Showing posts with label GS-7977 Plus Peg/Riba. Show all posts
Showing posts with label GS-7977 Plus Peg/Riba. Show all posts
Tuesday, April 16, 2013
Sofosbuvir plus Peginterferon and Ribavirin for Chronic HCV Infection
Sofosbuvir plus Peginterferon and Ribavirin for Chronic HCV Infection
In phase II trials, a 12-week regimen resulted in high virologic response 24 weeks after treatment, no sofosbuvir-specific adverse effects, and no virologic breakthrough.
Sofosbuvir is a nucleotide analogue that inhibits NS5B-directed hepatitis C virus (HCV) RNA replication. In vitro studies suggest that sofosbuvir has anti-viral activity against all HCV genotypes and a high barrier to resistance. The current industry-funded, phase II companion studies evaluated the efficacy of sofosbuvir in combination with peginterferon and ribavirin in HCV-infected patients without cirrhosis.
Lawitz and colleagues randomized 122 treatment-naive patients with HCV genotype 1 in a 2:2:1 allocation to receive sofosbuvir (200 mg or 400 mg) or placebo daily in combination with peginterferon (180 µg weekly) plus ribavirin (1000–1200 mg daily) for 12 weeks. Patients with HCV genotypes 2 or 3 received open-label sofosbuvir plus peginterferon and ribavirin for 12 weeks. Some patients received an additional 12 to 36 weeks of peginterferon/ribavirin depending on viral response. In the randomized cohort, sustained virologic response (SVR) rates at 12 weeks post-treatment were 90%, 91%, and 58% in the 200 mg, 400 mg, and placebo groups, respectively. Although SVR rates were similar between the sofosbuvir groups, 3 patients in the 200-mg group had viral relapse versus none in the 400-mg group. Among the cohort with genotypes 2 and 3, the SVR rate was 92%. The most common adverse effects were peginterferon- and ribavirin-related.
Kowdley and colleagues randomized 316 treatment-naive patients with HCV genotypes 1, 4, or 6 in a 1:2:3 allocation to receive sofosbuvir (400 mg) daily in combination with peginterferon (180 µg weekly) and ribavirin (1000–1200 mg daily) for 12 weeks, the same drug regimen for 24 weeks, or the 12-week regimen followed by either sofosbuvir monotherapy or sofosbuvir plus ribavirin for another 12 weeks. SVR rates were 89%, 89%, and 87% at 24 weeks post-treatment for the 3 groups, respectively. SVR rates were 82% for 11 patients with genotype 4 and 100% for 5 patients with genotype 6. Baseline viral load and IL28B genotype did not affect SVR rates. As with the companion study, most adverse effects were associated with peginterferon and ribavirin and not with sofosbuvir. No evidence of HCV resistance was noted in either study.
Comment: Key observations from these trial findings include: (1) the average sustained virologic response rate was 90% for a 12-week sofosbuvir regimen in all HCV genotypes; (2) 12 weeks of therapy seems to be as effective as 24 weeks; (3) sofosbuvir should be administered at a dose of 400 mg daily; (4) sofosbuvir is well tolerated and adds no new adverse effects to the regimen; (5) resistance development does not seem to be a concern; and (6) traditional predictors of response, such as IL28B genotype and baseline viral load, do not seem to affect response rates. The ongoing phase III studies will hopefully verify the safety and efficacy of the sofosbuvir regimen. Future studies should evaluate its efficacy in patients who are treatment-experienced or have cirrhosis.
— Atif Zaman, MD, MPH
Published in Journal Watch Gastroenterology April 12, 2013
Citation(s):
Lawitz E et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic treatment-naïve patients with genotypes 1, 2, and 3 hepatitis C infection: A randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013 Mar 15; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S1473-3099(13)70033-1)
Kowdley KV et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): An open-label, randomised, multicentre phase 2 trial. Lancet 2013 Mar 15; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(13)60247-0)
Tuesday, May 1, 2012
GS-7977 Induces Rapid, Durable Drops in Viral Load
Medscape Medical News from:
The International Liver Congress 2012
This coverage is not sanctioned by, nor a part of, the European Association for the Study
of the Liver.
From Medscape Medical News
New HCV Drug Induces Rapid, Durable Drops in Viral Load
Daniel M. Keller, PhD
April 30, 2012 (Barcelona, Spain) — In 3 phase 2 trials of GS-7977, there was a concordance between the sustained virologic response (SVR) 4 weeks after the end of therapy (SVR4) and SVRs at 12 and 24 weeks after therapy (SVR12 and SVR24) in treatment-naive patients infected with hepatitis C virus (HCV) genotypes 1, 2, or 3.
No patient relapsed after posttreatment week 12, and 99% of patients with SVR4 for whom posttreatment week 12 data were available achieved SVR12, Eric Lawitz, MD, from Alamo Medical Research in San Antonio, Texas, reported here at the International Liver Congress 2012.
GS-7977 (formerly PSI-7977) is a specific nucleotide analogue inhibitor of HCV NS5B RNA polymerase and is taken orally once daily. Previous reports have shown that it has broad antiviral activity against HCV genotypes 1, 2, and 3, with or without interferon, in treatment-naive patients, and has a high barrier to the development of viral resistance.
The aim of the study was to evaluate concordance between SVR4 and SVR12 or SVR24 among treatment-naive patients taking GS-7977 400 mg daily in the PROTON (n = 144), ELECTRON (n = 120), and ATOMIC (n = 332) phase 2 clinical trials. The trial protocols differed somewhat, but in general were various combinations and durations of GS-7977, pegylated interferon (Peg-IFN), and ribavirin.
In the PROTON and ATOMIC trials, depending on viral genotype, patients received GS-7977 plus Peg-IFN/ribavirin for 12 weeks followed by Peg-IFN for 12 weeks, Peg-IFN/ribavirin alone for 48 weeks, GS-7977 plus Peg-IFN/ribavirin for 12 or 24 weeks, GS-7977 plus PegIFN/ribavirin for 12 weeks followed by 12 weeks of GS-7977 alone or by GS-7977 plus ribavirin.
In the ELECTRON trial, some patients with genotypes 2 or 3 virus received similar combinations but only out to 12 weeks. Other patients with genotypes 1, 2, or 3 received GS-7977 plus ribavirin for 12 weeks.
The analysis involved only patients treated with GS-7977 400 mg in combination with interferon, ribavirin, or both for at least 4 weeks who had SVR4 plus SVR12 or SVR4 plus SVR24 data available. Of the 596 patients in the 3 studies, 259 (43%) were eligible for analysis.
At baseline in all treatment groups, mean age ranged from 43 to 52 years, and most patients were white, male, had similar body mass indices (mean, 26 to 28 kg/m²), and had interleukin-28B genotype non-CC. Mean baseline HCV RNA levels were mainly in the range of 6.3 to 6.7 log10 IU/mL.
Dr. Lawitz presented results for virologic response at the end of therapy and for SVR4, SVR12, and SVR24.
"If we look at all regimens and look at the concordance between SVR4 and SVR12, we can see that 249 of the 251 [patients] were concordant between SVR4 and SVR12 — a concordance rate of 99%," he said. "If we look at concordance between SVR4 and SVR24, we can see that although the numbers are smaller, there is complete concordance — all 107 patients who had an SVR4 achieved an SVR24.... The concordance held, irrespective of the presence or absence of interferon. However, the dataset is fairly small in the noninterferon arm, limiting conclusions."
Dr. Lawitz concluded that "much of the concordance is due to the high response rates observed across all treatment groups. To date, relapse after week 4 is infrequent and was only observed in patients who received a peg-interferon-containing regimen."
Session moderator George Papatheodoridis, MD, associate professor of medicine and gastroenterology at the Medical School of Athens University, staff member at Hippokration General Hospital, in Athens, Greece, and a member of the European Association for the Study of the Liver Governing Board Scientific Committee, told Medscape Medical News that GS-7977 "is a very interesting, very promising molecule. It seems to be rather safe and very effective, even in combination with ribavirin." Dr. Papatheodoridis was not involved in any of the studies.
In terms of new drugs to treat HCV, he said, "some of the new molecules are very genotype-specific.... Most of the protease inhibitors are developed to work only for genotype 1; some of them work for genotype 2, but not 3 and 4. The nucleoside polymerase inhibitors seem to work better across almost all genotypes, so this is the only class [of drug] that is not that genotype-specific."
Dr. Papatheodoridis wondered about the use of SVR4 as a standard efficacy measure. "I don't think that SVR4 will and should be the standard for SVR," he told Medscape Medical News. "Of course, we know that the FDA and most of the physicians have now accepted SVR12. So probably...SVR12 is going to be the standard for reporting trials in the near future. Still, with all these combinations, patients should have at least 1 examination, maybe 6 months or 12 months after SVR12, so we can be sure that this SVR remains over time. I think that SVR12 is going to be the standard from now on, but the patients treated with the new regimens should be followed for a bit longer."
He admitted that SVR4 looks predictive of later sustained responses. "You expect most of the patients to relapse soon after stopping treatment [if they are going relapse]. Of course, SVR4 is reasonable; we know and we expect that it is going to be associated with SVR12 and SVR24. There is no rush to decide the SVR just 4 weeks after treatment.... We should be sure that we eradicated the virus," he cautioned.
Dr. Lawitz reports financial relationships with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Medarex, Medtronic, Merck, Novartis, Pharmasset, Roche, sanofi-aventis, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Tibotec, Vertex Pharmaceuticals, ViroChem Pharma, and ZymoGenetics. Dr. Papatheodoridis has disclosed no relevant financial relationships.
The International Liver Congress 2012: Abstract 7. Presented April 19, 2012.
Conference News
The International Liver Congress 2012
This coverage is not sanctioned by, nor a part of, the European Association for the Study
of the Liver.
From Medscape Medical News
New HCV Drug Induces Rapid, Durable Drops in Viral Load
Daniel M. Keller, PhD
April 30, 2012 (Barcelona, Spain) — In 3 phase 2 trials of GS-7977, there was a concordance between the sustained virologic response (SVR) 4 weeks after the end of therapy (SVR4) and SVRs at 12 and 24 weeks after therapy (SVR12 and SVR24) in treatment-naive patients infected with hepatitis C virus (HCV) genotypes 1, 2, or 3.
No patient relapsed after posttreatment week 12, and 99% of patients with SVR4 for whom posttreatment week 12 data were available achieved SVR12, Eric Lawitz, MD, from Alamo Medical Research in San Antonio, Texas, reported here at the International Liver Congress 2012.
GS-7977 (formerly PSI-7977) is a specific nucleotide analogue inhibitor of HCV NS5B RNA polymerase and is taken orally once daily. Previous reports have shown that it has broad antiviral activity against HCV genotypes 1, 2, and 3, with or without interferon, in treatment-naive patients, and has a high barrier to the development of viral resistance.
The aim of the study was to evaluate concordance between SVR4 and SVR12 or SVR24 among treatment-naive patients taking GS-7977 400 mg daily in the PROTON (n = 144), ELECTRON (n = 120), and ATOMIC (n = 332) phase 2 clinical trials. The trial protocols differed somewhat, but in general were various combinations and durations of GS-7977, pegylated interferon (Peg-IFN), and ribavirin.
In the PROTON and ATOMIC trials, depending on viral genotype, patients received GS-7977 plus Peg-IFN/ribavirin for 12 weeks followed by Peg-IFN for 12 weeks, Peg-IFN/ribavirin alone for 48 weeks, GS-7977 plus Peg-IFN/ribavirin for 12 or 24 weeks, GS-7977 plus PegIFN/ribavirin for 12 weeks followed by 12 weeks of GS-7977 alone or by GS-7977 plus ribavirin.
In the ELECTRON trial, some patients with genotypes 2 or 3 virus received similar combinations but only out to 12 weeks. Other patients with genotypes 1, 2, or 3 received GS-7977 plus ribavirin for 12 weeks.
The analysis involved only patients treated with GS-7977 400 mg in combination with interferon, ribavirin, or both for at least 4 weeks who had SVR4 plus SVR12 or SVR4 plus SVR24 data available. Of the 596 patients in the 3 studies, 259 (43%) were eligible for analysis.
At baseline in all treatment groups, mean age ranged from 43 to 52 years, and most patients were white, male, had similar body mass indices (mean, 26 to 28 kg/m²), and had interleukin-28B genotype non-CC. Mean baseline HCV RNA levels were mainly in the range of 6.3 to 6.7 log10 IU/mL.
Dr. Lawitz presented results for virologic response at the end of therapy and for SVR4, SVR12, and SVR24.
"If we look at all regimens and look at the concordance between SVR4 and SVR12, we can see that 249 of the 251 [patients] were concordant between SVR4 and SVR12 — a concordance rate of 99%," he said. "If we look at concordance between SVR4 and SVR24, we can see that although the numbers are smaller, there is complete concordance — all 107 patients who had an SVR4 achieved an SVR24.... The concordance held, irrespective of the presence or absence of interferon. However, the dataset is fairly small in the noninterferon arm, limiting conclusions."
Dr. Lawitz concluded that "much of the concordance is due to the high response rates observed across all treatment groups. To date, relapse after week 4 is infrequent and was only observed in patients who received a peg-interferon-containing regimen."
Session moderator George Papatheodoridis, MD, associate professor of medicine and gastroenterology at the Medical School of Athens University, staff member at Hippokration General Hospital, in Athens, Greece, and a member of the European Association for the Study of the Liver Governing Board Scientific Committee, told Medscape Medical News that GS-7977 "is a very interesting, very promising molecule. It seems to be rather safe and very effective, even in combination with ribavirin." Dr. Papatheodoridis was not involved in any of the studies.
In terms of new drugs to treat HCV, he said, "some of the new molecules are very genotype-specific.... Most of the protease inhibitors are developed to work only for genotype 1; some of them work for genotype 2, but not 3 and 4. The nucleoside polymerase inhibitors seem to work better across almost all genotypes, so this is the only class [of drug] that is not that genotype-specific."
Dr. Papatheodoridis wondered about the use of SVR4 as a standard efficacy measure. "I don't think that SVR4 will and should be the standard for SVR," he told Medscape Medical News. "Of course, we know that the FDA and most of the physicians have now accepted SVR12. So probably...SVR12 is going to be the standard for reporting trials in the near future. Still, with all these combinations, patients should have at least 1 examination, maybe 6 months or 12 months after SVR12, so we can be sure that this SVR remains over time. I think that SVR12 is going to be the standard from now on, but the patients treated with the new regimens should be followed for a bit longer."
He admitted that SVR4 looks predictive of later sustained responses. "You expect most of the patients to relapse soon after stopping treatment [if they are going relapse]. Of course, SVR4 is reasonable; we know and we expect that it is going to be associated with SVR12 and SVR24. There is no rush to decide the SVR just 4 weeks after treatment.... We should be sure that we eradicated the virus," he cautioned.
Dr. Lawitz reports financial relationships with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Medarex, Medtronic, Merck, Novartis, Pharmasset, Roche, sanofi-aventis, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Tibotec, Vertex Pharmaceuticals, ViroChem Pharma, and ZymoGenetics. Dr. Papatheodoridis has disclosed no relevant financial relationships.
The International Liver Congress 2012: Abstract 7. Presented April 19, 2012.
Conference News
- EASLNew HCV Drug Induces Rapid, Durable Drops in Viral Load
- EASLInterferon Lambda Beats Alfa in Clearing HCV Genotype 2 or 3
- EASLNonalcoholic Fatty Liver Disease Raises Liver Cancer Risk
- EASLNew Protease Inhibitor TMC435 Cures Most HCV Patients
- EASLPancreatitis Events Halt Development of Alisporivir for HCV
Medscape Gastroenterology © 2012 WebMD, LLC
Thursday, April 19, 2012
EASL-GS-7977 SVR Data for 12-Week Regimen of GS-7977 Plus Peg and Ribavirin in Geno 1 Hepatitis C Patients
Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients
- ATOMIC Data Demonstrate High Cure Rates in Genotype 1 Patients With 12 Weeks of
Treatment
BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq:GILD) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA <25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.
"These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates," said Kris Kowdley, MD, Director of the Liver Center of Excellence at the Virginia Mason Medical Center in Seattle and the study's principal investigator. "An all-oral regimen for HCV remains the ultimate treatment goal. In the interim, these results suggest that we may soon be able to end the complex process of response-guided HCV therapy and shorten the duration of treatment, which would be a significant advance for patients and for physicians who manage their care."
In this study, 52 patients were randomized to the 12-week treatment arm. One patient was lost to follow up during the course of treatment. At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. At the 12-week, post-treatment time period, data were available for 50/51 patients, as one patient was lost to follow up during the post-treatment time period. Of the 50 patients, 47 (94 percent) remained HCV RNA undetectable. Three patients experienced viral relapse after the end of treatment.
Overall, GS-7977 was well tolerated. The frequency and severity of adverse events were consistent with the historical safety profile of Peg-IFN and RBV and included fatigue, headache, nausea, chills and insomnia.
About ATOMIC
ATOMIC is an ongoing Phase 2 randomized open-label clinical trial evaluating the efficacy, safety and tolerability of a regimen containing GS-7977 (400 mg once daily), Peg-IFN (180 ug weekly injection) and RBV (500 mg twice daily) for the treatment of chronic HCV infection in treatment-naïve patients. Patients with genotype 1 HCV (n=316) who were non-cirrhotic and had HCV RNA of at least 50,000 IU/mL were randomized (1:2:3) to receive the regimen for 12 weeks (n=52), 24 weeks (n=109) or 12 weeks followed by re-randomization (1:1) to receive an additional 12 weeks of either GS-7977 alone or GS-7977 plus RBV (n=155). Additionally, 16 patients with HCV genotypes 4 and 6 received the 24-week regimen of GS-7977, Peg-IFN and RBV.
Four-week response rates following completion of therapy from two additional arms of ATOMIC also were presented at the International Liver Congress. Patients in all arms of the study will be followed to determine their 12- and 24-week sustained virologic response rates.
Additional information about the study can be found at www.clinicaltrials.gov. GS-7977 is an investigational product and its safety and efficacy has 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 that the proportion of patients who maintain a sustained virologic response 24 weeks post-treatment 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 the ATOMIC study and subsequent clinical trials involving GS-7977 plus Peg-IFN and RBV. As a result, GS-7977 may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of GS-7977 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. Further, Gilead may be unable to develop an all-oral antiviral regimen for HCV genotype 1 patients or a pangenotypic regimen for all HCV patients. 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, 2011, 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 or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000 .
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-868-5215 (Investors)
shubbard@gilead.com
Patrick O'Brien, 650-522-1936 (Investors)
pobrien@gilead.com
Cara Miller, 650-576-7849 (Media)
cmiller@gilead.com
- ATOMIC Data Demonstrate High Cure Rates in Genotype 1 Patients With 12 Weeks of
Treatment
BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq:GILD) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA <25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.
"These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates," said Kris Kowdley, MD, Director of the Liver Center of Excellence at the Virginia Mason Medical Center in Seattle and the study's principal investigator. "An all-oral regimen for HCV remains the ultimate treatment goal. In the interim, these results suggest that we may soon be able to end the complex process of response-guided HCV therapy and shorten the duration of treatment, which would be a significant advance for patients and for physicians who manage their care."
In this study, 52 patients were randomized to the 12-week treatment arm. One patient was lost to follow up during the course of treatment. At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. At the 12-week, post-treatment time period, data were available for 50/51 patients, as one patient was lost to follow up during the post-treatment time period. Of the 50 patients, 47 (94 percent) remained HCV RNA undetectable. Three patients experienced viral relapse after the end of treatment.
Overall, GS-7977 was well tolerated. The frequency and severity of adverse events were consistent with the historical safety profile of Peg-IFN and RBV and included fatigue, headache, nausea, chills and insomnia.
About ATOMIC
ATOMIC is an ongoing Phase 2 randomized open-label clinical trial evaluating the efficacy, safety and tolerability of a regimen containing GS-7977 (400 mg once daily), Peg-IFN (180 ug weekly injection) and RBV (500 mg twice daily) for the treatment of chronic HCV infection in treatment-naïve patients. Patients with genotype 1 HCV (n=316) who were non-cirrhotic and had HCV RNA of at least 50,000 IU/mL were randomized (1:2:3) to receive the regimen for 12 weeks (n=52), 24 weeks (n=109) or 12 weeks followed by re-randomization (1:1) to receive an additional 12 weeks of either GS-7977 alone or GS-7977 plus RBV (n=155). Additionally, 16 patients with HCV genotypes 4 and 6 received the 24-week regimen of GS-7977, Peg-IFN and RBV.
Four-week response rates following completion of therapy from two additional arms of ATOMIC also were presented at the International Liver Congress. Patients in all arms of the study will be followed to determine their 12- and 24-week sustained virologic response rates.
Additional information about the study can be found at www.clinicaltrials.gov. GS-7977 is an investigational product and its safety and efficacy has 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 that the proportion of patients who maintain a sustained virologic response 24 weeks post-treatment 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 the ATOMIC study and subsequent clinical trials involving GS-7977 plus Peg-IFN and RBV. As a result, GS-7977 may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of GS-7977 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. Further, Gilead may be unable to develop an all-oral antiviral regimen for HCV genotype 1 patients or a pangenotypic regimen for all HCV patients. 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, 2011, 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 or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000 .
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-868-5215 (Investors)
shubbard@gilead.com
Patrick O'Brien, 650-522-1936 (Investors)
pobrien@gilead.com
Cara Miller, 650-576-7849 (Media)
cmiller@gilead.com
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