title: Safety and efficacy of sofosbuvir plus ledipasvir with and without ribavirin for chronic HCV genotype-1 infection: a systematic review and meta-analysis.
abstract: Ledipasvir and sofosbuvir are new direct-acting antiviral agents for patients with HCV infection. Ledipasvir inhibits the HCV non-structural 5A protein, while sofosbuvir is a nucleotide polymerase inhibitor. Many studies have evaluated the safety and efficacy of ledipasvir and sofosbuvir combination with and without ribavirin for patients with chronic HCV genotype-1.
  
  
  
  A computer literature search of PubMed, SCOPUS, Web of Knowledge and Cochrane CENTRAL has been conducted. Studies were screened for eligibility and data were extracted. Sustained virological response (SVR) rate and commonly reported adverse events were pooled as risk ratio (RR) using Review Manager version 5.3 for windows and OpenMeta (Analyst) software.
  
  
  
  Eight randomized controlled trials (n=1,892) were pooled in the final analysis. A 12-week ledipasvir and sofosbuvir regimen achieved SVR in 97.5% and 89% of non-cirrhotic and cirrhotic patients, respectively. A 24-week ledipasvir and sofosbuvir regimen achieved SVR in 99.6% and 92.6% in non-cirrhotic and cirrhotic patients, respectively. When ribavirin was added to the treatment regiment, the SVR did not differ significantly in either of the treatment regimens (12-week SVR: 93.9% versus 96.7%, RR=0.97, P=0.19 and 24-week SVR: 94.8% versus 97.2%, RR=0.98, P=0.24).
  
  
  
  The combination of sofosbuvir and ledipasvir achieved high SVR rates (>90%) in both cirrhotic and non-cirrhotic patients with HCV genotype-1. The addition of ribavirin to this regimen did not significantly increase the SVR rates.
authors: Faculty of Medicine, Zagazig University, Zagazig, Egypt.|Medical Research Group of Egypt, Cairo, Egypt.|Student Research Unit, Zagazig University, Zagazig, Egypt.
authors: Hussien
authors: H
authors: Ahmed
authors: Medical Research Group of Egypt, Cairo, Egypt.|Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
authors: Ahmed
authors: A
authors: Elgebaly
authors: Medical Research Group of Egypt, Cairo, Egypt.|Faculty of Medicine, Ain Shams University, Cairo, Egypt.|NovaMed Medical Research Association, Cairo, Egypt.
authors: Abdelrahman Ibrahim
authors: AI
authors: Abushouk
authors: Medical Research Group of Egypt, Cairo, Egypt.|Faculty of Medicine, Cairo University, Cairo, Egypt.
authors: Ali Mohamed
authors: AM
authors: Hammad
authors: Medical Research Group of Egypt, Cairo, Egypt.|Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
authors: Attia
authors: A
authors: Attia
authors: Faculty of Medicine, Zagazig University, Zagazig, Egypt.|Medical Research Group of Egypt, Cairo, Egypt.|Student Research Unit, Zagazig University, Zagazig, Egypt.|School of Medicine, Liverpool University, Liverpool, UK.
authors: Ahmed
authors: A
authors: Negida
mesh_terms: D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017594:Publication Bias; D012367:RNA, Viral; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; D012367:RNA, Viral; C586541:ledipasvir; D012254:Ribavirin; D000069474:Sofosbuvir