PMID- 26786792
OWN - NLM
STAT- MEDLINE
DCOM- 20171116
LR  - 20211204
IS  - 1478-3231 (Electronic)
IS  - 1478-3223 (Linking)
VI  - 36
IP  - 7
DP  - 2016 Jul
TI  - The combination of daclatasvir and sofosbuvir for curing genotype 2 patients who 
      cannot tolerate ribavirin.
PG  - 971-6
LID - 10.1111/liv.13069 [doi]
AB  - BACKGROUND: 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. METHODS: We conducted an open-label observational, prospective study 
      on a subgroup of GT-2 patients either naive 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. RESULTS: 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. CONCLUSIONS: 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.
CI  - (c) 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Mangia, Alessandra
AU  - Mangia A
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
FAU - Arleo, Andrea
AU  - Arleo A
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
FAU - Copetti, Massimiliano
AU  - Copetti M
AD  - Biostatic Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, 
      Italy.
FAU - Miscio, Maria
AU  - Miscio M
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
FAU - Piazzolla, Valeria
AU  - Piazzolla V
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
FAU - Santoro, Rosanna
AU  - Santoro R
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
FAU - Squillante, Maria Maddalena
AU  - Squillante MM
AD  - Liver Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20160207
PL  - United States
TA  - Liver Int
JT  - Liver international : official journal of the International Association for the 
      Study of the Liver
JID - 101160857
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Pyrrolidines)
RN  - 49717AWG6K (Ribavirin)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Aged
MH  - Antiviral Agents/*administration & dosage/adverse effects
MH  - Carbamates
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Fatigue/chemically induced
MH  - Female
MH  - Hepacivirus/genetics
MH  - Hepatitis C, Chronic/complications/*drug therapy
MH  - Humans
MH  - Imidazoles/*administration & dosage/adverse effects
MH  - Italy
MH  - Liver Cirrhosis/complications
MH  - Male
MH  - Prospective Studies
MH  - Pyrrolidines
MH  - Ribavirin
MH  - Sofosbuvir/*administration & dosage/adverse effects
MH  - Sustained Virologic Response
MH  - Valine/analogs & derivatives
MH  - Viral Load
OTO - NOTNLM
OT  - daclatasvir
OT  - genotype-2
OT  - ribavirin free
OT  - sofosbuvir
EDAT- 2016/01/21 06:00
MHDA- 2017/11/29 06:00
CRDT- 2016/01/21 06:00
PHST- 2015/11/20 00:00 [received]
PHST- 2016/01/10 00:00 [accepted]
PHST- 2016/01/21 06:00 [entrez]
PHST- 2016/01/21 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
AID - 10.1111/liv.13069 [doi]
PST - ppublish
SO  - Liver Int. 2016 Jul;36(7):971-6. doi: 10.1111/liv.13069. Epub 2016 Feb 7.