Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease - Data from the German Hepatitis C-Registry (DHC-R)

Background and aims Grazoprevir/elbasvir (GZR/EBR) and glecaprevir/pibrentasvir (G/P) are two treatment options for patients with chronic hepatitis C and a baseline glomerular filtration rate (GFR) < 30 ml/min. Real world data in this special patient population is sparse so far. Thus, we analyzed safety and effectiveness data within the German Hepatitis C-Registry (DHC-R).

Method The DHC-R is a real-world registry including about 17,300 patients. Data were analyzed as of Jun 30, 2019. The analysis is based on 2,773 patients with documented GFR at baseline treated with GZR/EBR (N = 1,041), GZR/EBR + RBV (N = 53) and G/P (N = 1,679), respectively. For the per protocol analysis, non-adherent patients, patients with missing data and patients lost to follow-up were excluded.

Results The baseline characteristics of the total study cohort were as follows: 70 %/4 %/21 %/5 % HCV-genotype 1/2/3/4; 64.7 % male; age 50 ± 14 years, 96 % Caucasian, 83 % treatment-naïve,12 % cirrhosis). 94 (3.4 %) patients with baseline GFR < 30 ml/min initiated antiviral therapy with GZR/EBR (N = 57), GZR/EBR + RBV (N = 4), or G/P (N = 33). They suffered significantly more frequent from diabetes mellitus, hypertension, and coronary heart disease than individuals with GFR > 30 ml/min and showed the following baseline characteristics: 78 %/3 %/13 %/5 % HCV-genotype 1/2/3/4; 13 % cirrhosis; 81 % treatment-naïve. Antiviral therapy was associated with a GFR improvement in 30/2,063 (1.5 %) individuals, a deterioration to GFR < 30 ml/min occurred in in 3/2,063 (0.1 %) patients. Adverse events (AE) occurred in 32.3 % of patients with GFR < 30 ml/min vs. 30 % of cases with GFR > 30 ml/min. Serious AE were significantly more frequent in individuals with GFR < 30 ml/min (7.5 % vs. 1.4 %), but unrelated to antiviral therapy in six of seven cases. One patient suffered from a cholestatic hepatitis possibly related to GZR/EBR. Treatment discontinuation due to (serious) AE occurred in no patient with GFR < 30 and in 0.1 % of patients with GFR >30 ml/min. Per-Protocol overall SVR rates did not differ significantly between cases with GFR < 30 vs. > 30 ml/min (99 % vs. 99 %).

Conclusion GZR/EBR and G/P show a favorable safety profile and high antiviral effectiveness in patients with chronic hepatitis C and a GFR < 30 ml/min.

Publication History

Article published online:
08 September 2020