This article is more than 5 years old. Information may no longer be current.

EXPEDITION-1: Glecaprevir/ pibrentasvir yields 99% SVR12

AMSTERDAM — All but one patient in a recent cohort treated with the novel regimen glecaprevir/pibrentasvir achieved sustained virologic response, according to data presented at the International Liver Congress.

Xavier Forns, MD, of the Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS in Barcelona, Spain, presented data for 146 patients treated for 12 weeks with glecaprevir/pibrentasvir (GP, AbbVie), an NS3/4A inhibitor and an NS5A inhibitor. Eligible participants had HCV genotype 1, 2, 4, 5 or 6 infection. SVR12 served as the primary endpoint. Relapse or virologic failure were the secondary endpoints.

Baseline data indicated that two patients had NS3 polymorphisms and 53 patients had NS5A polymorphisms.

“All but one patient achieved SVR12,” Forns reported. The lone patient who marred the data had genotype 1a disease and experienced a relapse, he added.

“There were no treatment-emergent substitutions present in NS3,” Forns said.

The adverse event profile indicated that 69% of patients experienced any event. The serious adverse event rate was 8%. Fatigue occurred in 19% of the cohort, while 14% experienced headache and 10% experienced pruritus. “There is really nothing important to say,” he said of the adverse events.

There was one death from a cerebral hemorrhage that Forns reported was unrelated to the study drug.

Laboratory analysis indicated no important elevations in ALT or AST, according to Forns.

“[Glecaprevir/pibrentasvir] for 12 weeks achieved a 99% SVR rate in this intention-to-treat population of patients with genotypes 1, 2, 4, 5 or 6 HCV infection and compensated cirrhosis,” he concluded. – by Rob Volansky

Reference:

Forns X, et al. Abstract #GS-006. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam. 

Disclosure: Forns reports receiving grants from MSD and Roche and being an advisor for AbbVie, Gilead, Janssen and MSD.