PMID- 30576344
OWN - NLM
STAT- MEDLINE
DCOM- 20190529
LR  - 20201209
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 12
DP  - 2018
TI  - Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without 
      ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan.
PG  - e0209299
LID - 10.1371/journal.pone.0209299 [doi]
LID - e0209299
AB  - BACKGROUND: The real-world data for the effectiveness and safety of 
      sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with 
      hepatitis C virus genotype 1 (HCV-1) infection remain limited in Taiwan. METHODS: 
      A total of 273 chronic HCV-1 patients receiving 8, 12, or 24 weeks of SOF/LDV 
      with or without RBV were enrolled. The sustained virologic response rate at week 
      12 off-therapy (SVR12) by evaluable population (EP) and per-protocol population 
      (PP) were assessed for effectiveness. The treatment discontinuation rate due to 
      adverse events (AEs) and serious AE rate were assessed for safety. Baseline 
      patient characteristics and on-treatment HCV viral kinetics associated with SVR12 
      were analyzed. RESULTS: The SVR12 rates by EP and PP analyses were 96.7% (95% 
      confidence interval [CI]: 93.9%-98.3%) and 97.5% (95% CI: 94.8%-98.8%), 
      respectively. The rates of treatment discontinuation due to AE and serious AE 
      were 0.4% and 4.4%, respectively. Seven patients with true virologic failure were 
      relapsers. In 2 patients who were lost-to follow-up, one expired at treatment 
      week 3 due to pneumonia which was considered not related to treatment, and one 
      declined follow-up at off-therapy week 4. The SVR12 rates were comparable in 
      terms of baseline patient characteristics and viral decline at week 4 of 
      treatment. CONCLUSIONS: SOF/LDV with or without RBV for 8-24 weeks is well 
      tolerated and achieves a high SVR12 rate in patients with HCV-1 infection in 
      Taiwan.
FAU - Liu, Chen-Hua
AU  - Liu CH
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin 
      Branch, Douliou, Taiwan.
FAU - Liu, Chun-Jen
AU  - Liu CJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
FAU - Su, Tung-Hung
AU  - Su TH
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Yang, Hung-Chih
AU  - Yang HC
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Department of Microbiology, National Taiwan University College of Medicine, 
      Taipei, Taiwan.
FAU - Hong, Chun-Ming
AU  - Hong CM
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
FAU - Tseng, Tai-Chung
AU  - Tseng TC
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Chen, Pei-Jer
AU  - Chen PJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
FAU - Chen, Ding-Shinn
AU  - Chen DS
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Genomics Research Center, Academia Sinica, Taipei, Taiwan.
FAU - Kao, Jia-Horng
AU  - Kao JH
AUID- ORCID: 0000-0002-2442-7952
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
LA  - eng
PT  - Journal Article
DEP - 20181221
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Fluorenes)
RN  - 0 (ledipasvir, sofosbuvir drug combination)
RN  - 49717AWG6K (Ribavirin)
RN  - E2OU15WN0N (Uridine Monophosphate)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/*administration & dosage/adverse effects
MH  - Benzimidazoles/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fluorenes/*administration & dosage/adverse effects
MH  - Genotype
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/*drug therapy/*virology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Ribavirin/*administration & dosage/adverse effects
MH  - Safety
MH  - Sofosbuvir
MH  - Sustained Virologic Response
MH  - Taiwan
MH  - Treatment Outcome
MH  - Uridine Monophosphate/administration & dosage/adverse effects/*analogs & 
      derivatives
PMC - PMC6303025
COIS- Chen-Hua Liu: advisory board for Abbvie, Gilead Science, Merck Sharp & Dohme; 
      speaker's bureau for Abbott, Abbvie, Gilead Science, Merck Sharp & Dohme; 
      research grant from Abbvie, Gilead Science, Merck Sharp & Dohme. Jia- Horng Kao: 
      advisory board for Abbott, Abbvie, Bristol-Myers Squibb, Gilead Sciences, 
      GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker's bureau for 
      Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Science, GlaxoSmithKline, 
      Merck Sharp & Dohme, Novartis, Roche. Ding-Shinn Chen: advisory board for Abbvie, 
      Gilead Science, GlaxoSmithKline, Merck Sharp & Dohme, Novartis. Pei-Jer Chen: 
      advisory board for Abbvie, Novartis, Roche. All other authors declare no 
      competing interests. This does not alter our adherence to PLOS ONE policies on 
      sharing data and materials.
EDAT- 2018/12/24 06:00
MHDA- 2019/05/30 06:00
PMCR- 2018/12/21
CRDT- 2018/12/22 06:00
PHST- 2018/10/28 00:00 [received]
PHST- 2018/12/03 00:00 [accepted]
PHST- 2018/12/22 06:00 [entrez]
PHST- 2018/12/24 06:00 [pubmed]
PHST- 2019/05/30 06:00 [medline]
PHST- 2018/12/21 00:00 [pmc-release]
AID - PONE-D-18-31141 [pii]
AID - 10.1371/journal.pone.0209299 [doi]
PST - epublish
SO  - PLoS One. 2018 Dec 21;13(12):e0209299. doi: 10.1371/journal.pone.0209299. 
      eCollection 2018.