title: Safety and efficacy of once daily ledipasvir/sofosbuvir fixed-dose combination in patients with chronic hepatitis C.
abstract: BACKGROUND
  During the past couple of years, the regulatory authorities have approved seven new direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C (CHC). In 2014, the US FDA approved the fixed dose combination of ledipasvir (LDV) plus sofosbuvir (SOF) for the treatment of genotype (GT) 1 HCV and the European Commission Granted its marketing authorization to treat patients with GT1 and 4. This regimen showed outstanding rates of virologic response along with a favorable safety profile with a very low rate of both virologic failure and treatment discontinuation.
  
  
  METHODS
  In this review, we sought to review the pharmacokinetics, clinical efficacy and safety profile pertaining to LDV/SOF combination in treatment of CHC with special emphasis on phase III clinical trials.
  
  
  CONCLUSIONS
  In all phase III trials, the 12-week course of this new interferon (IFN)-sparing regimen has delivered high virologic cure rates among patient with GT1 and 4 both treatment-naïve and - experienced Data about its effectiveness in patients under 18 years of age, end-stage renal disease and patients with significant other organ involvement are eagerly awaited.
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: N
authors.initials: N
authors.lastname: Gamal
authors.affiliation: a Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
authors.forename: P
authors.initials: P
authors.lastname: Andreone
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects*; D017326:Clinical Trials, Phase III as Topic; D004359:Drug Therapy, Combination / Q000009:adverse effects*; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects*; D016174:Hepacivirus / Q000187:drug effects; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D012449:Safety; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D000069474:Sofosbuvir
keywords: Ledipasvir; efficacy; hepatitis C; safety; sofosbuvir