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

Drug Des Devel Ther. 2015 Nov 11;9:6027-33. doi: 10.2147/DDDT.S95499. eCollection 2015.

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).

Conclusion: 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.

Keywords: chronic hepatitis C; direct acting antiviral agents; dual antiviral therapy; ultra-rapid virologic response; very-rapid virologic response.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Video-Audio Media

MeSH terms

  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Comparative Effectiveness Research
  • Drugs, Generic / adverse effects
  • Drugs, Generic / therapeutic use*
  • Egypt
  • Female
  • Hepacivirus / drug effects*
  • Hepatitis C, Chronic / blood
  • Hepatitis C, Chronic / diagnosis
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • RNA, Viral / blood
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Therapeutic Equivalency
  • Time Factors
  • Treatment Outcome
  • Viral Load

Substances

  • Antiviral Agents
  • Drugs, Generic
  • RNA, Viral
  • Sofosbuvir