A late stage trial of Vertex Pharmaceuticals Inc's eagerly anticipated hepatitis C drug
“TELAPREVIR” showed impressive cure rates for black patients and for patients with advanced liver disease.
In the Phase III study known as Advance, 62 percent of black patients who received
telaprevir achieved sustained viral response (SVR), which is considered tantamount to a cure. That compared with just a 25 percent cure rate from the current standard drugs of
pegylated interferon and
ribavirin.
The study's overall cure rates 75% for
telaprevir in combination with the current standard drugs versus 44% for the standard drugs alone was previously released. But full details of the trial were being presented for the first time at the American Association for the Study of Liver Diseases meeting in Boston.
Breaking out an analysis of black patients in the trial was significant because of the greater prevalence of hepatitis C and historically lower cure rates for that population.
FACT: African Americans bare a large proportion of the burden of hepatitis C in the United States compared with Caucasians and the overall general population.
According to data compiled from 1999 to 2002, one in seven African American men between the ages of 50 and 59 in the United States is living with hepatitis C.
Telaprevir, from a new class of antiviral drugs, is widely expected to be approved by U.S. regulators next year. Vertex plans to complete its application seeking approval this year.
Excitement over the drug has been high, and a similar experimental medicine is being developed by Merck & Co. It is said to believe that Merck & Co have demonstrated significantly higher cure rates than current drugs and the potential to cut treatment duration in half for many patients.
Cutting treatment duration from the current 48 weeks is a huge advantage as the current drugs, which must still be taken with the new medicines, can cause debilitating flu-like symptoms that cause many patients to discontinue treatment or avoid it altogether. It is believed that thousands of patients with hepatitis C have been putting off treatment to await the new, more effective medicines.
In the Advance study, 58% of patients who received
telaprevir met the criteria for a 24 week treatment duration. Said criteria called for levels of the virus in the blood to fall to undetectable levels after 4 and 12 weeks of treatment.
A separate study demonstrated no additional benefit from extending
telaprevir treatment to the full 48 weeks in patients who met the criteria for shorter duration treatment.
A further sub-group analysis of the Advance data showed that
telaprevir led to a 62% cure rate in hepatitis C patients with advanced liver fibrosis or cirrhosis compared with a 33% SVR rate on standard drugs. Patients with those conditions, which can lead to liver cancer or need for a transplant, are also traditionally more difficult to treat than the overall hepatitis C population.
It was said that the Phase III program, starting people with 12 weeks of
telaprevir-based combination therapy resulted in significant improvements in viral cure rates, regardless of race, extent of liver damage or experience with prior treatment.
