Trial Suggests New Drug Could Cut Hepatitis C Treatment Time

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Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 Apr 2007 - 1:00 PDT

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Vertex Pharmaceuticals Inc has released early results of a trial on new hepatitis C drug telaprevir that suggest it could significantly reduce the treatment time for the disease.

The planned interim results of the PROVE 1 clinical trial on telaprevir were announced at Barcelona on Saturday at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).

PROVE 1 is the first trial to evaluate short-duration treatment using the investigational hepatitis C protease inhibitor telaprevir (TVR or VX-950) with pegylated interferon (peg-IFN) and ribavirin (RBV) in genotype 1-infected hepatitis C patients who have not received treatment for hepatitis before.

The trial showed a high rate of rapid viral response (RVR) in patients treated with telaprevir, and a low rate of on-treatment viral breakthrough, and suggests that some patients can be cleared of the virus with 12 weeks of telaprevir-based therapy.

Telaprevir is a joint development between global biotech company Vertex Pharmaceuticals Inc and Tibotec Pharmaceuticals Ltd, of Cork, Ireland.

Dr John McHutchison, Principal Investigator of the PROVE 1 study and Director of Gastroenterology and Hepatology Research at Duke Clinical Research Institute, based in Durham, North Carolina, US, said:

"The high rates of RVR observed in the telaprevir groups in PROVE 1, and the fact that some patients have remained persistently viral negative 20 weeks after stopping the 12 weeks of telaprevir-based therapy, suggest that we may be able to shorten the treatment duration in genotype 1 HCV patients."

He suggested there is a strong possibility that high sustained viral response (SVR) rates could be achieved with treatments lasting 24 weeks.

"We look forward to 24 week follow-up data from the initial group of patients who stopped treatment at 12 weeks, and follow-up data from patients in the study who received 24 weeks of treatment," he added.

Adverse reactions caused 11 per cent of the 175 patients given telaprevir-based therapy to discontinue treatment, compared with 3 per cent in a placebo group. Symptoms of adverse events that led to discontinuation included rash, gastrointestinal problems and anemia.

The effectiveness and duration of current treatments for Hepatitis C is largely determined by the genotype of the virus.

The Hepatitis C virus has been evolving over thousands of years and has 6 genotypes and many subtypes. Their distribution varies throughout the world. Genotype 1b is the most common in Europe, followed by 2a, 2b, 2c and 3a. In North America genotype 1a is the most common, followed by 1b, 2a, 2b, 2c and 3a. Genotypes 4 and 5 are mostly found in Africa.

Genotypes 1 and 4 are not as responsive to treatments based on interferon compared with the others. Interferon treatment for genotypes 1 and 4 takes nearly a year, whereas it takes just under 6 months to treat genotypes 2 and 3 with the drug.

According to the World Health Organization, the Hepatitis C virus is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer.

It is estimated that 170 million people throughout the world are chronically infected with Hepatitis C (9 million in Europe), with 3 to 4 million new infections a year worldwide.

Hepatitis C is spread mostly by direct contact with human blood as a result of blood transfusions and re-using non-sterilized needles and syringes.

Click here for European Association for the Study of the Liver (EASL).

Click here for Hepatitis C Information Central.

Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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