Biotech Values

[DewDiligence]

Nearly lost in AASLD flurry—ABBV/ENTA’s GT4 results from the PEARL-1 study:

http://finance.yahoo.com/news/enanta-announces-results-phase-2b-130200689.html

PEARL-I studied AbbVie’s all-oral, interferon-free investigational treatment combining two [i.e. no ABT-333] direct-acting antivirals (ABT-450/r and ombitasvir [ABT-267]) with or without ribavirin (RBV) for 12 weeks in non-cirrhotic adult patients with…GT1b and GT4.

…Results showed that 100 percent of genotype 4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie’s investigational treatment with RBV.

…There were no discontinuations due to adverse events...

ABBV/ENTA reported results from the GT1b portion of PEARL-1 in Nov 2013 (#msg-93662501), but the above data for the GT4 portion of the study are new.

(The PEARL-1 GT4 arm without ribavirin produced an SVR of 91%—vs 100% with ribavirin—so inclusion of ribavirin is advisable for this 2-DAA regimen in GT4 patients.)

GT4 is mainly a Middle East strain, but it has a prevalence of 5-15% in France and Spain (two countries with a high proportion of residents with Middle East origin).