Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.
J Hepatol
; 62(5): 1040-6, 2015 May.
Article
em En
| MEDLINE
| ID: mdl-25450208
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 11 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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Ribavirina
/
Hepacivirus
/
Hepatite C Crônica
/
Sofosbuvir
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article