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AbbVie
announced detailed
results from its open-label Phase 2b study, PEARL-I, which demonstrated that
100 percent of genotype 4 (GT4) patients who were new to therapy (n=42/42)
or who had failed previous treatment with pegylated interferon (pegIFN) and
RBV (n=49/49) achieved sustained virologic response rates at 12 weeks
post-treatment (SVR[12]) after taking AbbVie's investigational treatment with
ribavirin (RBV). Additionally, 90.9 percent of patients who were new to
therapy achieved SVR[12 ](n=40/44) after taking the treatment without RBV.
These data will be presented today during a poster session at The Liver
Meeting® 2014.
"As many as 34 million people around the world are living with genotype 4
chronic hepatitis C, a population that is common in the Middle East and
Africa, where it accounts for more than 80 percent of all hepatitis C
cases,[i]" said Barry Bernstein, M.D., vice president, infectious disease
development, AbbVie. "The data from PEARL-I represent another important step
forward in realizing our commitment to advancing scientific knowledge in
hepatitis C with the ultimate goal of providing treatment options to as many
patients as possible."
PEARL-I studied AbbVie's all-oral, interferon-free investigational treatment
combining two direct-acting antivirals (ABT-450/ritonavir and ombitasvir) with
and without RBV for 12 weeks in non-cirrhotic adult patients with chronic
genotype 1b (GT1b) and GT4 hepatitis C virus (HCV) infection.
There were no discontinuations due to adverse events in PEARL-I. The most
commonly reported treatment-emergent adverse events (greater than 15 percent
in any group) were headache (29-33 percent), asthenia (weakness) (24-33
percent), fatigue (7-18 percent), nausea (9-17 percent) and insomnia (5-16
percent). One patient had a grade 3 liver function test elevation (AST> five
times the upper limit of normal), which was asymptomatic and resolved during
continued dosing. Four patients with hemoglobin decreases (anemia) required
RBV dose reductions; however, none of these patients required blood
transfusions or medication to boost their red blood cell production. In the
treatment-naïve group without RBV, on-treatment virologic breakthrough was
reported in one patient (2 percent) and two patients (5 percent) experienced
post-treatment relapse. There were no virologic failures in the other
treatment arms.
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