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Gilead Announces SVR Data for 12-Week Regimen of GS-7977
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.
Hector
- 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.
Hector
Always nice to see my doctor in print! I knew they were heavily into all the trials and said they had 20 different ones they were participating in.
There are currently approx. 40 new drugs in the HCV experimental phase.
Many will fall by the wayside and never see the light of day (or pharmacy shelves) .
I agree with Willy & OH, in that by where they are in the process it looks like an "all oral " regime would not be to market until 2015 or thereabouts ,however I feel given where some of the other drugs are in particular stages..before that ,there will be different treatments available to us than just the current two,with somewhat better efficacy ,less stringent dosing schedules and less adverse events,albeit with INF/Riba still the mainstay
JMO.....
Will
Many will fall by the wayside and never see the light of day (or pharmacy shelves) .
I agree with Willy & OH, in that by where they are in the process it looks like an "all oral " regime would not be to market until 2015 or thereabouts ,however I feel given where some of the other drugs are in particular stages..before that ,there will be different treatments available to us than just the current two,with somewhat better efficacy ,less stringent dosing schedules and less adverse events,albeit with INF/Riba still the mainstay
JMO.....
Will
Agree w/ Orphanedhawk. I've seen nothing from any of the leading companies suggesting approval before late 2014 at the earliest. 2015, possible early there could be 3 or even 4 of them though by 2015 end.
Time will tell.
willy
Time will tell.
willy
It is in the trial stage. People are being treated successfully without interferon but only in clinical trials.
How long until it goes through all the trails and is approved by the FDA is up to speculation.
It certainly will not be this year.
How long until it goes through all the trails and is approved by the FDA is up to speculation.
It certainly will not be this year.
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