LB-3. Final Results of ENABLE 1, a Phase 3, Multicenter Study of Eltrombopag as an Adjunct for Antiviral Treatment of Hepatitis C Virus-Related Chronic Liver Disease Associated With Thrombocytopenia. N. Afdhal; G. Dusheiko; E. G. Giannini; P. Chen; K. Han; A. Moshin; M. Rodriguez-Torres; S. Rugina; E. Lawitz; M. L. Shiffman; G. Tayyab; F. Poordad; Y. Mostafa Kamel; A. Brainsky; J. Geib; S. Y. Vasey; R. Patwardhan; F. M. Campbell; D. Theodore
Other AASLD abstracts I missed for $VRTX's Incivek that could be of interest
"#LB-8. Telaprevir Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Coinfected Patients: 24-Week Treatment Interim Analysis."
"#LB-23. Validation of an HCV NS3/4A Sequencing Assay for Evaluating Resistance to Boceprevir, Telaprevir and Protease Inhibitor Candidates in a Clinical Reference Laboratory Setting."
"#248. Follow-up of SVR Durability and Viral Resistance in Patients with Chronic Hepatitis C Treated with Telaprevir-Based Regimens: Interim Analysis of the EXTEND Study."
"#31. Efficacy and safety of telaprevir-based regimens in cirrhotic patients with HCV genotype 1 and prior peginterferon/ribavirin treatment failure: subanalysis of the REALIZE Phase III study."
"#32. Predictors of virologic response with telaprevir-based combination treatment in HCV genotype 1-infected patients with prior peginterferon/ribavirin treatment failure: post-hoc analysis of the Phase III REALIZE study."
"#35. Retreatment with telaprevir/Peg-IFN/RBV after a short exposure to telaprevir in Phase I studies: interim results from a Phase IIIb rollover trial (C219)"
"#2117. Importance of newly described rare hepatitis C virus NS3 protease resistance mutations in patients treated with telaprevir or boceprevir."
"#2104. Long-term follow-up analysis of the hepatitis C virus NS3 protease in patients treated with telaprevir or boceprevir – a comparison between clonal and deep sequencing."
"#2088. Rapid Emergence of Telaprevir Resistant Hepatitis C Virus Strain From Wild Type Clone in Vivo."
#2105. Sustained Virologic Response Rates and Viral Resistance Profiles Were Similar in Patients Treated with a Telaprevir-Based Regimen Regardless of Liver Fibrosis Stage."
On the basis of the results announced today and previously announced data from other treatment arms of the ZENITH study, Vertex intends to start a Phase 3 study to evaluate a total treatment duration of 12 weeks with this four-drug regimen in treatment naïve and relapser patients with genotype 1 chronic hepatitis C.
Here are the interim results from the phase-2 ZENITH study reported today at AASLD:
*50% (15/30) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Two people in the VX-222 (400 mg) treatment arm discontinued treatment before week 12 and did not achieve SVR12.
**38% (11/29) had undetectable hepatitis C virus at weeks 2 and 8 and were eligible to stop all treatment at week 12. Four people in the VX-222 (100 mg) treatment arm discontinued treatment before week 12 and two of them achieved SVR12.
+One person in the 12-week VX-222 (400 mg) treatment arm relapsed.
++Two people in the 12-week VX-222 (100 mg) treatment arm relapsed.