36 research outputs found

    Impact of safety-related dose reductions or discontinuations on sustained virologic response in HCV-infected patients: Results from the GUARD-C Cohort

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    BACKGROUND: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. METHODS: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. RESULTS: SVR24 rates were 46.1% (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1, 2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced 651 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with 651 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not 655. CONCLUSIONS: In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginterferon alfa-2a/ribavirin

    Serum ghrelin in female patients with rheumatoid arthritis during treatment with infliximab

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    SMS Gateway telah banyak dimanfaatkan oleh berbagai kalangan untuk berbagai kebutuhan, dan penggunaan SMS Gateway ini juga dapat di terapkan pada instansi sekolah. Salah satu tujuan instansi sekolah khususnya Sekolah Menengah Kejuruan adalah meningkatkan disiplin siswa untuk menyiapkan mereka di dunia kerja. Dalam hal ini, indikator kedisiplinan di sekolah adalah kehadiran siswa atau yang disebut absensi. Karena itulah dibutuhkan suatu aplikasi SMS Gateway yang berfungsi menyampaikan informasi ketidakhadiran siswa-siswi kepada pihak orang tua.Jenis penelitian yang digunakan oleh penulis adalah penelitian terapan. Penelitian terapan ditekan pada pemanfaatan pengetahuan baru tersebut untuk keperluan yang lebih praktis dan diagmatis. Dan kemudian diterjemahkan ke bahasa pemprograman dengan membuat aplikasi database menggunakan Program Embarcadero Delphi XE 7.Dari hasil penelitian, perancangan dan implementasi Aplikasi SMS Gateway Untuk Absensi Siswa Pada SMK Negeri 4 Banjarmasin mampu memberikan konfirmasi ketidak hadiran siswa-siswi setiap hari melalui pesan singkat SMS yang langsung dikirimkan ke nomor handphone orang tua

    Telemetric Assessment of Continuous Positive Airways Pressure (CPAP) Effectiveness and Adherence in Obstructive Sleep Apnea during COVID-19 Pandemic

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    Obstructive sleep apnea is the most common sleep-related breathing disorder. In the pandemic times of the new coronavirus SARS-CoV-2, CPAP (Continuous Positive Airway Pressure) therapy of obstructive sleep apnea became even more challenging. After the pandemic outbreak in March 2020, most CPAP treatment recommendations changed because of rising concerns about CPAP usage safety for patients and their families. Therefore, we examined the effectiveness of CPAP and adherence to the therapy of 149 adults with obstructive sleep apnea in the period of two years from 4 March 2019 to 3 March 2021 (before pandemic breakout and during the first year of pandemic). Data on CPAP parameters and adherence to therapy were obtained via a telemetric system. Together, our results demonstrated that the COVID-19 pandemic had no significant impact on CPAP therapy parameters and adherence in whole study group. However, detailed analysis acknowledged that some demographic and clinical features influenced CPAP therapy. The results showed that across subgroups of patients differentiated on the basis of age, gender, co-existing diabetes mellitus, or hypertension, the COVID-19 pandemic seemed to affect CPAP effectiveness. Our results provide a good starting point for discussion on CPAP therapy recommendations during pandemic times

    Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir.

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    INTRODUCTION Glecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1-6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV. METHODS Data were pooled from nine countries (13 November 2017-31 January 2020). Patients had HCV GT1-6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician's discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir. RESULTS Of 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation. CONCLUSIONS Glecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infected persons who use drugs and other underserved patients. TRIAL REGISTRATION These multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599

    Intensified peginterferon α-2a dosing increases sustained virologic response rates in heavy, high viral load hepatitis c genotype 1 patients with high low-density lipoprotein

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    BACKGROUND AND GOAL: Patients infected with hepatitis C virus (HCV) with elevated low-density lipoprotein (LDL) levels achieve higher sustained virologic response (SVR) rates after peginterferon (PegIFN)/ribavirin treatment versus patients with lower LDL. Our aim was to determine whether SVR rates in patients with low/elevated LDL can be improved by dose intensification. STUDY: In PROGRESS, genotype 1 patients with baseline HCV RNA≥400,000 IU/mL and body weight ≥85 kg were randomized to 48 weeks of 180 μg/wk PegIFN α-2a (40 kDa) plus ribavirin (A: 1200 mg/d; B: 1400/1600 mg/d) or 12 weeks of 360 μg/wk PegIFN α-2a followed by 36 weeks of 180 μg/wk, plus ribavirin (C: 1200 mg/d; D: 1400/1600 mg/d). This retrospective analysis assessed SVR rates among patients with low (<100 mg/dL) or elevated (≥100 mg/dL) LDL. Patients with high LDL (n=256) had higher baseline HCV RNA (5.86×10 IU/mL) versus patients with low LDL (n=262; 4.02×10 IU/mL; P=0.0003). RESULTS: Multiple logistic regression analysis identified a significant interaction between PegIFN α-2a dose and LDL levels on SVR (P=0.0193). The only treatment-related SVR predictor in the nested multiple logistic regression was PegIFN α-2a dose among patients with elevated LDL (P=0.0074); therefore, data from the standard (A+B) and induction (C+D) dose arms were pooled. Among patients with low LDL, SVR rates were 40% and 35% in the standard and induction-dose groups, respectively; SVR rates in patients with high LDL were 44% and 60% (P=0.014), respectively. CONCLUSIONS: Intensified dosing of PegIFN α-2a increases SVR rates in patients with elevated LDL even with the difficult-to-cure characteristics of genotype 1, high baseline viral load, and high body weight. Copyright © 2013 by Lippincott Williams & Wilkins
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