Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection after Failure of Pegylated Interferon and Ribavirin with an Earlier-Generation Protease Inhibitor: Final 24-Week Results from C-SALVAGE

Clinical Infectious Diseases

Volumn 62, Issue 1, 2016, Pages 32-36

  Buti, Maria ^a   Gordon, Stuart C ^b   Zuckerman, Eli ^c   Lawitz, Eric ^d   Calleja, Jose L ^e   Hofer, Harald ^f   Gilbert, Christopher ^g   Palcza, John ^g   Howe, Anita Y M ^g   Dinubile, Mark J ^g   Robertson, Michael N ^g   Wahl, Janice ^g   Barr, Eliav ^g   Forns, Xavier ^h  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b HENRY FORD HEALTH SYSTEM   (United States)

^c CARMEL MEDICAL CENTER   (Israel)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^e HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^f MEDICAL UNIVERSITY OF VIENNA   (Austria)

^g MERCK RESEARCH LABORATORIES   (United States)

^h HOSPITAL CLÍNIC   (Spain)

Author keywords

C SALVAGE; elbasvir; genotype 1; grazoprevir; resistance associated variants (RAVs)

Indexed keywords

BOCEPREVIR; ELBASVIR; GRAZOPREVIR; NONSTRUCTURAL PROTEIN 3; NONSTRUCTURAL PROTEIN 5A; PEGINTERFERON; PROTEINASE INHIBITOR; RIBAVIRIN; SIMEPREVIR; TELAPREVIR; VIRUS RNA; 2-(PYRROLIDIN-2-YL)-5-(2-(4-(5-(PYRROLIDIN-2-YL)-1H-IMIDAZOL-2-YL)PHENYL)BENZOFURAN-5-YL)-1H-IMIDAZOLE; ANTIVIRUS AGENT; BENZOFURAN DERIVATIVE; IMIDAZOLE DERIVATIVE; MK-5172; QUINOXALINE DERIVATIVE;

ARTICLE; CHRONIC HEPATITIS C; DNA POLYMORPHISM; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TREATMENT FAILURE; EC50; FOLLOW UP; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; LIMIT OF QUANTITATION; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RELAPSE; TREATMENT DURATION; VIRUS LOAD; ANTIVIRAL RESISTANCE; CLINICAL TRIAL; DRUG EFFECTS; GENETICS; HEPACIVIRUS; HEPATITIS C, CHRONIC; PROCEDURES; SALVAGE THERAPY; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

ANTIVIRAL AGENTS; BENZOFURANS; DRUG RESISTANCE, VIRAL; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; QUINOXALINES; RIBAVIRIN; SALVAGE THERAPY; TREATMENT OUTCOME;

EID: 84954341991     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ722     Document Type: Article

References (15)

1. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. Available at: http://www.hcvguidelines.org. Accessed 25 April 2015.
2. Gambarin-Gelwan M, Jacobson IM. Resistance-associated variants in chronic hepatitis C patients treated with protease inhibitors. Curr Gastroenterol Rep 2012; 14:47-54.
3. Barnard RJ, Howe JA, Ogert RA, et al. Analysis of boceprevir resistance associated amino acid variants (RAVs) in two phase 3 boceprevir clinical studies. Virology 2013; 444:329-36.
4. Sullivan JC, De Meyer S, Bartels DJ, et al. Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials. Clin Infect Dis 2013; 57:221-9.
5. Welsch C, Zeuzem S. Clinical relevance of HCV antiviral drug resistance. Curr Opin Virol 2012; 2:651-5.
6. Akuta N, Suzuki F, Fukushima T, et al. Utility of detection of telaprevir-resistant variants for prediction of efficacy of treatment of hepatitis C virus genotype 1 infection. J Clin Microbiol 2014; 52:193-200.
7. HCV Phenotype Working Group, HCV Drug Development Advisory Group. Ann Forum Collab HIV Res 2012; 14:1-10.
8. Forns X, Gordon SC, Zuckerman E, et al. Grazoprevir/elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent. J Hepatol 2015; 63:564-72.
9. Wedemeyer H, Jensen DM, Godofsky E, et al. Recommendations for standardized nomenclature and definitions of viral response in trials of hepatitis C virus investigational agents. Hepatology 2012; 56:2398-403.
10. Chen J, Florian J, Carter W, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013; 144:1450-5.
11. Yoshida EM, Sulkowski MS, Gane EJ, et al. Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus. Hepatology 2015; 61:41-5.
12. Poordad F, Agarwal K, Younes Z, Cohen D, XieW, Podsadecki T. Low relapse rate leads to high concordance of sustained virologic response (SVR) at 12 weeks with SVR at 24 weeks after treatment with ABT-450/ritonavir, ombitasvir, and dasabuvir plus ribavirin in subjects with chronic hepatitis C virus genotype 1 infection in the AVIATOR Study. Clin Infect Dis 2014; 60:608-10.
13. Koletzki D, Pattery T, Fevery B, Vanhooren L, Stuyver LJ. Amplification and sequencing of the hepatitis C virus NS3/4a protease and the NS5b polymerase regions for genotypic resistance detection of clinical isolates of subtypes 1a and 1b. Methods Mol Biol 2013; 1030:137-49.
14. Leitner T, Halapi E, Scarlatti G, et al. Analysis of heterogeneous viral populations by direct DNA sequencing. Biotechniques 1993; 15:120-7.
15. Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic HCV genotype 1, 4, or 6 infection: A randomized trial. Ann Intern Med 2015; 163:1-13.