Viekirax safety, efficacy comparable in HCV with chronic kidney disease
The safety and efficacy of Viekirax was comparable between patients with hepatitis C genotype 1b and chronic kidney disease and those without chronic kidney disease, according to a recently published study.
“The HCV infection rate in CKD patients is higher than that in the general population, and the anti-HCV antibody-positive rate increases with progression of CKD stage. HCV infection further exacerbates renal function in CKD patients, which have a risk of progression to end-stage renal disease (ESRD) and a high mortality rate,” the researchers wrote. “Introduction of antiviral therapy is recommended for chronic hepatitis C patients with CKD not only to prevent progression to liver cirrhosis and development of hepatocellular carcinoma but also to preserve renal function.”
To evaluate the safety and efficacy of Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) for HCV genotype 1b complicated by non-dialysis CKD, the researchers retrospectively reviewed the data of 235 patients with HCV genotype 1b who received Viekirax for 12 weeks between October 2012 and March 2017. No patients were undergoing dialysis or coinfected with HIV or hepatitis B. The researchers also included 181 patients without CKD in the study.
Overall, the rapid virologic response (RVR) rate was 78.7%, the end of treatment response (ETR) rate was 98.7%, and the sustained virologic response rate was 98.7%. The RVR rate (77.3%), ETR rate (98.9%) and SVR rate (98.9%) among patients without CKD were not significantly different compared with the RVR rate (83.3%), ETR rate (98.1%) and SVR rate (98.1%) among those with CKD.
Two patients without CKD experienced virologic failure, one of whom has Y93 substitution at NS5A region at baseline and one who withdrew 2 weeks after treatment initiation due to pulmonary edema related to ritonavir interaction with a calcium channel blocker. One patient with CKD experienced virologic failure.
The researchers observed no significant decrease in estimated glomerular filtration rate (eGFR) from baseline among patients with CKD.
The rate of treatment-emergent adverse events was not significantly different between the patients without CKD (21%) and the patients with CKD (27.8%). Most adverse events were mild to moderate and self-limiting and the incidence of adverse events that led to discontinuation was not significantly different between the two groups. – by Talitha Bennett
Disclosure: Healio.com/Hepatology was unable to determine the authors’ relevant financial disclosures at the time of publication.