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news.Results from a phase 3 clinical trial evaluating AbbVie's investigational pan-genotypic HCV regimen of glecaprevir/pibrentasvir (G/P) demonstrated high SVR rates in chronic hepatitis C patients with severe chronic kidney disease.
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The trial, Expedition-4, enrolled 104 patients including 85 who were receiving dialysis at enrollment, 20 with compensated cirrhosis and 44 who were not cured with sofosbuvir with ribavirin or interferon with ribavirin, with or without sofosbuvir.
The study showed treatment with G/P delivered a 98% (n=102/104) cure rate (SVR12) after 12 weeks of treatment.
In a modified intent-to-treat analysis, excluding subjects who did not achieve SVR for reasons other than virologic failure, the cure rate was 100% (n=102/102).
Mild or moderate were the majority of treatment associated adverse events (AEs). Pruritus, fatigue and nausea were the most commonly reported AEs.
AbbVie said of the 24% of patients who experienced severe AEs, none were considered related to G/P.
Four AEs resulted in the discontinuation of G/P and one patient died after achieving SVR4 because of a serious AE (intracerebral hemorrhage) considered not-related to G/P, the company said.
AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: "With our investigational, pan-genotypic regimen, our goal is to provide a safe and effective cure to patients across genotypes, including patients with severe chronic kidney disease, regardless of previous treatment status or presence of compensated cirrhosis.
"Our clinical development program reflects our ongoing commitment to addressing treatment areas of continued unmet need."
G/P regimen combines two antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. It is dosed once-daily as three oral tablets.
It is being assessed as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, that make up the majority of HCV patients.
AbbVie is also assessing G/P in patients with particular treatment challenges, like genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.
Image: AbbVie US Headquarters – Angle 3. Photo: courtesy of AbbVie Inc.