) presented the first detailed results from the PEARL-III pivotal
phase III study on its investigational hepatitis C virus (HCV)
infection therapy at the Retroviruses and Opportunistic
Infections (CROI) press conference. AbbVie's oral investigational
regimen comprises a fixed-dose combination of ABT-450
co-formulated with ABT-267 (once daily) and ABT-333 with or
without ribavirin (RBV), administered twice daily.
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The global, multi-center, randomized, double-blind,
placebo-controlled PEARL-III study (n = 419) evaluated the
efficacy and safety of AbbVie's cocktail therapy in
treatment-naïve non-cirrhotic chronic genotype 1b HCV infection
patients for 12 weeks.
The study met its primary endpoints. Sustained virologic response
rates after 12 weeks of treatment (SVR12) were 99.5% and 99% with
and without RBV, respectively. Additionally, there were no
discontinuations due to adverse events associated with the
AbbVie remains on track to file for its HCV treatment early in
the second quarter of 2014. We note that the U.S. Food and Drug
administration (FDA) has granted Breakthrough Therapy designation
to AbbVie's HCV regimen with and without RBV. The designation
should help expedite the review process for the candidate. The
company believes that its HCV combination therapy can clinch an
approval from the regulatory body this year itself.
AbbVie has partnered with
Enanta Pharmaceuticals, Inc.
). Enanta shares have risen 19.1% since AbbVie initially
presented data from four studies including PEARL-III in January.
We believe that AbbVie's investigational therapy has a good
chance of gaining approval based on high rates of response and
backed by low discontinuation rates.
However, we note that several companies are in the race to launch
their first all-oral treatment regime (without interferon
injection) for HCV patients with genotype 1 infection in the U.S.
Gilead Sciences Inc.
) is looking to get its once-daily fixed-dose HCV cocktail
treatment, ledipasvir plus Sovaldi, approved in the U.S. The
company has already submitted the marketing application to the
Bristol-Myers Squibb Company
) is not far behind with the FDA granting Breakthrough Therapy
designation to its all-oral combination of daclatasvir and
asunaprevir. We believe that apart from efficacy and safety,
dosing and pricing will play crucial roles in determining the
AbbVie currently carries a Zacks Rank #3 (Hold). Gilead is a
better-ranked stock with a Zacks Rank #1 (Strong Buy).