PMID- 30840774
OWN - NLM
STAT- MEDLINE
DCOM- 20200409
LR  - 20211204
IS  - 1096-9071 (Electronic)
IS  - 0146-6615 (Linking)
VI  - 91
IP  - 7
DP  - 2019 Jul
TI  - Ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir for 
      patients with hepatitis C virus genotype 1 infection who failed a prior course of 
      direct-acting antiviral therapy.
PG  - 1307-1312
LID - 10.1002/jmv.25448 [doi]
AB  - INTRODUCTION: Despite high efficacy of current direct-acting antiviral agents 
      (DAAs) in treating chronic hepatitis C virus (HCV) infection, a small portion of 
      patients fail treatment. QUARTZ-I was a phase 2, open-label, multicenter, 
      two-part study that assessed the safety and efficacy of 
      ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with dasabuvir (DSV) with or 
      without the addition of sofosbuvir (SOF) and/or ribavirin (RBV) in DAA 
      treatment-experienced adults with chronic HCV GT1 infection. MATERIALS AND 
      METHODS: Genotype 1 HCV-infected patients with or without compensated cirrhosis 
      had prior treatment failure to any DAA (part 1) or ledipasvir/SOF (part 2). 
      Patients received OBV/PTV/r + DSV +/- SOF with or without RBV for 12 or 24 weeks. 
      The primary endpoint of this study is the percentage of patients achieving 
      sustained virologic response at post-treatment week 12 (SVR12). RESULTS: In part 
      1 of the study, 95.5% (21/22) of patients achieved SVR12, and in part 2, the 
      SVR12 rate was 85.7% (6/7). Most adverse events (AEs) were mild and moderate in 
      severity. Two serious AEs occurred and were assessed as not being related to 
      study drug, of which one resulted in study drug discontinuation. Two patients 
      experienced grade 3 elevations of serum alanine aminotransferase, and no other 
      grade >/=3 laboratory abnormalities were observed. CONCLUSION: The multi-targeted 
      regimen of OBV/PTV/r + DSV +/- SOF with or without RBV was effective in the 
      treatment of patients who failed previous DAA regimens including NS3/4A protease 
      and NS5A and NS5B polymerase inhibitors. These results provide a promising 
      outcome for patients that traditionally had limited treatment options.
CI  - (c) 2019 Wiley Periodicals, Inc.
FAU - Poordad, Fred
AU  - Poordad F
AD  - The Texas Liver Institute/University of Texas Health, San Antonio, Texas.
FAU - Bennett, Michael
AU  - Bennett M
AD  - Medical Associates Research Group, San Diego, California.
FAU - Sepe, Thomas E
AU  - Sepe TE
AD  - Liver Center, University Gastroenterology, Providence, Rhode Island.
FAU - Cohen, Eric
AU  - Cohen E
AD  - AbbVie Inc., North Chicago, Illinois.
FAU - Reindollar, Robert W
AU  - Reindollar RW
AD  - Piedmont Healthcare/Carolinas Center for Liver Disease, Statesville, North 
      Carolina.
FAU - Everson, Gregory
AU  - Everson G
AD  - Division of Gastroenterology and Hepatology, University of Colorado Denver School 
      of Medicine, Aurora, Colorado.
FAU - Phillips, Raymond W
AU  - Phillips RW
AD  - Gastroenterology Group of Naples PA, Naples, Florida.
FAU - Siddique, Asma
AU  - Siddique A
AD  - Digestive Disease Institute, Virginia Mason Hospital and Medical Center, Seattle, 
      Washington.
FAU - Sullivan, J Greg
AU  - Sullivan JG
AD  - Parkway Medical Center, Birmingham, Alabama.
FAU - Pilot-Matias, Tami
AU  - Pilot-Matias T
AD  - AbbVie Inc., North Chicago, Illinois.
FAU - Abunimeh, Manal
AU  - Abunimeh M
AD  - AbbVie Inc., North Chicago, Illinois.
FAU - Cohen, Daniel E
AU  - Cohen DE
AD  - AbbVie Inc., North Chicago, Illinois.
FAU - Younes, Ziad
AU  - Younes Z
AUID- ORCID: 0000-0001-7382-3698
AD  - GastroOne, Germantown, Tennessee.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190319
PL  - United States
TA  - J Med Virol
JT  - Journal of medical virology
JID - 7705876
RN  - 0 (Anilides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Cyclopropanes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Macrocyclic Compounds)
RN  - 0 (Sulfonamides)
RN  - 2302768XJ8 (ombitasvir)
RN  - 56HH86ZVCT (Uracil)
RN  - 9DLQ4CIU6V (Proline)
RN  - CKR7XL41N4 (2-Naphthylamine)
RN  - DE54EQW8T1 (dasabuvir)
RN  - HG18B9YRS7 (Valine)
RN  - O3J8G9O825 (Ritonavir)
RN  - OU2YM37K86 (paritaprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - 2-Naphthylamine
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anilides/therapeutic use
MH  - Antiviral Agents/*therapeutic use
MH  - Carbamates/therapeutic use
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*drug effects/genetics
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Macrocyclic Compounds/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives
MH  - Ritonavir/therapeutic use
MH  - Sofosbuvir/therapeutic use
MH  - Sulfonamides/therapeutic use
MH  - Sustained Virologic Response
MH  - Uracil/analogs & derivatives/therapeutic use
MH  - Valine
OTO - NOTNLM
OT  - chronic hepatitis C
OT  - direct-acting antivirals
OT  - re-treatment
OT  - treatment-experienced
EDAT- 2019/03/07 06:00
MHDA- 2020/04/10 06:00
CRDT- 2019/03/07 06:00
PHST- 2018/10/12 00:00 [received]
PHST- 2018/12/21 00:00 [revised]
PHST- 2019/01/31 00:00 [accepted]
PHST- 2019/03/07 06:00 [pubmed]
PHST- 2020/04/10 06:00 [medline]
PHST- 2019/03/07 06:00 [entrez]
AID - 10.1002/jmv.25448 [doi]
PST - ppublish
SO  - J Med Virol. 2019 Jul;91(7):1307-1312. doi: 10.1002/jmv.25448. Epub 2019 Mar 19.