title: Efficacy and Safety of Sofosbuvir in the Treatment of Chronic Hepatitis C: The Dawn of a New Era.
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 that the co-administration of sofosbuvir, 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.
authors.affiliation: Department of Clinical Medicine and Surgery (Ed. 18), University of Naples "Federico II", via S. Pansini 5, I-80131 Naples, Italy. ivan.gentile@unina.it.
authors.forename: Ivan
authors.initials: I
authors.lastname: Gentile
authors.forename: Federico
authors.initials: F
authors.lastname: Borgia
authors.forename: Emanuela
authors.initials: E
authors.lastname: Zappulo
authors.forename: Antonio Riccardo
authors.initials: AR
authors.lastname: Buonomo
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Spera
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Castaldo
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Borgia
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000069474:Sofosbuvir