European regulators expand use of AbbVie's two-month hep C regimen
The landscape of hepatitis C — once a devastating liver-damaging disease — has changed dramatically since 2014, when the first raft of new therapies ushered in an era that has culminated in potential cure rates of more than 90% today, regardless of the patient’s genotype. The first of these revolutionary but pricey drugs was Sovaldi — its maker Gilead debuted the three-month regimen at an eye-popping $1,000 a pill.
As competition from rivals such as AbbVie and Merck heated up, similar curative results were achieved with combination regimens taken for shorter time periods, more hep C genotypes were covered and prices trickled lower. AbbVie on Friday said its eight-week, pan-genotype hep C regimen — Maviret — had secured approval in Europe for patients with chronic hep C with liver scarring.
Apart from the existing 12-week regimen approval, Maviret was already approved as a pan-genotypic, two-month regimen for previously untreated hep C patients without cirrhosis and for genotype 1, 2, 4, 5 and 6 patients with compensated cirrhosis.
“A shorter treatment duration means that more patients with HCV can be treated with an 8-week course of Maviret in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis,” said Janet Hammond, AbbVie’s VP of general medicine and virology therapeutic area, in a statement.
The drug, known as Mavyret in the United States, debuted in August 2017 as the cheaper alternative to Gilead’s blockbuster Sovaldi.
Although the crop of new hep C drugs has been helpful, a number of patients continue to suffer due to alcoholism, drug abuse, mental health problems or a combination thereof, making it an uphill task to complete 12-week regimens — so the shorter regimens could help these types of patients, Vincent Lo Re, a professor focused on hepatitis at the University of Pennsylvania School of Medicine, previously told Endpoints News.
Mavyret and Maviret generated nearly $1.5 billion in combined sales last year for AbbVie.