Provided by MM&M
FEBRUARY 03, 2014
AbbVie unveiled Phase-III trial results for its multi-drug hep. C regimen Friday, and the all-oral regimen looks impressive. Up to 99% of genotype-1b, treatment-naive patients taking the cocktail achieved SVR12 (sustained virologic response, or cure, at 12 weeks). And up to 96% of cirrhotic patients, or those with liver scarring and poor liver function, reached SVR after a three-month course of the regimen, which consists of ABT-450/r + -267 + -333.
Some specialists might find value in using a regimen like AbbVie's for their cirrhotic patients, but the question is how they compare against those offered up last December by Gilead for its HCV fixed-dose oral therapy. Gilead's two-drug all-oral regimen, which pairs recently approved antiviral Sovaldi with the experimental drug ledipasvir and ribavirin (RBV), saw 97% SVR12 in the treatment-naïve, while 94% of those in the same population got to SVR12 taking a RBV-free regimen.
Gilead has yet to break down how effective its regimen is in cirrhotic patients, but ISI Group analyst Mark Schoenebaum, in an investor note Friday, estimated the lower boundary to be around 95% SVR12 rate with and without ribavirin, based on other trial data.
While AbbVie's regimen showed strong efficacy, and demonstrated it in what has been the largest Phase-III program of an all-oral, interferon-free therapy for HCV GT1 patients to date, Schoenebaum—in another investor note from Friday—shared concerns that it may fall short when compared to Gilead's fixed-dose combo and that AbbVie's results were “right in-line with Street expectations.”
“Gilead's regimen continues to have potential commercial advantages on multiple points,” he wrote. Of those competitive advantages, Schoenebaum cited the Gilead regimen's lower pill burden (one pill daily vs. AbbVie's expected four to six), a potential for shorter duration (8 weeks vs. 12 weeks) and a possibly larger population to cater to that includes GT1-naïve patients, as well as a lack of ribavirin, which can lead to anemia.
Gilead's combo also stands to hit pharmacy shelves before the competition. The Foster City, CA, drugmaker said it will file within the first quarter of this year. AbbVie confirmed, along with Friday's data, that it won't file its regimen with regulators until the early part of the second quarter of this year.