PMID- 26096332
OWN - NLM
STAT- MEDLINE
DCOM- 20160119
LR  - 20220410
IS  - 1527-3350 (Electronic)
IS  - 0270-9139 (Linking)
VI  - 62
IP  - 4
DP  - 2015 Oct
TI  - Multicenter experience using simeprevir and sofosbuvir with or without ribavirin 
      to treat hepatitis C genotype 1 in patients with cirrhosis.
PG  - 1004-12
LID - 10.1002/hep.27937 [doi]
AB  - Interferon (IFN)-free regimens are needed to treat hepatitis C virus (HCV) 
      infection. Combined simeprevir (SMV) and sofosbuvir (SOF) with or without 
      ribavirin (RBV) results in high sustained virological response (SVR) rates along 
      with minimal adverse events (AEs) in patients with hepatitis C genotype 1 (HCV 
      GT1). The aim of this study was to report on the virological response, safety, 
      and tolerability of SOF and SMV with or without RBV in compensated and 
      decompensated patients with cirrhosis with HCV GT1 infection. Patients treated 
      with standardized clinical protocol utilizing SMV+SOF with or without RBV at 
      three transplant centers were retrospectively reviewed. A total of 119 patients 
      (61% male, 87% white, 69% subtype 1a, 30% Child-Pugh-Turcott [CPT]-B liver 
      cirrhosis [LC], and 82% were treatment experienced) received treatment and were 
      followed for a median of 38 weeks (range, 12-58). Sustained virological response 
      (SVR) at week 12 (SVR12) was achieved in 78% (92 of 118) of patients (95% 
      confidence interval: 69-85). Lower pretreatment Model for End Stage Liver Disease 
      (MELD) score was a predictor of SVR12 (P = 0.018). Baseline viral load, previous 
      treatment status, RBV use, or GT1 subtype did not impact SVR 12. The majority of 
      patients with SVR12 showed stability or improvement in MELD score. Treatment was 
      very well tolerated with mild degrees of AEs. CONCLUSIONS: The regimen of SMV+SOF 
      with or without RBV for 12 weeks was very well tolerated and resulted in high 
      SVR12 rates (78%) in HCV GT1 patients with LC. SVR12 was inversely related to 
      pretreatment MELD. SVR12 had favorable short-term impact on MELD score. Long-term 
      impact on disease stability is yet to be determined. Longer treatment duration or 
      the use of different regimen may still be needed in this population.
CI  - (c) 2015 by the American Association for the Study of Liver Diseases.
FAU - Aqel, Bashar A
AU  - Aqel BA
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
FAU - Pungpapong, Surakit
AU  - Pungpapong S
AD  - Department of Transplant, Mayo Clinic, Jacksonville, FL.
FAU - Leise, Michael
AU  - Leise M
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
FAU - Werner, K Tuesday
AU  - Werner KT
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
FAU - Chervenak, Amy E
AU  - Chervenak AE
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
FAU - Watt, Kymberly D
AU  - Watt KD
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
FAU - Murphy, Jennifer L
AU  - Murphy JL
AD  - Department of Transplant, Mayo Clinic, Jacksonville, FL.
FAU - Ryland, Kristen
AU  - Ryland K
AD  - Department of Transplant, Mayo Clinic, Jacksonville, FL.
FAU - Keaveny, Andrew P
AU  - Keaveny AP
AD  - Department of Transplant, Mayo Clinic, Jacksonville, FL.
FAU - McLemore, Ryan
AU  - McLemore R
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
FAU - Vargas, Hugo E
AU  - Vargas HE
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20150807
PL  - United States
TA  - Hepatology
JT  - Hepatology (Baltimore, Md.)
JID - 8302946
RN  - 0 (Antiviral Agents)
RN  - 0 (Drug Combinations)
RN  - 49717AWG6K (Ribavirin)
RN  - 9WS5RD66HZ (Simeprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/*administration & dosage
MH  - Drug Combinations
MH  - Female
MH  - Genotype
MH  - Hepacivirus/classification/genetics
MH  - Hepatitis C/complications/*drug therapy
MH  - Humans
MH  - Liver Cirrhosis/complications
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Ribavirin/*administration & dosage
MH  - Simeprevir/*administration & dosage
MH  - Sofosbuvir/*administration & dosage
EDAT- 2015/06/23 06:00
MHDA- 2016/01/20 06:00
CRDT- 2015/06/23 06:00
PHST- 2015/03/18 00:00 [received]
PHST- 2015/06/05 00:00 [accepted]
PHST- 2015/06/23 06:00 [entrez]
PHST- 2015/06/23 06:00 [pubmed]
PHST- 2016/01/20 06:00 [medline]
AID - 10.1002/hep.27937 [doi]
PST - ppublish
SO  - Hepatology. 2015 Oct;62(4):1004-12. doi: 10.1002/hep.27937. Epub 2015 Aug 7.