By Nancy A. Melville
Source
SAN DIEGO -- November 10, 2015 -- The combination of grazoprevir (GZR) and elbasvir (EBR), in a single tablet, shows strong efficacy in the treatment of hepatitis C virus (HCV) in patients with stage 4 or 5 chronic kidney disease (CKD), researchers reported here at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN).
The once-daily therapy combines a NS3/4A protease inhibitor and an NS5A replication complex inhibitor and is being investigated for a variety of HCV genotypes and in conditions ranging from HIV/HCV co-infection to opiate substitution therapy and liver cirrhosis.
The C-SURFER trial included 224 patients with stage 4 or 5 CKD who were on haemodialysis and had concomitant HCV genotype 1. Patients were randomised to either immediate treatment with GZR/EBR 100 mg/50 mg (n = 111) or deferred treatment, which consisted of placebo for 12 weeks followed by GZR/EBR 100 mg/50 mg.
The sustained virologic response (SVR) rate 12 weeks post-therapy in the GZR/EBR group was 94.6%, compared with 95% in placebo-treated patients after receiving deferred treatment.
The overall SVR rate after 12 weeks was 98.6%, excluding patients who had discontinued for reasons not related to the study drug.
Among 12 patients who failed to achieve SVR at 12 weeks, 3 had a virologic relapse, 1 discontinued due to an adverse event and 8 had administrative reasons.
Serious adverse events were reported in 16 (14%) patients in the GZR/EBR group and in 17 (15%) patients in the placebo group prior to their deferred treatment. The rate of discontinuation due to an adverse event in GZR/EBR-treated patients was 0% versus 4% in placebo-treated patients.
“Once-daily GZR/EBR for 12 weeks was highly effective with a low rate of adverse events in patients with advanced kidney disease and HCV genotype 1 infection,” wrote David Roth, MD, University of Miami, Miami, Florida, and colleagues in their presentation.
Funding for this study was provided by Merck.
[Presentation title: Grazoprevir (GZR)/Elbasvir (EBR) Treatment of Hepatitis C Virus (HCV) Infection in Patients With Chronic Kidney Disease Stage 4/5: Final Results of the C-SURFER Phase 3 Study]
To read more Conference Dispatch articles, click here.
SAN DIEGO -- November 10, 2015 -- The combination of grazoprevir (GZR) and elbasvir (EBR), in a single tablet, shows strong efficacy in the treatment of hepatitis C virus (HCV) in patients with stage 4 or 5 chronic kidney disease (CKD), researchers reported here at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN).
The once-daily therapy combines a NS3/4A protease inhibitor and an NS5A replication complex inhibitor and is being investigated for a variety of HCV genotypes and in conditions ranging from HIV/HCV co-infection to opiate substitution therapy and liver cirrhosis.
The C-SURFER trial included 224 patients with stage 4 or 5 CKD who were on haemodialysis and had concomitant HCV genotype 1. Patients were randomised to either immediate treatment with GZR/EBR 100 mg/50 mg (n = 111) or deferred treatment, which consisted of placebo for 12 weeks followed by GZR/EBR 100 mg/50 mg.
The sustained virologic response (SVR) rate 12 weeks post-therapy in the GZR/EBR group was 94.6%, compared with 95% in placebo-treated patients after receiving deferred treatment.
The overall SVR rate after 12 weeks was 98.6%, excluding patients who had discontinued for reasons not related to the study drug.
Among 12 patients who failed to achieve SVR at 12 weeks, 3 had a virologic relapse, 1 discontinued due to an adverse event and 8 had administrative reasons.
Serious adverse events were reported in 16 (14%) patients in the GZR/EBR group and in 17 (15%) patients in the placebo group prior to their deferred treatment. The rate of discontinuation due to an adverse event in GZR/EBR-treated patients was 0% versus 4% in placebo-treated patients.
“Once-daily GZR/EBR for 12 weeks was highly effective with a low rate of adverse events in patients with advanced kidney disease and HCV genotype 1 infection,” wrote David Roth, MD, University of Miami, Miami, Florida, and colleagues in their presentation.
Funding for this study was provided by Merck.
[Presentation title: Grazoprevir (GZR)/Elbasvir (EBR) Treatment of Hepatitis C Virus (HCV) Infection in Patients With Chronic Kidney Disease Stage 4/5: Final Results of the C-SURFER Phase 3 Study]
To read more Conference Dispatch articles, click here.
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