AbbVie Inc. ABBV 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. 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 and Infinity Pharmaceuticals, Inc. INFI. 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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