AMSTERDAM — Nearly 100% of a cohort of non-cirrhotic patients with HCV who had undergone liver transplantation responded to treatment with glecaprevir/pibrentasvir, according to data presented at the International Liver Congress.
“This combination offers a high barrier to resistance and is potent against common NS3 and NS5A polymorphisms,” Nancy Reau, MD, of Rush University Medical Center in Chicago, said in her presentation.
The phase 3, single arm, open-label, multicenter study included 100 patients evaluated for safety and efficacy of the study regimen. Eligible participants had genotypes 1 through 6 HCV (there were no genotype 5 patients in the final cohort) and were treated with a fixed-dose combination of 300 mg glecaprevir and 120 mg pibrentasvir (G/P, AbbVie) for 12 weeks. There were no restrictions on age, genotype, BMI or treatment experience with interferon, peginterferon, ribavirin or Sovaldi (sofosbuvir, Gilead). “The list of immune suppressants was quite permissive,” Reau added.
The data set included 80 liver transplant recipients and 20 renal transplant recipients included in the analysis. The researchers assessed the regimen for non-inferiority to historical 94% response rates. Virologic failure or post-treatment relapse served as secondary outcome measures.
The overall SVR12 rate was 99%, according to Reau. “This did meet the non-inferiority threshold,” she said.
Safety data indicated 85 events overall, with eight serious adverse events. Two of those events were potentially related to the study drugs, according to Reau. One was an episode of sinusitis and the other was an abnormality in liver function at post-treatment week 4.
Adverse events that occurred in more than 10% of the population included headache, fatigue, nausea, pruritus, and diarrhea.
Laboratory analysis indicated one grade 3 ALT elevation. “This patient did not have a modulation of therapy and went on to normalize enzymes at the end of the study,” Reau said.
She concluded that SVR12 was not impacted by baseline or viral characteristics. “Serious events were uncommon, and laboratory abnormalities were rare,” she said.
“Results of the phase-3b MAGELLAN-2 study demonstrate that the all-oral ribavirin-free G/P achieved high SVR rates with 12 weeks of treatment in non-cirrhotic, post-renal or post-liver transplantation patients with hepatitis C infection,” Reau said. – by Rob Volansky
Reference: Reau N, et al. Abstract LBO-03. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: Reau reports receiving grants from AbbVie and Gilead and consulting for Bristol-Myers Squibb, Gilead and Merck.