AbbVie takes aim at Gilead and BMS with 8-week hep C treatment

AbbVie is aiming to steal sales from hep C drugs from Gilead and BMS with a new combination offering a shorter, eight-week treatment for the most difficult-to-treat form of the disease.

Results presented at the International Liver Congress (ILC) in Amsterdam showed 95% of genotype 3 patients on its pan-genotypic regimen of glecaprevir+pibrentasvir were free of disease, 12 weeks after completing an eight-week treatment course.

The results were based on a previously untreated, cirrhosis-free, 157-patient arm of the ENDURANCE-3 study.

Another arm of the trial also met its goal, matching the performance of BMS’ Daclinza(daclatasvir) plus Gilead’s Sovaldi (sofosbuvir) over 12 weeks in genotype 3.

The Daclinza and Sovaldi combination is current standard of care for genotype 3 hepatitis, but AbbVie is attempting to produce a more patient-friendly alternative with a shorter regimen.

This follows the general pattern of hep C treatments in recent years, where manufacturers produced cures with more manageable side effects and increasingly short treatment durations.

Genotype 3 is the second most common form of the disease and is more difficult to treat, with Gilead’s newest combination, Epclusa (sofosbuvir+velpatasvir), requiring a 12-week treatment course.

Gilead’s Sovaldi (sofosbuvir) can also be used in genotype 3, but requires a 24-week treatment course with more side effects as it is taken in combination with ribavirin.

AbbVie also published results from the EXPEDITION-1 study showing a 99% cure rate 12 weeks after completion of a 12-week course in genotypes 1, 2, 4, 5, 6, without need for ribavirin.

The combination, which could be filed this year adds the NS3/4A protease inhibitor glecaprevir to pibrentasvir, an NS5a inhibitor, and the combination will be dosed daily as three oral tablets.

The combination therapy is part of a raft of new drugs that AbbVie hopes will replace sales lost as its inflammatory diseases blockbuster Humira goes off-patent, facing competition from cheaper biosimilar copycats, and newer and more effective branded rivals.

AbbVie expects sales of Humira to peak at around $18 billion per year, while sales of eight of its biggest selling new drugs, including the hepatitis C combination, could peak at between $25 billion and $30 billion annually if they are all approved.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.