title: Daclatasvir plus asunaprevir dual therapy for chronic HCV genotype 1b infection: results of Turkish early access program.
abstract: Background. Daclatasvir and asunaprevir dual therapy is approved for the treatment of HCV genotype 1b infection in several countries.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of daclatasvir and asunaprevir dual therapy in Turkish patients.
  
  
  METHODS
  Sixty-one patients with HCV genotype 1b were enrolled in the Turkish early access program. Most of the patients were in difficult-to-treat category. Patients were visited at each 4 week throughout the follow-up period. Laboratory findings and adverse events were recorded at each visit.
  
  
  RESULTS
  Fifty-seven of 61 enrolled patients completed 24 weeks of treatment. Two patients died as a result of underlying diseases at 12-14th weeks of treatment. Two patients stopped the treatment early as a consequence of virological breakthrough, and 2 patients had viral relapse at the post-treatment follow-up. Overall SVR12 rates were 90% (55/61) and 93.2% (55/59) according to intention-to-treat (ITT) and per protocol (PP) analysis respectively. In ITT analysis, SVR12 was achieved by 93% (13/14) in relapsers, 80% (12/15) in interferon-ineligible patients and 91% (20/22) in previous nonresponder patients. SVR12 rates were 86.5% and 91.4% in patients with cirrhosis according to ITT and PP analysis respectively. SVR12 was 95.8% in non-cirrhosis group in both analysis. Patients with previous protease inhibitor experience had an SVR12 of 87.5%. Common adverse events developed in 28.8% of patients. There were no treatment related severe adverse event or grade-4 laboratory abnormality.
  
  
  CONCLUSIONS
  Daclatasvir and asunaprevir dual therapy is found to be effective and safe in difficult-to-treat Turkish patients with HCV genotype 1b infection.
authors.affiliation: Department of Gastroenterology, Hacettepe University School of Medicine, Ankara, Turkey.
authors.forename: Seyfettin
authors.initials: S
authors.lastname: Köklü
authors.affiliation: Department of Infectious Disease, Karadeniz University School of Medicine, Trabzon, Turkey.
authors.forename: Iftihar
authors.initials: I
authors.lastname: Köksal
authors.affiliation: Department of Gastroenterology, Ege University School of Medicine, Izmir, Turkey.
authors.forename: Ulus Salih
authors.initials: US
authors.lastname: Akarca
authors.affiliation: Department of Gastroenterology, Gaziantep University School of Medicine, Gazianatep, Turkey.
authors.forename: Ayhan
authors.initials: A
authors.lastname: Balkan
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Yildirim Beyazit University School of Medicine, Ankara, Turkey.
authors.forename: Rahmet
authors.initials: R
authors.lastname: Güner
authors.affiliation: Department of Gastroenterology, Atatürk Education and Research Hospital, Ankara, Turkey.
authors.forename: Aylin
authors.initials: A
authors.lastname: Demirezen
authors.affiliation: Department of Gastroenterology, Mersin Government Hospital, Mersin, Turkey.
authors.forename: Memduh
authors.initials: M
authors.lastname: Sahin
authors.affiliation: Department of Gastroenterology, Ege University School of Medicine, Izmir, Turkey.
authors.forename: Sila
authors.initials: S
authors.lastname: Akhan
authors.affiliation: Department of Infectious Disease, Istanbul University, Cerrahpasa Medical School, Istanbul, Turkey.
authors.forename: Reşat
authors.initials: R
authors.lastname: Ozaras
authors.affiliation: Department of Gastroenterology, Ankara University School of Medicine, Ankara, Turkey.
authors.forename: Ramazan
authors.initials: R
authors.lastname: Idilman
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002219:Carbamates; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D006297:Health Services Accessibility / Q000191:economics; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D007546:Isoquinolines / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015397:Program Evaluation; D011759:Pyrrolidines; D012367:RNA, Viral / Q000235:genetics; D013449:Sulfonamides / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey; D014633:Valine / Q000031:analogs & derivatives; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D007546:Isoquinolines; D011759:Pyrrolidines; D012367:RNA, Viral; D013449:Sulfonamides; D014633:Valine; C549273:daclatasvir; C571889:asunaprevir