fatigue, itching, headache, rash, flu-like symptoms and nausea. About 4 percent of patients in the telaprevir group dropped out of the study because of adverse events, while about 3 percent discontinued in the control group, Vertex said.
The latest results from the Realize study are not just important to patients, but also to Vertex from a competitive standpoint. The company is preparing to face off against Merck’s boceprevir, another drug from the class of anti-viral drugs known as protease inhibitors. Merck released results from a pair of Phase III clinical trials last month, one in which patients were getting their first round of therapy, and another in which patients were getting re-treatment. The re-treated patients had a clinical cure rate of 59 percent to 66 percent, according to this recap from TheStreet.com.
Of course, the Merck and Vertex trials were designed differently, and didn’t test the drugs head to head, so it’s really an apples to oranges comparison. But Vertex offered some insight in this feature back in September 2008 about how it designed the Realize trial to hopefully provide a little extra advantage for its product in the minds of physicians.
Now that Vertex has cleared all three major trials that it needed to run to fill out its FDA application, the question of how telaprevir stacks up against the Merck drug and how it will be received by physicians and patients will take on even greater significance than before. You can be sure that patients are going to be hounding the company and the FDA about exactly when this drug might become commercially available in the U.S.
