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RUBY-I: Preliminary study shows safety of 3D + ribavirin in CKD
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VIENNA — A small cohort of patients with chronic kidney disease demonstrated favorable tolerability outcomes with the Viekira Pak, according to data presented during the Late Breaker session at the 2015 International Liver Congress.
HCV Next Editorial Board member Paul J. Pockros, MD, of Scripps Clinic in La Jolla, California, presented interim data for patients treated with Viekira Pak (ombitasvir, paritaprevir, ritonavir plus dasabuvir; Abbvie) daily with or without ribavirin 200 mg every day. Patients with genotype 1b disease were treated without ribavirin, and the genotype 1a patients received ribavirin.
Paul J. Pockros
“This three-drug regimen is metabolized in the liver and doesn’t require dose adjustment for patients with chronic kidney disease,” Pockros said.
The study design called for treatment of 20 patients. Pockros reported data for 14 patients.
Eligible participants included those with stage 4 or 5 chronic kidney disease who had no treatment experience and were not cirrhotic.
No serious adverse events were reported. Patients with genotype 1b experienced almost no adverse events, according to Pockros. Thirteen patients in the genotype 1a group experienced ribavirin-induced anemia.
“Most events were mild or moderate,” Pockros said. “There were no study drug discontinuations.”
One patient experienced diskitis and respiratory failure, and another experienced pseudoaneurysm, hemoperitoneum and small bowel obstruction. Treatment was interrupted in both patients.
“Neither of these events were thought to be due to treatment,” Pockros said. “Importantly, there were no significant changes in liver or kidney function during treatment.”
Clinicians also interrupted ribavirin treatment in eight patients due to hemoglobin criteria. There have been no blood transfusions performed.
Efficacy results indicated that all patients except one became undetectable by week 4. That exception was undetectable by week 6.
Two patients have reached 12-week sustained virologic response.
Preliminary Ctrough values of the drugs were comparable to those seen in other studies.
“This three-drug regimen was well tolerated in genotype 1 patients with advanced renal disease, including those on hemodialysis,” Pockros concluded. – by Rob Volansky
For More Information:
Pockros P, et al. Abstract L01. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Pockros reports receiving grants from Abbvie, BMS, Conatus, Gilead, Janssen, Merck and Roche Molecular; and consulting with Abbvie, BMS, Gilead and Janssen.