More data is rolling in from Vertex Pharmaceuticals on its lead drug for hepatitis C, and it looks like the medicine is continuing to live up to its own high expectations. The Cambridge, MA-based company said today that telaprevir’s effect on killing the virus is remaining durable on follow-up analysis, and the drug appears to just about as good in a more convenient twice-daily pill form instead of its standard three-times-a-day dosing schedule.
The data dump came in front of a prime audience of physicians attending the American Association for the Study of Liver Disease annual meeting today in San Francisco. The results appear to match up pretty consistently with what Vertex has reported previously, which I wrote about in this advance story.
To recap what’s at stake, telaprevir is aiming to be a first-in-class protease inhibitor against hepatitis C, a chronic liver disease. If it can deliver in the final stage of clinical trials, it will change the standard of treatment for the disease. An estimated 3.2 million people in the U.S. have hepatitis C infections, and about 170 million have it worldwide. Telaprevir must be taken with a pair of standard drugs, pegylated interferon alpha and ribavirin, which cause flu-like symptoms and must be taken for almost a year. The Vertex drug is highly anticipated, though, because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and in half the time. If approved, the product could generate $2.6 billion in U.S. sales in 2013, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.
“These are strong and striking early results,” says Freda Lewis-Hall, Vertex’s executive vice president for medicines development.
In the spirit of helping you keep all this data straight, because there’s a lot of it, we’re breaking this down into bite-size chunks. .
—The ‘107 study. This trial of patients who didn’t respond to previous treatment, produced data from more patients who were followed over a longer period than was previously reported. Researchers found that 68 of 104 patients, or about two-thirds, who got telaprevir along with standard drugs had no evidence of the virus in their blood after four weeks. That effectiveness appeared to be long-lasting. Researchers found that 41 of 71 patients (58 percent) followed for 24 weeks still had no evidence of the virus in the blood. Importantly, telaprevir is showing that it can wipe out the virus about 43 percent of the time in the toughest patients of all to treat—those who didn’t respond at all to a prior round of therapy.
The last time Vertex reported results from this trial, at a European meeting in April, it didn’t have any follow-up data that extended this long, or such strong data for what are called “null responder” patients. Of course, there were side effects, though. About 8 percent of patients dropped out of the study because of adverse events, with about half of them quitting because they developed a rash, the company said.
—The C208 study. This trial is about convenience for patients.
