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Updated: Mar 9, 2026

A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Hepatitis C: efficacy and safety in real life
Robert Flisiak1, Joanna Pogorzelska1, Marta Flisiak-Jackiewicz2
1Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
New interferon-free treatments for chronic Hepatitis C virus (HCV) infection show high sustained virologic response (SVR) rates in real-world studies. Ledipasvir/sofosbuvir and ombitasvir/paritaprevir/ritonavir regimens are effective and safe for genotypes 1 and 4.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Interferon-free direct-acting antiviral (DAA) regimens for chronic Hepatitis C virus (HCV) infection were approved in 2014-2015.
- Real-world data on the efficacy and safety of these novel treatments are accumulating.
Purpose of the Study:
- To present real-world data on the efficacy and safety of interferon-free regimens for chronic HCV infection up to September 2016.
- To compare the sustained virologic response (SVR) rates of different DAA combinations.
Main Methods:
- Systematic review and meta-analysis of published real-world studies.
- Inclusion of data from 13858 patients for ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) and 4260 patients for ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV.
- Analysis of safety data, including discontinuation rates due to adverse events.
Main Results:
- LDV/SOF±RBV achieved an overall SVR rate of 94% (92% in patients with cirrhosis).
- OBV/PTV/r±DSV±RBV achieved an overall SVR rate of 97% (97% in patients with cirrhosis).
- Discontinuation due to adverse events was low (≤3%), with serious adverse events reported in 0-11% of patients.
Conclusions:
- Real-world data support the use of LDV/SOF±RBV or OBV/PTV/r±DSV±RBV for chronic HCV genotypes 1 and 4 due to similar efficacy and safety profiles.
- Further real-world data are needed for patients with genotype 3 and other HCV genotypes.
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