Merck recently presented results from analyses supporting the use of Zepatier (elbasvir and grazoprevir) 50 mg/100 mg tablets for the treatment of multiple clinical indications, including patients with chronic kidney disease (CKD).The analyses were presented at The Liver Meeting 2016 Nov. 11-15 in Boston.
“Work remains to be done in the community’s efforts to reduce the global burden of chronic hepatitis C, and Merck is committed to pursuing this goal,” Dr. Eliav Barr, senior vice president of global clinical development, infectious diseases and vaccines for Merck Research Laboratories, said in a recent press release. “Our clinical development program continues to yield meaningful evidence for Zepatier in specific patient populations.”
Merck presented results from an integrated pooled analysis from the Phase 2 and Phase 3 development program of Zepatier assessing the clinical benefits of the drug on renal function in patients with advanced CKD (stage 3, with elevated estimated glomerular filtration rate, or eGFR).
Overall, 32 patients with stage 3 CKD and 1,657 patients with elevated eGFR were included in the analysis.
All patients received Zepatier with or without ribavirin therapy, an anti-viral drug, for 8, 12, 16 or 18 weeks. The results showed that at the end of treatment, among the 32 patients with stage 3 CKD, kidney function improved in 38 percent of the patients or remained stable in 63 percent of the patients.
The effectiveness and safety profile of Zepatier was evaluated in C-SURFER, a Phase 2/3 placebo-controlled clinical trial (NCT02092350) in cirrhotic and non-cirrhotic patients with chronic genotype 1 hepatitis C virus (HCV) infection and CKD.
The results from this study, presented at the International Liver Congress in April 2015 and published in The Lancet, showed that following 12 weeks of treatment with Zepatier, 99 percent (115/116) of patients with chronic hepatitis C virus infection and advanced CKD achieved a sustained response with no major treatment-related adverse events reported.
Other analyses presented at the meeting provided additional evidence of the clinical benefit of Zepatier in chronic hepatitis C virus (HCV) genotype (GT) 1- or GT4-infected patients, including those who receive opioid agonist therapy (OAT), are infected with chronic HCV GT1b, or use proton pump inhibitors (PPIs).
Zepatier is a fixed-dose combination product containing elbasvir, a hepatitis C virus NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults.