Short‐duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial

Direct‐acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C‐SWIFT study was to identify the...

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Published in:	Hepatology (Baltimore, Md.) Vol. 65; no. 2; pp. 439 - 450
Main Authors:	Lawitz, Eric, Poordad, Fred, Gutierrez, Julio A., Wells, Jennifer T., Landaverde, Carmen E., Evans, Barbara, Howe, Anita, Huang, Hsueh‐Cheng, Li, Jerry Jing, Hwang, Peggy, Dutko, Frank J., Robertson, Michael, Wahl, Janice, Barr, Eliav, Haber, Barbara
Format:	Journal Article
Language:	English
Published:	United States Wiley Subscription Services, Inc 01-02-2017
Subjects:	Adult Aged Amides Antiviral agents Antiviral drugs Benzofurans - administration & dosage Carbamates Chronic infection Cirrhosis Confidence Intervals Cyclopropanes Dose-Response Relationship, Drug Drug Administration Schedule Drug Therapy, Combination Female Follow-Up Studies Genotypes Hepacivirus - drug effects Hepacivirus - genetics Hepatitis Hepatitis C Hepatitis C - diagnosis Hepatitis C - drug therapy Hepatitis C, Chronic - diagnosis Hepatitis C, Chronic - drug therapy Hepatology Humans Imidazoles - administration & dosage Infections Liver cirrhosis Male Middle Aged Prospective Studies Pruritus Quinoxalines - administration & dosage Ribavirin Ribonucleic acid RNA RNA, Viral - analysis Sulfonamides Time Factors Treatment Outcome Viral Load - drug effects
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Summary:	Direct‐acting antiviral agents (DAAs) represent the standard of care for patients with hepatitis C virus (HCV) infection. Combining DAAs with different mechanisms may allow for shorter treatment durations that are effective across multiple genotypes. The aim of the C‐SWIFT study was to identify the minimum effective treatment duration across multiple genotypes. C‐SWIFT was an open‐label, single‐center trial in treatment‐naïve patients with chronic HCV genotype (GT)1 or 3 infection. All patients received elbasvir (EBR) 50 mg/grazoprevir (GZR) 100 mg with sofosbuvir (SOF) 400 mg for 4‐12 weeks. Patients with GT1 infection who failed therapy were eligible for retreatment with EBR/GZR+SOF and ribavirin for 12 weeks. The primary efficacy endpoint was sustained virological response [SVR]12 (SVR of HCV RNA <15 IU/mL 12 weeks after the end of therapy). Rates of SVR12 were 32% (10 of 31) and 87% (26 of 30) in patients without cirrhosis with GT1 infection treated for 4 and 6 weeks and 80% (16 of 20) and 81% (17 of 21) in GT1‐infected patients with cirrhosis treated for 6 and 8 weeks. Among GT3‐infected patients without cirrhosis, SVR12 was 93% (14 of 15) and 100% (14 of 14) after 8 and 12 weeks. SVR12 in GT3‐infected patients with cirrhosis was 83% (10 of 12) after 12 weeks of treatment. Twenty‐three GT1‐infected patients who relapsed following initial treatment completed retreatment; all achieved SVR12. In the initial treatment phase, there was one serious adverse event of pneumonia, which led to treatment discontinuation, and during retreatment, 1 patient discontinued ribavirin because of pruritus. Conclusion: Data from this study support the use of 8‐week treatment regimens that maintain high efficacy, even for patients with HCV GT3 infection. Retreatment of patients who failed short‐duration therapy was achieved through extended treatment duration and addition of ribavirin. (Hepatology 2017;65:439‐450).
Bibliography:	Potential conflict of interest: Dr. Lawitz consults for, advises for, is on the speakers' bureau for, and received grants from AbbVie, Bristol‐Myers Squibb, Gilead, Janssen, and Merck. He consults for, advises for, and received grants from Achillion, Enanta, Santaris, and Theravance. He consults for and advises for Novartis and Regulus. He received grants from Boehringer Ingelheim, GlaxoSmithKline, Roche, Salix, and Tacere. Dr. Gutierrez consults for, advises for, and received grants from Merck & Co., Inc. Dr. Poordad consults for, advises for, is on the speakers' bureau for, and received grants from Merck, Gilead, Bristol‐Myers Squibb, and AbbVie. Dr. Wells owns stock in Merck & Co., Inc. Dr. Landaverde has nothing to disclose. Ms. Evans is employed by, and own stock in Merck & Co., Inc. Dr. Howe was formerly employed by Merck & Co., Inc. Dr. Barr is employed by and owns stock in Merck. Dr. Evans is employed by and owns stock in Merck. Dr. Feng is employed by and owns stock in Merck. Dr. Haber is employed by and owns stock in Merck. Dr. Li is employed by and owns stock in Merck. Dr. Huang is employed by and owns stock in Merck. Dr. Hwang is employed by and owns stock in Merck. Dr. Robertson is employed by and owns stock in Merck. Dr. Wahl is employed by and owns stock in Merck. Dr. Dutko is employed by and owns stock in Merck. These data have been previously reported at The International Liver Congress 2015 (Vienna, Austria, April 22‐26, 2015) (Poordad et al.) and 2016 (Barcelona, Spain, April 13‐17, 2016) (Lawitz et al.), and The Liver Meeting 2015 (San Francisco, CA, November 13‐17, 2015) (Lawitz et al). Previous employee of Merck & Co., Inc.
ISSN:	0270-9139 1527-3350
DOI:	10.1002/hep.28877