Study on new hepatitis C drug shows possible SJS link
June 8th, 2010 by Jennifer Walker-Journey
Telaprevir, a new treatment for hepatitis C by Vertex Pharmaceuticals, is showing positive results from a late-stage study, boosting company shares. But TheStreet.com warns that despite the promising results, the treatment has issues that may be making investors cautious, including a link to the serious allergic reaction Stevens Johnson Syndrome (SJS).
The studies showed a 75 percent cure rate for hepatitis C in patients treated with a telaprevir-containing regimen over 24 weeks. The numbers are impressive, but TheStreet.com says they are largely what investors were expecting for a viral cure rate. About 55 percent of patients treated with telaprevir overall achieved viral cure within the 24-week treatment, a drop in what was observed in previous phase II studies.
Another concern is the development of SJS in a patient enrolled in the phase III study. The condition was diagnosed 11 weeks after telaprevir dosing had ended. The patient was hospitalized and eventually made a full recovery, but the question is how the FDA will react to the report. SJS, an allergic reaction to medication linked to numerous drugs, can be life threatening. It presents with a rash that can occur during use or even weeks or months after the medication has been discontinued.
Only 1.4 percent of the patients treated with telaprevir reported having discontinued the medication because of rash. While the number is low, rash is still an adverse event and, TheStreet.com says, “the disclosure of even one case of SJS puts the drug’s safety profile under further scrutiny.”