The Medicines Patent Pool (MPP) has announced a new, royalty-free license agreement with AbbVie for glecaprevir/pibrentasvir (G/P) - a World Health Organization (WHO)-recommended treatment for people living with chronic hepatitis C (HCV). The license will enable quality-assured manufacturers to develop and sell generic medicines containing G/P in 99 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.
"G/P is a priority therapy for licensing for the MPP, so this agreement with AbbVie is good news for public health," said Dr Marie-Paule Kieny, Chair of the MPP Governance Board. “It is a really important new option for a significant proportion of HCV patients throughout the world. As with previous MPP licenses, we look forward to facilitating access to generic versions of this product as quickly as possible in as many territories as possible.”
Globally, 71 million people are currently living with chronic HCV, many of them in LMICs. By the end of 2015, only 20 percent had been diagnosed and a mere seven percent of them had received treatment.
G/P is an all-oral, once-daily, pan-genotypic combination regimen and was originally approved in 2017. It has achieved high cure (SVR12) rates of 98 percent in treatment-naïve non-cirrhotic patients across all six genotypes of the virus. It is recommended by the WHO as a first-line treatment for eight weeks for treatment-naïve non-cirrhotic patients.
Further, the regimen is also indicated for use in HCV patients with any degree of renal impairment, including patients on dialysis. There are 95 countries and four territories included in the MPP/AbbVie license for G/P at this point.