title: High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study.
abstract: BACKGROUND
  As treatment for chronic hepatitis C (HCV) virus has evolved to all-oral, interferon-free directly acting antiviral (DAA) therapy, the impact of these improvements on patient adherence has not been described.
  
  
  METHODS
  Medication adherence was measured in 60 HCV, genotype-1, treatment-naïve participants enrolled in a phase 2a clinical trial at the National Institutes of Health and community clinics. Participants received either ledipasvir/sofosbuvir (LDV/SOF) (90 mg/400 mg) (one pill) daily for 12 weeks, LDV/SOF + GS-9451 (80 mg/day) (two pills) daily for 6 weeks, or LDV/SOF + GS-9669 (500 mg twice daily; three pills, two in the morning, one in the evening) for 6 weeks. Adherence was measured using medication event monitoring system (MEMS) caps, pill counts and patient report.
  
  
  RESULTS
  Overall adherence to DAAs was high. Adherence declined over the course of the 12-week treatment (p = 0.04). While controlled psychiatric disease or symptoms of depression did not influence adherence, recent drug use was a risk factor for non-adherence to 12-week (p = 0.01), but not 6-week regimens. Adherence as measured by MEMS was lower than by patient report.
  
  
  CONCLUSIONS
  Adherence to short courses of DAA therapy with 1-3 pills a day was excellent in an urban population with multiple risk factors for non-adherence.
authors.affiliation: Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Tess
authors.initials: T
authors.lastname: Petersen
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Kerry
authors.initials: K
authors.lastname: Townsend
authors.affiliation: Clinical Center Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.|Xavier University of Louisiana, New Orleans, LA, USA.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Gordon
authors.affiliation: Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Sreetha
authors.initials: S
authors.lastname: Sidharthan
authors.affiliation: Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.|Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
authors.forename: Rachel
authors.initials: R
authors.lastname: Silk
authors.affiliation: Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Nelson
authors.affiliation: Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.|Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
authors.forename: Chloe
authors.initials: C
authors.lastname: Gross
authors.affiliation: Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.|Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Monica
authors.initials: M
authors.lastname: Calderón
authors.affiliation: Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Proschan
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.|Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.|Gilead Sciences Inc., Foster City, CA, USA.
authors.forename: Anu
authors.initials: A
authors.lastname: Osinusi
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Polis
authors.affiliation: Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Masur
authors.affiliation: Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. SKottilil@ihv.umaryland.edu.|Division of Infectious Diseases, Institute of Human Virology, University of Maryland, Baltimore, MD, USA. SKottilil@ihv.umaryland.edu.|Division of Clinical Care and Research, Institute of Human Virology, N222, University of Maryland School of Medicine, 725 West Lombard St, Room S222, Baltimore, MD, 21201, USA. SKottilil@ihv.umaryland.edu.
authors.forename: Shyam
authors.initials: S
authors.lastname: Kottilil
authors.affiliation: Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.|Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD, USA.|Division of Hepatology, St. Josephs Hospital and Medical Center, Creighton University Medical School, Phoenix, AZ, USA.
authors.forename: Anita
authors.initials: A
authors.lastname: Kohli
mesh_terms: D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D016896:Treatment Outcome; D014505:Urban Population
chemical_list: D000998:Antiviral Agents
keywords: Adherence; DAA; HCV; MEMS