AbbVie Submits NDA for Pan-Genotypic Hepatitis C Drug

HCV patients without cirrhosis achieved SVR after 8 weeks of treatment with glecaprevir/pibrentasvir.

AbbVie recently submitted a new drug application (NDA) for a pan-genotypic hepatitis C virus (HCV) treatment of glecaprevir/pibrentasvir (G/P). G/P is a once-daily, 3-tablet regimen that combines 2 antiviral agents. Glecaprevir is a NS2/4A protease inhibitor, and pibrentasvir is a NS5A inhibitor.

The NDA was submitted due to positive results from phase 3 clinical trials that included patients with all major genotypes of HCV, according to a press release from AbbVie. The results from these studies showed that patients without cirrhosis achieved sustained virologic response (SVR) rates after 8 weeks of treatment with G/P. AbbVie said that this finding was particularly significant, since a majority of patients with HCV have not developed cirrhosis.

High SVR rates were sustained in patients with compensated cirrhosis after 12 weeks of treatment, according to AbbVie. Patients with severe chronic kidney disease also achieved high SVR rates with G/P treatment.

Additionally, patients who underwent prior treatment with a direct-acting antiviral regimen, but were not cured, achieved high SVR rates after 12 weeks of treatment.

The submission is supported by data from 8 studies in the drug’s clinical development program, according to the press release. G/P was evaluated in more than 2300 patients across all major genotypes, as well as in special patient populations.

Patients included in these studies were both new and experienced to treatment, with and without cirrhosis, and who had certain treatment challenges.

AbbVie previously announced data showing 97.5% of treatment-naïve patients with HCV without cirrhosis achieved SVR at 12 weeks. Common adverse events experienced by these patients were headache and fatigue.

New data shows that 98% of patients with severe chronic kidney disease achieved SVR at 12 weeks in a primary intent-to-treat analysis, according to the press release. In a modified analysis of these patients, 100% achieved SVR at 12 weeks. This analysis excluded patients who did not achieve SVR due to reasons unrelated to the treatment.

Common adverse events experienced by patients with severe chronic kidney disease included pruritus, fatigue, and nausea.

The FDA had previously granted G/P breakthrough designation for the treatment of patients with HCV who were not cured by treatment with direct-acting antivirals in genotype 1, including treatment with an Ns5A inhibitors, and/or a protease inhibitor, according to AbbVie. This breakthrough designation was due to positive results from the phase 2 MAGELLAN-1 clinical study.

"Our regimen of glecaprevir and pibrentasvir shows promise for patients by achieving high cure rates in Phase 3 clinical studies across all major hepatitis C genotypes," said Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie. "We look forward to working with the FDA as they review our New Drug Application, which we believe represents another important step toward a faster path to virologic cure for hepatitis C patients."