PMID- 26202761
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150728
LR  - 20220801
IS  - 1936-0541 (Electronic)
IS  - 1936-0533 (Linking)
VI  - 8
IP  - 4
DP  - 2014 Oct
TI  - Favorable adverse event profile of sofosbuvir/ribavirin compared to 
      boceprevir/interferon/ribavirin for treatment of hepatitis C.
PG  - 560-6
LID - 10.1007/s12072-014-9574-0 [doi]
AB  - BACKGROUND: Triple therapy for the treatment of hepatitis C virus (HCV) with 
      first-generation directly acting antiviral agents, the non-structural serine 
      protease inhibitors boceprevir (BOC) and telaprevir have resulted in improved 
      sustained virologic response (SVR) rates. However, a high incidence of adverse 
      events (AEs), high pill burdens and drug interactions remain significant barriers 
      to successful completion of therapy. The aim of this study was to evaluate the 
      AEs observed with BOC triple therapy in comparison to IFN-free 
      sofosbuvir/ribavirin (SOF/RBV) therapy in HCV monoinfected, genotype-1 (GT-1) 
      individuals. METHODS: We retrospectively evaluated HCV monoinfected, 
      treatment-naive or -experienced, GT-1 individuals treated with either BOC/IFN/RBV 
      at the Veterans Affairs Medical Center, Baltimore (n = 97) or SOF/RBV in the 
      NIAID SPARE clinical trial (n = 60). AEs, namely hematologic (hemoglobin, 
      neutrophil and platelet counts), hepatic (alanine transaminase or bilirubin) and 
      renal (eGFR), were measured according to the DAIDS toxicity table (version 1.0). 
      RESULTS: BOC/IFN/RBV was associated with significantly more AEs, most commonly 
      neutropenia, anemia and thrombocytopenia. In the SOF/RBV cohort, five (8 %) 
      patients discontinued treatment early, but none (0 %) were because of AEs, while 
      60 (62 %) patients on triple therapy discontinued treatment early, 34 (57 %) 
      because of AEs. SVR24 rates were 68 versus 34 % with SOF/RBV versus BOC/IFN/RBV. 
      CONCLUSIONS: SOF/RBV treatment was associated with fewer side effects than 
      BOC-based triple therapy, appearing to be a safer and more tolerable alternative 
      for HCV GT-1 subjects. These results show that emerging IFN-free therapies may 
      enhance patient adherence, allowing treatment of larger number of patients with 
      improved efficacy.
FAU - Narayanan, Shivakumar
AU  - Narayanan S
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
FAU - Townsend, Kerry
AU  - Townsend K
AD  - Laboratory of Immunoregulation, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, 
      Bethesda, MD, 20892, USA.
FAU - Macharia, Thomas
AU  - Macharia T
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
FAU - Majid, Adrian
AU  - Majid A
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
FAU - Nelson, Amy
AU  - Nelson A
AD  - Laboratory of Immunoregulation, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, 
      Bethesda, MD, 20892, USA.
FAU - Redfield, Robert R
AU  - Redfield RR
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
FAU - Kottilil, Shyam
AU  - Kottilil S
AD  - Laboratory of Immunoregulation, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, 
      Bethesda, MD, 20892, USA. skottilil@niaid.nih.gov.
FAU - Talwani, Rohit
AU  - Talwani R
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
FAU - Osinusi, Anu
AU  - Osinusi A
AD  - Division of Infectious Diseases, Institute of Human Virology, University of 
      Maryland School of Medicine, Baltimore, MD, USA.
AD  - Laboratory of Immunoregulation, National Institute of Allergy and Infectious 
      Diseases, National Institutes of Health, 10/11N204, 9000 Rockville Pike, 
      Bethesda, MD, 20892, USA.
LA  - eng
PT  - Journal Article
DEP - 20140921
PL  - United States
TA  - Hepatol Int
JT  - Hepatology international
JID - 101304009
OTO - NOTNLM
OT  - Adverse events
OT  - HCV monoinfection
OT  - Ribavirin
OT  - Sofosbuvir
EDAT- 2015/07/24 06:00
MHDA- 2015/07/24 06:01
CRDT- 2015/07/24 06:00
PHST- 2014/08/08 00:00 [received]
PHST- 2014/08/21 00:00 [accepted]
PHST- 2015/07/24 06:00 [entrez]
PHST- 2015/07/24 06:00 [pubmed]
PHST- 2015/07/24 06:01 [medline]
AID - 10.1007/s12072-014-9574-0 [pii]
AID - 10.1007/s12072-014-9574-0 [doi]
PST - ppublish
SO  - Hepatol Int. 2014 Oct;8(4):560-6. doi: 10.1007/s12072-014-9574-0. Epub 2014 Sep 
      21.