title: The very-rapid and the ultra-rapid virologic response to two treatment options in patients with chronic hepatitis C: an interim report of a prospective randomized comparative effectiveness study.
abstract: BACKGROUND
  We aimed in this interim report to compare two registered generic sofosbuvir products for the degree and speed of virologic response to a dual antiviral treatment protocol within the first 2 weeks of treatment.
  
  
  METHODS
  Data collected during the period of this interim report from the first 25 patients randomized to either one of two generic sofosbuvir products (Grateziano or Gratisovir) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment.
  
  
  RESULTS
  The baseline Log10 transformed virus load (Log polymerase chain reaction) showed a fairly similar marked and significant reduction in both groups by more than 4 and 5 Logs at the end of week 1 and 2 of starting treatment, respectively. The differences between the two treatment groups at both analysis points were not statistically significant (P>0.05) by repeated measures factorial analysis of variance test. The differences in proportions of patients with ultra-rapid virologic response at the end of week 1 and very-rapid virologic response at the end of week 2 in both groups were also not statistically significant (P>0.05).
  
  
  CONCLUSIONS
  We can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally fast and efficacious in reducing the hepatitis C virus load in our study setting.
authors.affiliation: Green Clinic and Research Center, Alexandria University, Alexandria, Egypt ; Abbas Helmy Clinics, Alexandria University, Alexandria, Egypt.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Yakoot
authors.affiliation: Tropical Medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
authors.forename: Alaa M
authors.initials: AM
authors.lastname: Abdo
authors.affiliation: Microbiology Department, High Institute of Public Health, Alexandria University, Alexandria, Egypt ; Mabarat El Asafra Labs, Alexandria, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Yousry
authors.affiliation: Pharco Corporation, Alexandria, Egypt.
authors.forename: Sherine
authors.initials: S
authors.lastname: Helmy
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D004534:Egypt; D005260:Female; D016174:Hepacivirus / Q000187:drug effects*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016568:Drugs, Generic; D012367:RNA, Viral; D000069474:Sofosbuvir
keywords: chronic hepatitis C; direct acting antiviral agents; dual antiviral therapy; ultra-rapid virologic response; very-rapid virologic response