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AASLD 2011: Sustained Response is Durable among Hepatitis C Patients Treated with Telaprevir

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Almost all chronic hepatitis C patients who achieved sustained virological response (SVR) using the recently approved HCV protease inhibitor telaprevir (Incivek) plus pegylated interferon and ribavirin continued to have undetectable viral load nearly 2 years later, according to data presented at the recent American Association for the Study of Liver Disease (AASLD) Liver Meeting in San Francisco.

The ADVANCE, REALIZE, and ILLUMINATE trials demonstrated that adding telaprevir to standard therapy significantly increased the rate of sustained response, or continued undetectable HCV RNA at 24 weeks after the completion of therapy.

Investigators with the EXTEND Study Team looked at whether treatment response was durable with longer follow-up. EXTEND is a 3-year study of participants who received at least 1 dose of telaprevir in selected Phase 2 and 3 trials including ADVANCE (genotype 1 treatment-naive) and REALIZE (genotype 1 previously treated).

Kenneth Sherman presented findings from the second interim analysis at the Liver Meeting. This analysis included 223 patients who achieved SVR (followed for a median 21 months) and 185 non-responders who did not achieve SVR (followed for a median of 29 months). A total of 228 were originally in Phase 2 studies and 180 were in Phase 3 trials; 162 were treatment-naive and 246 were treatment-experienced.

Results

  • > 99% of patients -- all but 1 -- maintained SVR during follow-up.
  • 1 individual experienced late relapse 48 weeks after prematurely discontinuing therapy (after 10 weeks total treatment time).
  • The recurring virus matched the prior strain, indicating relapse rather than reinfection.
  • Among 162 patients who did not achieve SVR and had available genetic sequencing data, 85% no longer had detectable telaprevir-resistant HCV variants, which had been replaced by wild-type virus.
  • More people with HCV subtype 1b had wild-type virus at their last study visit compared to those with subtype 1a (95% vs 77%, respectively).
  • Looking at specific resistance mutations, replacement with wild-type virus ranged from 82% to 100%.
  • No patients with long-term SVR experienced liver-related clinical events, compared with 4 non-responders (2 with transplants due to liver cancer, 1 with hepatic encephalopathy, 1 with ascites).

"In this interim analysis, SVR after telaprevir-based therapy was durable," the researchers concluded. "In patients who did not achieve SVR during telaprevir-based therapy, resistant variants were replaced by wild-type."

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Reference

KE Sherman, MS Sulkowski, F Zoulim, et al. (EXTEND Study Team). 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. 62nd Annual Meeting of the American Association for the Study of Liver Disease (AASLD 2011). San Francisco, November 4-8. 2011. Abstract 248.