What You Need To Know About Telaprevir
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The most important aspect of using this drug is using it to its best advantage possible. You can only do this by finding the right doctor. Please if you read anything, please read the link below.
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Treating with Telaprevir will include *SOC Standard of care therapy
(SOC) for hepatitis C is a FDA approved regime consisting of pegylated interferon and ribavirin
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What Is A Priority Review?
Vertex is asking the FDA to decide on approval in six months instead of ten.
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When Will Telaprevir Be Available To Us ?
If the FDA grants priority review *fast track , and the drug is approved, possible availability could be by spring.
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What are the stats ?
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Treatment-Naive / Genotype 1 =75% Cure
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(SVR: Sustained Virological Response= No virus detected 24 months after last medicine was taken.)
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75 percent of treatment-naïve patients chronically infected with genotype 1 HCV achieved an SVR
(SVR: Sustained Virological Response= No virus detected 24 months after last medicine was taken.)
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75 percent of treatment-naïve patients chronically infected with genotype 1 HCV achieved an SVR
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New data from this study showed that 62% of African Americans/Blacks achieved SVR with telaprevir compared to 25% of African Americans/Blacks who were treated with pegylated-interferon and ribavirin alone. Additionally, 62% of people with advanced liver fibrosis or cirrhosis (scarring of the liver) achieved SVR with telaprevir compared to 33% who were treated with pegylated-interferon and ribavirin alone.
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See :ADVANCE trial
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Treatment Duration
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The ILLUMINATE Trial
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Shorter Treatment Duration = 24 weeks vs 48 weeks
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Viral cure rates of 92% and 88% with 24 and 48-week regimens, respectively, in people who met certain response criteria-
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ILLUMINATE trial enrolled 540 patients and demonstrated 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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"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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Previously Treated / Treated before / Genotype 1 = 65% Cure
See: REALIZE
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What is the REALIZE trial?
REALIZE is a pivotal Phase 3 clinical trial of telaprevir in combination with peginterferon alfa-2a and ribavirin 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.
Who Was Enrolled In The Trial And What Were The Results ?
Patients in the study were enrolled based on their response to prior treatment:
Out Of 662 Enrolled In The Study
53% were prior relapsers 354 relapsers
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Relapsers: People whose HCV RNA drops to an undetectable level with treatment but rises again after treatment ends.
Results In Relapsers = 86%
Among relapsers, the telaprevir-based regimen led to an 86 percent cure rate compared with 24 percent from standard of care
Relapsers: People whose HCV RNA drops to an undetectable level with treatment but rises again after treatment ends.
Results In Relapsers = 86%
Among relapsers, the telaprevir-based regimen led to an 86 percent cure rate compared with 24 percent from standard of care
Out Of 662 Enrolled In The Study
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19% were prior partial responders124 partial responders
19% were prior partial responders124 partial responders
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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.
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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Results In Partial Responders = 57%
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?
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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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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Results Null Responders = 31%
In null responders there was a 31 % percent cure rate compared to 5% in standard of care
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Did Any Of These Patients Have Cirrhosis Or A High Viral Load ?
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.
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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What If I Am Genotype 2 or 3/ Treatment-Naive
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From The : Association for the Study of the Liver (EASL 2010)
05/14/10
05/14/10
*Treating with telaprevir without pegylated interferon (small study)
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49 previously untreated participants with genotype 2 or 3 chronic hepatitis C were assigned to receive telaprevir alone (750 mg every 8 hours), telaprevir with pegylated interferon alfa-2a (Pegasys) plus 800 mg ribavirin, or pegylated interferon/ribavirin with placebo for 2 weeks. . All participants then received pegylated interferon/ribavirin through week 24 (the standard duration of treatment for these genotypes)..
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Geno 2
Geno 2
Genotype 2 telaprevir alone: SVR 56%;
Genotype 2 telaprevir/pegylated interferon/ribavirin: SVR 100%
Genotype 2 *SOC pegylated interferon/ribavirin: SVR 89%.
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Geno 3
Genotype 3 telaprevir alone: SVR 50%;
Genotype 3 telaprevir and pegylated interferon/ribavirin: SVR 67%;
Genotype 3 pegylated interferon/ribavirin: SVR 44%.
Genotype 2 is more responsive than genotype 3 here and also in SOC= Standard of Care.
Complete Information
Complete Information
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What Is The Difference Between Pegylated Interferon and Telaprevir?
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 .
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Telaprevir is an oral agent (Pill Taken By Mouth). Telaprevir "directly" targets the HCV protease, a protein the virus needs to reproduce in the body. Telaprevir is used with SOC.
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Who Makes Telaprevir ?.
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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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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Nov 2010;
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