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Title: | Grazoprevir, ruzasvir, and uprifosbuvir for hepatitis C virus after NS5A treatment failure. | Authors: | Jacobson I.M.;Jumes P.;Huang H.-C.;Butterton J.;Robertson M. ;Wahl J.;Barr E.;Joeng H.-K.;Martin E.;Serfaty L.;Luetkemeyer A.;Gane E.J.;Hansen J.B.;Laursen A.L.;Pianko S. ;Nahass R.;Zeuzem S.;Wyles D.;Wedemeyer H.;Ben-Ari Z. | Institution: | (Wyles) University of Colorado School of Medicine, Denver, CO, United States (Wedemeyer) Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany (Ben-Ari) Sheba Medical Center, Tel Hashomer, Israel (Gane) Auckland Hospital, Auckland, New Zealand (Hansen) Aalborg University Hospital, Department of Gastroenterology, Aalborg, Denmark (Jacobson) Mount Sinai Beth Israel and Icahn School of Medicine at Mount Sinai, New York, NY, United States (Laursen) Department of Infectious Diseases, Aarhus University Hospital, Skejby, Aarhus, Denmark (Luetkemeyer) Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, United States (Nahass) ID Care, Hillsborough, NJ, United States (Pianko) Monash Medical Centre, Clayton, VIC, Australia (Zeuzem) Goethe University Hospital, Frankfurt, Germany (Jumes, Huang, Butterton, Robertson, Wahl, Barr, Joeng, Martin) Merck & Co., Inc., Kenilworth, NJ, United States (Serfaty) Service d'Hepatologie, Hopital Saint-Antoine, Universite Pierre & Marie Curie, Paris, France | Issue Date: | 29-Nov-2017 | Copyright year: | 2017 | Publisher: | John Wiley and Sons Inc. (P.O.Box 18667, Newark NJ 07191-8667, United States) | Place of publication: | United States | Publication information: | Hepatology. 66 (6) (pp 1794-1804), 2017. Date of Publication: December 2017. | Journal: | Hepatology | Abstract: | People with hepatitis C virus (HCV) infection who have failed treatment with an all-oral regimen represent a challenging treatment population. The present studies evaluated the safety and efficacy of grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, in participants who had failed an NS5A inhibitor-containing regimen. C-SURGE (PN-3682-021) and C-CREST Part C (PN-3682-011 and -012) were open-label, multicenter studies. Participants who had previously relapsed following an NS5A inhibitor-containing all-oral regimen were retreated with grazoprevir 100 mg, ruzasvir 60 mg, and uprifosbuvir 450 mg alone for 24 weeks or with ribavirin for 16 weeks. The primary efficacy endpoint was sustained virologic response (HCV RNA below the limit of quantitation [<15 IU/mL]) 12 weeks after treatment completion (SVR12). In C-SURGE, SVR12 was achieved by 49/49 (100%) and 43/44 (98%) genotype (GT)1 participants in the 24-week no ribavirin arm and the 16-week plus ribavirin arm (lost to follow-up, n = 1), respectively. In C-CREST Part C, SVR12 was achieved by 23/24 (96%) participants treated for 16 weeks with ribavirin (GT1, 2/2 [100%]; GT2, 13/14 [93%]; GT3, 8/8 [100%]). One participant with GT2 infection discontinued study medication after a single dose of grazoprevir, ruzasvir, and uprifosbuvir plus ribavirin due to serious adverse events of vomiting and tachycardia. The presence of baseline resistance-associated substitutions had no impact on SVR12. No participant who completed treatment in either study experienced virologic failure. Conclusion(s): Grazoprevir, ruzasvir, and uprifosbuvir, with or without ribavirin, for 16 or 24 weeks was safe and highly effective in participants with HCV infection who had previously failed NS5A inhibitor-containing therapy. (Hepatology 2017;66:1794-1804).Copyright © 2017 by the American Association for the Study of Liver Diseases. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1002/hep.29358 | Link to associated publication: | Click here for full text options | PubMed URL: | 28688129 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28688129] | ISSN: | 0270-9139 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/38586 | Type: | Article | Subjects: | male medication compliance multicenter study nausea/si [Side Effect] open study patient compliance phase 2 clinical trial priority journal pruritus/si [Side Effect] randomized controlled trial rash/si [Side Effect] retreatment single drug dose sustained virologic response tachycardia/si [Side Effect] vomiting/si [Side Effect] elbasvir/cb [Drug Combination] elbasvir plus grazoprevir/dt [Drug Therapy] *grazoprevir/ae [Adverse Drug Reaction] *grazoprevir/ct [Clinical Trial] *grazoprevir/cb [Drug Combination] *grazoprevir/dt [Drug Therapy] hemoglobin/ec [Endogenous Compound] ledipasvir plus sofosbuvir/dt [Drug Therapy] *ribavirin/ae [Adverse Drug Reaction] *ribavirin/ct [Clinical Trial] *ribavirin/cb [Drug Combination] *ruzasvir/ae [Adverse Drug Reaction] *ruzasvir/ct [Clinical Trial] *ruzasvir/cb [Drug Combination] *ruzasvir/dt [Drug Therapy] *uprifosbuvir/ae [Adverse Drug Reaction] *uprifosbuvir/ct [Clinical Trial] *uprifosbuvir/cb [Drug Combination] *uprifosbuvir/dt [Drug Therapy] virus RNA/ec [Endogenous Compound] Hepatitis C virus subtype 2c monotherapy adult aged *antiviral therapy article combination drug therapy controlled study diarrhea/si [Side Effect] *drug efficacy *drug safety drug treatment failure drug withdrawal fatigue/si [Side Effect] female follow up headache/si [Side Effect] hemoglobin blood level *hepatitis C/dt [Drug Therapy] *hepatitis C/et [Etiology] hepatitis C/dt [Drug Therapy] *Hepatitis C virus Hepatitis C virus genotype 1 Hepatitis C virus genotype 2 Hepatitis C virus genotype 3 Hepatitis C virus subtype 1a Hepatitis C virus subtype 1b Hepatitis C virus subtype 2a Hepatitis C virus subtype 2b Hepatitis C virus subtype 3a Hepatitis C virus subtype 3b human insomnia/si [Side Effect] limit of quantitation headache / side effect hemoglobin blood level *hepatitis C / *drug therapy / *etiology hepatitis C / drug therapy *Hepatitis C virus Hepatitis C virus genotype 1 Hepatitis C virus genotype 2 Hepatitis C virus genotype 3 Hepatitis C virus subtype 1a Hepatitis C virus subtype 1b Hepatitis C virus subtype 2a Hepatitis C virus subtype 2b Hepatitis C virus subtype 3a Hepatitis C virus subtype 3b human insomnia / side effect limit of quantitation male medication compliance monotherapy multicenter study nausea / side effect open study patient compliance phase 2 clinical trial priority journal pruritus / side effect randomized controlled trial rash / side effect retreatment single drug dose sustained virologic response tachycardia / side effect vomiting / side effect combination drug therapy Article controlled study aged adult *antiviral therapy diarrhea / side effect *drug efficacy *drug safety drug treatment failure drug withdrawal fatigue / side effect female follow up |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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