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Lawitz, E., Poordad, F., Pang, P.S., et al. (2013) Sofosbuvir and Ledipasvir Fixed-Dose Combination with and without Ribavirin in Treatment-Naive and Previously Treated Patients with Genotype 1 Hepatitis C Virus Infection (LONE-STAR): An Open-Label, Randomised, Phase 2 Trial. The Lancet, 383, 515-523.

has been cited by the following article:

  • TITLE: A New Era in the Management of the Hepatitis C

    AUTHORS: Alfredo Arredondo Bruce, Osmani Risco Morales

    KEYWORDS: Hepatitis C, Sustained Virologic Response, Intolerable Side Effects or Adverse Events, Sofosbuvir and Simeprevir

    JOURNAL NAME: International Journal of Clinical Medicine, Vol.5 No.12, June 20, 2014

    ABSTRACT: Hepatitis C is an infection caused by the hepatitis C virus that attacks the liver and leads to inflammation. The current standard-of-care regimens include a protease inhibitor—telaprevir or boceprevir—in combination with pegylated interferon and ribavirin. HepatitisC treatment options on the horizon hold promise for better viral clearance with less toxicity than current regimens. There are new data about new drugs, both direct-acting antivirals while minimizing intolerable side effects or adverse events. Developed new data from 4 phase 3 trials with the hepatitis C drug sofosbuvir and ribavirin show that a 12-week regimen is effective in treating HCV genotypes 1 through 6. In the Annual Scientific Meeting and Postgraduate Course of the American College of Gastroenterology, different research was presented that was drawn from 4 phase 3 studies: NEUTRINO, FISSION, POSITRON and FUSION which enrolled different types of patients, who received Sofosbuvir with Peginterferon Alfa 2a and Ribavirin for 12 or 24 weeks in treatment; for all studies, the primary end point was sustained virologic response at 12 and 24 weeks posttreatment. In all studies, sofosbuvir was well tolerated, with a low incidence of adverse events. In conjunction with the suggested brief duration of this regimen, this indicates that drug combinations should improve treatment adherence compared with IFN-based treatment. In conclusion, 2 novel direct-acting antiviral agents—sofosbuvir and simeprevir—target various components of the HCV genome. Advantages of these drugs include a high barrier to viral resistance, a shorter duration of treatment, once-daily dosing, absence of food restrictions, few clinically significant drug interactions, and similar efficacy in all genotypes.