SVR 24 (Sustained Virologic Response) with Current DAA HCV Therapy (Pegylated Interferon alpha 2a/2b, Ribavirin, Telaprevir [TVR]/Boceprevir [BOC]) in Naive and Prior Interferon and Ribavirin Treatment Response (PR)

Abstract

Purpose: To confirm SVR 24 rates reported in registration DAA HCV therapy trials with TVR/BOC based on naive and patient's treatment history with pegylated interferon and ribavirin (PR). Methods: Retrospective data review of patients considered for G1 DAA HCV therapy from 2011-2013. Ninety of the 139 patients identified in the database met criteria after DAA HCV therapy initiation and SVR 24 analysis. The other 49 patients have not yet completed therapy. Results: The mean age of the 90 patients was 56, with 47 males and 43 females. Ethnic distribution was as follows: 38 (42%) patients were Caucasian, 34 (37%) patients were African-American, 13 were Hispanics (14%), and four were Asians, who represented 4% of the total cohort. Seven of these patients were after a solid organ transplant (Six after liver transplant and one after a simultaneous liver and kidney transplant. Seventy-one (78%) were genotype 1a. All 90 patients were analyzed based on the following characteristics from prior pegylated and interferon treatment (PR): Relapser, non-responder, null responder, unknown treatment response, and naïve to HCV therapy. Concurrently, advanced stages of liver fibrosis (stage 3-4) were evaluated in each of these sub-groups to determine its impact on SVR 24. SVR 24 rates were highest for relapsers, which was (N=19) 68%, non-responders had an SVR24 of (N=17) 24%, null -responders had 4 (0%) SVR. The patients who were in the naïve group had a low SVR (N=35) 37%. There were 15 patients who had no knowledge of their prior PR therapy or had no records supporting their PR, who also had a low SVR24 of 29%. Fourteen patients completed shorter duration (RGT-Response guided therapy) of therapy 24/28 weeks, based on TVR/BOC as the DAA agent. Twenty-six of the 90 patients discontinued DAA HCV therapy from either physical side effects or emotional side effects of therapy. Seven of these patients stopped prior to starting TVR/BOC because of lack of interferon responsiveness (<1 log decline at Week 4) (Table 1).Table: Table. Prior HCV Treatment (PR) and SVR 24 (%) with DAA HCV TherapyConclusion: Relapsers had the highest SVR 24 rates; advanced stage 3-4 fibrosis did not alter the SVR 24 rates in this group. This finding of SVR 24 is lower, but consistent with registration trials for TVR and BOC. The whole cohort of 90 patients had a larger proportion of African Americans (37%), 50% of patients had stage 3-4 fibrosis, and the majority of patients represented genotype 1a (78%), which are not representative of the registration trials of TVR/BOC. These factors contribute negatively to SVR24. We plan on further multivariate analysis of our data to quantify statistical significance of viral factors, host factors, and compliance as determinants of lower SVR 24 rates in the whole cohort, naive, and each sub-group treated with prior PR. Disclosure - Abdullah Mubarak, MD- Speaker Vertex, Merck, Salix.