PMID- 29087397
OWN - NLM
STAT- MEDLINE
DCOM- 20171218
LR  - 20181113
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 112
IP  - 12
DP  - 2017 Dec
TI  - Open Label Study of 8 vs. 12 Weeks of Ledipasvir/Sofosbuvir in Genotype 6 
      Treatment Naive or Experienced Patients.
PG  - 1824-1831
LID - 10.1038/ajg.2017.399 [doi]
AB  - OBJECTIVES: Hepatitis C genotype 6 (HCV-GT6) is one of the most prevalent 
      genotypes in Southeast Asia. Ledipasvir and sofosbuvir fixed-dose combination 
      (LDV/SOF FDC) for 12 weeks has been shown to be effective for multiple HCV 
      genotypes including treatment-naive HCV-6. Our goal was to examine treatment 
      outcomes in a diverse HCV-6 population. METHODS: We prospectively enrolled 60 
      HCV-GT6 patients at four US centers. Treatment -naive without cirrhosis patients 
      received open-labeled LDV/SOF FDC orally once a day for 8 weeks; All cirrhotic 
      and/or treatment-experienced patients received LDV/SOF FDC for 12 weeks. The 
      primary outcome was sustained virological response 12 weeks after therapy 
      (SVR12). Secondary outcomes were adverse events (AEs) and/or serious adverse 
      events (SAEs). All patients gave written consent. RESULTS: Overall mean age was 
      58+/-10 and 58% were male. All patients were Asian and foreign born. The 8-week 
      group included 20 patients (33.3%) and the 12-week included 40 patients (66.7%). 
      There were 2 (5%) patients with decompensation, 3 with liver cancer (7.5%), and 
      14 with prior treatment (35%) in the 12-week group. SVR12 was 95.0% for the 
      8-week group (19/20) and 95.0% for the 12-week group (38/40). AEs included 
      fatigue (5%), insomnia (3.3%), headache (1.7%), and nausea (1.7%); however, all 
      patients completed the intended treatment duration. There were two 
      treatment-unrelated SAEs. CONCLUSIONS: LDV/SOF FDC for 8 or 12 weeks was safe and 
      effective for patients without cirrhosis or prior treatment failure as well as 
      for patients with cirrhosis and/or prior treatment failure, respectively.
FAU - Nguyen, Mindie H
AU  - Nguyen MH
AD  - Stanford University Medical Center, Stanford, Caliornia, USA.
FAU - Trinh, Huy
AU  - Trinh H
AD  - San Jose Gastroenterology, San Jose, California, USA.
FAU - Do, Son
AU  - Do S
AD  - Digestive Health Associates of Texas, Dallas, Texas, USA.
FAU - Nguyen, Thuan
AU  - Nguyen T
AD  - Liver and Digestive Consultants, Houston, Texas, USA.
FAU - Nguyen, Pauline
AU  - Nguyen P
AD  - Stanford University Medical Center, Stanford, Caliornia, USA.
FAU - Henry, Linda
AU  - Henry L
AD  - Stanford University Medical Center, Stanford, Caliornia, USA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171031
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Fluorenes)
RN  - 013TE6E4WV (ledipasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Aged
MH  - Antiviral Agents/*therapeutic use
MH  - Benzimidazoles/*therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fluorenes/*therapeutic use
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/*drug therapy/pathology/virology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Sofosbuvir/*therapeutic use
MH  - Sustained Virologic Response
EDAT- 2017/11/01 06:00
MHDA- 2017/12/19 06:00
CRDT- 2017/11/01 06:00
PHST- 2017/07/14 00:00 [received]
PHST- 2017/09/15 00:00 [accepted]
PHST- 2017/11/01 06:00 [pubmed]
PHST- 2017/12/19 06:00 [medline]
PHST- 2017/11/01 06:00 [entrez]
AID - ajg2017399 [pii]
AID - 10.1038/ajg.2017.399 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2017 Dec;112(12):1824-1831. doi: 10.1038/ajg.2017.399. Epub 
      2017 Oct 31.