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1331115 tn?1536365740

what is Incivek???

what is  Incivek???
12 Responses
1747881 tn?1546179478
What is INCIVEK?

INCIVEK® (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.

http://www.incivek.com/
1747881 tn?1546179478
11 DESCRIPTION
INCIVEK (telaprevir) is an inhibitor of the HCV NS3/4A protease. The IUPAC name for telaprevir is (1S,3aR,6aS)-2-[(2S)-2-({(2S)-2-cyclohexyl-2-[(pyrazin-2-ylcarbonyl)amino]acetyl}amino)-3,3-dimethylbutanoyl]-N-[(3S)-1- (cyclopropylamino)-1,2-dioxohexan-3-yl]-3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrrole-1-carboxamide. Its molecular formula is C36H53N7O6 and its molecular weight is 679.85.

Telaprevir drug substance is a white to off-white powder with a solubility in water of 0.0047 mg/mL. Telaprevir interconverts to an R-diastereomer, VRT-127394, which is the major metabolite in plasma and is approximately 30-fold less potent than telaprevir. INCIVEK is available as a purple, capsule-shaped, film-coated tablet for oral administration containing 375 mg of telaprevir. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 40, dibasic calcium phosphate (anhydrous), FD&C Blue No. 2, hypromellose acetate succinate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY 12.1
Mechanism of Action Telaprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus [see Microbiology (12.4)].

12.4 Microbiology
Mechanism of Action Telaprevir is an inhibitor of the HCV NS3/4A serine protease, necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms of the NS4A, NS4B, NS5A and NS5B proteins and essential for viral replication. In a biochemical assay, telaprevir inhibited the proteolytic activity of the recombinant HCV NS3 protease domain with an IC50 value of 10 nM.

http://pi.vrtx.com/files/uspi_telaprevir.pdf

766573 tn?1365170066
Here is the WIKI
http://en.wikipedia.org/wiki/Telaprevir

The brand name is Telaprevir which is an antiviral drug known as protease inhibitor used in tandem with Interferon and Ribavarin to treat Chronic Hepatitis C primarily for people who have Genotypes 1a & 1b.

Back in the day it used to be just Interferon and Ribavirin but the success rate was abysmal so a third drug was finally added. The success rate is much higher now.
http://en.wikipedia.org/wiki/Telaprevir
1331115 tn?1536365740
Thanks for the info, I have had interferon treatment by itself in 1995 which did nothing to curtail my hep c. In 2005 I had the Pegasus interferon with  ribavirin pills which also didn't work. I don't remember my genotype but I remember my doctor telling its the type that doesn't respond well to treatment. If there is another treatment I would like to try it. So would Incivek have a chance after to fails with interferon therapy?
1747881 tn?1546179478
"So would Incivek have a chance after to fails with interferon therapy?"

Yes, incivek (telprevir) and victrelis (boceprevir, both new drugs released in 2011, have increased the average SVR (cure) rate to 70 to 80%, up from 40 to 50% in genotype 1 patients. Follow the link at the bottom of the page for more info



Boceprevir and telaprevir are the first two protease inhibitors available for the treatment of patients infected with hepatitis C virus (HCV) genotype 1. A sustained virological response (SVR) of 70–80% is observed when either of these protease inhibitors is utilized with pegylated interferon (PEG-IFN) and ribavirin (RBV) in treatment naïve patients. Both agents are also highly effective in patients who failed to achieve a SVR during previous treatment with PEG-IFN/RBV. A rapid virological response (RVR) is observed in 56–60% of treatment naïve patients. Patients who achieve a RVR can be treated with a shorter course of therapy (24–28 weeks) and still achieve a SVR rate of 90% or higher. Patients who do not achieve a RVR, those with cirrhosis and certain prior non-responders should be treated for 48 weeks. Although the SVR rates observed with boceprevir and telaprevir are quite similar both globally and within sub-populations, the treatment algorithms for the two agents are unique. The decision of which protease inhibitor to use should assess several factors including the treatment scheme, duration of therapy, adverse event profile, cost and the likelihood of achieving a RVR. The latter is highly dependent upon IFN sensitivity and the IL28B genotype.

AbbreviationsDAA
direct acting antivirals
eRVR
extended RVR
HCV
hepatitis C virus
IFN
interferon
PEG-IFN
pegylated interferon
RBV
ribavirin
RGT
response-guided therapy
RVR
rapid virological response
SOC
standard of care
SVR
sustained virological response



Boceprevir and telaprevir were the first two and are currently the only protease inhibitors to be approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of patients infected with hepatitis C virus (HCV) genotype 1. For the past decade, only 40–45% of these patients achieved a SVR when treated with PEG-IFN/RBV [1-4]. The duration of therapy was for a fixed 48 weeks. In contrast, when either of these two protease inhibitors is added to PEG-IFN/RBV, the SVR rate in treatment naïve patients increases to 70–80% [5-7]. Boceprevir and telaprevir are also highly effective in patients who fail to achieve a SVR during previous treatment with PEG-IFN/RBV [8, 9]. The availability of these two protease inhibitors has therefore revolutionized the treatment of chronic HCV. For the first time, physicians can tell their patients that it is much more likely they will be ‘cured’ of HCV following treatment.


It has been recognized in recent years that the likelihood of achieving a SVR during treatment with PEG-IFN/RBV was directly related to when the patient became HCV RNA undetectable during therapy [10]. Patients with a RVR, who became HCV RNA undetectable within 4 weeks after initiating treatment, had SVR rates in the 85–90% range and several studies strongly suggested that these patients could receive only 24 weeks of PEG-IFN/RBV [11-14]. This observation forms the cornerstone of response guided therapy (RGT) [10, 15, 16]; a concept that was readily incorporated into the treatment schemes developed for boceprevir and telaprevir.


This manuscript will review data from the phase 3 clinical trials performed with boceprevir and telaprevir in the treatment naïve population [5-7] and in patients who previously failed to achieve a SVR with PEG-IFN/RBV [8, 9]. We conclude by discussing issues that may lead to the selection of a specific protease inhibitor. Throughout this discussion, the reader must keep in mind that the phase 2 and 3 clinical trials that led to the approval of boceprevir and telaprevir were each performed against a placebo control (with PEG-IFN/RBV) and that these two protease inhibitors have never been directly compared. It is therefore impossible to conclude that either protease inhibitor is universally superior for the treatment of patients with chronic HCV genotype 1.

http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02718.x/full
1747881 tn?1546179478
Are you classified as a relapser (were undetectable for the virus at the end of treatment and it returned after stopping)
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