Suppr超能文献

慢性丙型肝炎:仿制药的效果与品牌药一样好吗?

Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?

作者信息

Premkumar Madhumita, Grover Gagandeep S, Dhiman Radha K

机构信息

Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.

Program Officer, Hepatitis C Virus Infection, Punjab, India.

出版信息

J Clin Exp Hepatol. 2017 Sep;7(3):253-261. doi: 10.1016/j.jceh.2017.08.003. Epub 2017 Sep 23.

Abstract

India has a large share of the hepatitis C virus (HCV) burden of the world. Unsafe medical practices and blood transfusions are the leading modes of transmission of HCV in India. The commonest HCV genotype in India is genotype 3 followed by genotype 1. While directly acting antivirals (DAAs) agents have become available at reasonable rates in India, cost of therapy remains a major barrier for control of HCV in India. Generic DAAs have been proven to be cost-saving in prior studies. We examined data from various studies in India and elsewhere using generic DAAs, and evaluated whether they are equally efficacious as the branded drugs. Since the availability of generic DAAs in the Indian market, there is a lot of real life data as well as prospective studies in special patient populations such as hematological disorders (thalassemia and hemophilia), chronic kidney disease, hemodialysis patients, post liver and renal transplant patients on immunosuppression, intravenous drug users, confections and other high risk groups. Control of HCV infection in India requires multi pronged approach. There is a need to formulate a health educational curriculum targeting not only the high-risk population but also the general population regarding the transmission of HCV. Adopting the dual approach of treating the old cases (decreasing the reservoir pool of HCV) and decreasing the incidence of new ones would help curtail the disease and decrease liver related mortality. In this scenario, the role of efficacious low cost generic medications is essential.

摘要

印度承担着全球很大一部分丙型肝炎病毒(HCV)负担。不安全的医疗行为和输血是印度HCV的主要传播方式。印度最常见的HCV基因型是3型,其次是1型。虽然直接作用抗病毒药物(DAAs)已在印度以合理价格上市,但治疗费用仍然是印度控制HCV的主要障碍。在先前的研究中,已证明仿制药型DAAs具有成本节约效果。我们研究了印度及其他地区使用仿制药型DAAs的各类研究数据,并评估它们是否与品牌药物具有同等疗效。自从仿制药型DAAs在印度市场上市以来,有大量来自现实生活的数据以及针对特殊患者群体的前瞻性研究,如血液系统疾病(地中海贫血和血友病)、慢性肾脏病、血液透析患者、肝和肾移植后接受免疫抑制治疗的患者、静脉吸毒者、糖果工人及其他高危人群。在印度控制HCV感染需要采取多管齐下的方法。有必要制定一个健康教育课程,不仅针对高危人群,也针对普通人群,内容涉及HCV的传播。采用治疗旧病例(减少HCV储存库)和降低新病例发病率的双重方法,将有助于控制该疾病并降低肝脏相关死亡率。在这种情况下,有效的低成本仿制药的作用至关重要。

相似文献

1
Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?
J Clin Exp Hepatol. 2017 Sep;7(3):253-261. doi: 10.1016/j.jceh.2017.08.003. Epub 2017 Sep 23.
2
Outcomes of Real-World Integrated HCV Microelimination for People Who Inject Drugs: An expansion of the Punjab Model.
EClinicalMedicine. 2021 Oct 17;41:101148. doi: 10.1016/j.eclinm.2021.101148. eCollection 2021 Nov.
3
Strategy and Efficacy of Generic and Pan-genotypic Sofosbuvir/Velpatasvir in Chronic Hepatitis C Virus: A Myanmar Experience.
J Clin Exp Hepatol. 2019 May-Jun;9(3):283-293. doi: 10.1016/j.jceh.2018.12.001. Epub 2018 Dec 19.
4
Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016.
J Clin Exp Hepatol. 2016 Jun;6(2):119-45. doi: 10.1016/j.jceh.2016.07.001. Epub 2016 Jul 2.
5
Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3.
J Hepatol. 2019 Jan;70(1):15-23. doi: 10.1016/j.jhep.2018.09.018. Epub 2018 Sep 26.
6
High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C.
Int J Infect Dis. 2018 Oct;75:109-114. doi: 10.1016/j.ijid.2018.07.025. Epub 2018 Aug 2.
7
Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection in 2015.
J Clin Exp Hepatol. 2015 Sep;5(3):221-38. doi: 10.1016/j.jceh.2015.09.002. Epub 2015 Sep 21.

引用本文的文献

1
Chronic Hepatitis B: Challenges and Successes in India.
Clin Liver Dis (Hoboken). 2021 Oct 15;18(3):111-116. doi: 10.1002/cld.1125. eCollection 2021 Sep.
2
Hepatitis C Virus Elimination by 2030: Conquering Mount Improbable.
Clin Liver Dis (Hoboken). 2021 Jan 13;16(6):254-261. doi: 10.1002/cld.978. eCollection 2020 Dec.
3
HCV Infection in Thalassemia Syndromes and Hemoglobinopathies: New Perspectives.
Front Mol Biosci. 2020 Jan 30;7:7. doi: 10.3389/fmolb.2020.00007. eCollection 2020.
6
Direct-Acting Antiviral Agents for HCV Infection.
J Clin Exp Hepatol. 2018 Mar;8(1):1-2. doi: 10.1016/j.jceh.2018.01.002. Epub 2018 Mar 26.

本文引用的文献

1
Generic Direct Acting Antivirals in Treatment of Chronic Hepatitis C Infection in Patients of Thalassemia Major.
J Clin Exp Hepatol. 2017 Sep;7(3):172-178. doi: 10.1016/j.jceh.2017.08.002. Epub 2017 Aug 23.
2
Daclatasvir-Sofosbuvir for treatment of hepatitis C virus in patients with inherited bleeding disorders.
Indian J Gastroenterol. 2017 Jul;36(4):332-333. doi: 10.1007/s12664-017-0777-x.
5
Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India.
PLoS One. 2017 May 17;12(5):e0176503. doi: 10.1371/journal.pone.0176503. eCollection 2017.
6
Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.
J Oncol Pract. 2017 Jun;13(6):352-355. doi: 10.1200/JOP.2016.019737. Epub 2017 Apr 26.
7
Treatment of chronic hepatitis C genotype 3 with Sofosbuvir-based therpy: a real-life study.
Hepatol Int. 2017 May;11(3):277-285. doi: 10.1007/s12072-017-9794-1. Epub 2017 Mar 31.
8
Early Acute Severe HCV Recurrence After Transplantation: From Universal Mortality to Cure.
J Clin Exp Hepatol. 2017 Mar;7(1):28-32. doi: 10.1016/j.jceh.2016.10.004. Epub 2016 Oct 29.
9
Experience with direct acting anti-viral agents for treating hepatitis C virus infection in renal transplant recipients.
Indian J Gastroenterol. 2017 Mar;36(2):137-140. doi: 10.1007/s12664-017-0745-5. Epub 2017 Mar 27.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验