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|Title:||SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR TREATMENT OF CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAIVE PATIENTS: RESULTS FROM QUEST-2, A PHASE III TRIAL|
|Authors:||MANNS, M.; MARCELLIN, P.; POORDAD, F. P. Fred; ARAUJO, E. Stanislau Affonso de; BUTI, M.; HORSMANS, Y.; JANCZEWSKA, E. J. Ewa; VILLAMIL, F.; PEETERS, M.; LENZ, O.; OUWERKERK-MAHADEVAN, S.; KALMEIJER, R.; BEUMONT-MAUVIEL, M.|
|Citation:||JOURNAL OF HEPATOLOGY, v.58, suppl.1, p.S568-S568, 2013|
|Abstract:||Background and Aims: Simeprevir is a potent, once-daily, oral, investigational HCV NS3/4A protease inhibitor. QUEST-2 (NCT01290679) is a Phase III, randomised, double-blind, placebo-controlled trial assessing the efficacy, safety and tolerability of simeprevir versus placebo as part of a regimen including peginterferon a-2α (pegIFNα-2a) or pegIFNα-2b/ribavirin (PR) in treatment-naïve patients chronically infected with genotype-1 HCV.Safety and SVR12 results from a primary (Week 60) analysis are presented. Methods: Patients (n=391), randomised 2:1 and stratified by HCV genotype-1 subtype and host IL28B genotype, received simeprevir (150mg QD)+PR or placebo+PR for 12 weeks, followed by PR alone. Total treatment duration was 24 or 48 weeks (simeprevir group) based on response-guided therapy (RGT) criteria (HCVRNA < 25IU/mL Week 4 and undetectable Week 12) or 48 weeks (placebo group). Table 1 Percentage of patients achieving SVR12 Placebo/PR Simeprevir/PR All patients 50% 81% Treated with pegIFNα-2a/pegIFNα-2b 62%/42% 88%/78% Patients who met RGT criteria not applicable 86% IL28B genotype CC/CT/TT 81%/41%/19% 96%/80%/58% HCV subtype 1a or other/1b 46%/53% 80%/82% METAVIR score F0–F2/F3–F4 51%/47% 85%/66% Results: Simeprevir/PR was superior to placebo/PR; SVR12: 81 vs 50%, respectively (p < 0.001). The majority (91%) of simeprevir-treated patients met RGT criteria and completed treatment at Week 24. Overall, 79% of simeprevir and 13% of placebo-treated patients achieved RVR. Treatment with simeprevir/PR led to lower rates of on-treatment failure and relapse compared to placebo/PR (7 vs 32% and 13 vs 24%, respectively). The incidence of AEs was similar between groups, regardless of the pegIFN used. The most common AEs were fatigue, influenza-like illness, pruritus and headache. A slightly higher proportion of simeprevir patients experienced rash and photosensitivity, compared to placebo (27 vs 20% and 4 vs 1%, respectively). There was no difference in the proportion of patients experiencing anaemia. Conclusions: Simeprevir 150mg QD was well tolerated, leading to a high SVR12 rate of 81% when administered with either pegIFNα-2a or pegIFNα-2b. The majority of patients (91%) receiving simeprevir was able to shorten therapy to 24 weeks.|
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Comunicações em Eventos - HC/ICHC
Comunicações em Eventos - LIM/47
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