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AbbVie’s HCV Combo Favorable in Japanese Phase III Study


AbbVie Inc. ABBV announced positive top-line data from a phase III study on its pan-genotypic ribavirin (RBV)-free regimen of glecaprevir/pibrentasvir (G/P) in Japanese patients. The combination drug is being assessed for the treatment of chronic hepatitis C virus (HCV).

So far this year, AbbVie’s share price has increased 2.6%, better than the 1.8% gain recorded by the Zacks classified Large-Cap Pharma industry.

Data from the phase III CERTAIN-1 study showed that eight weeks of treatment with G/P led to high SVR12 rates in Japanese patients suffering from genotype 1 (GT1) chronic HCV without cirrhosis. Data showed that 99% of chronic HCV-infected patients without cirrhosis, and without the Y93H variant, achieved SVR12 with eight weeks of treatment with G/P.

HCV affects around 1 million people in Japan, which accounts for one of the highest rates of the infection in the industrialized world. Moreover, around 60–70% of these patients are infected with GT1 chronic HCV, indicating significant need for medicines in this field.

CERTAIN-1, which compared eight weeks of treatment with the G/P regimen with 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), is part of AbbVie's global G/P clinical development program.

In Dec 2016, AbbVie submitted a New Drug Application (NDA) to the FDA for G/P based on data from eight registration studies in the G/P clinical development program. Data from the studiesshowed that eight weeks of treatment with G/P achieved high SVR12 rates across all major genotypes of chronic HCV.

AbbVie has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Epizyme, Inc. EPZM, Kite Pharma, Inc. KITE and Anika Therapeutics Inc. ANIK. While Epizyme and Kite Pharma sport a Zacks Rank #1 (Strong Buy), Anika has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Epizyme’s loss estimates narrowed 2.3% for 2017 over the last 60 days. The company posted lower-than-expected losses in each of the four trailing quarters, with an average positive surprise of 14.03%.

Kite Pharma’s loss estimates narrowed by 2.1% for 2017 over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters, with an average beat of 7.89%.

Anika’s earnings estimates for 2017 were up 0.5% in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price gained 28.3% in 2016.

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