Merck & Co’s investigational single-tablet hepatitis C combination therapy elbasvir/grazoprevir has shown promise in the treatment of patients who also have advanced kidney disease, including those on dialysis.
The all-oral, ribavirin-free treatment regimen was tested in a Phase III trial in both treatment-naïve and treatment-experienced patients with advanced CKD stages 4 or 5 and chronic HCV genotype 1 infection.
Data show that three months’ therapy with elbasvir/grazoprevir resulted in high rates of response, with 99% achieving a sustained virologic response 12 weeks after completing treatment (SVR12). And crucially, this was achieved regardless of patient characteristics, including difficult-to-treat populations such as African-Americans and those receiving haemodialysis.
Chronic HCV infection is both a cause and complication of the treatment of CKD, but despite recent medical breakthroughs there remains a lack of proven therapeutic options for CKD patients with the disease. The data - first presented at the International Liver Congress 2015 in April and now published online in The Lancet - seem to back use of elbasvir/grazoprevir in a broad patient population.
US regulators are currently considering Merck’s application to market the combination pill for treatment of chronic HCV genotypes 1, 4 and 6 under a priority review, with a decision expected by the end of January.