Treating HCV Genotype 1 Infection in Patients with Advanced Kidney Disease

Atif Zaman, MD, MPH reviewing Roth D et al. Lancet 2015 Oct 5.

A regimen of grazoprevir and elbasvir was effective in 99% of patients.

Despite the recent advances in all-oral treatment regimens for patients with hepatitis C virus (HCV) genotype 1 infection, treatment options for patients with advanced kidney disease are still limited.

In an industry-funded, phase III study, investigators randomized 224 patients with stage 4 or 5 chronic kidney disease with or without hemodialysis and HCV genotype 1 infection to receive grazoprevir (100 mg; an NS3/4A protease inhibitor) and elbasvir (50 mg; an NS5A inhibitor) in a single pill or placebo daily for 12 weeks. An additional 11 patients received treatment in an open-label fashion for purposes of intensive pharmacokinetic analysis. Of all 235 patients, 80% were treatment-naive, 6% had cirrhosis, 46% were African-American, and 76% were hemodialysis dependent. The primary efficacy outcome was sustained virologic response 12 weeks after treatment was stopped (SVR12) in the two treatment groups (randomized and open-label cohorts) compared with a historical control cohort with an SVR12 of 45%.

Of 116 evaluable patients, SVR12 was achieved in 115 (99%). The most frequent adverse events were headache, nausea, and fatigue, which occurred at similar frequencies in the treatment and placebo groups.

CITATION(S):

Roth D et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): A combination phase 3 study. Lancet 2015 Oct 5; [e-pub].