title: Real-world Experience with Sofosbuvir-based Regimens for Chronic Hepatitis C, Including Patients with Factors Previously Associated with Inferior Treatment Response.
abstract: The introduction of sofosbuvir, a direct acting antiviral, has revolutionized the treatment of chronic hepatitis C virus (HCV). Phase 3 clinical trials have demonstrated the efficacy, simplicity, and tolerability of sofosbuvir-based regimens and report high rates of sustained virological response (SVR) rates. The purpose of this study was to assess whether clinical trial findings translate into a real-world setting, particularly with treatment of chronic HCV in our diverse, multiethnic population of Hawai'i. Retrospective analysis was performed for 113 patients with genotype 1-6 HCV infection being treated at the Queen's Liver Center between January 2014 and March 2015. SVR rates for our cohort were slightly lower than the rates published by the clinical trials. Data analysis also suggested that most baseline characteristics previously associated with inferior response might not be as significant for sofosbuvir-based regimens; in our cohort, male gender was the only factor significantly related to increased risk of virologic relapse. Pacific Islanders also had higher rate of relapse compared to other ethnic groups, but the small number of patients treated in this subgroup make it difficult to validate this finding. While newer all-oral treatment regimens have been introduced since this study, we highlight the importance of comparing real-world versus clinical trial results for new treatments, and provide data analyses for treatment of chronic HCV in Hawai'i.
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Christina J
authors.initials: CJ
authors.lastname: Wu
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Marina M
authors.initials: MM
authors.lastname: Roytman
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Leena K
authors.initials: LK
authors.lastname: Hong
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Leslie
authors.initials: L
authors.lastname: Huddleston
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Ruby
authors.initials: R
authors.lastname: Trujillo
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Alvin
authors.initials: A
authors.lastname: Cheung
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Peter
authors.initials: P
authors.lastname: Poerzgen
authors.affiliation: John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI (CJW, MMR, NCST).
authors.forename: Naoky C S
authors.initials: NC
authors.lastname: Tsai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006254:Hawaii; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000494:pharmacology*; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000069474:Sofosbuvir
keywords: HCV; Sovaldi; effectiveness; real-world; sofosbuvir