克林顿总统、辉瑞公司和Mylan公司宣布新协议，为发展中国家耐药HIV患者降低药价
辉瑞公司承诺：服用二线HIV/AIDS药物的病人服用治疗结核病药物降价60%，每剂降至1美元，以此来提高获得药物的机会。
Mylan旗下子公司Matrix供应的每天服用一次的四种HIV/AIDS二线治疗药物组合，目前一年要花475美元，到2010年为425美元，比目前价格最低的替代方案还低28%。
二者相结合，关于HIV和结核病——HIV感染者的主要死因——的新协议加强了把预防和治疗两种疾病的工作更好地结合起来的要求。
纽约州纽约市——比尔·克林顿总统今天宣布了两个重要的补充性协议，以便能够为发展中国家正在服用二线抗逆转录病毒药物（ARV）治疗HIV/AIDS的病人提供更好、更便宜的治疗。四种抗逆转录病毒药物的二线治疗方案首次能够以每年低于500美元获得。此外，正在服用二线抗逆转录病毒药物的病人服用治疗结核病（TB）的重要药物的价格降低了60%，降至每剂1美元。
"感谢我的基金会的艾滋病行动组织（HIV/AIDS Initiative）的工作，2百万HIV/AIDS感染者现在能够获得救命的治疗了，"克林顿总统说，"但是他们的继续生存还要依靠终生不间断地获得药物和高质量、能支付得起的医疗保健。今天宣布的协议会帮助确保我们能够终生维持治疗，并且更好地治疗同时患有HIV和结核病的患者，这两个关键步骤正在改变全球HIV/AIDS疫情的局面。"
针对对更便宜的二线抗逆转录病毒药物的需要，Mylan和旗下子公司Matrix正在设法使人们能够得到所需的全部四种药物——atazanavir(ATV)、ritonavir(RTV)、tenofovir(TDF)和lamivudine(3TC)——使对标准的一线抗逆转录病毒药物产生耐药性的病人能够得到每日一次的治疗。四种药物分为三个药片，TDF和3TC复合在一个药片中。今天三片药可以作为单独的药品得到，总价为每年不到475美元。从2010年开始，Matrix还将把所有药片放在一个包里——"二线药物包"——以每年425美元的价格出售。非洲、亚洲、拉丁美洲和加勒比地区的克林顿基金会（Clinton Foundation）采购联盟成员国政府可以得到这些新的产品和价格。TDF+3TC是美国食品和药物管理局(FDA)批准的，ATV和RTV还有待世界卫生组织（WHO）批准。
Mylan公司董事长和首席执行官Robert J. Coury说："确保发展中国家能够持续获得有效的治疗，是全球抗击HIV/AIDS工作的重要元素。Mylan和Matrix很骄傲能够继续自己关于创造和引进创新和便宜的制药方案的承诺。这包括我们的'二线药物包'，这会减轻病人的药物负担，帮助病人遵从医嘱。我们的便宜、热稳定性好的RTV也体现了在药品开发上的另一项进步，它能够经的起世界上急需治疗的地区的环境条件。"
在引证把HIV/AIDS和结核病治疗相结合的重要性时，克林顿总统还宣布与辉瑞公司达成协议，降低rifabutin——一种用于治疗服用二线抗逆转露病毒药物病人的结核病的药物——的价格，扩大其可得性。这标志着克林顿基金会艾滋病行动组织（CHAI）首次与以研发为主的制药公司达成价格协议，也是就结核病达成的首个价格协议。这一价格在所有非洲、亚洲、东欧、拉丁美洲、中东和加勒比发展中国家的市场上都能得到。结核病是HIV阳性患者的主要死因。世界卫生组织报告说：所有HIV感染者中有超过三分之一的人感染了结核病，这在2007年导致超过450，000人死亡。
辉瑞公司董事长和首席执行官Jeffrey B. Kindler说："辉瑞公司正在从事许多全球健康项目，例如与克林顿基金会艾滋病行动组织一起找到把人们和所需的药物联系起来的新方法。我们正在致力于创新的解决方案，以便把医疗保健带给那些过去经常被忽视的顾客，并且用有社会责任感、可持续和有商业利益的方法来做这件事。"
"二线药物包"
Matrix公司今天宣布的新产品会创造一种更方便的二线抗逆转录病毒药物治疗选择。病人用每天一次，吃三片药来代替每天两次，每次吃五片以上的药的其他治疗方法。此外新产品还将首次包括热稳定性好的RTV，其运输和销售不需要一直冷藏。
世界卫生组织注意到了其在方便和便宜上的优点，已经把开发包括ATV和RTV在内的二线抗逆转录病毒治疗确定为重中之重。但是由于目前的RTV配方需要一直冷藏——对受基础设施限制的发展中国家来说是一个重大挑战——直到现在这种治疗方法在大部分地区仍然是无法得到的。各国在预期到药品的特性和价格有所改进之后，已经开始在其国家治疗方针中采用这种治疗方法，克林顿基金会预期更多国家会跟进，利用今天宣布的协议。
如果充分利用，与其他治疗方法目前的价格相比，新的产品和价格在今后5年中累积能够节约成本4亿美元。虽然今天低收入和撒哈拉以南非洲国家所有正在接受治疗的病人中只有3%正在接受二线抗逆转录病毒治疗，但是由于二线药物比一线药物价格高，这些病人占全部抗逆转录病毒治疗开支的将近20%。今后几年中这些百分比会稳定增长，因为遭遇一线药物治疗失败的HIV/AIDS患者的人数日益增长。到2008年底，所有发展中国家中已经有200，000至250，000名二线病人。预期今后三年中这一数字会翻番。
联合援助计划（UNITAID）可能通过其与克林顿基金会艾滋病行动组织合作实施的二线项目（Second-Line Project），帮助造成了今天宣布的抗逆转录病毒药物价格下降。联合援助计划资助这一项目，已经通过在25个受益国增加和凝聚需求，为重要的二线药物创造了可靠的市场。可预测的需求鼓励供应商加速研发新产品，还通过实现规模经济和降低产品风险使他们能够提供较低的价格。
治疗二线HIV/AIDS患者的结核病协同感染
与辉瑞公司达成的协议，使同时需要结核病治疗的二线抗逆转录病毒治疗病人有了更加有效和便宜的治疗选择。HIV-结核病协同感染的治疗由于标准结核病药物与蛋白酶抑制剂——抗逆转录病毒药物类，是二线治疗的基石——之间人们不愿看到的交互作用而变得更加复杂。为了抵消这种作用，医生经常要调整病人的抗逆转录病毒治疗，增加特定药物的标准剂量，这会产生更高的毒性，较差的治疗效果，成本也会显著增加。辉瑞公司的rifabutin不会干扰蛋白酶抑制剂，让病人可以以标准剂量服用抗逆转录病毒药物。
2009年三月，世界卫生组织通过把rifabutin增加到《基本药物目录》（EML）中，强调了rifabutin的重要性。今天宣布的与辉瑞公司达成的协议，使同时治疗二线抗逆转录病毒治疗病人的结核病和HIV更加便宜，与目前首选的治疗选择相比，在为期六个月的整个结核病疗程中，药物总成本要节约大约200美元（33%）。
持续努力以确保治疗的质量和可支付性
联合援助计划、英国国际发展部（United Kingdom Department for International Development）和盖茨夫妇基金会（Bill & Melinda Gates Foundation）的财政支持使克林顿基金会能够从事这一工作。今天宣布的两项协议，只是克林顿基金会及其合作伙伴为确保以最便宜的价格提供最高质量的服务而采取的最新行动。
这些协议反映了克林顿基金会艾滋病行动组织确保人们能够得到高质量药物的承诺。辉瑞公司的rifabutin已经得到美国食品和药物管理局(U.S. FDA)批准。辉瑞公司还在准备申请世界卫生组织药品预认证项目（WHO Prequalification Programme）。Matrix公司的TDF/3TC复合片已经得到美国食品和药物管理局批准。Matrix公司正在与世界卫生组织药品预认证项目和世界卫生组织专家评审小组（Expert Review Panel，ERP）一起为ATV和热稳定的RTV填写档案；档案登记包括确定与参照药物的生物等效性的数据。一旦世界卫生组织专家评审小组、世界卫生组织药品预认证项目或美国食品和药物管理局批准，药品就可以由各国政府用全球抗击艾滋病、结核病和疟疾基金的资助采购。
更多信息见http://www.clintonfoundation.org/
President Clinton, Pfizer, and Mylan Announce New Agreements to Lower Prices of Medicines for Patients with Drug-Resistant HIV in Developing Countries
Pfizer commits to improve access through a 60 percent price decrease to $1 per dose on drug to treat TB in patients taking second-line HIV/AIDS medications.
Once-daily four-drug combination for "second-line" treatment of HIV/AIDS available from Matrix, a Mylan company,
at $475 annually today and at $425 annually in 2010, 28 percent lower than the current lowest-priced alternative.
Combined, the new agreements on HIV and TB -- the leading cause of death of people living with HIV --
reinforce calls for more integrated prevention and treatment of the two diseases.
New York, NY -- President Bill Clinton announced two important and complementary agreements today to enable better, more affordable treatments for patients on second-line antiretroviral (ARV) therapy for HIV/AIDS in the developing world. For the first time, a second-line regimen of four ARVs will be available for under $500 annually. Additionally, the cost of a key drug for treating tuberculosis (TB) in patients using second-line ARVs has been reduced by 60 percent, to $1 per dose.
"Thanks to the work of my Foundation's HIV/AIDS Initiative, 2 million people living with HIV/AIDS are now able to access lifesaving treatment," President Clinton said. "But their continued survival depends on uninterrupted access to medicines and quality and affordable health care throughout their entire life. Today's announcement will help ensure we can sustain treatment over a lifetime and better treat patients with both HIV and TB, two key steps in turning the tide of the global HIV/AIDS pandemic."
Addressing the need for more affordable second-line ARVs, Mylan and Matrix, a Mylan company, are making available all four drugs – atazanavir (ATV), ritonavir (RTV), tenofovir (TDF), and lamivudine (3TC) – needed to enable once-daily treatment of patients who have developed resistance to standard first-line ARVs. The four drugs will be available in three pills, with tenofovir and lamivudine combined into a single pill. The three pills are being made available today as separate products, with a total price of less than $475 annually. Matrix also will sell the pills together in one package – a "second-line-in-a-box" – at $425 annually starting in 2010. These new products and prices will be available to governments that are members of the Clinton Foundation's Procurement Consortium across Africa, Asia, Latin America, and the Caribbean. TDF+3TC is FDA approved, and ATV and RTV are pending approval by the World Health Organization (WHO).
Mylan Chairman and Chief Executive Officer Robert J. Coury said, "Ensuring sustainable access to effective treatments in the developing world is a critical element in the global fight against HIV/AIDS. Mylan and Matrix are proud to continue our commitment of creating and introducing innovative and affordable pharmaceutical solutions. This includes our 'second-line-in-a-box,' which will reduce patient pill burden and facilitate patient compliance. Our affordable, heat-stable version of ritonavir also represents another advance in the development of products that can withstand environmental conditions in parts of the world where treatment is desperately needed."
Citing the importance of integrating HIV/AIDS and tuberculosis treatment, President Clinton also announced an agreement with Pfizer to reduce the price and expand the availability of rifabutin, a drug used to treat tuberculosis in patients taking second-line ARVs. This marks CHAI's first pricing agreement with a research-based pharmaceutical company, as well as its first pricing agreement on tuberculosis. Pfizer will sell the product at $1 per 150 mg dose, or $90 for a full course of treatment over six months. This price will be available throughout developing markets in Africa, Asia, Eastern Europe, Latin America, the Middle East, and the Caribbean. Tuberculosis is the leading cause of death among HIV-positive patients. The WHO reports that over one-third of all individuals living with HIV also are infected with tuberculosis, resulting in over 450,000 deaths in 2007.
Jeffrey B. Kindler, Chairman and CEO of Pfizer stated that, "Pfizer is pursuing numerous global health projects like this one with the Clinton HIV/AIDS Initiative to find new ways to connect people to the medicines they need. "We are working on innovative solutions to bring health care to customers who have often been neglected in the past and do this in a socially responsible, sustainable, and commercially viable way."
"Second-line-in-a-box"
The new Matrix product announced today will create a more convenient second-line ARV treatment option. Patients will take three pills once a day instead of five or more pills twice daily with alternative regimens. Additionally, the products will include the first ever heat-stable version of ritonavir, which does not require continuous refrigeration for its transport and distribution.
Noting advantages in convenience and affordability, WHO has identified the development of a second-line ARV therapy including atazanavir and ritonavir as a top priority. However, until now, this regimen has been largely unavailable since the existing ritonavir formulation required continuous refrigeration, a major challenge for developing countries with limited infrastructure. Countries have begun to adopt this regimen in national treatment guidelines in anticipation of improved product features and pricing, and the Clinton Foundation expects many more to follow suit to take advantage of the agreements announced today.
If fully adopted, the new products and prices would enable cumulative cost savings of $400 million over the next 5 years, when compared with recent prices paid for alternative regimens. Although only 3 percent of total patients on treatment in low-income and sub-Saharan African countries are taking second-line ARVs today, these patients account for nearly 20 percent of total ARV expenditures because of the high cost of second-line drugs compared to first-line drugs. These percentages will grow steadily in the coming years as increasing numbers of HIV/AIDS patients experience first-line treatment failure. There were between 200,000 and 250,000 second-line patients across the developing world at the end of 2008. This number is expected to double over the next three years.
UNITAID helped to make the second-line ARV price reductions announced today possible through its Second-Line Project, implemented by CHAI in partnership with UNITAID. UNITAID funding for this project has created a reliable market for key second-line medicines by increasing and aggregating demand across 25 beneficiary countries. Predictability of demand encourages suppliers to pursue accelerated R&D on new products and enables them to offer lower prices by achieving economies of scale and reducing production risks.
Treating tuberculosis co-infection in second-line HIV/AIDS patients
The agreement with Pfizer enables a more effective and affordable treatment option for second-line ARV patients who also require treatment for tuberculosis. The treatment of HIV-tuberculosis co-infection is complicated by an undesirable interaction between standard tuberculosis medicines and protease inhibitors – the class of ARVs that represent the backbone of second-line treatment. To counteract this effect, clinicians often adjust a patient's ARV therapy to increase the normal dose of certain drugs, producing higher levels of toxicity, worse treatment outcomes, and significantly higher costs. Pfizer's rifabutin does not interfere with protease inhibitors, allowing patients to take ARVs at normal doses.
WHO highlighted the importance of rifabutin by adding it to the Essential Medicines List (EML) in March 2009. The announcement with Pfizer today makes it more affordable to treat TB and HIV simultaneously among patients on second-line ARV therapy, cutting total drug costs by nearly $200 (or 33 percent) over a full six-month course of TB treatment when compared to the most-preferred current treatment option.
Ongoing efforts to ensure the quality and affordability of treatment
The financial support of UNITAID, the United Kingdom Department for International Development, and the Bill & Melinda Gates Foundation has enabled the Clinton Foundation to pursue this work. The two agreements announced today represent only the latest steps that the Clinton Foundation and its partners have taken to ensure that the highest quality treatments are available at the most affordable prices.
These agreements reflect CHAI's commitment to ensuring the availability of high-quality drugs. Pfizer's rifabutin is approved by the United States Food and Drug Administration (U.S. FDA). Pfizer also is preparing to file with the WHO Prequalification Programme. Matrix has received U.S. FDA approval for its tenofovir/lamivudine combination pill. Matrix has filed dossiers for atazanavir and heat-stable ritonavir with the WHO Prequalification Program and WHO Expert Review Panel (ERP); dossier submissions include data establishing bioequivalence to the reference drugs. Once approved by the WHO ERP, WHO Prequalification Program, or U.S. FDA, products can be purchased by governments using funds from the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
Learn more at www.clintonfoundation.org.
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