AbbVie submits NDA for investigational regimen for all HCV genotypes

AbbVie has submitted a New Drug Application to the FDA for its investigational pan-genotypic regimen of glecaprevir/pibrentasvir for chronic hepatitis C, the company announced.

This regimen combines two antiviral agents — 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor — which is administered in three oral tablets once-daily, according to a press release.

“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,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the press release. “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.”

Eight registrational studies in the regimen’s clinical development program support the NDA. These studies evaluated more than 2,300 patients from 27 countries and included genotypes 1 through 6, patients who were new and experienced to treatment, those with compensated cirrhosis and without cirrhosis, those with certain treatment challenges like severe chronic kidney disease, and those who were not cured with a previous direct-acting antiviral containing regimen.

Phase 3 clinical data showed high SVR across all major genotypes in patients without cirrhosis after 8 weeks of therapy, and high SVR rates in patients with compensated cirrhosis after 12 weeks of therapy. Patients with limited treatment options, like those with severe CKD, also achieved high SVR rates, as did difficult to treat patients like those not cured by previous DAA regimens in as little as 12 weeks.

Previously reported data also showed 8 weeks of treatment led to a 97.5% SVR rate across all major genotypes in patients without cirrhosis and who were new to treatment in 12 weeks. In addition, data presented at The Liver Meeting showed 12 weeks of treatment led to 98% SVR among 104 chronic HCV patients with severe CKD in a primary intent-to-treat analysis. Excluding patients who did not achieve SVR for reasons other than virologic failure showed a 100% SVR12 rate. Pruritus, fatigue and nausea were the most common adverse events for CKD patients, while headache and fatigue were the most common for patients without cirrhosis and new to treatment across genotypes.

The FDA granted breakthrough therapy designation to the G/P regimen for HCV genotype 1 patients not cured by a previous DAA therapy, including therapy with an NS5A inhibitor and/or protease inhibitor, in September.

Disclosures: Severino is employed by AbbVie.