Glecaprevir/pibrentasvir shows safety, efficacy in patients with HCV, renal disease

BOSTON — A novel regimen demonstrated pangenotypic activity and safety in patients with hepatitis C infection with advanced chronic kidney disease, according to findings presented during the Late Breaker session at The Liver Meeting 2016.

“Currently there are limited interferon and ribavirin-free DAA regimens available” for this patient population, Edward J. Gane, MD, of the Liver Unit at Auckland City Hospital in New Zealand, said in his presentation. “Clearly this is still a population with an unmet medical need, particularly those patients infected with genotypes 2, 3, 5 or 6.”

The current data set involves 12 weeks of daily treatment with glecaprevir (ABT-493, AbbVie) 300 mg, an NS3/4A inhibitor, and pibrentasvir (ABT-530, AbbVie) 120 mg, an NS5A inhibitor, both of which are pangenotypic drugs that do not undergo significant renal excretion. SVR12 served as the primary endpoint. Researchers also assessed safety endpoints in all patients who were treated with at least one dose of the study drugs.

The analysis included 104 patients with HCV genotypes 1 through 6 and stage 4 and 5 CKD. Forty-two percent were treatment-experienced, 19% had compensated cirrhosis and more than 40% were on a proton pump inhibitor. Most the cohort (88%) had stage 5 CKD.

Gane reported 102 of 104 patients, or 98%, achieved SVR12 with no virologic failures.

“Glecaprevir/pibrentasvir achieved high efficacy in patients with stage 4 or 5 chronic kidney disease and hepatitis C infection,” he said. “G/P was a well-tolerated regimen with a favorable safety profile in this difficult-to-treat population.”

One patient discontinued therapy after 3 weeks due to diarrhea; another died of a complication unrelated to therapy. Most of the adverse events related to treatment were mild or moderate. The serious adverse event rate was 24%, but none of those events were associated with the treatment regimen. There were four discontinuations involving pruritus, fluid overload or uncontrolled hypertension. These four discontinuations received at least 8 weeks of treatment and achieved SVR12.

There were five cases of grade 3 anemia, but all cases had grade 2 anemia at baseline. There were no grade 2 or greater ALT or AST elevations throughout the study. There was a single grade 3 bilirubin elevation.

“The results of this study demonstrate that a ribavirin free G/P regimen can achieve a high SVR12 rate in this population of severe renal impairment or end-stage renal disease on hemodialysis,” Gane said. – Katrina Altersitz and Rob Volansky

Reference:

Gane EJ, et al. Abstract LB-11. Presented at: The Liver Meeting; Nov. 11-15, 2016; Boston.

Disclosures: Gane reports being on the advisory committee or review panel of AbbVie, Achillion, Gilead Sciences, Janssen and Merck, and speaking and teaching for AbbVie, Alnylam, Gilead Sciences and Merck.