title: Effectiveness of ledipasvir/sofosbuvir in real-world patients with chronic hepatitis C: a collaborative treatment approach.
abstract: The effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in routine use in clinical practice for the management of chronic hepatitis C virus (HCV) has not been well described. Data with prior agents suggest that management of HCV using an interprofessional approach in clinical practice is associated with better outcomes. This single-centre, prospective, observational cohort study evaluated patients treated with LDV/SOF for 8, 12 or 24 weeks as part of the standardized interprofessional treatment protocol at Novant Health Infectious Diseases Specialists. Eighty-four patients treated with LDV/SOF were evaluated; of these, 97.5% and 91.7% of patients achieved a sustained virological response (SVR) in the per-protocol analysis and the intention-to-treat analysis, respectively. Two patients were not cured after relapse of HCV. No patients required LDV/SOF discontinuation and all patients completed the appropriate treatment duration. The majority (56%) of patients reported no adverse effects and all adverse effects that were reported were mild. The most commonly reported adverse effects were headache and fatigue. SVR and tolerability rates were similar to those seen in the clinical trials. LDV/SOF was associated with a successful translation from the clinical trial setting to clinical practice. A collaborative treatment approach should be considered in the management of HCV.
authors.affiliation: Department of Pharmacy, Novant Health Forsyth Medical Center, Winston-Salem, NC, USA; Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA. Electronic address: johnsonsw@campbell.edu.
authors.forename: Steven W
authors.initials: SW
authors.lastname: Johnson
authors.affiliation: Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA.
authors.forename: Shelby R
authors.initials: SR
authors.lastname: Ammirati
authors.affiliation: Department of Pharmacy, Novant Health Forsyth Medical Center, Winston-Salem, NC, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Hartis
authors.affiliation: Infectious Disease Specialists, Novant Health, Winston-Salem, NC, USA.
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Weber
authors.affiliation: Infectious Disease Specialists, Novant Health, Winston-Salem, NC, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Morgan
authors.affiliation: Infectious Disease Specialists, Novant Health, Winston-Salem, NC, USA.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Darnell
authors.affiliation: Infectious Disease Specialists, Novant Health, Winston-Salem, NC, USA.
authors.forename: Adwait
authors.initials: A
authors.lastname: Silwal
authors.affiliation: Department of Pharmacy, Novant Health Forsyth Medical Center, Winston-Salem, NC, USA.
authors.forename: Holly N
authors.initials: HN
authors.lastname: Schmidlin
authors.affiliation: Infectious Disease Specialists, Novant Health, Winston-Salem, NC, USA.
authors.forename: David H
authors.initials: DH
authors.lastname: Priest
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: HCV; Hepatitis C virus; LDV/SOF; Ledipasvir/sofosbuvir; Real-life