Patients with hepatitis C virus (HCV) infection and severe renal impairment may soon have a new all-oral direct-acting antiviral treatment regimen available, according to a multicenter, open-label, phase 3 study published in the New England Journal of Medicine.1
Researchers identified 104 patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection who also had compensated liver disease (with or without cirrhosis) and stage 4 or 5 chronic kidney disease, dependence on dialysis, or both.1 Of the patients, 42% received previous treatment for HCV infection, with most having been treated with a combination of interferon and ribavirin. Patients received 3 coformulated tablets per day, each containing the NS3/4A protease inhibitor glecaprevir (100 mg) and the NS5A inhibitor pibrentasvir (40 mg) for 12 weeks.
The primary end point of the study was met with 98% of patients (102 of 104 patients; 95% CI, 95-100) demonstrating a sustained virologic response.1 There were no reports of virologic failure during treatment and no reports of virologic relapse after the end of treatment.
Pruritus, fatigue, and nausea were each reported in at least 10% of patients.1 Similar to other studies of patients with severe renal impairment receiving direct-acting antiviral treatment regimens,2-4 24% of patients experienced at least one serious adverse event.1 Four patients experienced an adverse event that lead to discontinuation of the study drug.
In a population with limited treatment options, the investigators concluded that “treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection.”1
Disclosures: This study was funded by AbbVie.
- Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017;377:1448-1455.
- Roth D, Nelson DR, Bruchfeld A, et al. http:Grazoprevir plus elbasvir in treatment naïve and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386:1537-1545.
- Pockros PJ, Reddy KR, Mantry PS, et al. Efficacy of direct-acting antiviral combination for patients with hepatitis C virus genotype 1 infection and severe renal impairment or end-stage renal disease. Gastroenterology. 2016;150:1590-1598.
- Hassanein T, Vierling J, Reddy KR, et al. RUBY-I, Cohort 2: treatment of HCV genotype 1 infection in patients with severe or end-stage renal disease, including patients with cirrhosis. Abstract presented at: Asian Pacific Association for the Study of the Liver Single Topic Conference on Hepatitis C; June 10-12, 2016; Kaohsiung, Taiwan.