|Systematic (IUPAC) name|
|Trade names||Incivek, Incivo|
|Licence data||US FDA:|
|Pregnancy cat.||B (US)|
|Legal status||℞-only (US)|
|Routes||Oral ? or IV|
|Mol. mass||679.85 g/mol|
| (what is this?)
Telaprevir (VX-950), marketed under the brand names Incivek and Incivo, is a pharmaceutical drug for the treatment of hepatitis C co-developed by Vertex Pharmaceuticals and Johnson & Johnson. It is a member of a class of antiviral drugs known as protease inhibitors. Specifically, telaprevir inhibits the hepatitis C viral enzyme NS3.4A serine protease. Telaprevir is only indicated for use against hepatitis c genotype 1 viral infections and hasn´t been proven to have an effect on or being safe when used for other genotypes of the virus. The standard therapy of pegylated interferon and ribavirin is less effective on genotype 1 and telaprevir offers a welcome addition to the treatment of this genotype.
Clinical trials and approvals
In a randomized controlled trial (ADVANCE) of patients in whom standard treatment with peginterferon alfa-2a and ribavirin had failed, repeat treatment with the addition of telaprevir was more likely to have a sustained virological response (SVR) than repeat treatment with peginterferon alfa-2a and ribavirin alone. In patients who received peginterferon alfa-2a and ribavirin for a year, the addition of telaprevir for 24 weeks achieved a SVR of 53% compared to 14% in patients who did not receive telaprevir. In that study, shorted treatment with only three months of telaprevir and six months of treatment peginterferon alfa-2a and ribavirin achieved an SVR of 51%. In a second randomized controlled trial (REALIZE) of patients who had previously relapsed or had only a partial response, rates of SVR were higher in patients treated with telaprevir (83% to 88%) compared to 24% in controls. In a third trial (ADVANCE) for previously untreated patients, patients taking telaprevir had a SVR (69% to 75%) versus 44% in the control group.
On April 28, 2011, the FDA Antiviral Drugs Advisory Committee voted 18-0 to recommend approval telaprevir for people with genotype 1 chronic hepatitis C. The committee reviewed clinical trial data (including findings from the Phase 3 ADVANCE, ILLUMINATE, and REALIZE studies) showing that combining telaprevir with pegylated interferon and ribavirin produced a higher cure rate–and in less time–than standard therapy alone. This improvement is most notable for hard-to-treat patients including those with HCV genotype 1, people with liver cirrhosis, and those who did not respond to a prior course of interferon-based therapy. Merck's boceprevir, also a new anti hepatitis C drug, was given a positive recommendation by the same committee, on the previous day. Telaprevir was fully approved for use in the United States in May 2011.
On December 19, 2012, Vertex announced it would add a “Black Box” warning of possible side effects on the US labels of telaprevir, following "reports of a small number of fatal skin reactions in patients who continued to receive Incivek combination therapy after a serious skin reaction was identified.”. The FDA reported that two people had died from serious skin reactions caused by the Incivek combination treatment and that a total of 112 patients had developed serious skin reactions of two different types.
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- "FDA recommends approval for Telaprevir and Boceprevir". 3 May 2011.
- "FDA Approves Telaprevir for HCV". May 23, 2011.
- Staff, Boston.com. December 19, 2012. Vertex updates label of hepatitis C drug after reports of a ‘small number of fatal skin reactions’