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|Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C Infected Patients|
- Phase 3 Study with a Fixed-Dose Combination Tablet of Sofosbuvir and GS-5885 Now Underway -
“These results indicate that adding GS-5885 to sofosbuvir-based regimens
may enhance SVR rates, potentially offering HCV genotype 1 infected
patients a convenient 12-week course of oral therapy,” said Professor
Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.
Data from five additional arms of the ELECTRON study examining sofosbuvir-based therapy in various patient populations also will be presented:
Preliminary data from a subset of an ongoing cohort in the ELECTRON study in which nine genotype 1 previous null responders were treated with sofosbuvir, GS-5885 and ribavirin for 12 weeks also will be presented on Tuesday. Thus far, three of the nine patients have reached the four-week post-treatment time point and all three remain HCV negative.
Both sofosbuvir in combination with ribavirin and sofosbuvir in combination with GS-5885 and ribavirin were well tolerated in the ELECTRON study. In the sofosbuvir combined with GS-5885 and ribavirin groups, there was one discontinuation due to an adverse event unrelated to study drugs. Despite stopping therapy at week 8, this patient also achieved SVR4.
The most common adverse events were headache, fatigue, upper respiratory tract infection and nausea. The most common clinically significant grade 3/4 laboratory abnormality was a hemoglobin reduction.
Additional Safety Data for GS-5885
In a poster presentation at The Liver Meeting on
Researchers concluded that GS-5885 is safe and well tolerated. No laboratory abnormalities or other safety signal of concern has been observed in the GS-5885 development program.
Sofosbuvir and GS-5885 are investigational products and their safety and efficacy have not yet been established.
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 weeks post-treatment will not be as favorable as
the sustained virologic response rates reported in this press release,
the possibility that results from the arm of the ELECTRON study
evaluating the efficacy and safety of sofosbuvir, GS-5885 and ribavirin
in genotype 1 previous null responder patients will not be favorable
once four and 12 week post-treatment data from all nine patients are
available and the possibility of unfavorable results from additional
arms of the ELECTRON study and subsequent clinical trials involving
sofosbuvir and GS-5885 with and without ribavirin. As a result,
sofosbuvir and GS-5885 as single agents or as a fixed-dose combination
may never be successfully commercialized. Further, 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. 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 quarter ended
For more information on
Gilead Sciences, Inc.
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