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– Viral Relapse Seen Post Treatment with GS-7977 Plus Ribavirin –
– Awaiting Data for Treatment-Naïve Genotype 1 Patients –
“These data answer an important question about the use of GS-7977 and
ribavirin for the treatment of genotype 1 null responder patients,
suggesting that additional direct acting antivirals may be necessary to
effectively treat this patient population,” said
GS-7977 is a nucleotide analog polymerase inhibitor that is currently being studied for the treatment of chronic hepatitis C. A number of ongoing Phase 2 and Phase 3 studies are evaluating the safety and efficacy of the compound with and without RBV and/or pegylated interferon (Peg-IFN) in patients with genotypes 1-6 who are treatment naïve, treatment experienced, or have had a “null” response to Peg-IFN.
Genotype 2 and 3 data from the ELECTRON study were presented at the 62nd
annual meeting of the
Results from ongoing studies in genotype 1 treatment-naïve patients will be available in the coming months. The first data evaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve patients will come from an arm of the QUANTUM study with 25 patients at the end of the first quarter of 2012. This will be followed in the second quarter by data from the ELECTRON study involving 25 patients and, early in the third quarter, data on GS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM study will become available.
Conference Call
Gilead will host a conference call today,
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 of unfavorable results from the ELECTRON and QUANTUM
studies, including in genotype 1 treatment-naïve patients, as well as
other clinical trials evaluating GS-7977 with or without RBV and/or
Peg-IFN or in combination with other antivirals; the anticipated timing
for receiving clinical data and making regulatory filings; and Gilead’s
ability to develop an all-oral antiviral regimen for HCV genotype 1
patients or a pangenotypic regimen for all HCV patients. As a result,
GS-7977 may never be successfully commercialized. Further, Gilead may
make a strategic decision to discontinue development of GS-7977 if, for
example, it 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 Quarterly Report on Form 10-Q for
the quarter ended
For more information on
Source:
Gilead Sciences, Inc.Susan Hubbard, 650-522-5715 (Investors)Amy Flood, 650-522-5643 (Media)
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