– Interim Results Reported from ELECTRON and QUANTUM Studies –
BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) –Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim data from
the Phase 2 ELECTRON study examining the investigational once-daily oral
agent GS-7977 plus ribavirin (RBV) in treatment-naïve patients with
genotype 1 chronic hepatitis C virus (HCV) infection. Of the 25 patients
who completed 12 weeks of treatment with the GS-7977-based regimen, 88
percent of patients (n=22/25) remained HCV RNA undetectable four weeks
after completion of treatment. Three patients experienced viral relapse.
These findings are being presented this week during a poster session
(Poster #1113) at the 47th Annual Meeting of the European
Association for the Study of the Liver (International Liver Congress
2012) in Barcelona, Spain.
“These preliminary results suggest that 12 weeks of therapy with
once-daily oral GS-7977 and ribavirin may be enough to cure hepatitis C
in many genotype 1 patients, including those who are currently not
candidates to receive interferon,” said Professor Edward Gane, MD,
Deputy Director and Hepatologist, New Zealand Liver Transplant Unit,
Auckland City Hospital in New Zealand, and principal investigator of the
ELECTRON study. “Further investigation of GS-7977 in a variety of
patient populations and combinations will be important in assessing the
drug’s potential as part of an all-oral regimen for hepatitis C.”
Results from three additional arms of the ELECTRON study examining
GS-7977-based therapy in various patient populations are also being
presented this week at the International Liver Congress. These include
null responder genotype 1 patients, and genotype 2 and genotype 3
patients, both treatment-naïve and prior non-responders.
Overall, GS-7977 was well tolerated and exhibited a favorable safety
profile. No patients experienced viral rebound during treatment. No
patients discontinued therapy due to an adverse event. The most common
adverse events were fatigue, dizziness and headache, and two grade 3/4
laboratory abnormalities were reported.
Gilead today also announced interim results from a second Phase 2 trial
(QUANTUM) examining a 12- and 24-week duration of GS-7977 plus RBV in
treatment-naïve patients. Twenty-five patients were randomized to the
12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients;
and two genotype 2 patients. Two genotype 1 patients discontinued
therapy prematurely during the 12-week treatment period. At the
four-week post-treatment time period, data were available for 17
genotype 1 patients. Of these, 10/17 (59 percent) remained HCV RNA
undetectable. Seven patients (41 percent) experienced viral relapse.
Additionally, seven of the patients who have reached the eight week
post-treatment time period, and who achieved SVR4, remain HCV RNA
The overall safety and efficacy profile of GS-7977 was consistent with
that seen in ELECTRON. No patients experienced viral rebound while on
treatment and no patients discontinued therapy due to an adverse event.
Eleven of the 25 patients (44 percent) in ELECTRON and three of 19
patients (16 percent) in QUANTUM had the IL28B C/C genetic polymorphism.
Each of the three patients who relapsed in the ELECTRON study had a
different IL28B polymorphism (C/C, C/T or T/T). The seven patients who
relapsed in the QUANTUM study either had IL28B C/T (n=4) or IL28B T/T
(n=3) genetic polymorphisms. Patients in both studies will continue to
be observed to determine sustained virologic response rates at weeks 12
and 24 of follow-up (SVR12 and SVR24).
“The early results from these studies confirm that GS-7977 has the
potential to become the cornerstone of an efficacious, all-oral
combination regimen for many patients with chronic hepatitis C
infection,” said John McHutchison, MD, Senior Vice President, Liver
Disease Therapeutics, Gilead Sciences. “We look forward to more data
unfolding as our trials progress and we expect to initiate additional
studies with GS-7977 in combination with other oral antivirals in our
pipeline in the coming months. Our goal is to develop a short, simple,
safe and effective single tablet regimen for HCV patients throughout the
ELECTRON is an ongoing Phase 2 randomized open-label clinical study
evaluating GS-7977 for the treatment of chronic HCV infection. The
primary endpoint of the trial is the safety and tolerability of GS-7977
400 mg once-daily for 8 or 12 weeks, with and without RBV and/or Peg-IFN
in HCV patients with genotypes 1, 2 or 3. Study populations include
treatment-naïve non-cirrhotic patients and those who have failed prior
interferon based therapies or “null” responders.
QUANTUM is a Phase 2 randomized double-blind placebo-controlled clinical
study evaluating GS-7977 for the treatment of chronic HCV infection. The
current active arms of the trial are examining GS-7977 400 mg once-daily
plus RBV for 12 or 24 weeks in cirrhotic and non-cirrhotic
treatment-naïve HCV patients with genotypes 1, 2 and 3. The results
announced today are for the cohort of patients who have received and
completed 12 weeks of therapy with GS-7977 plus RBV (n=25).
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North America, Europe and Asia
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com
or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000 .
SOURCE: Gilead Sciences, Inc.