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

Eric Lawitz, Fred Poordad, Julio A. Gutierrez, Jennifer T. Wells, Carmen E. Landaverde, Barbara Evans, Anita Howe, Hsueh Cheng Huang, Jerry Jing Li, Peggy Hwang, Frank J. Dutko, Michael Robertson, Janice Wahl, Eliav Barr, Barbara Haber

Research output: Contribution to journalArticle

53 Scopus citations

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. 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).

Original languageEnglish (US)
Pages (from-to)439-450
Number of pages12
JournalHepatology
Volume65
Issue number2
DOIs
StatePublished - Feb 1 2017

ASJC Scopus subject areas

  • Hepatology

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    Lawitz, E., Poordad, F., Gutierrez, J. A., Wells, J. T., Landaverde, C. E., Evans, B., Howe, A., Huang, H. C., Li, J. J., Hwang, P., Dutko, F. J., Robertson, M., Wahl, J., Barr, E., & Haber, B. (2017). Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology, 65(2), 439-450. https://doi.org/10.1002/hep.28877