EVALDO STANISLAU AFFONSO DE ARAUJO

(Fonte: Lattes)
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Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/47 - Laboratório de Hepatologia por Vírus, Hospital das Clínicas, Faculdade de Medicina

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  • conferenceObject
    Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naive patients: efficacy in difficult-to-treat patient sub-populations in the QUEST 1 and 2 phase III trials
    (2013) JACOBSON, Ira M.; DORE, Gregory J.; FOSTER, Graham R.; FRIED, Michael W.; MANNS, Michael P.; MARCELLIN, Patrick; POORDAD, Fred; ARAUJO, Evaldo S.; PEETERS, Monika; LENZ, Oliver; OUWERKERK-MAHADEVAN, Sivi; ROSA, Guy De La; KALMEIJER, Ronald; SINHA, Rekha; BEUMONT-MAUVIEL, Maria
  • conferenceObject
    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
    (2013) 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.
    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.
  • conferenceObject
    SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR TREATMENT OF CHRONIC HCV GENOTYPE 1 INFECTION IN TREATMENT-NAIVE EUROPEAN PATIENTS IN THE QUEST-1 AND QUEST-2 PHASE III TRIALS
    (2014) FOSTER, G. R.; JACOBSON, M.; DORE, G. J.; FRIED, M.; MANNS, M.; MARCELLIN, P.; POORDAD, F.; ARAUJO, E. S. Affonso de; PEETERS, M.; LENZ, O.; OUWERKERK-MAHADEVAN, S.; ROSA, G. De La; KALMEIJER, R.; SINHA, R.; BEUMONT-MAUVIEL, M.
  • article 323 Citação(ões) na Scopus
    Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial
    (2014) MANNS, Michael; MARCELLIN, Patrick; POORDAD, Fred; ARAUJO, Evaldo Stanislau Affonso de; BUTI, Maria; HORSMANS, Yves; JANCZEWSKA, Ewa; VILLAMIL, Federico; SCOTT, Jane; PEETERS, Monika; LENZ, Oliver; OUWERKERK-MAHADEVAN, Sivi; ROSA, Guy De La; KALMEIJER, Ronald; SINHA, Rekha; BEUMONT-MAUVIEL, Maria
    Background Pegylated interferon (peginterferon) alfa 2a or 2b plus ribavirin regimens were the standard of care in patients with hepatitis C virus (HCV) infection, but the sustained virological response can be suboptimum in patients with HCV genotype 1 infection. The efficacy, safety, and tolerability of the combination of simeprevir, a one-pill, once-daily, oral HCV NS3/4A protease inhibitor versus placebo, plus peginterferon alfa 2a or 2b plus ribavirin was assessed in treatment-naive patients with HCV genotype 1 infection. Methods In the QUEST-2, phase 3 study, done at 76 sites in 14 countries (Europe, and North and South Americas), patients with confirmed chronic HCV genotype 1 infection and no history of HCV treatment were randomly assigned with a computer-generated allocation sequence in a ratio of 2: 1 and stratified by HCV genotype 1 subtype and host IL28B genotype to receive simeprevir (150 mg once daily, orally), peginterferon alfa 2a (180 mu g once weekly, subcutaneous injection) or 2b (according to bodyweight; 50 mu g, 80 mu g, 100 mu g, 120 mu g, or 150 mu g once weekly, subcutaneous injection), plus ribavirin (1000-1200 mg/day or 800-1400 mg/day, orally; simeprevir group) or placebo (once daily, orally), peginterferon alfa 2a or 2b, plus ribavirin (placebo group) for 12 weeks, followed by just peginterferon alfa 2a or 2b plus ribavirin. Total treatment duration was 24 weeks or 48 weeks (simeprevir group) based on criteria for response-guided therapy (ie, HCV RNA <25 IU/mL undetectable or detectable at week 4 and undetectable week 12) or 48 weeks (placebo). Patients, study personnel, and the sponsor were masked to treatment assignment. The primary efficacy endpoint was sustained virological response at 12 weeks after the planned end of treatment (SVR12). Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01290679. Results from the primary (SVR12, week 60) analysis are presented. Findings 209 (81%) of 257 patients in the simeprevir group and 67 (50%) of 134 in the placebo group had SVR12 (adjusted difference 32.2%, 95% CI 23.3-41.2; p<0.0001). The incidences of adverse events were similar in the simeprevir and placebo groups at 12 weeks (246 [96%] vs 130 [97%]) and for the entire treatment (249 [97%] vs 132 [99%]), irrespective of the peginterferon alfa used. The most common adverse events were headache, fatigue, pyrexia, and influenza-like illness at 12 weeks (95 [37%) vs 45 [34%], 89 [35%] vs 52 [39%], 78 [30%] vs 48 [36%], and 66 [26%] vs 34 [25%], respectively) and for the entire treatment (100 [39%] vs 49 [37%], 94 [37%] vs 56 [42%], 79 [31%] vs 53 [40%], and 66 [26%] vs 35 [26%], respectively). Rash and photosensitivity frequencies were higher in the simeprevir group than in the placebo group (61 [24%] vs 15 [11%] and ten [4%] vs one [<1%], respectively). There was no difference in the prevalence of anaemia between the simeprevir and placebo groups (35 [14%] vs 21 [16%], respectively, at 12 weeks, and 53 [21%] vs 37 [28%], respectively, during the entire treatment). Interpretation Addition of simeprevir to either peginterferon alfa 2a or peginterferon alfa 2b plus ribavirin improved SVR in treatment-naive patients with HCV genotype 1 infection, without worsening the known adverse events associated with peginterferon alfa plus ribavirin.