Biotest的Zutectra（R）在一项针对肝移植患者的研究中证明了生

StephenW

PRESS RELEASE

Biotest's Zutectra(R) demonstrates improved quality of life in a study with liver transplant patients

- Zutectra(R) offers convenient home therapy option for high risk Hepatitis B induced liver transplant patients during COVID-19 pandemic

- Zutectra(R) is the only Hepatitis B immunoglobulin product worldwide for self-administration at home

- New data of a multicentre observational study reveal improved quality of life with Zutectra compared to other applications forms

- Zutectra demonstrated significant improvement in pain reduction and increased patient convenience

- Study results support positive commercial outlook


Dreieich, 8 June 2020. Home care therapy with Zutectra(R) is a valuable option for liver transplant (LT) patients, especially during the current COVID-19 pandemic. Patients are not required to visit the hospital and remain independent from contacts with medical professionals. This minimizes contacts and the risk of infection in these immunosuppressed patients, while keeping them on therapy to prevent Hepatitis B recurrence.

Zutectra(R) is the worldwide only subcutaneous (SC) Hepatitis B immunoglobulin (HBIG) product and was developed to provide a convenient option for outpatient therapy. The preference of SC over intramuscular (IM) and intravenous (IV) application forms was confirmed by a recently published study in the Journal "Health and Quality of Life Outcomes".[1]

The multicentre, observational study was conducted in nine LT centres in Italy including 86 patients. Previously to inclusion into the study liver transplanted patients have been on IV or IM HBIG therapy for at least 6 month before switching to Zutectra(R). Two validated quality of life questionnaires evaluating different categories of technical aspects of therapy as well as mental and physical conditions have been used before and 6 months after switching to Zutectra(R).

Zutectra(R) demonstrated significant improvements in most of the tested domains, such as side effects, satisfaction with the HBIG therapy, pain, physical functioning, physical and emotional role limitations, and social functioning.

The authors concluded: "The striking improvement in treatment satisfaction further suggests that SC HBIG can represent the treatment of choice for most LT patients."
Biotest sees an opportunity to expand market share, through switching patients to the only subcutaneous HBIG in the current COVID-19 pandemic and beyond.

About Zutectra(R)
Zutectra(R) was specifically developed by Biotest for the long-term treatment of patients after liver transplantation preventing hepatitis B virus re-infection. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it gives patients the opportunity of self-administration. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option. The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra(R) in 2009. Zutectra(R) is currently marketed in the EU member states and major ROW markets.

About Hepatect(R) CP
Hepatect(R) CP is a hepatitis B virus (HBV)-specific hyperimmunoglobulin preparation. Approved in over 35 countries Hepatect(R) CP is one of the leading HBV immunoglobulin brands worldwide. It is indicated for the prevention of HBV re-infection after liver transplantation and for immunoprophylaxis of HBV infection. Prophylaxis of HBV infection may be required in case of accidental exposure in non-immunised subjects (e.g. needle stick injury), in haemodialysis patients, until vaccination has become effective, in the newborn of a hepatitis B virus carrier-mother, and in subjects who did not show an immune response after vaccination. Hepatect(R) CP is available as ready-to-use solution for intravenous administration.

StephenW

新闻稿

Biotest的Zutectra（R）在一项针对肝移植患者的研究中证明了生活质量的改善

-Zutectra（R）为高风险乙型肝炎引起的肝移植患者在COVID-19大流行期间提供便利的家庭疗法

-Zutectra（R）是全球唯一可在家中自我管理的乙型肝炎免疫球蛋白产品

-一项多中心观察性研究的新数据显示，与其他申请表相比，Zutectra改善了生活质量

-Zutectra在减轻疼痛和改善患者便利性方面显示出显着改善

-研究结果支持积极的商业前景


德赖艾希，2020年6月8日。Zutectra（R）的家庭护理疗法是肝移植（LT）患者的宝贵选择，尤其是在当前的COVID-19大流行期间。不需要患者去医院就医，也不必与医疗专业人员联系。这使这些免疫抑制患者的接触和感染风险降至最低，同时让他们接受治疗以预防乙型肝炎复发。

Zutectra（R）是全球唯一的皮下（SC）乙型肝炎免疫球蛋白（HBIG）产品，其开发目的是为门诊治疗提供方便的选择。最近发表在《健康与生活质量结果》杂志上的一项研究证实了SC优于肌内（IM）和静脉内（IV）申请表。[1]

该多中心观察性研究在意大利的9个LT中心进行，包括86位患者。在纳入研究之前，肝移植患者在转用Zutectra之前已接受IV或IM HBIG治疗至少6个月。在转用Zutectra（R）之前和之后的6个月中，已经使用了两份经过验证的生活质量调查问卷，评估了不同类别的治疗技术以及精神和身体状况。

Zutectra（R）在大多数测试领域都表现出显着改善，例如副作用，对HBIG治疗的满意度，疼痛，身体机能，身体和情感角色的局限性以及社交功能。

作者得出结论：“治疗满意度的显着提高进一步表明，SC HBIG可以代表大多数LT患者的首选治疗方法。”
通过将患者转移到当前COVID-19大流行及以后的唯一皮下HBIG中，Biotest看到了扩大市场份额的机会。

关于Zutectra（R）
由Biotest特别开发的Zutectra（R）用于肝移植后患者的长期治疗，可预防乙肝病毒再感染。它是全球首款预装注射器中的现成可用的乙型肝炎免疫球蛋白溶液，用于皮下给药，它为患者提供了自我给药的机会。这为主治医师和患者提供了一种痛苦更少，节省时间和更简单的治疗选择。欧盟委员会已于2009年向Biotest授予了乙肝免疫球蛋白Zutectra（R）的销售许可。Zutectra（R）目前在欧盟成员国和主要的ROW市场上销售。

关于Hepatect（R）CP
Hepatect（R）CP是乙型肝炎病毒（HBV）特异的超免疫球蛋白制剂。 Hepatect（R）CP已在35个国家/地区获得批准，是全球领先的HBV免疫球蛋白品牌之一。它可用于预防肝移植后的HBV再感染和免疫预防HBV感染。在非免疫受试者，血液透析患者，直到疫苗接种有效之前，在乙肝病毒携带者新生儿中以及在以下人群中意外接触的情况下，可能需要预防HBV感染：接种疫苗后未显示免疫反应。 Hepatect（R）CP可用作静脉内给药的即用型溶液。