As you know treatment for HCV has been improving with leaps and bounds in the last five years. Treating according to genotype appears to be changing with a possible shorter treatment duration. Even more impressive is the data showing an improved SVR outcome in genotype 1. ,In the United States 70 percent of affected individuals are infected with genotype 1 the most difficult to treat.
These new drugs (Telprevir, Boceprevir) according to clinical studies have shown to improve SVR in these difficult to treat groups:
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See the summary of treatment outcomes on both drugs below
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Genotype 1
Relapsers
Partial Responders
NullResponders
Cirrhosis
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The Re-Cap,
Telaprevir.
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Earlier Study
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Telaprevir using PROVE 3 was a randomized, double-blind, placebo-controlled Phase 2b study. The study enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders, prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The results included 453 patients who were enrolled and received at least one dose of study drug.k
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A majority (58%) had HCV genotype 1a, the rest had 1b; 16% had compensated cirrhosis. About 60% were prior non-responders (never achieved undetectable HCV RNA), 36% were relapsers (undetectable HCV RNA during treatment with viral load rebound during the post-treatment follow-up period), and 7% experienced viral breakthrough during treatment.
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Telaprevir has shown unprecedented sustained viral response or SVR rates in hepatitis C-infected treatment-failure patients, including those with cirrhosis, according to data from Vertex Pharmaceuticals.
Telaprevir has proved superior efficacy across all HCV genotype 1 non-responders and up to 76% in prior relapsers and patients with cirrhosis.
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For cirrhosis patients, 53% and 45% of success rate was achieved in the 24- and 48-week telaprevir-based treatment arms compared to 8% in the control arm – these results were similar to those obtained for patients without cirrhosis.
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Telaprevir/Realize Trial
New drug from vertex can treat hard-to-cure hepatitis C patients.
Realize Trial,
Details of the trial
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The trial looked at 662 hepatitis C patients whose bodies seemed to be resistant to all other treatments.,
The participants were divided in 3 groups. ,
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The ones who responded to treatment but then relapsed during the follow-up period were put in the first group ,
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Patients who partially responded to treatment but whose virus never completely disappeared consisted the second group, ,
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Patients who never responded well to treatment at all were a part of the third group.
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ll The total treatment period was extended to 48 weeks from the regular 24 weeks as these patients have a form of the hepatitis C virus that is more stubborn or harder to treat
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lResults of the trial k
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Treatment With Current SOC-standard of care is the "control group"
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65 percent of patients treated with telaprevir plus the standard of care were cured, or sustained viral response compared to 17 percent of patients in the control group who were re-treated with just the standard of care, the trial claimed.
lDividing the results into the different groups
86 percent of re-lapsers were cured after telaprevir treatment compared to 24 percent in the control arm.
Partially responders Among the second group, the cure rate for the telaprevir-treated patients was 57 percent compared to 15 percent for the control arm.
Finally, in the last group which consisted of the most difficult to treat patients, telaprevir achieved a 31 percent cure rate compared to 5 percent for the control arm.
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m Results across all three patients types were statistically significant in favor of telaprevir over standard of care, officials report.
Source
http://www.themedguru.com
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You Must REALIZE This Drug Works by Now
Quote From The Montely Fool
On the surface, that 65% cure rate (telaprevir) looks comparable to the 66% of the treatment-experienced patients who were cured on boceprevir, but the control group patients in Merck's trial were cured 21% of the time, meaning that telaprevir apparently did a better job.
Vertex was nice enough to break down the cure rates between the treatment classes (those who had relapsed vs. those who had not responded vs. those who had partially responded) in its press release, but Merck (boceprevir) didn't. So, we'll have to wait until Merck presents more data before we can get an accurate picture of how the two drugs match up in treatment-experienced patients.
Boceprevir
HCV SPRINT-2 Final Results.
Final Results Pivotal Phase III Data/Boceprevir/AASLD 2010
Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting. In total, more than 20 oral and poster presentations of clinical studies highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented.
As previously reported, Merck plans to submit a New Drug Application (NDA) for boceprevir to the U.S. Food and Drug Administration (FDA) on a rolling basis, and expects to complete regulatory submissions in the U.S. and E.U. in 2010.
The AASLD presentations of the boceprevir Phase III data will include sustained virologic response (SVR)1 rates by patient sub-groups, including treatment-naïve patients (African-American/Black and non-African-American/Black), patients who experienced prior relapse, prior non-responders, and patients with a poor response to interferon, defined as having achieved less than a 1 log decrease in viral load (HCV-RNA) after a 4-week Peg/riba lead-in period.
The HCV RESPOND-2 and HCV SPRINT-
Two studies each evaluated two treatment strategies with boceprevir to assess the ability to improve SVR and potentially shorten overall treatment duration compared to Peg/riba alone:
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•Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks, and in which treatment-naïve patients with undetectable virus during weeks 8 through 24 were able to stop all treatment at 28 weeks; and
•48 weeks of treatment (4-week Peg/riba lead-in followed by the addition of boceprevir for 44 weeks). In both studies, all patients were treated with a 4-week lead-in of PEGINTRON (1.5 mcg/kg/week) and an investigational dose of REBETOL (600-1,400 mg/day), followed by the addition of boceprevir (800 mg three times a day).
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Boceprevir:
.August 8, 2010
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