Merck’s hepatitis C virus (HCV) regimen Zepatier (grazoprevir/elbasvir) cured the virus at high rates among those with severe chronic kidney disease (CKD), according to medical records from the U.S. Department of Veterans Affairs (VA).
Researchers conducted a retrospective database analysis of 1,528 individuals with genotype 1 or 4 of hep C and stage 3 of CKD (an estimated glomerular filtration rate, or eGFR, between 30 and 59) or stage 4 or 5 or CKD (an eGFR below 30) who were treated with Zepatier for 12 or 16 weeks between February and December 2016. The cohort was drawn from the VA Corporate Data Warehouse, which is a national database of electronic medical records for the VA. All the cohort members had at least one inpatient or outpatient medical visit within a year of receiving hep C treatment and had at least two eGFR test results at least 90 days apart.
Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Washington, DC
A total of 18.6 percent (284 of 1,528) of the individuals had compensated cirrhosis (the milder form of the advanced liver disease), 19.9 percent (304 of 1,528) had decompensated cirrhosis (the more advanced form) and 5 percent (76 of 1,528) were coinfected with HIV.
Typically, an individual is considered cured of hep C if he or she has an undetectable viral load 12 weeks after completing treatment; this is known as a sustained virologic response, or SVR12. For this study, the researchers accepted viral load test results at least 10 to 12 weeks post-treatment to determine if someone was cured. For those who lacked a viral load test result during this period, the study authors looked at test result data from any point at least four weeks after the end of treatment. (Having an SVR4 is a very good indicator that someone will maintain an undetectable viral load for another eight weeks and achieve an SVR12.) Data on viral load test results taken at least 12 weeks post-treatment were available for 81.9 percent of the cohort.
Those with stage 3 CKD had a cure rate of 97.1 percent (758 of 781) while those with stage 4 or 5 CKD had a cure rate of 95.6 percent (714 of 747).
To read a press release about the study, click here.