title: The combination of daclatasvir and sofosbuvir for curing genotype 2 patients who cannot tolerate ribavirin.
abstract: The current standard-of-care for treatment of HCV genotype 2 (GT-2) patients is the combination of sofosbuvir (SOF) with weight-based ribavirin (RBV). Patients with HCV GT-2 infection and ribavirin contraindications require the use of SOF plus NS5A inhibitor daclatasvir (DCV) which is not reimbursed everywhere.
  
  
  
  We conducted an open-label observational, prospective study on a subgroup of GT-2 patients either naïve or treatment experienced (TE) with contraindications to the use of RBV. Patients with cirrhosis of Child-Pugh-Turcotte (CPT) class A and B or advanced fibrosis with comorbidities were included. They were assigned to receive 12 or 24 weeks of SOF/DCV. The primary end point of the study was sustained virological response (SVR) defined as HCV RNA levels <12 IU/ml, 12 weeks post treatment.
  
  
  
  Out of 106 patients with GT-2 who received treatment at our unit from July 2014 to June 2015, 20 (18.8%) patients, whose treatment could not be deferred, were ribavirin intolerant; 19 received SOF/DCV combination for 12 or 24 weeks. The majority of the patients was men, 58% had cirrhosis, and 58% were TE. All treated patients achieved SVR regardless of treatment duration. The most common adverse events (AEs) were fatigue, headache and nausea. No discontinuations due to AEs were observed. Two patients had oesophageal bleeding but continued treatment and achieved SVR; one patient developed HCC 12 weeks post treatment, but remained HCV RNA undetectable.
  
  
  
  This study supports the use of SOF/DCV for 12 weeks in non-cirrhotics or 24 weeks in cirrhotic GT-2 patients who cannot tolerate RBV, including those with decompensated disease.
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mangia
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Arleo
authors.affiliation: Biostatic Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Copetti
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Miscio
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Piazzolla
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Santoro
authors.affiliation: Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Maria Maddalena
authors.initials: MM
authors.lastname: Squillante
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002219:Carbamates; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D007558:Italy; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D011446:Prospective Studies; D011759:Pyrrolidines; D012254:Ribavirin; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D000072230:Sustained Virologic Response; D014633:Valine / Q000031:analogs & derivatives; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D012254:Ribavirin; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: daclatasvir; genotype-2; ribavirin free; sofosbuvir