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Clin Infect Dis. 2016 Sep 15;63(6):776-783. doi: 10.1093/cid/ciw387. Epub 2016 Jun 19.

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

Author information

1
Toronto Centre for Liver Disease, Sandra Rotman Centre for Global Health, University of Toronto, Ontario, Canada.
2
Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
3
Goethe University Hospital, Frankfurt, Germany.
4
University of California, San Diego.
5
University of Florida, Gainesville.
6
Saint Louis University School of Medicine, Missouri.
7
Hannover Medical School, Germany.
8
University of Cincinnati, Ohio.
9
Liver Wellness Center, Little Rock, Arkansas.
10
Virginia Commonwealth University Health System, Richmond.
11
University of Nebraska Medical Center, Omaha.
12
University of North Carolina, Chapel Hill.
13
Carolinas Healthcare System, Charlotte, North Carolina.

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 >10(5) 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.

KEYWORDS:

cirrhosis; genotype 3; interferon; ribavirin; sofosbuvir

PMID:
27325691
PMCID:
PMC4996139
DOI:
10.1093/cid/ciw387
[Indexed for MEDLINE]
Free PMC Article

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