AbbVie’s HOLKIRA PAK approved for treatment of chronic GT1 Hepatitis C

HOLKIRA PAK is an all-oral, short-course interferon-free treatment, with or without ribavirin (RBV) for the treatment of genotype 1 hepatitis C patients in Canada.

The approval follows six pivotal Phase 3 clinical trials, during which HOLKIRA PAK, with or without ribavirin, cured an overall 97% of GT1 HCV patients.

Approximately 98% of patients completed treatment, with a mere 0.2% overall rates of discontinuation due to adverse reactions in both Phase 2 and 3 trials.

HOLKIRA PAK was evaluated in more than 2,300 patients in over 25 countries, demonstrating consistently high cure rates across a large and diverse patient population

AbbVie Canada general manager Stéphane Lassignardie said: "By delivering high cure rates, our all-oral, interferon-free regimen provides adults living with genotype 1 chronic hepatitis C with a breakthrough solution."

University Health Network Toronto Western Hospital Francis Family Liver Clinic hepatologist Dr. Jordan Feld said: "As physicians, we are thrilled to have an alternative to interferon.

"In just 12 to 24 weeks of pills with few or no side effects, we are able to cure people who have been living with this disease for decades."

HOLKIRA PAK comprises fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg), dosed once daily, and dasabuvir (250mg) with or without ribavirin dosed twice daily.

The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with an aim to optimize sustained virologic response across different patient populations.

According to the Public Health Agency of Canada, an estimated 242,500 Canadians are currently living with hepatitis C.