Real-world effectiveness of peginterferon α-2b plus ribavirin in a Canadian cohort of treatment-naïve chronic hepatitis C patients with genotypes 2 or 3: results of the PoWer and RediPEN studies

• Published in: European journal of clinical microbiology & infectious diseases 2016-04, Vol.35 (4), p.597-609
• Main Authors: Marotta, P., Bailey, R., Elkashab, M., Farley, J., Feinman, S. V., Peltekian, K., Poliquin, M., Witt-Sullivan, H., Rampakakis, E., Drolet, M., Cooper, C.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antiviral Agents - therapeutic use; Biomedical and Life Sciences; Biomedicine; Canada; Female; Genotype; Hepacivirus - classification; Hepacivirus - genetics; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Interferon alpha-2; Interferon-alpha - therapeutic use; Internal Medicine; Male; Medical Microbiology; Middle Aged; Original; Original Article; Polyethylene Glycols - therapeutic use; Prospective Studies; Recombinant Proteins - therapeutic use; Recurrence; Ribavirin - therapeutic use; Treatment Outcome; Young Adult
• ISSN: 0934-9723; 1435-4373
• DOI: 10.1007/s10096-016-2576-1

The purpose of this investigation was to assess the real-life effectiveness of pegylated interferon (peg-IFN) α-2b with ribavirin (RBV) in a cohort of treatment-naïve patients with chronic genotypes 2 (G2) or 3 (G3) hepatitis C virus (HCV) infection. A post-hoc pooled analysis of two Canadian multicenter, observational studies, RediPEN and PoWer, was carried out. A total of 1242 G2- or G3-infected patients were included. The primary outcome was sustained virologic response (SVR). Secondary endpoints included early virologic response (EVR), end-of-treatment (EOT) response, and relapse. Multivariate logistic regression was used to identify independent predictors of treatment response. SVR in G2 and G3 was 74.4 % and 63.6 %, respectively. Relapse occurred in 12.7 % and 19.1 % of G2- and G3-infected patients achieving EOT response, respectively. Overall, G3 was found to independently predict reduced SVR [odds ratio (OR) = 0.20; p  = 0.007] and increased relapse (OR = 6.84; p  = 0.022). Among G3-infected patients, increasing fibrosis score was the most important factor predicting reduced SVR [F2 vs. F0/F1 (OR = 0.41; p  = 0.009); F3 vs. F0/F1 (OR = 0.72; p  = 0.338); F4 vs. F0/F1 (OR = 0.27; p  = 0.001)]. Male gender (OR = 13.16; p  = 0.020) and higher fibrosis score [F2 vs. F0/F1 (OR = 9.72; p  = 0.016); F3/F4 vs. F0/F1 (OR = 4.23; p  = 0.113)] were associated with increased relapse in G3 patients. These results support the real-life effectiveness of peg-IFN α-2b plus ribavirin in HCV G2- and G3-infected patients. Overall, genotype was identified as the most significant predictor of treatment outcome. Fibrosis score and gender were key outcome predictors in the G3-infected population. In clinical settings, peg-INF/RBV offers an alternative for patients without access to all oral direct-acting antivirals.