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Vertex' Telaprevir Triple Therapy Improves Viral Cure Rates In HCV Patients

Vertex Pharmaceuticals Inc. (VRTX) Thursday said an interim analysis of its ongoing phase 2 study showed rapid viral response to its investigational Telaprevir triple therapy, among people with genotype 1 chronic hepatitis C who were new to treatment.

Hepatitis C is a serious liver disease caused by the hepatitis C virus, or HCV. Chronic hepatitis C can lead to serious, life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.

Vertex' VX-222 is an investigational, oral, non-nucleoside inhibitor of HCV NS5B polymerase. The company has worldwide commercial rights for VX-222.

In the ongoing phase 2 study dubbed ZENITH, 106 people have been enrolled for four treatment arms, evaluating two-drug and four-drug combination regimens. Safety and tolerability are the primary endpoints of the study. The secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response, which is defined as undetectable HCV after the end of the treatment.

In this study, VX-222, telaprevir and ribavirin are given twice daily. Arms A and B were designed to evaluate the all-oral, two-drug combination regimens of VX-222 (400 mg or 100 mg) and telaprevir (1,125 mg). Both of these study arms were discontinued due to a pre-defined stopping rule related to viral breakthrough.

Arms C and D are ongoing and designed to evaluate the four-drug combination regimens of VX-222 (400 mg and 100 mg), telaprevir (1,125 mg), pegylated-interferon and ribavirin.

An additional treatment arm has been added to the study to evaluate an all-oral, three-drug regimen of VX-222, telaprevir and ribavirin in people with genotype 1b chronic hepatitis C. This study arm is now open for enrollment. The company may add a sixth and final arm to the trial per protocol based on data from the study.

Interim data from Arms C and D showed that 90 percent of those who received VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin had undetectable hepatitis C virus at week 12.

Half of those in the VX-222 (400 mg) treatment group were eligible to stop all treatment at week 12. People in this group who were not eligible to stop all treatment at 12 weeks were assigned to receive 24 total weeks of treatment - 12 weeks of the four-drug regimen followed by 12 weeks of pegylated-interferon and ribavirin alone.

In the low dose VX-222 (100 mg) treatment group 83 percent of the patients had undetectable hepatitis C virus at week 12.

Using an intent-to-treat analysis, 57 percent of people treated with VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin had undetectable hepatitis C virus by week two. Among people who were treated with VX-222 (100 mg) in combination with telaprevir, pegylated-interferon and ribavirin, 38 percent had undetectable hepatitis C virus by week two.

Most frequently reported adverse events in the study were mild gastrointestinal symptoms and fatigue.

Commenting on the interim data, Robert Kauffman, Senior Vice President and Chief Medical Officer for Vertex, stated, "Telaprevir triple therapy demonstrated significant improvements in viral cure rates and an ability to halve treatment time to 24 weeks for many people in late-stage studies."

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. The U.S. FDA and Health Canada have granted priority review for the company's applications for the approval of telaprevir. The FDA's Antiviral Drugs Advisory Committee is scheduled to be convened on April 28 to discuss the New Drug Application for telaprevir. Target response date is set at May 23.

VRTX closed Wednesday's trading at $38.48.

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