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J Hepatol. 2015 May;62(5):1040-6. doi: 10.1016/j.jhep.2014.10.044. Epub 2014 Nov 5.

Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.

Author information

1
Ruane Medical and Liver Health Institute, Los Angeles, CA, USA. Electronic address: pjruane@RuaneMedical.com.
2
Ruane Medical and Liver Health Institute, Los Angeles, CA, USA.
3
Gilead Sciences, Inc., Foster City, CA, USA.

Abstract

BACKGROUND & AIMS:

We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV).

METHODS:

Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25IU/ml) 12 weeks after cessation of therapy (SVR12).

RESULTS:

Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n=31) or 24 weeks (n=29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49-83%) in the 12-week group, and by 93% of patients (95% CI, 77-99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event.

CONCLUSIONS:

The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.

KEYWORDS:

Direct-acting antiviral; Egyptian; Genotype 4; Hepatitis C virus; Interferon-free therapy; Sofosbuvir

PMID:
25450208
DOI:
10.1016/j.jhep.2014.10.044
[Indexed for MEDLINE]
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