作者: Yen, Cho-Li ; Wang, Liang-Jen ; Chang, Jia-Jang ; Chen, Chih-Ken ; Chen, Shuo-Wei ; Chen, Li-Wei ; Liu, Ching-Jung ; Lee, Tsung-Shih ; Chien, Rong-Nan

BACKGROUND:

This study investigates differences in depression and anxiety between patients with chronic hepatitis C who are treated with peginterferon alpha-2a (PegIFN-α-2a) plus ribavirin and those who are treated with peginterferon alpha-2b (PegIFN-α-2b) plus ribavirin.

METHODS:

In this 24 week, non-randomized, observational, prospective study, 55 patients with chronic hepatitis C were treated with PegIFN-α-2a plus ribavirin (Group 1), and 26 patients were treated with PegIFN-α-2b plus ribavirin (Group 2). All patients underwent assessment using the Hospital Anxiety and Depression Scale (HADS) at the baseline and at weeks 4, 12 and 24. Patients with depression scores (HADS-D) ≥ 8 and anxiety scores (HADS-A) ≥ 8 were defined as having depression and anxiety, respectively. The factors that were associated with depression and anxiety during the 24 week antiviral treatment were determined.

RESULTS:

During the 24 week antiviral treatment, the proportion of patients with depression significantly increased over time in both groups (Group 1: p = 0.048; Group 2: p = 0.044). The proportion of patients with anxiety did not significantly change during the follow-up period in either group. Incidences of depression or anxiety did not differ significantly between Group 1 and Group 2. A history of alcohol use disorder was an independent predictor of depression at week 12 (p < 0.001) and week 24 (p < 0.001), and a poor virological response to treatment was associated with depression at week 24 (p = 0.029). Patients who had more physical comorbidities were more likely to suffer from anxiety at week 12 (p = 0.038).

CONCLUSIONS:

This study did not identify significant differences in depression or anxiety between in patients with chronic hepatitis C who underwent a 24 week antiviral treatment regimen with PegIFN-α-2a plus ribavirin and those who underwent a regiment with PegIFN-α-2b plus ribavirin. Future research with larger samples and a randomized, controlled design are required to verify the findings in this study.

TRIAL REGISTRATION:

This clinical study has been registered at ClinicalTrials.gov. (Trial registration: NCT02943330 ).

2011-07-01·JOURNAL OF GASTROENTEROLOGY

Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients.

Article

作者: Chayama, Kazuaki ; Kuwata, Yasuaki ; Ohmura, Takumi ; Ozeki, Itaru ; Sato, Takahiro ; Kamiya, Naohiro ; Akaike, Jun ; Toyota, Joji ; Karino, Yoshiyasu ; Yamada, Ichimaro ; Kumada, Hiromitsu ; Arakawa, Tomohiro

BACKGROUND/AIMS:

Anemia is commonly observed as a side effect in a treatment with protease inhibitors combined with peginterferon alpha and ribavirin for hepatitis C virus infection. This study assessed the safety, tolerability, viral kinetics, and selection of variants in telaprevir monotherapy for 24 weeks, and outcomes of the off-study treatment with peginterferon alpha-2b and ribavirin among Japanese female patients at a median age of 54 years who were difficult to treat with the standard therapy (peginterferon alpha-2b and ribavirin) alone in Japan.

METHODS:

Four treatment-naïve patients with chronic hepatitis C virus subtype 1b infection received telaprevir (750 mg every 8 h) alone for 24 weeks. All patients then started the off-study treatment with peginterferon alpha-2b and ribavirin. Safety, tolerability, hepatitis C virus RNA levels, and emergence of telaprevir-resistant variants were monitored.

RESULTS:

During the 24 weeks of telaprevir monotherapy, there was no discontinuation due to adverse events, but 2 patients stopped the intake at weeks 6 and 15 because of viral breakthrough. Emergence of telaprevir-resistant variants was observed in 3 patients who showed viral breakthrough. These variants were eliminated by the off-study treatment, and sustained virological response was achieved in all patients.

CONCLUSIONS:

Anemia was manageable by carefully adjusting the ribavirin dosage in the standard therapy that followed telaprevir monotherapy. This sequential regimen seems to be safer and more tolerable than the triple combination of telaprevir, peginterferon alpha, and ribavirin, especially among elderly females with low baseline hemoglobin.

2010-02-01·PHARMAZIE

Prediction models for feverishness developed during interferon therapy of chronic hepatitis C patients.

Article

作者: Ishii, K ; Dai, Y ; Motege, E ; Uesawa, Y ; Mohri, K

Pegylated interferon (peginterferon) and ribavirin combination therapy is used extensively for therapy of chronic hepatitis C. Most patients that receive this therapy are known to develop influenza-like symptoms with fever and headache. Therefore, we attempted to construct a multiple-regression model to predict the intensity of feverishness from the profiles of such patients. A retrospective survey of the medical charts of patients with chronic hepatitis C that have been on peginterferon-alpha-2b and ribavirin combination therapy was performed. Body temperatures of patients at 8.5 h after receiving interferon injection on day one of therapy were the objective variables. Patients' profiles such as sex, age, and blood test results before the injection were defined as explanatory variables. Genetic algorism with leave-one-out cross-validation as selection pressure was applied in the selection of variables. The final model for prediction was determined by bootstrap validation. As a result, a significant multiple-regression model including sex, BUN, and leukocyte count as descriptors was constructed. The prediction of patients with severe fever in the model equation is of some help regarding the proper use of antipyretics in interferon therapy.

项与聚乙二醇干扰素α-2b生物类似药(Virchow Group) 相关的新闻（医药）

2023-12-12

·赛柏蓝

干扰素“小国采”：4图分析

全国首次干扰素集采，由江西医保局于上周发布了《关于干扰素省际联盟集中带量采购文件的政策解读》，集采正式文件《干扰素省际联盟集中带量采购公告（第1号）》也已于11月2号公布。本次集采由江西省牵头，涉及除广东、江苏、云南以外的全国28个省份，堪称“小国采”。截至目前，化药、中药（中成药、中药饮片、中药配方颗粒）都已进行过覆盖全国或接近全国范围的大面积集采，唯有除胰岛素（第六批国采）外的生物药尚未进行全国范围的集采，本次由江西牵头的28个省联盟生物药干扰素集采自然倍受关注。本次集采共涉及8个剂型、15个品种、43个规格，报量3,044万片/万粒/万支/万瓶，采购额13.09亿元（按首年约定采购量计算基数*最高有效申报价格计）。01行业现状根据半衰期长短，干扰素又分为短效干扰素和长效干扰素，据《中国干扰素市场发展现状分析与投资趋势预测报告（2022-2029年）》数据，2020年，我国干扰素市场规模为32.3亿元，其中，短效干扰素22.31亿元（占69%）、长效干扰素9.99亿元（31%）。我国已上市的短效干扰素主要有重组人干扰素α1b、重组人干扰素α2a和重组人干扰素α2b，长效干扰素主要有聚乙二醇干扰素α2a、聚乙二醇干扰素α2b等。其中，最知名的是北京三元基因药业用于治疗多种病毒性疾病和恶性肿瘤重组人基因工程α1b干扰素（运德素®），是中国第一个具有独立知识产权的基因工程一类新药。02集采规则一、采购周期：4年二、报价：不高于省级或省际联盟集采最低中选价。三、中选规则1、申报企业＞3家：按价格从低到高排名，前70%拟中选。2、申报企业2家或1家：满足以下条件之一即可拟中选：（1）降幅≥3家品种拟中选评价降幅*0.5注：注册分类是生物制品一类的系数是0.4，注册分类是二类的系数为0.45；（2）不符合条件1的，则将报价降幅从高到低排序，排名前60%的拟中选；（3）首次报价不满足以上条件的，可以二次报价，符合条件1可拟中选。四、中选价格调整根据执行一个采购年度的实际采购量与“上一个采购年度”的“年化实际采购量”的比值（Q值）调整中选价格，中选企业还需上报中选品种经第三方审计的归属净利润和归属净利润增长率，即中选产品获利多的还得再降价。03品种一、采购量本次集采15个品种的首年约定采购量计算基数为3,044万片/万粒/万支/万瓶，其中，人干扰素a1b（注射剂）采购量最大。其中，采购量＞500万片/万粒/万支/万瓶的有3个品种，即人干扰素a1b（注射剂，777万瓶）、人干扰素a2b(阴道泡腾胶囊，515万粒)、人干扰素a2b（阴道泡腾片，506万片），上述3个品种采购量合计1,798万片/万粒/万支/万瓶，占了总采购量的59%。采购量＞200万片/万粒/万支/万瓶的有3个品种，即人干扰素a2b（注射剂，302万瓶）、人干扰素a2b（凝胶剂，296万支）、人干扰素a2b（喷雾剂，255万支）。采购量最少的是人干扰素a2a（软膏剂），只有546支。（详见图一）二、采购额本次集采总采购额为13.09亿元（按首年约定采购量计算基数*最高有效申报价格计），其中，聚乙二醇干扰素a-2b（注射剂）采购额最大。采购额＞2亿元的有3个品种，即聚乙二醇干扰素a-2b（注射剂，3.95亿元），人干扰素a2b（阴道泡腾片，2.23亿元）、人干扰素a1b（注射剂，2.07亿元），上述3个品种合计采购额8.25亿元，占了总采购额的63%。采购额＞1亿元的有2个品种，即人干扰素a2b（凝胶剂，1.29亿元）、人干扰素a2b（喷雾剂，1.09亿元）；采购额＞7,000万元的有2个品种，即人干扰素a2b（注射剂，9,504万元）、人干扰素a2b（阴道泡腾胶囊，7,701万元）；采购额最小的是人干扰素a2a（软膏剂），只有2,195元。（详见图二） 04省份下面再将各省份采购量和采购额进行排名。一、采购量本次集采首年约定采购量计算基数最大的省份是四川省。采购量＞200万片/万粒/万支/万瓶的有5个省，即四川、浙江、重庆、山东和陕西，采购量分别为269、235、233、207、203万片/万粒/万支/万瓶，上述5省采购量合计1,148万片/万粒/万支/万瓶，占了总采购量的38%。采购量最少的是西藏，采购量只有7,378片/粒/支/瓶。本次集采的牵头单位江西省，采购量为123万片/万粒/万支/万瓶，位居第12位。（详见图三）二、采购额本次集采采购额（按首年约定采购量计算基数*最高有效申报价格计）最大的是四川省。采购额＞1亿元的有4个省，即四川（1.13亿元）、山东（1.05亿元）、福建（1.05亿元）、北京（1.02亿元），上述4省份合计采购额4.25亿元，占了总采购额的1/3。采购额＞6,000万元的有5个省，即湖北（7,416万元）、重庆（7,091万元）、湖南（6,844万元）、浙江（6,585万元）、陕西（6,302万元）。采购额＞5,000万元的有3个省，即安徽（5,717万元）、河北（5,499万元）、辽宁（5,333万元）。采购额最小的也是西藏，采购额只有46万元。牵头单位江西省，采购额为4017万元，位居第15位。（详见图四）本次集采将对干扰素的现有市场格局产生一定影响。 END特约作者 | 张自然博士责任编辑 | 郑瑶赛柏蓝药械交流群扫描下方二维码加入医药代理商转型交流群扫描下方二维码加入

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100 项与聚乙二醇干扰素α-2b生物类似药(Virchow Group) 相关的药物交易

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