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逾百万人获得丙肝高效药物治疗

世界卫生组织 2018-02-12 19:38:44
自两年前使用具有突破性的丙肝新治愈方法以来,低收入和中等收入国家已有逾百万人得到治疗。

当直接作用抗病毒药物于2013年被首次批准用于丙肝治疗时,人们普遍担心其昂贵的价格会使全世界8000多万名慢性丙肝感染者望尘莫及。

新型药物的治愈率达到95%以上,与以往治疗方式相比副作用则更少,且能够在三个月内使该病得到完全治愈。然而大约8.5万美元这一最初估计价格即使在高收入国家也使人难以承受。

国家情况显示可以实现丙肝治疗
由于在世卫组织和其它合作伙伴支持下采取了一系列药物获取策略,包括阿根廷、巴西、埃及、格鲁吉亚、印度尼西亚、摩洛哥、尼日利亚、巴基斯坦、菲律宾、罗马尼亚、卢旺达、泰国和乌克兰在内的多个低收入和中等收入国家开始使存有需求的病人真正得到这一药物。这类战略包括通过许可协议、本地生产和价格谈判进行非专利药品竞争。

 
Gottfried Hirnschall 博士
世卫组织艾滋病毒和
全球肝炎规划司长
“最大限度地获取能够救命的丙肝治疗是世卫组织的一项工作重点。一些国家开始取得的重要进展令人鼓舞。然而大多数人依然无法获得药物。”

近日发布的一份世卫组织最新报告《获得丙肝治疗全球报告:着重于克服障碍》显示,政治意愿、民间社会倡导和价格谈判如何促进解决丙肝问题。该病每年使近70万人丧命,并给卫生系统的能力和资源带来了沉重负担。


 
Suzanne Hill 博士
世卫组织基本药物和
卫生产品司长
“为使这些治疗方法更具可负担性,在一些国家达成的许可协议和本地生产做法发挥了很大作用。”
比如,埃及三个月治疗价格从2014年的900美元降到了2016年的不足200美元。

“但各国支付的数额之间依然存在巨大差别。有些丙肝负担最大的中等收入国家依然要支付十分高昂的费用。世卫组织正在就此以及其它昂贵药物制定新的定价模式,以增进所有国家获得所有基本药物。”

——Suzanne Hill 博士
世卫组织基本药物和卫生产品司长


80%的需求者依然面临挑战
在中等收入国家,用索非布韦(sofosbuvir)和达卡他韦(daclatasvir)治疗三个月的价格差别很大。费用从巴西的9400美元到罗马尼亚的7.99万美元不等。

费用高昂使包括欧盟在内的一些国家采取了治疗配给做法,这些国家的价格协议并没有将对整个受感染人口进行治疗的全部费用考虑在内。


“近日发布的这份有关丙肝药物获得性、价格、专利和注册的报告将有利于创造迫切需要的市场透明度,这应促进各国努力加大获得直接作用抗病毒药物。我们希望,各国对肝炎治疗指南做出更新,努力消除获得性方面的障碍,并使每位存有需求者及时得到这些药物。”

——Gottfried Hirnschall 博士
世卫组织艾滋病毒和
全球肝炎规划司长


2016年5月,194个会员国在世界卫生大会上通过了史无前例的全球卫生部门病毒性肝炎战略,一致同意到2030年消除病毒性肝炎这一公共卫生威胁。该战略包括一项在该期限以前对80%的需求者进行治疗的目标。

世卫组织于2014年和2016年发布了推荐使用直接作用抗病毒药物的指南,并将其纳入到了基本药物清单之内——所编制的这一清单意在满足人群的重点医疗需求;使所需的基本药物在所有时间、以适当的数量、以卫生体系和社区能够承受的价格进行提供。

丙肝在中国
中国约有1000万人感染了慢性丙肝,是世界上感染丙肝人数最多的国家,占全球1.3-1.5亿丙肝者的7%。每50名需要治疗的丙肝患者中,目前在治的人数不足1人。妨碍治疗的最大难题是中国目前没有DAA药物。

 
施贺德博士
世卫组织驻华代表
“中国政府2016年4月宣布将加速DAA药物在中国的注册,这是一个极好的消息。我们希望这一承诺变为现实,造福于丙肝感染者。目前尚不确定加速注册过程需要多久,但这些药物在中国一天得不到注册,每天就会有数千人遭受感染丙肝的痛苦。”




Over 1 million treated with highly effective hepatitis C medicines
High prices–a major barrier to access

Over one million people in low- and middle-income countries have been treated with a revolutionary new cure for hepatitis C since its introduction two years ago.

When Direct Acting Antivirals (DAAs) were first approved for hepatitis C treatment in 2013, there were widespread fears that their high price would put them out of reach for the more than 80 million people with chronic hepatitis C infections worldwide.

The new medicines have a cure rate of over 95%, fewer side effects than previously available therapies, and can completely cure the disease within three months. But at an initial estimated price of some US$85 000 they were unaffordable even in high-income countries.


Countries show hepatitis C treatment is achievable

Thanks to a series of access strategies supported by the World Health Organization (WHO) and other partners, a range of low- and middle-income countries, including Argentina, Brazil, Egypt, Georgia, Indonesia, Morocco, Nigeria, Pakistan, Philippines, Romania, Rwanda, Thailand and Ukraine – are beginning to succeed in getting drugs to people who need them. Strategies include competition from generic medicines through licensing agreements, local production and price negotiations.

"Maximizing access to lifesaving hepatitis C treatment is a priority for WHO," says Dr Gottfried Hirnschall, Director of WHO's Department of HIV and Global Hepatitis Programme. "It is encouraging to see countries starting to make important progress. However, access still remains beyond the reach for most people."

A new WHO report, Global Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers, released recently shows how political will, civil society advocacy and pricing negotiations are helping address hepatitis C, a disease which kills almost 700 000 people annually and places a heavy burden on health systems’ capacities and resources.


"Licensing agreements and local production in some countries have gone a long way to make these treatments more affordable," says Dr Suzanne Hill, WHO Director for Essential Medicines and Health Products. For example, the price of a three-month treatment in Egypt dropped from US$900 in 2014 to less than US$200 in 2016.

"But there are still huge differences between what countries are paying. Some middle-income countries, which bear the largest burden of hepatitis C, are still paying very high prices. WHO is working on new pricing models for these, and other expensive medicines, in order to increase access to all essential medicines in all countries," says Dr Hill.

80% of people in need still face challenges

Among middle-income countries, the price for a three-month treatment of sofosbuvir and daclatasvir varies greatly. Costs range from US$9 400 in Brazil to US$79 900 in Romania.


High costs have led to treatment rationing in some countries, including in the European Union, where price agreements have not accounted for the full cost of treating the whole affected population.

"The report on access, prices, patents and registration of hepatitis C medicines will help create the much needed market transparency which should support country efforts to increase access to DAAs," said Dr Hirnschall. "We hope countries will update their hepatitis treatment guidelines, work to remove barriers to access, and make these medicines available promptly for everyone in need."

In May 2016, at the World Health Assembly, 194 countries adopted the first-ever Global Health Sector Strategy on Viral Hepatitis, agreeing to eliminate hepatitis as a public health threat by 2030. The strategy includes a target to treat 80% of people in need by this date.

WHO issued guidelines recommending the use of DAAs in 2014 and 2016 and included DAAs on its Essential Medicines List – which is compiled to address the priority healthcare needs of populations; to make needed essential medicinesavailable at all times in adequate amounts, at a price the health system and community can afford.


Hepatitis C in China

Approximately 10 million people are estimated to live with chronic hepatitis C in China. China has the largest numbers of hepatitis C in the world, accounting for 7% of the world’s 130-150 million people living with HCV.  Less than 1 in 50 hepatitis C patients in need of treatment are currently receiving it. The biggest barrier for getting treatment is that these DAA drugs are not yet available in China.
 
“The Government of China announced in April 2016 a commitment to accelerate registration of DAA drugs in China – which is great news. We need to see this commitment turned into a better reality for people living with hepatitis. It is still unclear how long the acceleration process will take. Everyday these medicines are not registered in China, thousands of patients suffer the consequences of hepatitis C infection,” said Dr Schwartländer.