In patients with hepatitis C virus (HCV) with glomerular filtration rate (GFR) less than 30 ml/min, different direct-acting antiviral agent (DAA) therapies may be safely used with high sustained virological response 12 (SVR12) rates, according to study results published in the European Journal of Gastroenterology and Hepatology.
DAAs have revolutionized the treatment of chronic HCV in patients with normal GFR; however, sofosbuvir (SOF), a DAA that inhibits nonstructural protein 5B, is not currently approved for the treatment of patients with a GFR less than 30 ml/min. Therefore, patients with advanced kidney disease have been excluded from clinical trials involving SOF treatment. The aim of this study was to investigate the use, effectiveness and tolerability of DAAs including SOF in patients with HCV with GFR less than 30 ml/min.
The researchers analyzed data from 5733 patients from the German Hepatitis C-Registry with chronic kidney disease who initiated a DAA therapy between February 2014 and September 2015. All patients had a documented GFR at baseline, and 46 patients (0.8%) had a baseline GFR less than 30 ml/min. The primary effectiveness end point was the proportion of patients with SVR12, defined as HCV-ribonucleic acid below 25 IU/ml 12 weeks after the end of treatment.
Researchers revealed that SVR12 rates did not differ between the group with GFR less than 30 ml/min and the group with GFR more than 30 ml/min (91% vs 96%). There were 9 patients with a baseline GFR of more than 30 ml/min who presented with a GFR less than 30 ml/min at the end of treatment. Adverse events did not differ in patients with GFR less than 30 ml/min vs more than 30 ml/min. However, serious adverse events were significantly more frequent in patients with GFR less than 30 ml/min (treatment without ribavirin 13% vs 3%, P =.02; treatment with ribavirin 33% vs 5%, P <.001). Serious adverse events and discontinuation of treatment were associated with ribavirin therapy.
Limitations of the study includes the limited DAA treatment options for patients with GFR less than 30 ml/min at the time of the analysis, and SOF-based regimens represented off-label uses as well as the absolute number of patients with GFR less than 30 ml/min was low in comparison with the total number of patients treated in the German Hepatitis C-Registry. Due to these limitations, researchers were unable to identify significant risk factors for treatment failures.
The study researchers concluded that different DAA therapies may be safely used with high SVR12 rates in patients with HCV and GFR less than 30 ml/min, except for ribavirin due to poor tolerability.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Wiegand J, Buggisch P, Mauss S, et al. Hepatitis C therapy with direct antiviral agents in patients with advanced chronic kidney disease: real-world experience of the German Hepatitis C-Registry (Deutsches Hepatitis C-Register). Eur J Gastroenterol Hepatol. 2019;31(11):1424-1431.