AbbVie Inc. (ABBV - Free Report) announced that data from two phase III studies, EXPEDITION-1 and ENDURANCE-3, evaluating its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) for all genotypes of Hepatitis C virus (HCV) were presented at The International Liver Congress.
This next-generation HCV programis a combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, administered orally, once daily. AbbVie discovered glecaprevir while investigating HCV protease inhibitors and regimens in collaboration with Enanta Pharmaceuticals, Inc. (ENTA - Free Report) . The goal is to bring a RBV-free once-daily pan-genotypic combination to the market.
In the past one year, AbbVie's shares outperformed the Zacks classified Large Cap Pharma industry. AbbVie's shares returned 3.8% while the industry lost 3.1% in the same period.
We note that the single arm, open-label EXPEDITION-1 study, evaluated the G/P regimen without ribavirin for the treatment of patients with chronic Hepatitis C with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A). The study met its primary endpoint. Data from the study showed that 99% of the patients treated with G/P achieved sustained virologic response at 12 weeks post-treatment (SVR12).
The ENDURANCE-3 study evaluated ribavirin free G/P regimen for the treatment of patients with HCV genotype 3 infection without cirrhosis for 8 weeks. Full data from the study showed that 95% of the patients treated with G/P achieved SVR12 with both eight and twelve weeks of treatment with G/P. The study also demonstrated non-inferiority of the regimen in comparison to sofosbuvir plus daclatasvir (SOF+DCV), a current standard of care for the indication, in the 12-week study arm. We remind investors that top-line data presented from the same study last year showed that 97.5% of the patients treated with G/P achieved SVR12 in eight weeks. We remind investors that G/P is under priority review in the U.S. and Japan and was granted accelerated assessment by the EMA.
There are approximately 130 to 150 million people with chronic HCV with 15% - 30% risk of progression to cirrhosis of liver in the next 20 years. Therefore, the positive data from these studies demonstrate the possibility of the G/P regimen to be a standard of care for HCV genotypes.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Grifols, S.A. (GRFS - Free Report) and Infinity Pharmaceuticals, Inc. (INFI - Free Report) . Both Grifols and Infinity sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Grifols' earnings estimates increased 10.5% for 2017 over the last 60 days. The company’s shares have appreciated 23.3% so far this year.
Shares of Infinity have gained 45.9% this year so far, while the company’s loss estimates for 2017 narrowed almost 6% in the past 60 days.
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