Treatment Response in Sofosbuvir-Based Therapy of HCV
Treatment Response in Sofosbuvir-Based Therapy of HCV
We analyzed clinical and laboratory data of all consecutive patients aged 18 years or older with treatment initiation for chronic HCV genotype 1, 2, 3 or 4 infection between January and June 2014 in a retrospective, longitudinal study at four investigational sites in Germany. One patient was non-adherent to the antiviral treatment plan and showed no SVR. This patient was included in the intention-to-treat (ITT) analysis.
Patients were treated with a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV for either 12 or 24 weeks, depending on genotype, pretreatment history, presence of liver cirrhosis or contraindications according to the approved treatment recommendations. SOF was administered at 400 mg once daily and RBV dose was based on body weight (1000 mg per day for <75 kg and 1200 mg per day for ≥75 kg in a divided dose) in all patients. Peg-IFN-alfa-2a was applied at a dosing of 180 μg once weekly to patients with genotype 1, 3 or 4 according to the individual treatment protocol. Serum HCV-RNA and standard laboratory tests were regularly assessed at baseline, at weeks 4, 12 and 24 of treatment and at additional time points, if deemed necessary, as well as at 12 weeks of follow-up. The lower limit of quantification (LLOQ) was 12 IU/ml (Abbott RealTime (ART) HCV assay (Abbott Molecular, Des Plaines, IL, USA). Liver cirrhosis was confirmed by liver histology or by evaluation of data sets from non-invasive tests, comprising fibroscan measurement, ultrasound examination, imaging by computed tomography or magnetic resonance, presence of esophageal varices and laboratory values. No patient with decompensated liver cirrhosis was included in the analysis. The institutional Ethics Committee (Ethikkommission der Medizinischen Fakultät Heidelberg) approved the protocol and the study was conducted in accordance with the Guidelines for Good Clinical Practice and the Declaration of Helsinki.
Continuous data are expressed by mean values and standard deviation. Categorical variables are expressed as absolute and relative numbers. Continuous data over time was analyzed with one-sample t-test and categorical data with chi-square test. A p value <0.05 was considered statistically significant. Statistical analysis was performed using GraphPad Prism software (version 6.0, GraphPad Software, Inc., La Jolla, CA, USA).
Patients and Methods
Patient Population and Study Design
We analyzed clinical and laboratory data of all consecutive patients aged 18 years or older with treatment initiation for chronic HCV genotype 1, 2, 3 or 4 infection between January and June 2014 in a retrospective, longitudinal study at four investigational sites in Germany. One patient was non-adherent to the antiviral treatment plan and showed no SVR. This patient was included in the intention-to-treat (ITT) analysis.
Patients were treated with a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV for either 12 or 24 weeks, depending on genotype, pretreatment history, presence of liver cirrhosis or contraindications according to the approved treatment recommendations. SOF was administered at 400 mg once daily and RBV dose was based on body weight (1000 mg per day for <75 kg and 1200 mg per day for ≥75 kg in a divided dose) in all patients. Peg-IFN-alfa-2a was applied at a dosing of 180 μg once weekly to patients with genotype 1, 3 or 4 according to the individual treatment protocol. Serum HCV-RNA and standard laboratory tests were regularly assessed at baseline, at weeks 4, 12 and 24 of treatment and at additional time points, if deemed necessary, as well as at 12 weeks of follow-up. The lower limit of quantification (LLOQ) was 12 IU/ml (Abbott RealTime (ART) HCV assay (Abbott Molecular, Des Plaines, IL, USA). Liver cirrhosis was confirmed by liver histology or by evaluation of data sets from non-invasive tests, comprising fibroscan measurement, ultrasound examination, imaging by computed tomography or magnetic resonance, presence of esophageal varices and laboratory values. No patient with decompensated liver cirrhosis was included in the analysis. The institutional Ethics Committee (Ethikkommission der Medizinischen Fakultät Heidelberg) approved the protocol and the study was conducted in accordance with the Guidelines for Good Clinical Practice and the Declaration of Helsinki.
Statistical Analysis
Continuous data are expressed by mean values and standard deviation. Categorical variables are expressed as absolute and relative numbers. Continuous data over time was analyzed with one-sample t-test and categorical data with chi-square test. A p value <0.05 was considered statistically significant. Statistical analysis was performed using GraphPad Prism software (version 6.0, GraphPad Software, Inc., La Jolla, CA, USA).
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