Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study

Jordan J. Feld, Raoel Maan, Stefan Zeuzem, Alexander Kuo, David R. Nelson, Adrian M. Di Bisceglie, Michael P. Manns, Ken Sherman, Lynn M. Frazier, Richard Sterling, Mark E Mailliard, Monica Schmidt, Lucy Akushevich, Monika Vainorius, Michael W. Fried

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background. Sofosbuvir (SOF) is active against all hepatitis C virus (HCV) genotypes, and SOF-based therapies lead to high rates of sustained virologic response (SVR). However, genotype 3 (GT3) HCV remains a challenge with lower SVR rates reported, particularly in patients with cirrhosis. This study reports the effectiveness and safety of SOF-based therapy in patients with GT3 HCV treated in clinical practice. Methods. Hepatitis C Virus Therapeutic Registry and Research Network is an international, prospective observational study evaluating patients treated in usual clinical practice. Patients with GT3 HCV were analyzed to assess predictors of treatment response and adverse events using descriptive statistics and multivariable logistic regression. Results. Treatment outcomes were available for 197 patients treated with SOF and ribavirin (RBV), with or without peginterferon, including 54% with cirrhosis and 49% who failed prior therapy. Of 178 patients treated with SOF/RBV, 60% achieved SVR at 12 weeks (SVR12), compared with 84% of 19 patients treated with SOF/peginterferon/RBV. For patients treated with SOF/RBV, the SVR12 rate was 58% in treatment-naive patients with cirrhosis, and 42% in those with cirrhosis who failed prior therapy. In noncirrhotic patients, SVR12 rates were 89% in treatment-naive and 88% in treatment-experienced patients. After controlling for age and sex, absence of cirrhosis (odds ratio [OR], 6.4; 95% confidence interval [CI], 2.78-14.74), albumin levels ≥3.2 g/dL (OR, 12.48; 95% CI, 3.86-40.33), and platelet count >105 cells/μL (OR, 7.44; 95% CI, 3.51-15.78) were associated with greater odds of SVR12. Conclusions. SVR rates were acceptable in patients with GT3 HCV without cirrhosis; however, in those with cirrhosis, treatment with SOF/RBV was suboptimal, highlighting the need for new therapies for this population.

Original languageEnglish (US)
Pages (from-to)776-783
Number of pages8
JournalClinical Infectious Diseases
Volume63
Issue number6
DOIs
StatePublished - Sep 15 2016

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Chronic Hepatitis C
Hepacivirus
Genotype
Safety
Infection
Ribavirin
Fibrosis
Therapeutics
Odds Ratio
Confidence Intervals
Sofosbuvir
Therapeutic Human Experimentation
Platelet Count
Observational Studies
Registries
Albumins
Logistic Models
Prospective Studies

Keywords

  • cirrhosis
  • genotype 3
  • interferon
  • ribavirin
  • sofosbuvir

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Feld, J. J., Maan, R., Zeuzem, S., Kuo, A., Nelson, D. R., Di Bisceglie, A. M., ... Fried, M. W. (2016). Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study. Clinical Infectious Diseases, 63(6), 776-783. https://doi.org/10.1093/cid/ciw387

Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection : Results of the HCV-TARGET Study. / Feld, Jordan J.; Maan, Raoel; Zeuzem, Stefan; Kuo, Alexander; Nelson, David R.; Di Bisceglie, Adrian M.; Manns, Michael P.; Sherman, Ken; Frazier, Lynn M.; Sterling, Richard; Mailliard, Mark E; Schmidt, Monica; Akushevich, Lucy; Vainorius, Monika; Fried, Michael W.

In: Clinical Infectious Diseases, Vol. 63, No. 6, 15.09.2016, p. 776-783.

Research output: Contribution to journalArticle

Feld, JJ, Maan, R, Zeuzem, S, Kuo, A, Nelson, DR, Di Bisceglie, AM, Manns, MP, Sherman, K, Frazier, LM, Sterling, R, Mailliard, ME, Schmidt, M, Akushevich, L, Vainorius, M & Fried, MW 2016, 'Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study', Clinical Infectious Diseases, vol. 63, no. 6, pp. 776-783. https://doi.org/10.1093/cid/ciw387
Feld, Jordan J. ; Maan, Raoel ; Zeuzem, Stefan ; Kuo, Alexander ; Nelson, David R. ; Di Bisceglie, Adrian M. ; Manns, Michael P. ; Sherman, Ken ; Frazier, Lynn M. ; Sterling, Richard ; Mailliard, Mark E ; Schmidt, Monica ; Akushevich, Lucy ; Vainorius, Monika ; Fried, Michael W. / Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection : Results of the HCV-TARGET Study. In: Clinical Infectious Diseases. 2016 ; Vol. 63, No. 6. pp. 776-783.
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T2 - Results of the HCV-TARGET Study

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AU - Zeuzem, Stefan

AU - Kuo, Alexander

AU - Nelson, David R.

AU - Di Bisceglie, Adrian M.

AU - Manns, Michael P.

AU - Sherman, Ken

AU - Frazier, Lynn M.

AU - Sterling, Richard

AU - Mailliard, Mark E

AU - Schmidt, Monica

AU - Akushevich, Lucy

AU - Vainorius, Monika

AU - Fried, Michael W.

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N2 - Background. Sofosbuvir (SOF) is active against all hepatitis C virus (HCV) genotypes, and SOF-based therapies lead to high rates of sustained virologic response (SVR). However, genotype 3 (GT3) HCV remains a challenge with lower SVR rates reported, particularly in patients with cirrhosis. This study reports the effectiveness and safety of SOF-based therapy in patients with GT3 HCV treated in clinical practice. Methods. Hepatitis C Virus Therapeutic Registry and Research Network is an international, prospective observational study evaluating patients treated in usual clinical practice. Patients with GT3 HCV were analyzed to assess predictors of treatment response and adverse events using descriptive statistics and multivariable logistic regression. Results. Treatment outcomes were available for 197 patients treated with SOF and ribavirin (RBV), with or without peginterferon, including 54% with cirrhosis and 49% who failed prior therapy. Of 178 patients treated with SOF/RBV, 60% achieved SVR at 12 weeks (SVR12), compared with 84% of 19 patients treated with SOF/peginterferon/RBV. For patients treated with SOF/RBV, the SVR12 rate was 58% in treatment-naive patients with cirrhosis, and 42% in those with cirrhosis who failed prior therapy. In noncirrhotic patients, SVR12 rates were 89% in treatment-naive and 88% in treatment-experienced patients. After controlling for age and sex, absence of cirrhosis (odds ratio [OR], 6.4; 95% confidence interval [CI], 2.78-14.74), albumin levels ≥3.2 g/dL (OR, 12.48; 95% CI, 3.86-40.33), and platelet count >105 cells/μL (OR, 7.44; 95% CI, 3.51-15.78) were associated with greater odds of SVR12. Conclusions. SVR rates were acceptable in patients with GT3 HCV without cirrhosis; however, in those with cirrhosis, treatment with SOF/RBV was suboptimal, highlighting the need for new therapies for this population.

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KW - cirrhosis

KW - genotype 3

KW - interferon

KW - ribavirin

KW - sofosbuvir

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