title: Eight- or 12-Week Treatment of Hepatitis C with Ledipasvir/Sofosbuvir: Real-World Experience in a Large Integrated Health System.
abstract: BACKGROUND
  Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system.
  
  
  METHODS
  All patients receiving LDV/SOF, without ribavirin, were identified from pharmacy records, and outcomes are reported. Only treatment-naïve patients without evidence of cirrhosis and hepatitis C viral load less than 6 million IU/ml were candidates for 8-week therapy. Treatment was at clinician discretion, but delivered by a multidisciplinary team and reviewed for appropriateness and adherence to these criteria by one of the authors, all experienced in hepatitis C treatment. Sustained viral response at 12 weeks (SVR 12) was contrasted between those receiving 8 and those receiving 12 weeks of treatment.
  
  
  RESULTS
  Completed prescriptions for LDV/SOF, without ribavirin, as of 30 September 2015 were identified in 1021 patients. Five patients discontinued therapy due to medical reasons and 35 had incomplete follow-up viral load data, thus there were 981 evaluable patients: 377 treated for 8 weeks and 604 treated for 12 weeks. SVR 12 was virtually identical at 93.6 and 93.5%, respectively. Baseline characteristics differed between the two groups, as only treatment-naïve, non-cirrhotic, non-HIV-infected patients were eligible for an 8-week course of therapy.
  
  
  CONCLUSIONS
  Eight-week courses of LDV/SOF are comparable to 12-week courses in real-world use among selected patients supported by a multidisciplinary team.
authors.affiliation: Division of Infectious Diseases, Kaiser Permanente, 99 Montecillo Rd, Northern California Region, San Rafael, CA, 94903, USA.|Division of Gastroenterology, Kaiser Permanente, Northern California Region, San Rafael, CA, USA.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Lai
authors.affiliation: Division of Infectious Diseases, Kaiser Permanente, 99 Montecillo Rd, Northern California Region, San Rafael, CA, 94903, USA.
authors.forename: Maxwell A
authors.initials: MA
authors.lastname: Witt
authors.affiliation: Division of Gastroenterology, Kaiser Permanente, Northern California Region, San Rafael, CA, USA.
authors.forename: Mary Patricia
authors.initials: MP
authors.lastname: Pauly
authors.affiliation: Division of Gastroenterology, Kaiser Permanente, Northern California Region, San Rafael, CA, USA.
authors.forename: Joanna
authors.initials: J
authors.lastname: Ready
authors.affiliation: Division of Infectious Diseases, Kaiser Permanente, 99 Montecillo Rd, Northern California Region, San Rafael, CA, 94903, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Allerton
authors.affiliation: Division of Gastroenterology, Kaiser Permanente, Northern California Region, San Rafael, CA, USA.
authors.forename: Suk
authors.initials: S
authors.lastname: Seo
authors.affiliation: Division of Infectious Diseases, Kaiser Permanente, 99 Montecillo Rd, Northern California Region, San Rafael, CA, 94903, USA. david.j.witt@kp.org.
authors.forename: David J
authors.initials: DJ
authors.lastname: Witt
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D019033:Delivery of Health Care, Integrated; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use*; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir