title: Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.
abstract: OBJECTIVE
  We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV).
  
  
  METHODS
  Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25IU/ml) 12 weeks after cessation of therapy (SVR12).
  
  
  RESULTS
  Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n=31) or 24 weeks (n=29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49-83%) in the 12-week group, and by 93% of patients (95% CI, 77-99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event.
  
  
  CONCLUSIONS
  The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA. Electronic address: pjruane@RuaneMedical.com.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Ruane
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Dani
authors.initials: D
authors.lastname: Ain
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Stryker
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Meshrekey
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Mina
authors.initials: M
authors.lastname: Soliman
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Wolfe
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Riad
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
authors.forename: Sameh
authors.initials: S
authors.lastname: Mikhail
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Kersey
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Deyuan
authors.initials: D
authors.lastname: Jiang
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Benedetta
authors.initials: B
authors.lastname: Massetto
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Doehle
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Kirby
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Knox
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: William T
authors.initials: WT
authors.lastname: Symonds
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000379:methods; D004534:Egypt; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000208:ethnology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012324:RNA-Dependent RNA Polymerase / Q000037:antagonists & inhibitors; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load / Q000187:drug effects / Q000379:methods; D017361:Viral Nonstructural Proteins / Q000037:antagonists & inhibitors
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D017361:Viral Nonstructural Proteins; D012254:Ribavirin; C087036:NS-5 protein, hepatitis C virus; D012324:RNA-Dependent RNA Polymerase; D000069474:Sofosbuvir
keywords: Direct-acting antiviral; Egyptian; Genotype 4; Hepatitis C virus; Interferon-free therapy; Sofosbuvir