biostudies-literatureWelzel TMNCATS NIH HHSNIDA NIH HHSNIDDK NIH HHSNIA NIH HHS1844-1852https://www.ebi.ac.uk/biostudies/studies/S-EPMC5595101biostudies-literatureUnknown66(10)<h4>Objective</h4>Due to a high efficacy in clinical trials, sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these regimens for GT2 in HCV-TARGET participants.<h4>Design</h4>HCV-TARGET, an international, prospective observational study evaluates clinical practice data on novel antiviral therapies at 44 academic and 17 community medical centres in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice. The primary efficacy outcome was sustained virological response 12 weeks after therapy (SVR12).<h4>Results</h4>Between December 2013 and April 2015, 321 patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and RBV. Prior treatment experience and cirrhosis was more frequent among patients in the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline were significantly associated with SVR12. Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to AEs occurred in 2.8%.<h4>Conclusions</h4>In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.<h4>Trial registration number</h4>NCT01474811.GutEffectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.PMC5595101UL1 TR000064K24 DK070528P30 AG028740K24 DK066144K24 DA034621P30 DK034989UL1 TR001863UL1 TR001427Reddy RKPockros PGalati JSMorelli GZeuzem SAkushevich LDi Bisceglie ANelson DRFried MWAlqahtani SKuo ASulkowski MSVainorius MDarling JFrazier LMLim JKHCV-TARGET Study GroupWelzel TMfalseEffectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.<h4>Objective</h4>Due to a high efficacy in clinical trials, sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these regimens for GT2 in HCV-TARGET participants.<h4>Design</h4>HCV-TARGET, an international, prospective observational study evaluates clinical practice data on novel antiviral therapies at 44 academic and 17 community medical centres in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice. The primary efficacy outcome was sustained virological response 12 weeks after therapy (SVR12).<h4>Results</h4>Between December 2013 and April 2015, 321 patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and RBV. Prior treatment experience and cirrhosis was more frequent among patients in the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline were significantly associated with SVR12. Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to AEs occurred in 2.8%.<h4>Conclusions</h4>In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.<h4>Trial registration number</h4>NCT01474811.2017-01-01T00:00:00Z2017 Oct2026-06-08T06:49:39.39Z2026-06-08T03:14:10.779ZS-EPMC55951012741863210.1136/gutjnl-2016-311609