The US-based Vertex Pharmaceuticals Incorporated, a global biotechnology company, has released promising early results of a trial on new hepatitis C drug, telaprevir. The drug could significantly reduce the treatment time, it has been shown.
The planned interim results of the 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).
This drug has an enormous amount of promise," Dr. Ira Jacobson, one of the study's lead investigators, said in a telephone interview. "I think treatments like this will radically alter our perception of optimal duration of therapy for hepatitis C."
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the liver and blood of people with the disease. A serious public health concern affecting 3.4 million individuals in the United States, is spread primarily through direct contact with the blood of infected people. Though many people with hepatitis C may not experience symptoms nor be aware of their infection, others may have symptoms such as jaundice and fatigue.
Hepatitis C significantly increases a person's risk for developing chronic liver disease, cirrhosis, the need for liver transplantation, liver cancer, or death.
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.
The Vertex 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.
Full results will not be available until the second half of this year, Vertex said. Two larger mid-stage clinical trials are under way as the company works to design the pivotal late-stage studies that will be used to make a case for approval of the medicine.
Vertex Chief Medical Officer John Alam said the interim data had heightened optimism about future clinical results.
"Seeing this response rate in 12 weeks, our confidence in the 24-week treatment arm goes up substantially," he said.
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.