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Real-World Study on Sofosbuvir-based Therapies in Asian Americans With Chronic Hepatitis C

Pan, Calvin Q., MD, FAASLD, FACG, MACP*,†; Tiongson, Benjamin C., MD‡,§; Hu, Ke-Qin, MD; Han, Steven-Huy B., MD; Tong, Myron, MD#; Chu, Danny, MD**; Park, James, MD*; Lee, Tai Ping, MD††; Bhamidimarri, Kalyan Ram, MD‡‡; Ma, Xiaoli, MD§§; Xiao, Pei Ying, MD∥∥; Mohanty, Smruti R., MD¶¶; Wang, Dan, BS##

Journal of Clinical Gastroenterology: February 2019 - Volume 53 - Issue 2 - p 147–154
doi: 10.1097/MCG.0000000000001078
LIVER, PANCREAS & BILIARY TRACT: Original Articles
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Background: Limited data exist with regard to treatment outcomes in Asian Americans with chronic hepatitis C (CHC). We evaluated sofosbuvir (SOF)-based regimens in a national cohort of Asian Americans.

Methods: Eligible Asian Americans patients with CHC who had posttreatment follow-up of 24 weeks for SOF -based therapies from December 2013 to June 2017 were enrolled from 11 sites across the United States. The primary endpoint was sustained virologic response (SVR) rates at posttreatment weeks 12 and 24. Secondary endpoints were to evaluate safety by tolerability and adverse events (AEs).

Results: Among 231 patients screened, 186 were enrolled. At baseline, 31% (57/186) patients were cirrhotic, 34% (63/186) were treatment experienced. Most of the subjects (42%, 79/186) received ledispavir/SOF therapy. The overall SVR12 was 95%, ranging from 86% in genotype (GT) 1b on SOF+ribavirin to 100% in GT 1b patients on ledipasvir/SOF at subgroup analyses. SVR12 was significantly lower in cirrhotic than in noncirrhotic patients [88% (50/57) vs. 98% (126/129), P<0.01]. Stratified by GT, SVR12 were: 96% (43/45) in GT 1a; 93% (67/72) in GT 1b; 100% (23/23) in GT 2; 90% (19/21) in GT 3; 100% (1/1) in GT 4; 83% (5/6) in GT 5; and 100% (16/16) in GT 6. Cirrhotic patients with treatment failure were primarily GT 1, (GT 1a, n=2; GT 1b, n=4) with 1 GT 5 (n=1). Patients tolerated the treatment without serious AEs. Late relapse occurred in 1 patient after achieving SVR12.

Conclusions: In Asian Americans with CHC, SOF-based regimens were well tolerated without serious AEs and could achieve high SVR12 regardless of hepatitis C viral infection GT.

*Department of Medicine, Division of Gastroenterology and Hepatology, NYU Langone Health, NYU School of Medicine

**Downtown Gastroenterology PC, New York

Interfaith Medical Center

∥∥Division of Gastroenterology and Hepatology, SUNY Downstate Medical Center

¶¶Division of Gastroenterology and Hepatology, NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn

††Division of Hepatology, Sandra Atlas Bass Center for Liver Disease, Donald and Barbara Zucker School of Medicine at Hofstraa/Northwell Health, Manhasset

##Saint Johns University, Jamaica, NY

Beijing Youan Hospital, Capital Medical University, Beijing, China

§University of the East Ramon Magsaysay Memorial Medical Center Inc., Quezon City, NCR, Philippines

Division of Gastroenterology and Hepatology, University of California, Irvine, School of Medicine, Orange

Pfleger Liver Institute, David Geffen School of Medicine at UCLA

#Division of Gastroenterology and Hepatology, Huntington Medical Research Institutes, Pasadena, CA

‡‡Transplant Hepatology, University of Miami Miller School of Medicine, Miami, FL

§§Division of Gastroenterology and Hepatology, Hahnemann University Hospital, Drexel College of Medicine, Philadelphia, PA

Supported by a research grant from Gilead Sciences Inc., although there was no agreement with regard to data confidentiality between the sponsor (Gilead Sciences) and the authors. Gilead Sciences had no part in the design or performance of the study, in the data analysis, in the writing or editing of the manuscript, or in the decision to submit the manuscript for publication.

C.Q.P.: proposed the concept, designed the study, wrote the protocol, obtained funding, and managed the study. B.C.T.: performed the statistics. C.Q.P.: interpreted the data and wrote the manuscript with assistance from B.C.T. and C.Q.P.: performed critical reviews, communicated with the journal, and addressed comments from reviewers. All authors contributed to data collection.

C.Q.P.: received grants from Gilead, Bristol Myers Squibb, and Merck. He also serves as a consultant or advisor for Gilead, and speaker for Gilead, Abbvie, and Intercept. K.-Q.H.: serves as a speaker for Gilead, Merck, and Intercept. S.-H.B.H.: has received research grant from Medical Procare PLLC and Gilead Sciences, He is a speaker for Gilead. M.T.: received grants from Gilead and Bristol Myers Squibb. D.C.: is a speaker for Gilead. J.P.: is a speaker for Gilead, Abbvie, and Bayer. T.P.L.: has received grant from Gilead. K.R.B.: served as advisor for Eisai pharmaceuticals, Merck Sciences, Abbvie, Gilead, Alexion pharmaceutical, and Intercept. X.M.: is a consultant for Gilead. S.R.M.: is a speaker and consultant for Gilead, Merck, and Abbvie. The remaining authors declare that they have nothing to disclose.

Address correspondence to: Calvin Q. Pan, MD, FAASLD, FACG, MACP, 132-21, 41st Ave, Flushing, NY 11355 (e-mail: Panc01@NYU.edu).

Received February 7, 2018

Accepted May 3, 2018

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