Telaprevir
Encyclopedia
Telaprevir marketed as the brand name Incivek, is a pharmaceutical drug for the treatment of hepatitis C
co-developed by Vertex
and Johnson & Johnson
. It is a member of a class of antiviral drug
s known as protease inhibitor
s. Specifically, telaprevir inhibits the hepatitis C virus NS3.4A serine protease.
In a randomized controlled trial
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 response than repeat treatment with peginterferon alfa-2a and ribavirin alone.
Telaprevir is the first hepatitis C drug that has demonstrated activity in patients who have failed prior therapy.
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/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.
Hepatitis C
Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
co-developed by Vertex
Vertex Pharmaceuticals
Vertex Pharmaceuticals is a biotechnology company with activities spanning the length of the pharmaceutical product pipeline, from target identification through to clinical trials and marketing. Most of its activity has been in collaboration with much larger pharmaceutical firms, though some of its...
and Johnson & Johnson
Johnson & Johnson
Johnson & Johnson is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500....
. It is a member of a class of antiviral drug
Antiviral drug
Antiviral drugs are a class of medication used specifically for treating viral infections. Like antibiotics for bacteria, specific antivirals are used for specific viruses...
s known as protease inhibitor
Protease inhibitor (pharmacology)
Protease inhibitors are a class of drugs used to treat or prevent infection by viruses, including HIV and Hepatitis C. PIs prevent viral replication by inhibiting the activity of proteases, e.g.HIV-1 protease, enzymes used by the viruses to cleave nascent proteins for final assembly of new...
s. Specifically, telaprevir inhibits the hepatitis C virus NS3.4A serine protease.
In a randomized controlled trial
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
of patients in whom standard treatment with peginterferon alfa-2a and ribavirin
Ribavirin
Ribavirin is an anti-viral drug indicated for severe RSV infection , hepatitis C infection and other viral infections. Ribavirin is a prodrug, which when metabolised resembles purine RNA nucleotides...
had failed, repeat treatment with the addition of telaprevir was more likely to have a sustained response than repeat treatment with peginterferon alfa-2a and ribavirin alone.
Telaprevir is the first hepatitis C drug that has demonstrated activity in patients who have failed prior therapy.
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/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
Boceprevir
Boceprevir is a protease inhibitor used as a treatment for hepatitis C genotype 1. It binds to HCV nonstructural 3 active site....
, 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.