title: Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.
abstract: 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.
  
  
  
  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).
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors: Eric
authors: E
authors: Lawitz
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors: Fred
authors: F
authors: Poordad
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors: Julio A
authors: JA
authors: Gutierrez
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors: Jennifer T
authors: JT
authors: Wells
authors: Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX.
authors: Carmen E
authors: CE
authors: Landaverde
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Barbara
authors: B
authors: Evans
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Anita
authors: A
authors: Howe
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Hsueh-Cheng
authors: HC
authors: Huang
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Jerry Jing
authors: JJ
authors: Li
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Peggy
authors: P
authors: Hwang
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Frank J
authors: FJ
authors: Dutko
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Michael
authors: M
authors: Robertson
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Janice
authors: J
authors: Wahl
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Eliav
authors: E
authors: Barr
authors: Merck & Co., Inc, Kenilworth, NJ.
authors: Barbara
authors: B
authors: Haber
mesh_terms: D000328:Adult; D000368:Aged; D000577:Amides; D001572:Benzofurans / Q000008:administration & dosage*; D002219:Carbamates; D016001:Confidence Intervals; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011810:Quinoxalines / Q000008:administration & dosage*; D012367:RNA, Viral / Q000032:analysis; D013449:Sulfonamides; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects*; D047029:Lactams, Macrocyclic
chemical_list: D000577:Amides; D001572:Benzofurans; D002219:Carbamates; D003521:Cyclopropanes; D007093:Imidazoles; D011810:Quinoxalines; D012367:RNA, Viral; D013449:Sulfonamides; C578009:grazoprevir; D047029:Lactams, Macrocyclic; C000589335:elbasvir