Monday, October 25, 2010

Quick Study; FAQ SVR Rates Treating With Telaprevir

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Quick Study; FAQ SVR Rates Treating With Telaprevir
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*The information/protocol available on Telaprevir is limited the HCV community is still waiting for more information to be released for a better understanding of the safety, and efficacy of Telaprevir used in combination with pegylated interferon and ribavirin. .
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See all links for detailed trial information.
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Nov 1 2010/Vertex Announces Start of/Phase 3b Study of Twice-Daily Telaprevir in People Not Treated Previously for Hepatitis C .

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What If I Have Never Been On HCV Therapy Before, According To The Trials What Are My Chances For Reaching SVR ?
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(SVR: Sustained Virological Response= No virus detected 24 months after last medicine was taken.)
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In May, Vertex released results from the Phase III ADVANCE trial, which demonstrated that the telaprevir combination helped 75 percent of treatment-naïve patients chronically infected with genotype 1 HCV achieve an SVR.
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No Benefit to Extending Therapy to 48-Weeks, 24-Weeks Sufficient
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In June the ILLUMINATE trial which enrolled 540 patients demonstrated that the majority of previously" untreated patients" with HCV who responded early to treatment with telaprevir achieved an SVR after 24 weeks instead of the current standard treatment duration of 48 weeks. Viral cure rates of 92% and 88% with 24 and 48-week regimens , respectively, in people who met certain response criteria. 72% of all 540 people treated with telaprevir in the study achieved a viral cure.
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"This trial was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus was undetectable at weeks 4 and 12 of treatment (extended rapid viral response or eRVR). People in the trial who met these eRVR criteria and who remained on treatment were then randomized at week 20 to receive 24 or 48 weeks of total treatment. People who did not meet these criteria were assigned to 48 weeks of pegylated-interferon and ribavirin therapy".
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When Will Telaprevir Be FDA Approved ?,
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Update Jan 20 2010
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On Jan 20th Vertex's drug Telaprevir Received FDA Priority Review" both in U.S. and Canada. On Jan 6th Mercks Boceprevir received FDA Priority Review and EMA Accelerated Assessment. The estimation is both drugs will be FDA approved and ready for market in 2011-2012
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What Is The Difference Between Pegylated Interferon and Telaprevir?
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Standard of care therapy (SOC) for hepatitis C is a FDA approved regime consisting of pegylated interferon and ribavirin. This therapy is based on bioengineered versions of the "natural" immune system protein alpha interferon, (Alpha interferon: A protein produced by the body in response to an infection) but only attacks the virus "indirectly". The side effects can be debilitating, with SVR achieved only half the time, depending on Genotype . Telaprevir is an experimental oral agent (Pill Taken By Mouth) for the treatment of hepatitis C . Telaprevir "directly" targets the HCV protease, a protein the virus needs to reproduce in the body.
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Who Makes Telaprevir ?
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Vertex began the clinical development of Telaprevir in 2004 and is collaborating with Johnson & Johnson and Mitsubishi Tanabe Pharma. Johnson & Johnson will handle the commercialization of the drug outside North America and the Far East, Mitsubishi Pharma will be responsible for Japan and certain areas of the Far East.
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What If I Was On HCV Therapy Before And Failed ?
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In Sept Vertex released results from the Phase III REALIZE trial, which showed that nearly two-thirds of patients with genotype 1 hepatitis C virus (HCV) who failed to respond to prior therapy were able to achieve a sustained viral response (SVR) following treatment with the company's experimental drug telaprevir used in combination with standard care .
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What is the REALIZE trial?
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REALIZE is a pivotal Phase 3 clinical trial of telaprevir in combination with peginterferon alfa-2a (PEG) and ribavirin (RBV) in 662 people with genotype 1 chronic hepatitis C who "failed" to achieve sustained virological response (SVR or viral cure) with prior pegylated interferon-based therapy. The trial evaluated the safety, efficacy and tolerability.
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Who Was Enrolled In The Trial And What Were The Results ?
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Patients in the study were enrolled based on their response to prior treatment:
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Out Of 662 Enrolled In The Study
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53% were prior relapsers
354 relapsers
Relapsers: People whose HCV RNA drops to an undetectable level with treatment but rises again after treatment ends.
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What were the results ?
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The Results : SVR RATES
Among relapsers, the telaprevir-based regimen led to an 86 percent cure rate compared with 24 percent from standard of care
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Out Of 662 Enrolled In The Study
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19% were prior partial responders
124 partial responders
Partial responders: People who have at least a 2 log10 (100-times) drop in HCV RNA, but do not reach undetectable levels in the blood by week 24.
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What were the results ?
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The Results: SVR RATE
In Partial responders a 57 percent telaprevir cure rate among the partial responders versus 15 percent standard care.
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Out Of 662 Enrolled In The Study
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28% were prior null responders.
184 null responders
Null responders: People who failed to reduce HCV RNA by at least 2 log10 (100 times) after 12 weeks of prior treatment, which is the currently recommended Food and Drug Administration (FDA) definition for clinical trials of investigational hepatitis C treatments.
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What Is A 2 Log Drop?
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Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL or lower.
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What where the results ?
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The Results: SVR RATE
In null responders there was a 31 % percent cure rate compared to 5% in standard of care
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Tell Me More About These Patients
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In this study, 26% of patients overall had cirrhosis and 89% of patients overall had a high viral load (HCV RNA More Then 800,000 IU/mL) when entering the study.
Specifically in the null responder population, there were an even greater number of people with cirrhosis (33%) and high viral load (95%). Approximately 50% of patients were genotype 1a and 50% were genotype 1b.
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How Much Will Telaprevir Cost?
The New York Times estimates that the cost of telaprevir treatment will be tens of thousands of dollars.
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Whats The Bottom Line ?
The buzz is the average cost for treating with Telprevir is estimated at $70,000 according to a vertex conference in June of 2010.
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Additional Costs ?
The Rescue Drugs
On this blog is an abstract, citing the cost of rescue drugs during triple therapy.
The data will be presented at the upcoming AASLD.l
Costs Associated with Protease Inhibitor-Based Combination/Rescue Drugs/AASLD 2010kl
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Estimation
Up to $4825 for anemia (assuming epo use rate of 22%), $2837 for depression, $566 for diarrhea $633 for rash.
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Updated Nov 2 2010
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See Links For Complete Trial Information
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Top Line Results Phase III REALIZE Slide Video Presentation
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For all clinical updates on these and other new hepatitis c drugs see the results from the AASLD on this blog
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