Share Article
-- Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients --
-- Second Phase 3 Study Evaluating Fixed-dose Combination of Sofosbuvir and GS-5885 to Begin Later this Month --
“Since the acquisition of Pharmasset only a year ago, we have fully
enrolled four Phase 3 studies of sofosbuvir and during the first quarter
of this year we will have initiated two Phase 3 studies of the
sofosbuvir and GS-5885 fixed-dose combination,” said
Update on Phase 2 ELECTRON Study
Gilead today announced full data from one cohort of the ongoing Phase 2 ELECTRON study examining a 12-week course of all-oral therapy with sofosbuvir, GS-5885 and ribavirin (RBV) among genotype 1 HCV patients who had previously failed to respond to an interferon (IFN)-containing regimen, or “null responders.”
Preliminary data, presented in November at the annual meeting of the
Results from eight other arms of the ELECTRON study, evaluating
sofosbuvir alone and with RBV and/or pegylated IFN, were published
earlier this month in the
Advancing a Fixed-Dose Combination Tablet for HCV
Gilead is currently evaluating a once-daily fixed-dose combination tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3 trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV among a range of genotype 1 HCV patient populations.
- ION-1: This Phase 3 trial was initiated in
October 2012 and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks among treatment-naïve genotype 1 patients. Pending a review of results from the two 12-week arms (n=50/arm) of an initial enrollment of 200 patients, ION-1 will continue to recruit patients and assess sofosbuvir/GS-5885 in a total of 800 individuals. - ION-2: Gilead today announced that a second Phase 3
study for sofosbuvir/GS-5885, ION-2, is expected to begin screening
patients in
January 2013 . This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy among 400 treatment-experienced genotype 1 HCV patients. Participants in this study will have failed past therapy with regimens containing IFN or IFN plus a protease inhibitor. - LONESTAR: Gilead also announced that enrollment is now underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among genotype 1 treatment-naïve patients. Two additional arms in this trial will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks among treatment-experienced genotype 1 patients who had previously received a protease inhibitor-containing regimen. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir andGS-5885 for only eight weeks of treatment.
Sofosbuvir, GS-5885 and the fixed-dose combination tablet are investigational products and their safety and efficacy have not yet been established.
Four ongoing Phase 3 studies will support Gilead’s initial regulatory
filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV
among genotype 2/3 treatment-naïve, treatment-experienced and
interferon-intolerant patients, and for sofosbuvir in combination with
RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4,
5 and 6. Topline results from the first Phase 3 study, POSITRON, were
announced in
About
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 that the proportion of patients who maintain a sustained
virologic response 12 and 24 weeks post-treatment in the null responder
arm of the ELECTRON study will not be as favorable as the sustained
virologic response rates reported in this press release, and the
possibility of unfavorable results from additional arms of ELECTRON and
other clinical trials involving sofosbuvir and sofosbuvir and GS-5885
with and without RBV. As a result, sofosbuvir and GS-5885 as single
agents or as a fixed-dose combination may never be successfully
commercialized. In addition, Gilead may make a strategic decision to
discontinue development of the compounds or the fixed-dose combination
regimen if, for example, Gilead believes commercialization will be
difficult relative to other opportunities in its pipeline. Further,
Gilead may be unable to file for regulatory approval of sofosbuvir and
the fixed-dose combination of sofosbuvir/GS-5885 in the currently
anticipated timelines or at all. If marketing approval is granted for
any of these products, there may be significant limitations on their
use. 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 Quarterly Report on Form 10-Q for the quarter ended
For more information on
Source:
Gilead SciencesPatrick O’Brien, 650-522-1936 (Investors)Cara Miller, 650-522-1616 (Media)
Other News
Some of the content on this page is not intended for users outside the U.S.