Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: Results of the real-world, clinical practice HCV-TARGET study

Tania M. Welzel, David R. Nelson, Giuseppe Morelli, Adrian Di Bisceglie, Rajender K. Reddy, Alexander Kuo, Joseph K. Lim, Jama Darling, Paul Pockros, Joseph S. Galati, Lynn M. Frazier, Saleh Alqahtani, Mark S. Sulkowski, Monika Vainorius, Lucy Akushevich, Michael W. Fried, Stefan Zeuzem

Research output: Contribution to journalArticle

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Abstract

Objective 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. Design 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). Results 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%. Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.

LanguageEnglish (US)
Pages1844-1852
Number of pages9
JournalGut
Volume66
Issue number10
DOIs
StatePublished - Oct 1 2017

Fingerprint

Ribavirin
Genotype
Safety
Infection
Fibrosis
Therapeutics
Sofosbuvir
Sleep Initiation and Maintenance Disorders
North America
Exanthema
Serum Albumin
Liver Cirrhosis
Nausea
Medical Records
Observational Studies
Antiviral Agents
Fatigue
Headache
Anemia
Multivariate Analysis

Keywords

  • Clinical Trials
  • Genotype
  • Hepatitis C

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Welzel, T. M., Nelson, D. R., Morelli, G., Di Bisceglie, A., Reddy, R. K., Kuo, A., ... Zeuzem, S. (2017). Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: Results of the real-world, clinical practice HCV-TARGET study. Gut, 66(10), 1844-1852. DOI: 10.1136/gutjnl-2016-311609

Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection : Results of the real-world, clinical practice HCV-TARGET study. / Welzel, Tania M.; Nelson, David R.; Morelli, Giuseppe; Di Bisceglie, Adrian; Reddy, Rajender K.; Kuo, Alexander; Lim, Joseph K.; Darling, Jama; Pockros, Paul; Galati, Joseph S.; Frazier, Lynn M.; Alqahtani, Saleh; Sulkowski, Mark S.; Vainorius, Monika; Akushevich, Lucy; Fried, Michael W.; Zeuzem, Stefan.

In: Gut, Vol. 66, No. 10, 01.10.2017, p. 1844-1852.

Research output: Contribution to journalArticle

Welzel, TM, Nelson, DR, Morelli, G, Di Bisceglie, A, Reddy, RK, Kuo, A, Lim, JK, Darling, J, Pockros, P, Galati, JS, Frazier, LM, Alqahtani, S, Sulkowski, MS, Vainorius, M, Akushevich, L, Fried, MW & Zeuzem, S 2017, 'Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: Results of the real-world, clinical practice HCV-TARGET study' Gut, vol 66, no. 10, pp. 1844-1852. DOI: 10.1136/gutjnl-2016-311609
Welzel, Tania M. ; Nelson, David R. ; Morelli, Giuseppe ; Di Bisceglie, Adrian ; Reddy, Rajender K. ; Kuo, Alexander ; Lim, Joseph K. ; Darling, Jama ; Pockros, Paul ; Galati, Joseph S. ; Frazier, Lynn M. ; Alqahtani, Saleh ; Sulkowski, Mark S. ; Vainorius, Monika ; Akushevich, Lucy ; Fried, Michael W. ; Zeuzem, Stefan. / Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection : Results of the real-world, clinical practice HCV-TARGET study. In: Gut. 2017 ; Vol. 66, No. 10. pp. 1844-1852
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abstract = "Objective 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. Design 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). Results 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\{%}. Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.",
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N2 - Objective 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. Design 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). Results 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%. Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection.

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