Elbasvir-grazoprevir effective against HCV in chronic kidney disease

Last Updated: 2017-06-12

By Will Boggs MD

NEW YORK (Reuters Health) - The fixed-dose combination of elbasvir and grazoprevir is safe and effective for treating chronic hepatitis C virus (HCV) infection in patients with stage 4-5 chronic kidney disease (CKD), according to results from the C-SURFER study.

"Treatment of HCV-infected CKD patients is generally much lower than that of the general population even though chronic HCV infection affects outcome in these patients,�€ Dr. Annette Bruchfeld from Karolinska University Hospital, in Stockholm, Sweden, told Reuters Health by email. �€œTo amend this situation, it is important that nephrologists get involved in this discussion, as well as in treatment decisions.�€

�€œIn patients with stage 4-5 (<30 mL/min estimated glomerular filtration rate, GFR) CKD, HCV infection can accelerate the decline in kidney function, influence health-related quality of life (HRQOL), and impair survival in dialysis and both patient and graft survival in kidney transplantation,�€ she explained. �€œInterferon-based therapy has been cumbersome due to an increased risk of adverse events and a lack of expertise in treating this special population.�€

Dr. Bruchfeld and colleagues from 68 centers worldwide investigated sustained virological response (SVR) and other outcomes among 235 patients with chronic HCV infection and stage 4-5 CKD, including 111 assigned to immediate treatment and 113 assigned to deferred treatment with elbasvir-grazoprevir and 11 assigned to intensive pharmacokinetic assessment.

In the overall modified full analysis set, 98.6% of patients achieved SVR at 12 weeks, including 99.1% of those assigned to immediate treatment and 98.0% of those assigned to deferred treatment, the team reports in The Lancet Gastroenterology and Hepatology, online May 30.

Health-related quality of life did not change significantly in either the immediate or the deferred treatment group.

Safety observations were similar for patients in the two treatment groups. Only one serious adverse event was deemed related to study drugs, a case of tubulointerstitial nephritis in a patient with pre-existing membranous glomerulonephritis.

Pharmacokinetic data did not differ meaningfully between patients on hemodialysis and those not receiving hemodialysis.

�€œAs shown earlier in the previously published C-SURFER trial the full data set from the current study confirms the high efficacy of this combination regimen (elbasvir plus grazoprevir),�€ Dr. Bruchfeld concluded. �€œThis drug combination or other with a similar effect should become standard-of-care in patients with stage 4-5 CKD.�€

Merck Sharp and Dohme markets the combination drug as Zepatier. The company sponsored the trial, employed several authors and had various relationships with the rest, including Dr. Bruchfeld.

SOURCE: http://bit.ly/2r9HR5b

Lancet Gastroenterol Hepatol 2017.