US approval for hepatitis C drug telaprevir

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The US Food and Drug Administration has approved a new hepatitis C drug telaprevir (Incivek), the agency announced today.

Telaprevir is a direct-acting antiviral drug (an HCV protease inhibitor), licensed for use in combination with the current standard treatment, pegylated interferon and ribavirin.

The drug has been developed by Vertex, which will market the drug in the United States.

Glossary

virologic response

Reduction in viral replication in response to treatment, especially achievement of an undetectable viral load.

 

pegylated interferon

Pegylated interferon, also known as peginterferon, is a chemically modified form of the standard interferon, sometimes used to treat hepatitis B and C. The difference between interferon and peginterferon is the PEG, which stands for a molecule called polyethylene glycol. The PEG does nothing to fight the virus. But by attaching it to the interferon (which does fight the virus), the interferon will stay in the blood much longer. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

standard of care

Treatment that experts agree is appropriate, accepted, and widely used for a given disease or condition. In a clinical trial, one group may receive the experimental intervention and another group may receive the standard of care.

rash

A rash is an area of irritated or swollen skin, affecting its colour, appearance, or texture. It may be localised in one part of the body or affect all the skin. Rashes are usually caused by inflammation of the skin, which can have many causes, including an allergic reaction to a medicine.

Telaprevir is the second HCV protease inhibitor to be approved this month. The US Food and Drug Administration approved boceprevir (Victrelis) on 13 May.

The safety and effectiveness of telaprevir was evaluated in three phase 3 clinical trials with about 2250 adult patients who were previously untreated, or who had received prior therapy. In all studies, patients also received the drug with standard of care. In previously untreated patients, 79% of those receiving telaprevir experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment), compared to standard treatment alone.

The sustained virologic response for patients treated with telaprevir across all studies, and across all patient groups, was between 20 and 45% higher than current standard of care.

The studies indicate that hepatitis C treatment can be shortened from 48 weeks to 24 weeks in most patients when telaprevir is used in the first 12 weeks. Sixty per cent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90%.

Telaprevir is dosed as two pills taken three times a day with food. It should be taken in combination with pegylated interferon and ribavirin for the first 12 weeks. Most people with a good early response to the combination regimen at 12 weeks can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard care.

The most commonly reported side-effects in patients receiving telaprevir in combination with pegylated interferon and ribavirin include rash, low red blood cell count (anaemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain.

Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.

Telaprevir is expected to receive European Union marketing approval in the second half of 2011.