedemeyer H. .
JOURNAL OF HEPATOLOGY, 2018, 69 (02) :461-511
[7]   Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial [J].
Forns, Xavier ;
Lee, Samuel S. ;
Valdes, Joaquin ;
Lens, Sabela ;
Ghalib, Reem ;
Aguilar, Humberto ;
Felizarta, Franco ;
Hassanein, Tarek ;
Hinrichsen, Holger ;
Rincon, Diego ;
Morillas, Rosa ;
Zeuzem, Stefan ;
Horsmans, Yves ;
Nelson, David R. ;
Yu, Yao ;
Krishnan, Preethi ;
Lin, Chih-Wei ;
Kort, Jens J. ;
Mensa, Federico J. .
LANCET INFECTIOUS DISEASES, 2017, 17 (10) :1062-1068
[8]   High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis [J].
Gane, Edward ;
Poordad, Fred ;
Wang, Stanley ;
Asatryan, Armen ;
Kwo, Paul Y. ;
Lalezari, Jacob ;
Wyles, David L. ;
Hassanein, Tarek ;
Aguilar, Humberto ;
Maliakkal, Benedict ;
Liu, Ran ;
Lin, Chih-Wei ;
Ng, Teresa I. ;
Kort, Jens ;
Mensa, Federico J. .
GASTROENTEROLOGY, 2016, 151 (04) :651-+
[9]   Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection [J].
Gane, Edward J. ;
Hyland, Robert H. ;
Yang, Yin ;
Svarovskaia, Evguenia ;
Stamm, Luisa M. ;
Brainard, Diana M. ;
McHutchison, John G. ;
Stedman, Catherine A. M. .
GASTROENTEROLOGY, 2017, 152 (06) :1366-1371
[10]   Clinical Pharmacokinetics and Pharmacodynamics of Ledipasvir/Sofosbuvir, a Fixed-Dose Combination Tablet for the Treatment of Hepatitis C [J].
German, Polina ;
Mathias, Anita ;
Brainard, Diana ;
Kearney, Brian P. .
CLINICAL PHARMACOKINETICS, 2016, 55 (11) :1337-1351