Elbasvir/grazoprevir plus sofosbuvir in treatment-naive and treatment-experienced cirrhotic patients with hepatitis C virus genotype 3 infection treated for 8, 12, or 16 weeks: final results of the C-ISLE study

Foster, Graham; Agarwal, Kosh; Cramp, M.; Moreea, Sulleman; Barclay, Stephen T.; Collier, Jane; Brown, Ashley; Ryder, SD; Ustianowski, Andrew; Forton, Daniel; Fox, Raymond; Gordon, Fiona; Rosenberg, William; Mutimer, D.J.; Du, Jiejun; Gilbert, C.; Robertson, Michael; Barr, Eliav; Haber, Barbara

doi:10.1016/s0168-8278(17)31407-1

Cited by 6 publications

(6 citation statements)

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“…(18) For genotype 2 and 3 infection, the NS5B inihibitor sofosbuvir (SOF) is highly active (19). Additional trials have demonstrated the efficacy of GZR-EBR in combination with SOF for genotype 3 infection(20, 21)…”

Section: Introductionmentioning

confidence: 99%

Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus–Infected Donors to Noninfected Recipients

et al. 2018

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Background Given the high mortality rate for those with end-stage kidney d sease on dialysis and the efficacy and safety of current hepatitis C virus (HCV) treatments, currently-discarded kidneys from HCV-infected (HCV+) donors may be a neglected public health resource. Objective To determine the tolerability and feasibility of kidney transplantation (KT) from HCV+ donors to HCV-uninfected recipients (HCV D+/R−) in combination with direct-acting antivirals (DAAs) as pre- and post-transplant prophylaxis. Design Open-label, non-randomized trial. (ClinicalTrials.gov: NCT02781649) Setting Single-center. Participants 10 HCV-uninfected KT candidates over the age of 50 years with no available living donors. Intervention KT from deceased donors ages 13–50 years with a positive HCV RNA and HCV antibody test. All recipients received a dose of grazoprevir 100 mg/elbasvir 50 mg (GZR/EBR) immediately prior to transplant. For genotype 1 donors, recipients continued GZR/EBR for 12 weeks post-transplant; for genotype 2 or 3 donors, sofosbuvir 400 mg was added to GZR/EBR for 12 weeks of triple-therapy. Measurements The primary safety outcome was the incidence of adverse events related to GZR-EBR. The primary efficacy outcome was the proportion recipients with HCV RNA less than the lower limit of quantification 12 weeks after prophylaxis. Results Among 10 HCV D+/R− there were no treatment-related adverse events and HCV RNA was not detected in any recipient 12 weeks after treatment. Limitations Nonrandomized study design and small number of patients. Conclusions Pre- and post-transplant HCV treatment was safe and prevented chronic hepatitis C in HCV D+/R− KT. If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for HCV− KT candidates.

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Section: Introductionmentioning

confidence: 99%

Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus–Infected Donors to Noninfected Recipients

et al. 2018

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“…In a genotype 3 CHC patient with cirrhosis, 53 patients who failed previous treatment (including 2 SOF+R therapy) were treated with EBR/GZR and SOF for 12 wk, or with EBR/GZR+SOF with ribavirin for 12 wk, or with EBR/GZR+SOF with ribavirin for 16 wk. The SVR were 100% (17/17), 94% (17/18) and 94% (17/18), respectively [ 57 ].…”

Section: Treatment Approach For Patients Who Failed Previous Daa Treamentioning

confidence: 99%

Recent update of the 2017 Korean Association for the Study of the Liver (KASL) treatment guidelines of chronic hepatitis C: Comparison of guidelines from other continents, 2017 AASLD/IDSA and 2016 EASL

Yeon

2018

Clin Mol Hepatol

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The paradigm for the treatment of chronic hepatitis C (CHC) has been changed due to the development of direct acting antivirals (DAAs) of hepatitis C virus (HCV). The high sustained virologic response rate and ease of administration makes the DAAs approach ideal to contribute to the complete eradication of HCV. Currently, treatment options for individual patients vary depending on the genotype or subtype of HCV, presence or absence of liver cirrhosis, previous experience of antiviral treatment or resistance associated substitutions. Because of drug avalilability, cost-effectiveness, preference, compliance and greater possibility of desirable effects and presumed patient-important outcomes may vary between countries, treatment options for individual patients are different. The review focuses on the comparing the current treatment options for CHC in other continents with the 2017 Korea Association for the Study of the Liver guidelines.

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“…In a phase 2 study comparing 12 weeks of elbasvir/grazoprevir and sofosbuvir, 12 weeks of elbasvir/grazoprevir, sofosbuvir, and ribavirin, and 16 weeks of elbasvir/grazoprevir and sofosbuvir in cirrhotic patients with genotype 3 HCV, the SVR were 100% (17/17), 94% (17/18), and 94% (17/18), respectively [ 94 ].…”

Section: Treatment Of Chronic Hepatitis C or Compensated Cirrhosis Pamentioning

confidence: 99%

“…In a study of genotype 3 CHC patients with cirrhosis, 53 patients who failed with previous treatment (including 2 on sofosbuvir and ribavirin combination therapy) were retreated with elbasvir/grazoprevir and sofosbuvir for 12 weeks, elbasvir/grazoprevir, sofosbuvir, and ribavirin for 12 weeks, or elbasvir/grazoprevir and sofosbuvir for 16 weeks [ 94 ]. The SVR were 100% (17/17), 94% (17/18), and 94% (17/18), respectively.…”

Section: Retreatment Of Patients With Daa Treatment Failurementioning

confidence: 99%

2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C

2018

Clin Mol Hepatol

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Elbasvir/grazoprevir plus sofosbuvir in treatment-naive and treatment-experienced cirrhotic patients with hepatitis C virus genotype 3 infection treated for 8, 12, or 16 weeks: final results of the C-ISLE study

Cited by 6 publications

References 0 publications

Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus–Infected Donors to Noninfected Recipients

Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus–Infected Donors to Noninfected Recipients

Recent update of the 2017 Korean Association for the Study of the Liver (KASL) treatment guidelines of chronic hepatitis C: Comparison of guidelines from other continents, 2017 AASLD/IDSA and 2016 EASL

2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C

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