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VIDEOVertex Proves Telaprevir Could Be First, Best for Hep C
New data reinforces that so far, the biotech's hepatitis C drug is leading the way in treatment of the disease.
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Vertex released further data on Tuesday that showed its hepatitis C drug telaprevir is effective in curing previously untreated patients in half the time of the current standard of care. Of those patients that showed no signs of the virus after 12 weeks -- called rapid viral responders -- 92% of them achieved sustained virologic response, or SVR, in 24 weeks when treated with the standard of care and telaprevir. SVR is considered a cure by most doctors.
The overall cure rate in the phase 3 Illuminate study was 72%, slightly lower than in a previous phase 3 study called Advance. Yet, the Illuminate study gives further evidence that Vertex's telaprevir shows consistently positive results, as well as cuts down the time of care.
Cutting the time down on the standard of care is important to HCV patients because the treatment can be uncomfortable and cause unwanted side effects.
"Patients who had a rapid response to telaprevir-based regimens at weeks 4 and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy," Dr Kenneth Sherman, principal investigator of the trial, said in a statement.
Telaprevir and Merck’s (MRK) boceprevir are competing to become the new standard of care for the disease. Results released earlier in August by Merck showed that boceprevir cured 63% of never-before-treated patients in about 28 weeks. Merck also released data showing that previously treated patients responded to boceprevir with cure rates of 59% to 66%.
Vertex has
yet to announce data from a trial of previously treated patients. The data from this study, called Realize, will be released in September. The biotech is expected to finish its rolling New Drug Application sometime during the second half of this year. Cowen & Co analyst Phil Nadeau expects that telaprevir sales could hit $3 billion in the US and another $1 billion overseas. Telaprevir and boceprevir have never been compared to each other in studies. While Vertex's drug appears to be the more effective of the two, it's important to take into account that not all of the data has been released and that the studies may have been set up differently, creating somewhat skewed results.
Hepatitis C, or HCV, is a disease that leads to swelling of the liver. The disease is asymptomatic and most people don't know they have it until severe liver damage is discovered. It's the leading cause of liver cancer, cirrhosis, and the main reason that people in the US need a liver transplant. According to the Center for Disease Control and Prevention, 3.2 million Americans are living with chronic hepatitis C.
Robert W. Baird analyst Tom Russo believes that the HCV market has plenty of room for more than one drug to achieve multi-billion-dollar status. Yet, he also called telaprevir the likely first-in-class/best-in-class drug.
Investors will have to wait until September to have all the facts before they officially crown telaprevir the winner in the HCV race.
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