Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C Virus Infection

References

• Messina JP , HumphreysI , FlaxmanAet al. Global distribution and prevalence of hepatitis C virus genotypes . Hepatology61 ( 1 ), 77 – 87 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Polaris Observatory HCV Collaborators . Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study . Lancet Gastroenterol. Hepatol.2 ( 3 ), 161 – 176 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Gomez EV , RodriguezYS , BertotLCet al. The natural history of compensated HCV-related cirrhosis: a prospective long-term study . J. Hepatol.58 ( 3 ), 434 – 444 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Butt AA , YanP , Lo ReV , 3rdet al. Liver fibrosis progression in hepatitis C virus infection after seroconversion . JAMA Intern. Med.175 ( 2 ), 178 – 185 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Wertheim JA , PetrowskyH , SaabS , Kupiec-WeglinskiJW , BusuttilRW . Major challenges limiting liver transplantation in the United States . Am. J. Transplant.11 ( 9 ), 1773 – 1784 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• AASLD and IDSA . HCV guidance: recommendations for testing, managing, and treating hepatitis C ( 2017 ). www.hcvguidelines.org
   Google Scholar
• European Association for the Study of the Liver . EASL recommendations on treatment of hepatitis C 2018 . J. Hepatol.69 ( 2 ), 461 – 511 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Pawlotsky JM . Hepatitis C drugs: is next generation the last generation?Gastroenterology151 ( 4 ), 587 – 590 ( 2016 ).
   PubMed Web of Science ®Google Scholar
• Manns MP , ButiM , GaneEet al. Hepatitis C virus infection . Nat. Rev. Dis. Primers3 , 17006 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• WHO . Global health sectors strategy on viral hepatitis 2016–2021: towards ending viral hepatitis ( 2016 ). http://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf;jsessionid=C1D2C4268A94C9FFE3D529FFA3871943?sequence=1
   Google Scholar
• Dore GJ , FeldJJ . Hepatitis C virus therapeutic development: in pursuit of “perfectovir” . Clin. Infect. Dis.60 ( 12 ), 1829 – 1836 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Grebely J , DoreGJ , MorinS , RockstrohJK , KleinMB . Elimination of HCV as a public health concern among people who inject drugs by 2030 – what will it take to get there?J. Int. AIDS Soc.20 ( 1 ), 22146 ( 2017 ).
   PubMedGoogle Scholar
• Grebely J , HajarizadehB , DoreGJ . Direct-acting antiviral agents for HCV infection affecting people who inject drugs . Nat. Rev. Gastroenterol. Hepatol.14 ( 11 ), 641 – 651 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Grebely J , OserM , TaylorLE , DoreGJ . Breaking down the barriers to hepatitis C virus (HCV) treatment among individuals with HCV/HIV coinfection: action required at the system, provider, and patient levels . J. Infect. Dis.207 ( Suppl. 1 ), S19 – S25 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Petersen T , TownsendK , GordonLAet al. High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a Phase 2a study . Hepatol. Int.10 ( 2 ), 310 – 319 ( 2016 ).
   PubMed Web of Science ®Google Scholar
• Younossi ZM , StepanovaM , HenryL , NaderF , YounossiY , HuntS . Adherence to treatment of chronic hepatitis C: from interferon containing regimens to interferon and ribavirin free regimens . Medicine (Baltimore)95 ( 28 ), e4151 ( 2016 ).
   PubMed Web of Science ®Google Scholar
• Litwin AH , AgyemangL , AkiyamaMJet al. The PREVAIL Study: intensive models of HCV care for people who inject drugs (abstract and oral presentation PS-130) . J. Hepatol.66 ( 1 ), S72 ( 2017 ).
   Web of Science ®Google Scholar
• Townsend K , PetersenT , GordonLAet al. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir . AIDS30 ( 2 ), 261 – 266 ( 2016 ).
   PubMed Web of Science ®Google Scholar
• Christensen S , IngilizP , Schulze Zur WieschJet al. Significant changes of HCV patient characteristics over time in the era of direct antiviral agent therapy – are all HCV subpopulations treated similarly? – Results from the German Hepatitis C Cohort . J. Hepatol.68 ( Suppl. 1 ), S289 ( 2018 ).
   Google Scholar
• AbbVie . Mavyret US prescribing information ( 2017 ). www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf
   Google Scholar
• AbbVie . Maviret EU summary of product characteristics ( 2018 ). www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/004430/WC500233677.pdf
   Google Scholar
• AbbVie . Maviret Health Canada product monograph ( 2017 ). https://pdf.hres.ca/dpd_pm/00040732.PDF
   Google Scholar
• AbbVie . Maviret Japan prescribing information ( 2017 ). www.abbvie.co.jp/content/dam/abbviecorp/japan/docs/Maviret_tmpDocument.pdf
   Google Scholar
• Gilead Sciences . Vosevi EU summary of product characteristics ( 2017 ). www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/004350/WC500235373.pdf
   Google Scholar
• Gilead Sciences . Vosevi US prescribing information ( 2017 ). www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s002lbl.pdf
   Google Scholar
• Gilead Sciences . Vosevi Health Canada product monograph ( 2017 ). https://pdf.hres.ca/dpd_pm/00040726.PDF
   Google Scholar
• Gilead Sciences . Epclusa EU summary of product characteristics ( 2017 ). www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/004210/WC500211151.pdf
   Google Scholar
• Gilead Sciences . Epclusa US prescribing information ( 2017 ). www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s009lbl.pdf
   Google Scholar
• Gilead Sciences . Epclusa Health Canada product monograph ( 2017 ). https://pdf.hres.ca/dpd_pm/00041214.PDF
   Google Scholar
• Feld JJ , JacobsonIM , HézodeCet al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection . N. Engl. J. Med.373 ( 27 ), 2599 – 2607 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Foster G , AfdhalN , RobertsSKet al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection . N. Engl. J. Med.373 , 2608 – 2617 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Hezode C , ReauN , SvarovskaiaESet al. Resistance analysis in patients with genotype 1-6 HCV infection treated with sofosbuvir/velpatasvir in the Phase III studies . J. Hepatol.68 ( 5 ), 895 – 903 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Ng TI , TripathiR , ReischTet al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS3/4A protease inhibitor glecaprevir . Antimicrob. Agents Chemother.62 ( 1 ), pii:e01620-17 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Bukh J . The history of hepatitis C virus (HCV): Basic research reveals unique features in phylogeny, evolution and the viral life cycle with new perspectives for epidemic control . J. Hepatol.65 ( 1 Suppl .), S2 – S21 ( 2016 ).
   PubMedGoogle Scholar
• Ng TI , KrishnanP , Pilot-MatiasTet al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS5A inhibitor pibrentasvir . Antimicrob. Agents Chemother.61 ( 5 ), pii:e02558-16 ( 2017 ).
   Web of Science ®Google Scholar
• Gottwein JM , PhamLV , MikkelsenLSet al. Efficacy of NS5A inhibitors against hepatitis C virus genotypes 1-7 and escape variants . Gastroenterology154 ( 5 ), 1435 – 1448 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Lin CW , DuttaS , AsatryanAet al. Pharmacokinetics, safety, and tolerability of single and multiple doses of ABT-493: a first-in-human study . J. Pharm. Sci.106 ( 2 ), 645 – 651 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Lin CW , DuttaS , AsatryanAet al. Pharmacokinetics, safety, and tolerability following single and multiple doses of pibrentasvir in a first-in-human study . Clin. Pharmacol. Drug Dev.7 ( 1 ), 44 – 52 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Lin CW , EckertD , MensingS , LiuW . Glecaprevir and pibrentasvir exposures in hepatits C virus-infected subjects in Phase 2 and 3 studies (abstract and poster 1190) . Hepatology66 , 641A ( 2017 ).
   Web of Science ®Google Scholar
• Lin CW , DuttaS , DingBet al. Pharmacokinetics, safety, and tolerability of glecaprevir and pibrentasvir in healthy white, Chinese, and Japanese adult subjects . J. Clin. Pharmacol.57 ( 12 ), 1616 – 1624 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Gane E , PoordadF , ValdesJet al. Pharmacokinetics and safety of glecaprevir/pibrentasvir in adults with chronic genotype 1-6 hepatitis C virus infection and compensated cirrhosis: an integrated analysis (abstract and poster Thu-263) . J. Hepatol.66 ( 1 ), S306 ( 2017 ).
   Web of Science ®Google Scholar
• Kosloski MP , DuttaS , WangHet al. Pharmacokinetics, safety, and tolerability of next generation direct acting antivirals ABT-493 and ABT-530 in subjects with hepatic impairment (abstract and poster THU-231) . J. Hepatol.64 ( Suppl. 2 ), S406 ( 2016 ).
   Google Scholar
• Kosloski MP , ZhaoW , MarburyTCet al. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of the glecaprevir and pibrentasvir combination in HCV-negative subjects . Antimicrob. Agents Chemother.62 ( 3 ), pii:e01990-17 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Kwo PY , PoordadF , AsatryanAet al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis . J. Hepatol.67 ( 2 ), 263 – 271 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Gane E , PoordadF , WangSet al. High efficacy of ABT-493 and ABT-530 treatment in patients with HCV genotype 1 or 3 infection and compensated cirrhosis . Gastroenterology151 ( 4 ), 651 – 659.e1 ( 2016 ).
   PubMed Web of Science ®Google Scholar
• Poordad F , FelizartaF , AsatryanAet al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment . Hepatology66 ( 2 ), 389 – 397 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Zeuzem S , FosterGR , WangSet al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection . N. Engl. J. Med.378 ( 4 ), 354 – 369 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Asselah T , KowdleyKV , ZadeikisNet al. Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis . Clin. Gastroenterol. Hepatol.16 ( 3 ), 417 – 426 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Wyles D , PoordadF , WangSet al. Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: a partially randomized Phase 3 clinical trial . Hepatology doi:10.1002/hep.29541 ( 2017 ) ( Epub ahead of print ).
   PubMedGoogle Scholar
• Forns X , LeeSS , ValdesJet al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre Phase 3 trial . Lancet Infect. Dis.17 ( 10 ), 1062 – 1068 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Poordad F , PolS , AsatryanAet al. Glecaprevir/pibrentasvir in patients with hepatitis C virus genotype 1 or 4 and past direct-acting antiviral treatment failure . Hepatology67 ( 4 ), 1253 – 1260 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Rockstroh J , LacombeK , VianiRMet al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study (abstract and poster 522) . J. Hepatol.66 , 1-S102-3 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Gane E , LawitzE , PugatchDet al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment . N. Engl. J. Med.377 ( 15 ), 1448 – 1455 ( 2017 ).
   PubMed Web of Science ®Google Scholar
• Reau N , KwoPY , RheeSet al. Magellan-2: safety and efficacy of glecaprevir/pibrentasvir in liver or renal transplant adults with chronic hepatitis C genotype 1-6 infection (abstract LBO-03) . J. Hepatol.66 ( 1 ), S90–S91 ( 2017 ).
   Web of Science ®Google Scholar
• Wyles D , WeilandO , YaoBet al. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection (abstract and oral PS-040) . J. Hepatol.68 , S23 ( 2018 ).
   Web of Science ®Google Scholar
• Puoti M , FosterGR , WangSet al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir: an integrated analysis of HCV genotype 1-6 patients without cirrhosis . J. Hepatol.69 ( 2 ), 293 – 300 ( 2018 ).
   PubMed Web of Science ®Google Scholar
• Flamm S , WylesD , AsatryanAet al. Efficacy and safety of glecaprevir/pibrentasvir in treatment-naive patients with chronic HCV genotype 3: an integrated Phase 2/3 analysis (abstract 62 and oral presentation) . Hepatology66 ( Suppl. 1 ), A35 ( 2017 ).
   Google Scholar
• Gane E , PoordadF , ZadeikisNet al. Efficacy, safety, and pharmacokinetics of glecaprevir/pibrentasvir in adults with chronic genotype 1-6 hepatitis C virus infection and compensated cirrhosis: an integrated analysis (abstract and oral 74) . Hepatology66 , A44 ( 2017 ).
   Web of Science ®Google Scholar
• Pol S , PockrosP , PugatchDet al. Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1-6 as a function of chronic kidney disease stage (abstract and poster SAT-273) . J. Hepatol.66 ( 1 ), S738 ( 2017 ).
   Google Scholar
• Foster GR , GrebelyJ , ShermanKEet al. Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1–6 and recent drug use (abstract and poster 1182) . Hepatology66 , A636 ( 2017 ).
   Google Scholar
• Foster GR , Kopecky-BrombergS , LeiY , MensaFJ . Safety and efficacy of glecaprevir/pibrentasvir in patients aged 65 years or older with chronic hepatitis C: a pooled analysis of Phase 2 and 3 clinical trials (abstract and poster 1188) . Hepatology66 , A640 ( 2017 ).
   Google Scholar
• Flamm S , ReddyR , ZadeikisNet al. Integrated efficacy, pharmacokinetics, and safety of glecaprevir/pibrentasvir in patients taking concomitant proton pump inhibitors and other acid-reducing drugs . Presented at : World Congress of Gastroenterology at ACG 2017.Orlando, FL, USA , 13–18 October2017 .
   Google Scholar
• Kwo PY , JonesPH , BarcombLet al. Safety and efficacy of statin management during glecaprevir/pibrentasvir treatment for chronic hepatitis C . Presented at : American College of Cardiology 2018.Orlando, FL, USA , 10–12 March2018 .
   Google Scholar
• Krishnan P , SchnellG , TripathiRet al. Pooled resistance analysis in HCV genotype 1-6 infected patients treated with glecaprevir/pibrentasvir in Phase 2 and 3 clinical trials (abstract and poster FRI-205) . J. Hepatol.66 ( 1 ), S-500 ( 2017 ).
   Web of Science ®Google Scholar
• Brown A , WelzelTM , ConwayBet al. Adherence to pangenotypic glecaprevir/pibrentasvir treatment and SVR12 in HCV-infected patients: an integrated analysis of the Phase 2/3 clinical trial program (abstract and oral 198) . Hepatology66 , A114 ( 2017 ).
   Web of Science ®Google Scholar
• Dufour J- , ZuckermanE , ZadeikisNet al. Safety of glecaprevir/pibrentasvir in adults with chronic hepatitis C genotype 1-6 hepatitis C virus infection: an integrated analysis (abstract and poster FRI-238) . J. Hepatol.66 ( 1 ), S515 ( 2017 ).
   Web of Science ®Google Scholar
• D‘Ambrosio R , PasuloL , PuotiMet al. Real-life effectiveness and safety of glecaprevir/pibrentasvir among 723 Italian patients with chronic hepatitis C: the Navigator-II Study . J. Hepatol.68 , S65 ( 2018 ).
   Web of Science ®Google Scholar
• Cornberg M , NaumannU , StoehrAet al. Real-world data on safety and effectiveness of glecaprevir/pibrentasvir for the treatment of patients with chronic hepatitis C virus infection: latest results from the German Hepatitis C-Registry . Presented at : 16th Annual International Symposium on Viral Hepatitis and Liver Disease’s Global Hepatitis Summit 2018.Toronto, Ontario, Canada , 14–17 June2018 .
   Google Scholar
• EMA . Maviret EPAR Assessment Report . ( 2017 ). www.ema.europa.eu/documents/assessment-report/maviret-epar-public-assessment-report_en.pdf
   Google Scholar