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Clinical Trial
. 2014 Sep 19;9(9):e107592.
doi: 10.1371/journal.pone.0107592. eCollection 2014.

Predictive factors for sustained virological response after treatment with pegylated interferon α-2a and ribavirin in patients infected with HCV genotypes 2 and 3

Affiliations
Clinical Trial

Predictive factors for sustained virological response after treatment with pegylated interferon α-2a and ribavirin in patients infected with HCV genotypes 2 and 3

Claus Niederau et al. PLoS One. .

Abstract

Background: Previous trials have often defined genotype 2 and 3 patients as an "easy to treat" group and guidelines recommend similar management.

Aims: The present study looks for differences between the two genotypes and analyzes predictive factors for SVR.

Methods: Prospective, community-based cohort study involving 421 physicians throughout Germany. The analysis includes 2,347 patients with untreated chronic HCV genotype 2 (n = 391) and 3 (n = 1,956) infection treated with PEG-IFN α-2a plus ribavirin between August 2007 and July 2012.

Results: When compared with genotype 2 patients, those with genotype 3 were younger, had a shorter duration of infection, lower values of total cholesterol, LDL cholesterol and BMI, a higher frequency of drug use as infection mode and male gender (p<0.0001, respectively), and a higher APRI score (p<0.005). SVR was higher in genotype 2 when compared with genotype 3 (64.7% vs. 56.9%, p = 0.004). By multivariate analysis of genotype 2 patients, low baseline γ -GT and RVR predicted SVR. In genotype 3 age ≤45 years, cholesterol>130 mg/dl, a low APRI score, and a γ-GT ≥3-times ULN, RVR, and RBV starting dose were associated with SVR by multivariate analysis.

Conclusions: The present study corroborates that liver fibrosis is more pronounced in genotype 3 vs. 2. SVR is higher in genotype 2 versus genotype 3 partly because of follow-up problems in genotype 3 patients, in particular in those infected by drug use. Thus, subgroups of genotype 3 patients have adherence problems and need special attention also because they often have significant liver fibrosis.

Trial registration: Verband Forschender Arzneimittelhersteller e.V., Berlin, Germany ML21645 ClinicalTrials.gov NCT02106156.

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Conflict of interest statement

Competing Interests: The authors have the following interests: Ulrich Alshuth has an affiliation to the commercial funders of this research study (Roche Pharma AG). Claus Niederau: Consulting: Boehringer Ingelheim, Janssen-Cilag, Janssen Therapeutic EMEA, MSD, GSK; Speakers Bureau: Boehringer Ingelheim, Janssen-Cilag, Gilead, MSD, Roche. Stefan Mauss: Adbord: Abbvie, BI, BMS, Gilead, Janssen, Roche; speakers bureau: Abbvie, BI, BMS, Gilead, Janssen, MSD, Roche; travel support: Abbvie, BI, BMS, Gilead, Janssen, MSD, Roche. Tim Zimmermann: Travel Grands and speech: Roche. Bernd Weber: Speaking and Teaching: Roche, Janssen-Cilag, MSD, Gilead. Bernd Bokemeyer: Concultancy: Roche. Dietrich Hueppe: Consulting: Roche, Gilead, BMS, Novartis, MSD, Janssen-Cilag. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

References

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