Viral breakthrough.
TheStreet reported Monday that Vertex disclosed a viral load rebound in their phase IIb study. The companies two experimental HCV drugs, VX-222 and Telaprevir needed to be modified after the breakthrough during the first four weeks of treatment.
"BREAKTHROUGH: the return of detectable viral load or high ALT levels in a person who had previously achieved a good virological or biochemical treatment response".
Quoted from the article: "The adversely affected patients were being treated with a low-dose of VX-222 plus telaprevir. That dosing regimen is being discontinued due to the viral breakthrough, Vertex said. Other hepatitis C patients continue treatment in the ongoing study with a high dose of VX-222 plus telaprevir as well as four-drug regimens of VX-222, telaprevir, long-acting interferon and ribavirin".
The article also mentioned "In its defense, Vertex said on a conference call that viral breakthrough in the low-dose VX-222/telaprevir arm of the study was not accompanied by any safety issues. Patients continue to be treated with a high-dose VX-222-telaprevir combination, also without safety issues. None of the patients in the remaining three arms of the 100-patient study have experienced viral breakthrough, the company said"
Vertex also announced today The Start of a Phase 3ba Study of Twice-Daily Telaprevir in People Not Treated Previously for Hepatitis C
Telaprevir® Vertex To File FDA Application “Within Weeks”
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