Telaprevir in Combination with Peginterferon and Ribavirin in Former Injection Drug Users with Chronic Hepatitis C: Findings of the Observational Integrate Study

Author: Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggman P, Kunkel J, Keim S, Jäkel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster G

Theme: Clinical Research Year: 2015

Background: INTEGRATE is an observational, multicenter, prospective study evaluating the efficacy and safety of telaprevir with peginterferon-alfa and ribavirin (PR) in ex-people who inject drugs (ex-PWIDs) infected with HCV genotype 1. Few data currently exist for direct-acting antiviral agents in HCV-infected PWIDs and ex-PWIDs.

Methods: Eligible patients were treatment-naïve or prior-relapser ex-PWIDs with any fibrosis stage, receiving addiction treatment. Patients received telaprevir plus PR prescribed according to local labels. Sustained virologic response (SVR12) (HCV RNA 90%. At follow-up, fewer patients reported anxiety/depression symptoms (HADS) (35/15%) than at baseline (43/33%), and median EQ-5D health outcomes score improved to 82 from 70 at baseline. The proportion of patients with an AUDIT (screen for excess drinking) score ≥8 remained unchanged from baseline.
The most frequently-reported AEs were anemia (39%), thrombocytopenia (30%), fatigue (26%) and pruritus (22%). Serious AEs were reported in nine patients (24%); AEs led to treatment discontinuation in six patients (13%).

Conclusion: The efficacy in the EE patients, and the safety of telaprevir plus PR reported in this observational cohort of ex-PWIDs, are comparable with Phase 3 data for telaprevir in HCV mono-infected patients with no history of drug use.

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