新型二合一单片药物:JULUCA(dolutegravir/rilpivirine)-成为全球首个也是唯一用于治疗HIV感染的治疗方案
2011年10月8日，美国FDA批准ViiV Healthcare的新药Juluca上市，治疗感染HIV-1的特定成人患者。Juluca首款获批治疗这一适应症的双药疗法。
关于Juluca
Juluca由dolutegravir与rilpivirine组成。Dolutegravir由ViiV Healthcare开发，是一款HIV-1整合酶链转移抑制剂（integrase strand transfer inhibitor，INSTI），能和其他抗逆转录病毒疗法形成组合，治疗感染HIV-1的成人患者；Rilpivirine则由Janssen Sciences Ireland UC开发，是一款非核苷逆转录酶抑制剂（non-nucleoside reverse transcriptase inhibitor，NNRTI）。
HIV是一类能削弱人体免疫系统的病毒。它能摧毁人体对抗疾病和感染的重要免疫细胞，严重影响患者的生活质量。
相关研究
在两项临床试验中，Juluca在成人中的安全性与有效性得到了评估。这两项研究招募了1024名志愿者，他们的病毒感染状况在当下的抗HIV疗法中已经得到了有效控制。这些志愿者被随机分为两组，一组继续接受目前的抗HIV疗法，另一组则使用Juluca。研究表明，Juluca能有效抑制HIV病毒，效果与这些志愿者曾使用的抗HIV疗法相当。
副作用
Juluca最常带来腹泻和头疼。严重的副作用包括皮疹和过敏反应、肝脏问题、以及抑郁等情绪变化。FDA的公告中指出Juluca不能与其他抗HIV药物联用，也可能和常见的药物产生反应。
研究人员表示，他们期待这款有效且使用药物更少的新疗法能进一步改善HIV患者的生活。
该产品将以50mg/25mg固定剂量片剂形式提供。
The New Combo HIV Drug Juluca (dolutegravir/rilpivirine)-The World's First and Only Monolithic Monolithic Treatment
On November 22, 2017, the U.S. Food and Drug Administration (FDA) approved Juluca (dolutegravir and rilpivirine 50mg/25mg tablets; ViiV and Janssen) as the first complete 2-drug regimen for certain HIV-1 infected adults Program, rather than the standard contains≥3 kinds of drugs AIDS treatment.
Juluca is intended to be used in adults infected with HIV-1 to replace current antiretroviral regimens with virological suppressants≥6 months of stable antiretroviral therapy (HIV-1 RNA <50copies/mL) , No history of treatment failure and no known replacement is associated with resistance to individual components of Juluca.
The safety and efficacy of Juluca was studied in two trials involving 1,024 patients who are currently virologically inhibited by antiretroviral therapy.
Patients are randomized to continue their current antiretroviral drug or switch to euphorbia. The data show that Juluca is effective in maintaining virological suppression and is comparable to those who continue using their original protocol.
At week 48, the proportion of patients in both treatment groups with HIV-1 RNA <50 copies/mL was 95% (treatment difference -0.2%, 95% CI: -3.0, 2.5). At Week 48, the proportion of HIV-1 RNA ≥50 copies/mL (virological failure) was 0.6% and 1.2%, respectively, in the Juluca group and the current ARV treatment group (treatment difference -0.6%, 95% CI: -1.7%, 0.6%).
Juluca most commonly reported diarrhea and headache are adverse reactions; serious effects include rash, allergic reactions, liver problems, depression or mood changes.
Juluca combines an HIV-1 integrase chain transfer inhibitor (INSTI) and a non-nucleoside reverse transcriptase inhibitor rilpivirine. The product will be provided as a 50mg/25mg fixed dose tablet.