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

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.

Author information

1
Green Clinic and Research Center, Alexandria University, Alexandria, Egypt ; Abbas Helmy Clinics, Alexandria University, Alexandria, Egypt.
2
Tropical Medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
3
Microbiology Department, High Institute of Public Health, Alexandria University, Alexandria, Egypt ; Mabarat El Asafra Labs, Alexandria, Egypt.
4
Pharco Corporation, Alexandria, Egypt.

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

PMID:
26628861
PMCID:
PMC4651553
DOI:
10.2147/DDDT.S95499
[Indexed for MEDLINE]
Free PMC Article

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