title: Clinical efficacy and tolerability of direct-acting antivirals in elderly patients with chronic hepatitis C.
abstract: BACKGROUND
  There is a lack of evidence-based data on aged patients with newer direct-acting antivirals (DAAs) and with shorter duration of treatment regimens involving DAAs with or without ribavirin (RBV) and pegylated interferon (Peg IFN).
  
  
  METHODS
  Medical records of 240 patients treated with DAAs with or without Peg IFN and RBV between January 2013 and July 2015 were retrospectively analyzed. Patients were divided into two groups: patients aged 65 years and older (N=84) and patients aged younger than 65 years (N=156). Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks after treatment, and adverse reactions were compared between the groups.
  
  
  RESULTS
  No statistically significant difference was observed with end of treatment response (98.8 vs. 98%, P=0.667) and sustained virologic response at 12 weeks after treatment (93.1 vs. 94.1%, P=0.767) between patients aged 65 and older and those younger than 65 years of age. Fatigue was the most common adverse event recorded (32.5%), followed by anemia (19.6%), leukopenia (11.7%), thrombocytopenia (10%), skin rash (8.3%), and headache (7.9%). The RBV dose was reduced in eight (8%) patients and four patients discontinued the RBV treatment because of severe anemia. RBV dose reduction or discontinuation did not reach statistical significance (P=0.913). Increased fibrosis, cirrhosis, aspartate aminotransferase, alanine aminotransferase, hemoglobin, and platelet levels seem to affect the sustained virologic response in the elderly. Twelve (6.28%) patients failed to respond to treatment and the failure rate was not significant (P=0.767) between the groups.
  
  
  CONCLUSIONS
  DAAs with or without IFN and RBV in the standard recommended 12 or 24-week treatment regimens are effective, well tolerated, and may be safely extended to elderly patients infected with chronic hepatitis C.
authors.affiliation: aDepartment of Medicine, Division of Gastroenterology and Hepatology, New York Presbyterian Brooklyn Methodist Hospital bDepartment of Medicine and Gastroenterology, Interfaith Medical Center, New York, USA.
authors.forename: Jagannath M
authors.initials: JM
authors.lastname: Sherigar
authors.forename: Vijay
authors.initials: V
authors.lastname: Gayam
authors.forename: Arifa
authors.initials: A
authors.lastname: Khan
authors.forename: Osama
authors.initials: O
authors.lastname: Mukhtar
authors.forename: Yavgeniy
authors.initials: Y
authors.lastname: Arefiev
authors.forename: Mazin
authors.initials: M
authors.lastname: Khalid
authors.forename: Imran
authors.initials: I
authors.lastname: Siddiqui
authors.forename: Ayyappa M
authors.initials: AM
authors.lastname: Rangaraju
authors.forename: Nibash
authors.initials: N
authors.lastname: Budhathoki
authors.forename: Mohammed
authors.initials: M
authors.lastname: Mansour
authors.forename: Debra
authors.initials: D
authors.lastname: Guss
authors.forename: Smruti R
authors.initials: SR
authors.lastname: Mohanty
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000201:enzymology / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D000072230:Sustained Virologic Response; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011480:Protease Inhibitors; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a