新型HIV复方新药Juluca（dolutegravir/rilpivirine），成为全球首个也是唯一一个二合一单片完整治疗方案
Juluca是一种固定剂量的复方药片，该药物由两种药物（dolutegravir/rilpivirine）组成，这两种药物之前已获批用于治疗HIV-1感染成人患者，适用于目前以稳定治疗方案治疗后病毒至少被抑制6个月，且没有治疗失败史及无已知与Juluca中单个成分耐药的患者。
在任何HIV治疗方案中限制药物的数量可以帮助降低患者的毒性。FDA药物评价与研究中心抗病毒产品部门主任Birnkrant博士如是称。HIV通过破坏抗击疾病与感染的重要细胞而使病人免疫系统变弱。据美国疾病控制与预防中心提供的信息，美国预计有110万人携带HIV，这种疾病仍是某些人群一个重要的死亡因素。
批准日期：2017年11月22日 公司：ViiV Healthcare
JULUCA(dolutegravir/rilpivirine)片，为口服使用
美国初次批准：2017
作用机制
JULUCA是一种固定-剂量HIV-1抗逆转录病毒药，dolutegravir和利匹韦林的组合[见微生物学]。
适应证和用途
JULUCA，dolutegravir，一个人免疫缺陷病毒型1(HIV-1) 整合酶链转移抑制剂(INSTI)，和利匹韦林[rilpivirine]，一个HIV-1非核苷逆转录酶抑制剂(NNRTI)的一个两-药组合，被表明作为一个完整方案对HIV-1感染的治疗在成年替代当前抗逆转录病毒方案在是病毒学被抑制患者(HIV-1 RNA低于50拷贝每mL)用一个稳定抗逆转录病毒方案共至少6个月与无治疗失败病史和无已知的取代伴随对JULUCA个体组分的抗性。
剂量和给药方法
● 每天与一餐口服1次一片。
● 利福布丁[Rifabutin]共同给药：服用另外一片的利匹韦林与JULUCA的25-mg片每天1次与一餐共利福布丁共同给药时间。
剂型和规格
每片含：50mg的dolutegravir(等同于52.6mg dolutegravir钠)和25mg的利匹韦林(等同于27.5mg利匹韦林盐酸盐).
● 以前对dolutegravir或利匹韦林超敏性反应。
● 与多非利特[dofetilide]共同给药。
● 与药物其中可能发生利匹韦林血浆浓度显著减低共同给药，这可能导致病毒学反应的丧失。
警告和注意事项
●严重的皮肤和超敏性反应特征为皮疹，构成性发现，和有时器官功能失调，包括肝损伤，曽报告与个体组分。如严重的皮肤或超敏性反应的体征或症状发生立即地终止JULUCA，因为一个延迟在停止治疗可能导致一个危及生命反应。
● 在患者接受 一个dolutegravir-含或利匹韦林-方案曽报告肝毒性。建议监视对肝毒性。
● 与含利匹韦林-或dolutegravir-方案的使用曽报告抑郁疾患。建议对严重的抑郁症状立即医学评价。
不良反应
观察到最常见不良反应(所有级别)在至少2%受试者为腹泻和头痛。
药物相互作用
● 因为JULUCA是一个完全方案，不推荐为HIV-1感染治疗与其他抗逆转录病毒药物共同给药。
● 对与JULUCA重要药物相互作用参考完整处方资料。
● 药物诱导或抑制CYP3A4或UGT1A1可能影响JULUCA各组分的血浆浓度。
● 药物增加胃pH或含多价阳离子可能减低JULUCA各组分的血浆浓度。
●与药物有已知尖端扭转性室速的风险考虑另外处方JULUCA。
在特殊人群中使用
● 哺乳：由于对HIV传播潜能建议不哺乳喂养。
包装规格/贮存和处置
每个JULUCA片含50mg的dolutegravir和25mg的利匹韦林，和是一个粉色，椭圆形，膜-包衣，双凸片在一侧凹陷有“SV J3T”。
30片瓶有抗-密封(含一个干燥剂) NDC 49702-242-13.
在原始包装中贮存和分发，避潮和保保持瓶紧密封闭。不要去掉干燥剂。贮存在20ºC至25ºC(68ºF至77ºF)；外出允许15ºC至30ºC(59ºF至86ºF)[见USP控制室温]。
Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection
US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.¹
Juluca is the first 2-drug regimen (2DR) comprising dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor.
Deborah Waterhouse, CEO, ViiV Healthcare said, "The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition."
This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-12 and SWORD-2,2 which showed the 2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (CAR 485/511 [95%], dolutegravir + rilpivirine 486/513 [95%] [adjusted difference -0.2% (95% confidence interval CI: 3.0%, 2.5%), pooled analysis]).2 Virologic suppression rates were similar between treatment arms.2  Drug related adverse events and adverse events leading to withdrawal occurred in low frequencies in both arms of the study, but more frequently in the investigational arm.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, "Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir. Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen."
Juluca is the first medicine in our 2-drug regimen pipeline, which looks to help lessen the lifetime burden of treatment for people living with HIV. Our R&D efforts are exploring the potential of two further 2-drug regimens both in phase III development, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, as well as cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients.
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HiV.
About HIV
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives. 
HIV has largely become a chronic treatable disease, with improved access to antiretroviral treatment leading to a 22% drop in global HIV mortality between 2009 and 2013,3 but more can be done for the estimated 36.7 million people living with HIV and 1.8 million individuals newly infected each year worldwide.4
About Juluca
Juluca is a 2-drug regimen, once-daily, single pill that combines the INSTI dolutegravir (50mg), with the NNRTI rilpivirine (25mg) taken once-daily as a complete HIV regimen for people living with HIV who are virologically suppressed. 
Two essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell's DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INSTIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells.