Vertex Hepatitis C Drug Shows 75 Percent Cure Rate
Make a commentBy Ed Silverman // May 26th, 2010 // 7:13 am
Hepatitis C is one of the hottest areas for drug development and Vertex Pharmaceuticals has released a study that gives new hope to patients and investors. The results show its Telaprevir treatment increased the cure rate to 75 percent in a pivotal tiral of previously untreated patients, while also reducing the time needed for treatment.
By contrast, the cure rate for patients who received only existing therapies was just 44 percent. Of those who got 12 weeks of telaprevir, 75 percent had a sustained viral response, meaning the virus was not detectable in their blood 24 weeks after completing treatment. That is seen as essentially a cure. The rate was 69 percent for those who got eight weeks of telaprevir (see the statement)
“These data support the vision that we have long had for fundamentally changing the treatment for hepatitis C,” Robert Kauffman, Vertex’s chief medical officer, told analysts in a conference call. Vertex also noted that discontinuation due to adverse events was rather low and there were no new safety signals.
After results from two more Phase III trials arrive in the third quarter, Vertex plans to apply for FDA approval. Initially, however, telaprevir will have to be used with existing treatments to prevent the hepatitis C virus from developing resistance to the drug. Meanwhile, Merck should announce late-stage trial results of its own boceprevir, which is a similar drug, later this year.
“These data set an impressively high bar for both safety and efficacy compared to previous Phase II data for telaprevir or Merck’s boceprevir,” writes Leerink Swann analyst Seamus Fernandez in an investor note. “In our opinion, it is difficult to imagine a meaningfully better outcome for boceprevir in the treatment naive setting.”
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Boceprevir, Hepatitis C, Merck, Telaprevir, Vertex Pharmaceuticals