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默沙东MK-5172/MK-8742治疗HIV/HCV感染疗效强劲

来源:生物谷 2014-03-07 09:06

2014年3月7日讯 /生物谷BIOON/ --默沙东(Merck & Co)3月6日公布了一项正在开展的II期研究(C-WORTHY Study)的新数据。该研究调查了丙型肝炎全口服组合疗法(MK-5172/MK-8742)用于治疗HIV/HCV合并感染的疗效和安全性。研究中,HIV/HCV合并感染患者接受了12周MK-5172/MK-8742治疗后,取得了强劲的HCV抑制,表明该组合疗法用于治疗HIV/HCV合并感染非常有效,同时,安全性与单纯HCV基因型1感染组中所观察到的一致。

在治疗的12周,HIV/HCV合并感染群体,MK-5172/MK-8742+利巴韦林(RBV)联合治疗组100%(29/29)HCV RNA水平低于25 IU/毫升,MK-5172/MK-8742治疗组为90%(26/29);HCV单独感染群体,MK-5172/MK-8742治疗组100%(13/13)HCV RNA水平低于25 IU/毫升。相关数据已提交至第21届逆转录病毒和机会性感染大会(CROI 2014)。

MK-5172和MK-8742均属于非常有前途的新一类抗病毒药物。MK-5172是一种实验性HCV NS3/4A蛋白酶抑制剂,MK-8742则是一种实验性HCV NS5A复制复合体抑制剂。此前,FDA于2013年10月授予MK-5172/MK-8742全口服方案突破性疗法认定。

慢性丙型肝炎是默沙东研发的优先重点。目前,该公司正在一个广泛的临床项目中评价MK-5172和MK-8742,包括多种HCV基因型感染初治患者、治疗失败的患者、以及其他重要的HCV亚群,如肝硬化和HCV/HIV合并感染。(生物谷Bioon.com)

英文原文:Merck hepatitis C drugs work in HIV co-infected patients -study

(Reuters) - A combination of oral drugs for hepatitis C developed by Merck & Co appeared to be well tolerated and highly effective in treating the liver disease in patients also infected with HIV, according to data from a midstage clinical trial presented on Wednesday.

The Merck drugs, MK-5172 and MK-8742, which belong to promising new classes of anti-viral medicines, were tested over a 12-week course of treatment both with and without the older hepatitis C drug ribavirin in co-infected patients.

After 12 weeks of treatment, all 29 patients who received the two Merck drugs and ribavirin had undetectable levels of the hepatitis C virus. Among those who got just the experimental Merck drugs, 26 of 29, or 90 percent, appeared to have the hepatitis C virus eliminated from their blood.

If the virus remains undetectable 12 weeks after completion of treatment, those patients are considered cured.

The available data from the ongoing study was presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. More detailed results of the study dubbed C-Worthy are expected to be presented at a European medical meeting in April, Merck said.

No co-infected patients discontinued treatment due to either an adverse side effect or study medication intolerance, Merck said. The most common side effects of fatigue and headache were no more prevalent in patients with hepatitis C and HIV infection than what had been observed in patients with hepatitis C alone.

A new era in treatment for the serious liver disease has begun with several companies, including Gilead Sciences Inc , AbbVie and Bristol-Myers Squibb Co, developing all oral treatment regimens that have demonstrated cure rates well in excess of 90 percent with treatment durations of just 12 weeks or shorter.

Current standard treatments take 24 to 48 weeks and include the injected drug interferon that causes miserable flu-like symptoms and cure about 75 percent of patients.

Those also living with the virus that causes AIDS are an important patient population.

About seven million people worldwide are co-infected with HIV and hepatitis C (HCV). Co-infected patients have a three times higher rate of progression to cirrhosis and a six times higher risk of liver decompression than those with HCV alone.

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