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Reviews on Recent Clinical Trials
ISSN (Print): 1574-8871
ISSN (Online): 1876-1038
Epub Abstract Ahead of Print
DOI: 10.2174/1574887108666131213120354      Price:  $95









Efficacy and Safety of Sofosbuvir in Treatment of Chronic Hepatitis C: The Dawn of the a New Era

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Author(s): Ivan Gentile, Federico Borgia, Emanuela Zappulo, Antonio Riccardo Buonomo, Anna Maria Spera, Giuseppe Castaldo and Guglielmo Borgia
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Abstract:
Hepatitis C virus (HCV) infection affects about 160 million people worldwide. Currently, it is treated with pegylated interferon (PEG-IFN) plus ribavirin, associated with a protease inhibitor in case of genotype 1 infection. However, this combination is often contraindicated and associated with severe adverse events that limit its use in clinical practice. Several drugs active against HCV are in an advanced phase of clinical development. Among these, sofosbuvir appears one of the most promising candidates for use in association with both interferon and interferon-free combinations. This review focuses on the results of several sofosbuvir-based phase III trials that have very recently become available. These studies show the administration of sofosbuvir associated with PEG-IFN and ribavirin for 12 weeks is associated with a very high rate of sustained virological responses (SVR) (about 90%) in naïve patients with genotypes 1, 4, 5 or 6. In patients infected by genotypes 2 or 3, the interferon-free combination of sofosbuvir and ribavirin administered for 12 weeks is associated with a SVR of 97% and 56% in naïve patients, and of 86% and 30% in experienced genotype 2 or 3 patients, respectively. The safety and tolerability profile is optimal and consistent with that of the other drugs administered in the combination (ribavirin and/or interferon). In conclusion, the recent phase III trials of sofosbuvir confirm the excellent results of phase II studies in terms of efficacy and safety and will probably open a new era in the fight against HCV
Affiliation:
Department of Molecular Medicine and Advanced Biotechnologies, University of Naples “Federico II, Naples, Italy