An enhanced version of Laboratory Corp. of America’s HCV GenoSure NS3/4 test capable of determining whether patients have the hepatitis C virus Q80K polymorphism is now available, the company said in a news release.
The test has increased importance after the FDA’s recent approval of Olysio (simeprevir, Janssen Therapeutics), an NS3/4 protease inhibitor that is significantly less successful at delivering sustained virologic response among patients with the naturally occurring Q80K polymorphism.
In two studies considered by the FDA’s Antiviral Drug Advisory Committee in November, a combined 84% of treatment-naive genotype 1a patients without Q80K achieved SVR12 while receiving Olysio, compared with 58% of patients with Q80K. Fifty-two percent of patients with Q80K in the placebo arm also reached SVR12.
In another study analyzing patients who previously relapsed using Olysio, 78% without Q80K achieved SVR12 compared with 47% of those with Q80K. Also, 30% of placebo patients with the polymorphism achieved SVR12.
Based on these results, Janssen advises that patients be screened for Q80K before Olysio is prescribed and to use a different therapy if Q80K — found in about one-third of HCV patients — is present, according to the release.
The test also provides resistance information related to use of HCV drugs Victrelis (boceprevir, Merck) and Incivek (telaprevir, Vertex Pharmaceuticals), the release said.