Vertex reports promising hepatitis C drug results
By Deena Beasley
LOS ANGELES, April 23 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) on Wednesday said early trial results show that its experimental hepatitis C treatment controlled or eradicated the virus in more than 80 percent of patients for whom previous treatment had failed.
The ongoing study involves only patients with chronic hepatitis C who were unable to achieve control of the serious liver disease with the standard treatment of pegylated interferon and ribavirin.
Vertex said interim results from the open-label trial found that 49 of 60 patients treated with three-times-a-day telaprevir in combination with the other two drugs showed a high rate of viral response after four weeks.
"We are shooting for a cure to the disease," said Kurt Graves, chief commercial officer at Vertex.
The company said the response appears to have been maintained, with no viral breakthrough, in the 36 patients who have completed 4 weeks of treatment and continued out to 8 weeks and in the 16 patients who have continued to 12 weeks of treatment.
"While early, these results are very promising. Patients who have not achieved sustained viral response with prior treatment represent the largest unmet medical need in hepatitis C," Dr. Fred Poordad, chief of hepatology at Cedars-Sinai's liver disease center in Los Angeles, and the study's lead investigator.
He said only 10 percent to 15 percent of patients have their virus eradicated when re-treated with current therapies.
The trial results were presented in Milan at a meeting of the European Association for the Study of the Liver.
Hepatitis C is a blood-borne disease that can cause chronic liver disease, liver cancer and cirrhosis. It affects roughly 170 million people worldwide.
Side effects of telaprevir include fatigue, nausea, headache and rash.
Vertex said nine patients dropped out of the trial before 12 weeks, including five whose viral loads did not drop far enough and two who experienced viral breakthrough. One patient discontinued treatment due to rash and one discontinued due to inflammation of the chest cavity.
Telaprevir is designed to block HCV protease, an enzyme essential for the virus to replicate.
Earlier trials in previously-untreated patients found that the drug eradicated the virus in more than 60 percent of patients -- a rate about 20 percent higher than that seen with current therapies.
Graves said Vertex is also testing a twice-daily regimen of telaprevir and expects to have interim results in May from a 440-patient trial testing the drug in patients not cured by prior interferon-based therapy.
The company also expects to complete late this year enrollment in a pivotal phase 3 trial of telaprevir in treatment-naive patients. (Editing by Carol Bishopric)
