PMID- 24811396 OWN - NLM STAT- Publisher LR - 20191120 IS - 1542-6270 (Electronic) IS - 1060-0280 (Linking) VI - 48 IP - 8 DP - 2014 Aug TI - Sofosbuvir: A Nucleotide NS5B Inhibitor for the Treatment of Chronic Hepatitis C Infection. PG - 1019-1029 AB - OBJECTIVE: To review the use of sofosbuvir for the treatment of chronic hepatitis C virus (HCV). DATA SOURCES: Review and nonreview articles were identified through MEDLINE (1996-April 2014), citations of articles, and meeting abstracts using keywords, including NS5B polymerase inhibitor, GS-7977, sofosbuvir, direct-acting antiviral (DAA), and others. STUDY SELECTION AND DATA EXTRACTION: Phase 1, 2, and 3 studies describing dose-ranging potential, pharmacokinetics, efficacy, safety, and tolerability of sofosbuvir were identified. DATA SYNTHESIS: Sofosbuvir is an NS5B polymerase inhibitor that was approved for use by the Food and Drug Administration in December 2013 for the treatment of chronic HCV in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) for genotype 1. Additionally, it has been evaluated with other oral DAAs, such as simeprevir and others in the pipeline. It is not recommended as monotherapy because of lower sustained virological response (SVR) rates in clinical studies. Most of the treatment regimens are 12 weeks in duration; however, certain populations require a longer duration. Sofosbuvir has activity against all 6 genotypes, although most clinical trials evaluated genotypes 1 to 3. Sofosbuvir has a favorable safety and tolerability profile, making it a recommended first-line agent for chronic HCV infection. CONCLUSION: In clinical trials, 12 weeks of sofosbuvir with concomitant peg-IFN and RBV therapy in treatment-naive and experienced HCV genotype 1 patients resulted in SVR rates of >90%. An all-oral regimen of sofosbuvir and RBV is highly effective for genotype 2 and 3 patients. Sofosbuvir was found to be tolerable with minimal adverse effects (AEs), and no treatment discontinuations occurred secondary to drug related AEs.. CI - (c) The Author(s) 2014. FAU - Rose, Lucia AU - Rose L AD - Western New England University, Springfield, MA, USA lrose@wne.edu. FAU - Bias, Tiffany E AU - Bias TE AD - Hahnemann University Hospital, Philadelphia, PA, USA. FAU - Mathias, Clinton B AU - Mathias CB AD - Western New England University, Springfield, MA, USA. FAU - Trooskin, Stacey B AU - Trooskin SB AD - Drexel University College of Medicine, Philadelphia, PA, USA. FAU - Fong, Jeffrey J AU - Fong JJ AD - MCPHS University-Worcester/Manchester, Worcester, MA, USA. LA - eng PT - Review DEP - 20140508 PL - United States TA - Ann Pharmacother JT - The Annals of pharmacotherapy JID - 9203131 OTO - NOTNLM OT - GS-7977 OT - NS5B polymerase inhibitor OT - chronic hepatitis C infection OT - sofosbuvir EDAT- 2014/05/09 06:00 MHDA- 2014/05/09 06:00 CRDT- 2014/05/10 06:00 PHST- 2014/05/10 06:00 [entrez] PHST- 2014/05/09 06:00 [pubmed] PHST- 2014/05/09 06:00 [medline] AID - 1060028014534194 [pii] AID - 10.1177/1060028014534194 [doi] PST - ppublish SO - Ann Pharmacother. 2014 Aug;48(8):1019-1029. doi: 10.1177/1060028014534194. Epub 2014 May 8.