title: Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir.
abstract: OBJECTIVE
  As the treatment of hepatitis C virus (HCV) infection has evolved to directly acting antiviral agents, the impact of these directly acting antiviral-only regimens on improving adherence to HCV treatment in HIV/HCV coinfected populations has not been evaluated. The study compared adherence to ledipasvir/sofosbuvir (LDV/SOF) in HCV monoinfected and HIV/HCV coinfected individuals.
  
  
  METHODS
  Adherence was measured from participants in two phase 2 open-label studies (NCT01805882 and NCT01878799).
  
  
  METHODS
  HCV treatment-naive, genotype 1 study individuals [HCV monoinfected participants (N = 20) and HIV/HCV coinfected participants, antiretroviral untreated (N = 13) or on combination antiretroviral therapy (N = 37)] were treated with LDV (90 mg) and SOF (400 mg) administered as one tablet once daily for 12 weeks. Adherence was measured using three tools: medication event monitoring system cap, pill count, and patient report.
  
  
  RESULTS
  Participants were predominately African American (83%) and male (73%), with a median age of 59 years. Participants had prompt HCV viral load decline and high adherence rates (97 ± 0.5% by medication event monitoring system). Participant adherence decreased significantly from early (baseline week 4) as compared with late (weeks 8-12) in therapy in all three groups - HCV monoinfected (P = 0.01), HIV/HCV antiretroviral untreated (P = 0.02), and HIV/HCV antiretroviral treated participants (P = 0.01).
  
  
  CONCLUSIONS
  Adherence to LDV/SOF in this urban population was high and comparable between HCV monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.
authors.affiliation: aLaboratory of ImmunoregulationbCritical Care Medicine Department, National Institutes of Health Clinical CentercClinical Center Pharmacy Department, National Institutes of Health, Bethesda, MarylanddCollege of Pharmacy, Xavier University of Louisiana, New Orleans, LouisianaeClinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick, Inc), Frederick National Laboratory for Cancer Research, Frederick, MarylandfDivision of Hepatology, St. Josephs Hospital and Medical Center, Creighton University Medical School, Phoenix, ArizonagDivision of Infectious Diseases, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MarylandhGilead Sciences Inc., Foster City, California, USA.
authors.forename: Kerry
authors.initials: K
authors.lastname: Townsend
authors.forename: Tess
authors.initials: T
authors.lastname: Petersen
authors.forename: Lori A
authors.initials: LA
authors.lastname: Gordon
authors.forename: Anita
authors.initials: A
authors.lastname: Kohli
authors.forename: Amy
authors.initials: A
authors.lastname: Nelson
authors.forename: Cassie
authors.initials: C
authors.lastname: Seamon
authors.forename: Chloe
authors.initials: C
authors.lastname: Gross
authors.forename: Lydia
authors.initials: L
authors.lastname: Tang
authors.forename: Anu
authors.initials: A
authors.lastname: Osinusi
authors.forename: Michael A
authors.initials: MA
authors.lastname: Polis
authors.forename: Henry
authors.initials: H
authors.lastname: Masur
authors.forename: Shyam
authors.initials: S
authors.lastname: Kottilil
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D060085:Coinfection / Q000188:drug therapy*; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage*; D015658:HIV Infections / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D000069474:Sofosbuvir / Q000008:administration & dosage*; D014505:Urban Population
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir