Multi-Genotype Hepatitis C Drug Application Lands in Front of the FDA

Another pangenotypic drug candidate to treat hepatitis C infection is under review.

AbbVie submitted a New Drug Application to the US Food and Drug Administration (FDA) for approval of a new antiviral combo.

The drug is an investigational pan-genotypic regimen of glecaprevir and pibrentasvir, a once-daily co-formulation dosed in three tablets. The product has been tested in several clinical trials, the company said in a release. Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor.

There are six major strains of the hepatitis C virus and, if approved, this eight-week ribavirin-free treatment would treat all of them in patients without cirrhosis. AbbVie and other drugmakers have been working to develop one drug that can treat all of them.

"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, AbbVie’s executive vice president of research and development and chief scientific officer, stated in the 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."

Promising results from phase 3 clinical studies recently indicated that the tested drug had high cure rates—measured by sustained virologic response (SVR) rates—across genotypes 1 through 6 of the hepatitis C virus in patients without cirrhosis. Data from the trials demonstrated that after eight weeks of treatment, 693 out of 711 (97.5%) of patients new to treatment achieved SVR at 12 weeks post treatment (SVR₁₂).

The researchers said there were also high SVR rates among patients with limited treatment options, such as those with severe chronic kidney disease—a population that has been historically difficult to treat. Instead of eight weeks, this group of patients, some of whom were on dialysis, took the drug for 12 weeks. A total of 102 out of 104 (98%) patients achieved SVR₁₂ after completing the treatment.

The most common side effects for those with severe chronic kidney disease included pruritus, fatigue, and nausea. The most common for patients of genotypes 1 through 6 who did not have cirrhosis and were new to treatment were headache and fatigue.

Overall, data submitted to the FDA includes results from eight studies that involved more than 2,300 patients in 27 countries. The drug was tested on patients who had never been treated and others who were treated but not cured with direct-acting antivirals.

The FDA has given AbbVie breakthrough therapy designation for the glecaprevir/pibrentasvir regimen. The designation serves to accelerate the FDA review process and is granted for investigational drugs that treat serious or life-threatening conditions with preliminary clinical evidence that demonstrate substantial improvement over existing therapies. AbbVie plans to submit a Marketing Authorization Application in the European Union in early 2017.

The news release was provided by AbbVie.

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