PMID- 28124511
OWN - NLM
STAT- MEDLINE
DCOM- 20170327
LR  - 20220317
IS  - 1365-2516 (Electronic)
IS  - 1351-8216 (Linking)
VI  - 23
IP  - 2
DP  - 2017 Mar
TI  - Ledipasvir-sofosbuvir and sofosbuvir plus ribavirin in patients with chronic 
      hepatitis C and bleeding disorders.
PG  - 198-206
LID - 10.1111/hae.13178 [doi]
AB  - INTRODUCTION: Chronic hepatitis C virus (HCV) infection is prevalent among 
      patients with inherited bleeding disorders and is a leading cause of mortality in 
      those with haemophilia. AIM: We evaluated the efficacy and safety of 
      ledipasvir-sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV 
      genotype 1-4 infection and an inherited bleeding disorder. METHODS: 
      Ledipasvir-sofosbuvir was administered for 12 weeks to patients with genotype 1 
      or 4 infection and for 12 or 24 weeks to treatment-experienced cirrhotic patients 
      with genotype 1 infection. Patients with genotype 2 and 3 infection received 
      sofosbuvir plus ribavirin for 12 and 24 weeks respectively. RESULTS: The majority 
      of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of 
      patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV 
      coinfected. Sustained virologic response at 12 weeks posttreatment was 99% 
      (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in 
      treatment-experienced cirrhotic patients with genotype 1 infection; 100% (10/10) 
      in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 
      infection. There were no treatment discontinuations due to adverse events (AEs). 
      The most frequent non-bleeding AEs were fatigue, headache, diarrhoea, nausea and 
      insomnia. Bleeding AEs occurred in 22 patients, of which all but one were 
      considered unrelated to treatment. CONCLUSION: Treatment with 
      ledipasvir-sofosbuvir for patients with HCV genotype 1 or 4 infection or 
      sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly 
      effective and well tolerated among those with inherited bleeding disorders.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Walsh, C E
AU  - Walsh CE
AUID- ORCID: 0000-0001-5378-9656
AD  - Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, USA.
FAU - Workowski, K
AU  - Workowski K
AD  - Emory University, Atlanta, GA, USA.
FAU - Terrault, N A
AU  - Terrault NA
AD  - University of California at San Francisco, San Francisco, CA, USA.
FAU - Sax, P E
AU  - Sax PE
AD  - Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
FAU - Cohen, A
AU  - Cohen A
AD  - Newark Beth Israel Medical Center, Barnabas Health, Newark, NJ, USA.
FAU - Bowlus, C L
AU  - Bowlus CL
AD  - University of California at Davis, Davis, CA, USA.
FAU - Kim, A Y
AU  - Kim AY
AD  - Massachusetts General Hospital, Boston, MA, USA.
FAU - Hyland, R H
AU  - Hyland RH
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - Han, B
AU  - Han B
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - Wang, J
AU  - Wang J
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - Stamm, L M
AU  - Stamm LM
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - Brainard, D M
AU  - Brainard DM
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - McHutchison, J G
AU  - McHutchison JG
AD  - Gilead Sciences Inc., Foster City, CA, USA.
FAU - von Drygalski, A
AU  - von Drygalski A
AD  - University of California at San Diego, San Diego, CA, USA.
FAU - Rhame, F
AU  - Rhame F
AD  - Abbott Northwestern Hospital, Minneapolis, MN, USA.
FAU - Fried, M W
AU  - Fried MW
AD  - University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
FAU - Kouides, P
AU  - Kouides P
AD  - The Mary M. Gooley Hemophilia Center, Rochester, NY, USA.
FAU - Balba, G
AU  - Balba G
AD  - MedStar Georgetown University Hospital, Washington, DC, USA.
FAU - Reddy, K R
AU  - Reddy KR
AD  - University of Pennsylvania, Philadelphia, PA, USA.
LA  - eng
PT  - Journal Article
DEP - 20170125
PL  - England
TA  - Haemophilia
JT  - Haemophilia : the official journal of the World Federation of Hemophilia
JID - 9442916
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Drug Combinations)
RN  - 0 (Fluorenes)
RN  - 013TE6E4WV (ledipasvir)
RN  - 49717AWG6K (Ribavirin)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/administration & dosage/*therapeutic use
MH  - Benzimidazoles/administration & dosage/*therapeutic use
MH  - Drug Combinations
MH  - Female
MH  - Fluorenes/administration & dosage/*therapeutic use
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ribavirin/administration & dosage/*therapeutic use
MH  - Sofosbuvir/administration & dosage/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - NS5A inhibitor
OT  - NS5B inhibitor
OT  - hepatitis C virus
OT  - ledipasvir-sofosbuvir fixed-dose combination
OT  - ribavirin
OT  - sofosbuvir
EDAT- 2017/01/27 06:00
MHDA- 2017/03/28 06:00
CRDT- 2017/01/27 06:00
PHST- 2016/12/20 00:00 [accepted]
PHST- 2017/01/27 06:00 [pubmed]
PHST- 2017/03/28 06:00 [medline]
PHST- 2017/01/27 06:00 [entrez]
AID - 10.1111/hae.13178 [doi]
PST - ppublish
SO  - Haemophilia. 2017 Mar;23(2):198-206. doi: 10.1111/hae.13178. Epub 2017 Jan 25.