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Gilead Sciences' CEO Discusses Q4 2011 Results - Earnings Call Transcript (PSI-7977 Gt1 HCV Discussion: Norbert W. Bischofberger)
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PSI-7977 Gt1 HCV Discussion: Norbert W. Bischofberger
And finally, turning to liver disease. John, Robin and Kevin have all mentioned the important acquisition of Pharmasset. We are proceeding with the Pharmasset Phase III development plan for GS-7977 in genotype 2 and 3 patients. This program consists of 2 studies, 1 in treatment-naïve patients with patent interferon ribavirin as the control arm, the second in interferon intolerant in eligible patients with placebo as the control arm. I'm pleased to report that the treatment-naïve study was initiated in mid-December, and since then, we have screened 145 patients. This trial is the rate-limiting study for filing because of the 24-week duration standard-of-care arm. Due to the great interest and fast enrollment, we anticipate that these 2 Phase III studies will reach target enrollment in the United States before we will be able to activate sites in other geographies.
As you know, results from the ELECTRON study were presented by Pharmasset at AASLD last October where GS-7977 and ribavirin for 12 weeks resulted in 10 out of 10 cures in genotype 2/3 patients. We're awaiting data from multiple studies in genotype 1 patients specifically from the ELECTRON study, which involve genotype 1, both treatment-naïve and null responders, as well as on the QUANTUM study, which involve genotype 1 treatment-naïve patients. We received news this week that our late breaker abstract has been accepted to CROI for 2 cohorts of genotype 1 HCV-infected patients from the ELECTRON study null responders and treatment naïve patients. In both cohorts of that study, all patients treated with GS-7977 and ribavirin achieved undetectable viral load at 4 weeks on treatment, also known as rapid biological response or RVR.
By the time we present those results, we will have 4 weeks of staying by watching for the response data or SVR4 from the nonresponder patients. Many of you noticed, but it's important to reiterate that RVR reflects biological response on treatment. However, the important measure of response and the accepted Phase III endpoint is SVR12, which is a sustained biological response 12 weeks after end of treatment. SVR4 data are a reasonable proxy for SVR12 as most patients that rebound after treatment discontinuation do so in the first 4 weeks.
We also anticipate that we will have a significant presence at the European Liver Conference taking place in Barcelona in April with over 17 submitted abstracts from our HCV effort alone. As Gilead has pioneered in HIV, we expect to bring forward next generation single type of regimens for the treatment of hepatitis C also. To that end, drug interactions will be carried out with 7977 and GS-5885 and other internal candidates, which will be followed by Phase II clinical studies.
Gilead Sciences' CEO Discusses Q4 2011 Results - Earnings Call Transcript
Seeking Alpha - 6 hours ago
Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Fourth Quarter 2011 Earnings Conference Call. My name is Stacy, and I will be your conference moderator for today. [Operator Instructions] As a reminder,
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