Tuesday, December 2, 2014

The Fix

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A study-in-progress reported on in the New England Journal of Medicine has recorded an incredible 97% cure rate by AbbVie’s new hepatitis C treatment regimen.

The breakthrough by AbbVie is significant as it helps a high-risk group that’s extremely vulnerable to the negative effects of the virus, the breakthrough by AbbVie is significant. In a mid-stage study of 34 patients, 33 were cured of the virus after 24 weeks of treatment. AbbVie’s experimental cocktail is a mix of ombitasvir, ritonavir, dasabuvir, ABT-450, and ribavirin, an antiviral drug used to supplement hepatitis C treatments. By discovering such an effective cocktail, the AbbVie researchers are following the course set by successful HIV maintenance regimens. 

Liver transplant patients are particularly in need of new hepatitis C treatments with better cure rates and fewer side effects. According to the researchers, after patients receive donated liver, even if they have been cleared of the virus previously, their HCV infection tends to reappear in an even more virulent fashion. 

Since more than 40% of the people on the U.S. liver transplant waiting list have hepatitis C, the potential financial benefits of such an effective regimen are obvious. AbbVie’s 2015 hepatitis C revenue is now estimated at $2.1 billion, if the drug is approved. Alex Arfaei, an analyst at BMO Capital Markets, wrote in a recent note to clients that, “We believe hep-C is the most important driver for AbbVie in 2015.” 

Released at the American Association for the Study of Liver Diseases conference in Boston, the AbbVie data also revealed cure rates as high as 100% in patients with genotype 4, a prevalent form of the virus in the Middle East and sub-Saharan Africa. Even more importantly for infected Americans, the results showed cure rates of over 90% for patients who were co-infected with HIV.

AbbVie expects its first hepatitis C treatment to be approved by the FDA as early as the end of 2014. Gilead’s ultra-expensive single pill solutions, like Harvoni and Sovaldi, have been tested in transplant patients as well, showing cure rates as high as 98% after 24 weeks of treatment. Analysts have said AbbVie’s regimen, which involves multiple pills, some taken twice a day, may deter patients. 

Barry Bernstein, Vice President of Infectious Disease Development at AbbVie, disagreed with such projections. Despite the apparent Gilead success, Bernstein believes transplant patients and co-infected patients need a greater sense of certainty. “This is a highly-motivated patient population," Bernstein said. "With relatively short course therapies, there is limited, if any, impact.”

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