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Gilead Reports Interim Data From Phase 2 LONESTAR Study

  Gilead Reports Interim Data From Phase 2 LONESTAR Study

 -- Company Plans to Initiate Phase 3 Study Evaluating Eight and 12 Weeks of
Therapy with Sofosbuvir and Ledipasvir for the Treatment of Chronic Hepatitis
                                     C --

Business Wire

FOSTER CITY, Calif. -- May 2, 2013

Gilead Sciences (Nasdaq: GILD) today announced plans to initiate a third Phase
3 clinical trial of the company’s investigational fixed-dose combination
tablet of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C
virus (HCV) infection. The study, called ION-3, will evaluate the once-daily
fixed-dose combination of sofosbuvir and ledipasvir for eight weeks with and
without ribavirin (RBV) and for 12 weeks without RBV in 600 non-cirrhotic,
treatment-naïve genotype 1 HCV-infected patients.

The design of ION-3 was based on interim results from the Phase 2 LONESTAR
study, which evaluated eight- and 12-week courses of therapy with the
once-daily fixed-dose combination of sofosbuvir and ledipasvir with and
without RBV in 60 treatment-naïve, non-cirrhotic patients.

In this study, 19/19 patients in the 12-week arm had a sustained virologic
response four weeks after completing therapy (SVR4) and 40/41 in the
eight-week arms had a sustained virologic response eight weeks after stopping
therapy (SVR8), with one relapse occurring in the arm receiving
sofosbuvir/ledipasvir without RBV.

Two additional cohorts in the LONESTAR study evaluated a 12-week course of the
fixed-dose combination of sofosbuvir and ledipasvir with or without RBV in 40
patients who had previously failed therapy with an HCV-specific protease
inhibitor-based regimen. Half of these treatment-experienced patients have
documented, compensated cirrhosis. Ninety-five percent of patients in both
arms achieved SVR4, one cirrhotic patient in the sofosbuvir and ledipasvir arm
relapsed and one patient in the sofosbuvir and ledipasvir plus RBV arm was
lost to follow-up.

Interim results from LONESTAR are summarized in the table below. Further
details from this study will be presented at a future scientific meeting.

Treatment               Treatment  Population                  Results
                         Duration
Sofosbuvir +             8 weeks     GT 1 treatment-naïve         95% (19/20)
ledipasvir                                                        SVR 8
Sofosbuvir +             8 weeks     GT 1 treatment-naïve         100% (21/21)
ledipasvir + RBV                                                  SVR 8
Sofosbuvir +             12 weeks    GT 1 treatment-naïve         100% (19/19)
ledipasvir                                                        SVR 4
Sofosbuvir +             12 weeks    GT 1 treatment-experienced   95% (18/19)
ledipasvir                                                        SVR 4
Sofosbuvir +             12 weeks    GT 1 treatment-experienced   95% (20/21)
ledipasvir + RBV                                                  SVR 4

“The LONESTAR results suggest that once-daily all-oral therapy with the
nucleotide NS5B inhibitor sofosbuvir and the NS5A inhibitor ledipasvir may
have the potential to cure most genotype 1 HCV infected patients with a
remarkably short treatment duration,” said Eric Lawitz, MD, President and
Medical Director, The Texas Liver Institute, University of Texas Health
Science Center, San Antonio, and Principal Investigator for the LONESTAR
study.

Both sofosbuvir in combination with ledipasvir, and sofosbuvir in combination
with ledipasvir and RBV were well tolerated in the LONESTAR study.

“Based upon the encouraging data derived from LONESTAR, we are continuing to
advance our research evaluating new drug combinations and shorter durations of
all-oral therapy that have the potential to simplify treatment for those
living with hepatitis C,” commented Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer at Gilead
Sciences.

About ION-3

ION-3 is a randomized, open label Phase 3 clinical trial evaluating the
efficacy and safety of sofosbuvir and ledipasvir for the treatment of chronic
HCV in non-cirrhotic, treatment-naïve genotype 1 infected patients.
Participants will be randomized to receive sofosbuvir and ledipasvir for eight
weeks (n=200), sofosbuvir and ledipasvir plus RBV for eight weeks (n=200), or
sofosbuvir and ledipasvir for 12 weeks (n=200). The primary endpoint of the
study is SVR12, defined as maintaining undetectable HCV RNA 12 weeks
post-treatment and considered a cure for HCV infection. The study is designed
to assess non-inferiority of the eight-week treatment duration arms to the
12-week treatment duration arm.

Two other ongoing Phase 3 studies are examining all-oral HCV therapy with
sofosbuvir and ledipasvir. ION-1 and ION-2 are testing 12- and 24-week courses
of the fixed-dose combination with and without RBV among treatment-naïve and
treatment-experienced genotype 1 HCV patients, including those with
compensated cirrhosis. Based on the results of the LONESTAR trial, Gilead has
amended ION-2 to shorten the duration of therapy in one of the two fixed-dose
combination arms without RBV from 24 to 12 weeks.

Additional information about ION-1, ION-2, ION-3 and LONESTAR can be found at
www.clinicaltrials.gov.

Sofosbuvir, ledipasvir and the fixed-dose combination tablet are
investigational products and their safety and efficacy have not yet been
established.

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 Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that are subject to
risks, uncertainties and other factors, including the possibility of
unfavorable results from the clinical studies evaluating sofosbuvir and the
sofosbuvir and ledipasvir fixed-dose combination, including from the ION-1,
ION-2 and ION-3 and LONESTAR studies. Gilead also faces risks related to its
ability to enroll patients in the ION-3 study, the need to modify or delay the
study and the risk of failing to obtain approval of sofosbuvir and/or the
sofosbuvir and ledipasvir fixed-dose combination from regulatory authorities.
As a result, sofosbuvir and the sofosbuvir and ledipasvir fixed-dose
combination may never be successfully commercialized. In addition, Gilead may
make a strategic decision to discontinue development of these products if, for
example, Gilead believes commercialization will be difficult relative to other
opportunities in its pipeline. These risks, uncertainties and other factors
could cause actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in detail in
Gilead’s Annual Report on Form 10-K for the year ended December 31, 2012, as
filed with the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at
  www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
              Public Affairs at 1-80-GILEAD-5 or 1-650-574-3000.

Contact:

Gilead Sciences
Patrick O’Brien, 650-522-1936 (Investors)
Amy Flood, 650-522-5643 (Media)