Gilead Sciences 2012 Annual Report Download - page 4

SOFOSBUVIR
Edward Gane, MD, Professor of Medicine at the University
of Auckland, New Zealand, is a leading expert on treating
chronic hepatitis C. As the principal investigator of
the ELECTRON study of Gilead’s investigational agent
sofosbuvir, Dr. Gane is excited by the potential of all-oral
regimens that could make treatment more effective and
tolerable for patients.
*HCV RNA undetectable four weeks after completing therapy.
Accelerating Clinical Development
Following the acquisition of Pharmasset in January
2012, we moved quickly to expand clinical testing
of hepatitis C therapies. Phase 3 trials exploring
sofosbuvir in various combinations with other agents
in genotype 1-6 patient populations are ongoing. In
2012, there were 21 new studies initiated, enrolling
more than 2,680 participants, and because of
patient and provider interest, we were able to
complete enrollment of some of these trials within
weeks. In addition to evaluating multiple hepatitis C
drug combinations in diverse genotypes and patient
populations, we are investigating ways to shorten
therapy from one year to a matter of weeks.
Transforming Treatment
Paradigms
Current interferon-based regimens
available for treating hepatitis C remain a
challenge for patients due to safety issues,
side effects, variable response rates and
burdensome injections. Because of this,
Gilead is advancing the development of all-
oral hepatitis C medicines with the goal of
improving tolerability and convenience and
increasing cure rates. In November 2012, we
reported a 100 percent sustained virologic
response rate (SVR4*) for treatment-naïve
genotype 1 hepatitis C patients enrolled
in a Phase 2 trial evaluating an all-oral
combination of sofosbuvir (GS-7977) and
ledipasvir (GS-5885) with ribavirin. Based
on these data, sofosbuvir and ledipasvir have
been co-formulated into a single pill, which
is now being studied in Phase 3 trials.
INNOVATION:
NEW TREATMENT
OPTIONS
FOR CHRONIC
HEPATITIS C
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