pro140,一种靶向CCR5的单克隆抗体,作为HIV-1感染的长效单药维持疗法。

Q2 Medicine
HIV Clinical Trials Pub Date : 2018-06-01 Epub Date: 2018-04-20 DOI:10.1080/15284336.2018.1452842
Kush Dhody, Nader Pourhassan, Kazem Kazempour, Derry Green, Shide Badri, Hana Mekonnen, Denis Burger, Paul J Maddon
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引用次数: 30

摘要

pro140是一种针对CCR5的人源化单克隆抗体,对嗜CCR5的HIV-1感染患者具有有效的抗病毒活性。在2b期研究中,我们评估了PRO 140单药治疗在进入试验时抗逆转录病毒联合治疗稳定的患者中维持病毒抑制超过24个月的长期疗效、安全性和耐受性。方法与结果41例成人纯ccr5型HIV-1病毒感染患者
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PRO 140, a monoclonal antibody targeting CCR5, as a long-acting, single-agent maintenance therapy for HIV-1 infection.

Background PRO 140 is a humanized monoclonal antibody targeting CCR5 with potent antiviral activity in patients with CCR5-tropic HIV-1 infection. In phase 2b studies, we evaluated the long-term efficacy, safety, and tolerability of PRO 140 monotherapy in maintaining viral suppression for over 24 months in patients who were stable on combination antiretroviral therapy on entry into the trials. Methods and Results Forty-one adult patients, infected exclusively with CCR5-tropic HIV-1 with viral loads <50 copies/mL, were switched from daily oral combination ART regimens to weekly PRO 140 monotherapy for 12 weeks. Participants who completed 12 weeks of treatment without experiencing virologic rebound were allowed to self-administer PRO 140 as a 350 mg subcutaneous injection weekly, for up to an additional 160 weeks. Participants were monitored bi-weekly for one year, and every four weeks thereafter for virologic rebound. PRO 140 provided virologic suppression in 23/41 (56.1%) participants for 12 weeks and was well tolerated. Ten (10) participants are currently ongoing, of which nine participants have completed more than two years of monotherapy treatment (47-129 weeks). Participants experiencing virologic rebound achieved full viral suppression upon re-initiation of oral combination ART regimen. Anti-PRO 140 antibodies were not detected in any patient, and no drug-related major adverse events or treatment discontinuations were reported. Conclusions PRO 140 has a potential to address an unmet need for a long-acting, single-agent, maintenance regimen for HIV infection in selected patients. Studies are underway to determine host and/or virologic factors that may predict treatment success on PRO 140 monotherapy. Moreover, it has sufficient potency for a prolonged period of monotherapy that it would be an excellent component of a multi long-acting drug combination.

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来源期刊
HIV Clinical Trials
HIV Clinical Trials 医学-传染病学
CiteScore
1.76
自引率
0.00%
发文量
0
审稿时长
>12 weeks
期刊介绍: HIV Clinical Trials is devoted exclusively to presenting information on the latest developments in HIV/AIDS clinical research. This journal enables readers to obtain the most up-to-date, innovative research from around the world.
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