PMID- 31173527
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR  - 20211204
IS  - 1747-4132 (Electronic)
IS  - 1747-4124 (Linking)
VI  - 13
IP  - 9
DP  - 2019 Sep
TI  - High SVR rate following retreatment of non-sustained virological responders to 
      sofosbuvir based anti-HCV therapies regardless of RAS testing: A real-life 
      multicenter study.
PG  - 907-914
LID - 10.1080/17474124.2019.1629287 [doi]
AB  - Aim: Evaluation of the efficacy and safety of sofosbuvir/daclatasvir/ribavirin 
      (SOF/DCV/RBV) in treating non-sustained virological responders (non-SVR12) to 
      prior sofosbuvir-based therapy, in absence of RAS testing in mass treatment, and 
      determination of the optimal timing to start re-treatment. Methods: 
      Real-life prospective observational study included prior non-responders to 
      24-weeks SOF-RBV (n = 679, 67%) or 12-weeks SOF- RBV- PEG (n = 335, 33%). 
      Patients were re-treated with daily SOF/DCV/RBV for 12 (n = 270) or 24 weeks 
      (n = 744). The primary efficacy endpoint was SVR12. The primary safety endpoints 
      were reported adverse events (AEs) from baseline to SVR12 time point. Results: We 
      included 1,014 patients [age 52 +/- 9 years, 58.48% men]. Cirrhosis was documented 
      in 46.98% and 27.5% of SOF-RBV and SOF-RBV-PEG non-responders respectively. 
      Overall, SVR12 was 90.6% [92.2% for 12 weeks therapy and 90.05% for 24 weeks 
      therapy]. Mild AEs occurred in 5.13% (n=52) and 3.1% (n=32) discontinued 
      treatment including eight on-treatment mortalities. Higher baseline FIB-4 and 
      shorter interval before starting retreatment (<6 months) were independent 
      predictors of non-SVR12 on multivariate regression analysis. Conclusion: 
      SOF/DCV/RBV is an effective and safe treatment option for non-responders to prior 
      sofosbuvir-based therapy. Six months interval before retreatment is optimal for 
      achieving favorable SVR.
FAU - Darweesh, Samar K
AU  - Darweesh SK
AUID- ORCID: 0000-0001-7428-4569
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - Elsaeed, Kadry
AU  - Elsaeed K
AD  - General Medicine, Hepatology and Gastroenterology Department, Faculty of 
      Medicine, Ain Shams University , Cairo , Egypt.
FAU - Omar, Heba
AU  - Omar H
AUID- ORCID: 0000-0002-9707-1141
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - El Raziky, Maissa
AU  - El Raziky M
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - Elakel, Wafaa
AU  - Elakel W
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - Elserafy, Magdy
AU  - Elserafy M
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - Ismail, Sohier Ahmed
AU  - Ismail SA
AD  - NHTMRI , Cairo , Egypt.
FAU - Gomaa, Ahmed A
AU  - Gomaa AA
AD  - Tropical Medicine Department, El- Fayoum University , Cairo , Egypt.
FAU - Mehrez, Mai
AU  - Mehrez M
AD  - Hepatology-Internal Medicine Department, National Hepatology, and Tropical 
      Medicine Research Institute , Cairo , Egypt.
FAU - El Kassas, Mahamed
AU  - El Kassas M
AD  - Endemic Medicine Department, Faculty of Medicine, Helwan University , Cairo , 
      Egypt.
FAU - Abdullah, Mohamed
AU  - Abdullah M
AD  - Medical Research Division, National Research Center , Cairo , Egypt.
FAU - Shaker, Mohammed Kamal
AU  - Shaker MK
AD  - Tropical Medicine Department, Ain Shams University , Cairo , Egypt.
FAU - Esmat, Gamal
AU  - Esmat G
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - El Shazly, Yehia
AU  - El Shazly Y
AD  - General Medicine, Hepatology and Gastroenterology Department, Faculty of 
      Medicine, Ain Shams University , Cairo , Egypt.
FAU - Doss, Wahid
AU  - Doss W
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University 
      , Cairo , Egypt.
FAU - Waked, Imam
AU  - Waked I
AD  - Hepatology Department, National Liver Institute, Menoufiya University , Shebeen 
      EL Kom , Egypt.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20190623
PL  - England
TA  - Expert Rev Gastroenterol Hepatol
JT  - Expert review of gastroenterology & hepatology
JID - 101278199
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Pyrrolidines)
RN  - 49717AWG6K (Ribavirin)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Antiviral Agents/*therapeutic use
MH  - Carbamates
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Imidazoles/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrrolidines
MH  - Retreatment
MH  - Ribavirin/*therapeutic use
MH  - Sofosbuvir/*therapeutic use
MH  - Treatment Outcome
MH  - Valine/analogs & derivatives
OTO - NOTNLM
OT  - Chronic HCV Genotype 4
OT  - Direct acting antivirals failure
OT  - daclatasvir
OT  - interval
OT  - ribavirin
OT  - safety
OT  - sofosbuvir
OT  - virologic response
EDAT- 2019/06/08 06:00
MHDA- 2020/01/28 06:00
CRDT- 2019/06/08 06:00
PHST- 2019/06/08 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
PHST- 2019/06/08 06:00 [entrez]
AID - 10.1080/17474124.2019.1629287 [doi]
PST - ppublish
SO  - Expert Rev Gastroenterol Hepatol. 2019 Sep;13(9):907-914. doi: 
      10.1080/17474124.2019.1629287. Epub 2019 Jun 23.