title: Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
abstract: OBJECTIVE
  Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis.
  
  
  METHODS
  Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug.
  
  
  RESULTS
  Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90×10(9)/L, and 17% with albumin <3.5g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant.
  
  
  CONCLUSIONS
  The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.
authors.affiliation: Toronto Centre for Liver Disease, University of Toronto, Toronto, ON, Canada. Electronic address: jordan.feld@uhn.ca.
authors.forename: Jordan J
authors.initials: JJ
authors.lastname: Feld
authors.affiliation: CUB Hôpital Erasme, Université Libre de Bruxelles, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Moreno
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Trinh
authors.affiliation: LAIR Centre, Vancouver, BC, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Tam
authors.affiliation: ZNA Stuivenberg, Antwerpen, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Bourgeois
authors.affiliation: Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Horsmans
authors.affiliation: Toronto Liver Centre, Toronto, ON, Canada.
authors.forename: Magdy
authors.initials: M
authors.lastname: Elkhashab
authors.affiliation: North Shore University Hospital, Manhasset, NY, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Bernstein
authors.affiliation: GastroOne, Germantown, TN, USA.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Younes
authors.affiliation: Piedmont Healthcare/Carolinas Center for Liver Disease, Statesville, NC, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Reindollar
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Lois
authors.initials: L
authors.lastname: Larsen
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Bo
authors.initials: B
authors.lastname: Fu
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Howieson
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Akshanth R
authors.initials: AR
authors.lastname: Polepally
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pangerl
authors.affiliation: AbbVie Inc., North Chicago, IL, USA.
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Shulman
authors.affiliation: The Texas Liver Institute/University of Texas Health Science Center, San Antonio, TX, USA.
authors.forename: Fred
authors.initials: F
authors.lastname: Poordad
mesh_terms: D015081:2-Naphthylamine; D000328:Adult; D000368:Aged; D000813:Anilides / Q000008:administration & dosage / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects; D003521:Cyclopropanes; D004334:Drug Administration Schedule; D004338:Drug Combinations; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D047029:Lactams, Macrocyclic; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D047028:Macrocyclic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014633:Valine
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D002219:Carbamates; D003521:Cyclopropanes; D004338:Drug Combinations; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D012254:Ribavirin; D014498:Uracil; D011392:Proline; D015081:2-Naphthylamine; C588260:dasabuvir; D014633:Valine; D019438:Ritonavir; C585405:paritaprevir
keywords: 3D; Cirrhosis; Direct-acting antivirals; TURQUOISE-III