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多替拉韦/利匹韦林:用于治疗人类免疫缺陷病毒 1 型感染的药物评价。

Dolutegravir/Rilpivirine: A Review in HIV-1 Infection.

机构信息

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2018 Nov;78(16):1741-1750. doi: 10.1007/s40265-018-1005-4.

Abstract

Dolutegravir/rilpivirine (Juluca) is the first two-drug single-tablet regimen (STR) to be approved for the treatment of HIV-1 infection in adults. The fixed-dose STR combines the integrase strand transfer inhibitor dolutegravir with the non-nucleoside reverse transcriptase inhibitor rilpivirine. In two phase III non-inferiority trials (SWORD-1 and SWORD-2) in treatment-experienced patients already virologically suppressed on their current antiretroviral (ART) regimen, switching to once-daily dolutegravir plus rilpivirine maintained virological suppression over 48 weeks. Switching to a two-drug regimen of dolutegravir plus rilpivirine was also associated with high rates of virological suppression in real-world observational studies. Switching to once-daily dolutegravir plus rilpivirine was generally well tolerated and associated with more favourable renal and bone parameters than remaining on the current ART regimen. Longer-term, dolutegravir plus rilpivirine demonstrated durable maintenance of virological suppression and remained generally well tolerated for up to 100 weeks. Thus, dolutegravir/rilpivirine provides a convenient alternative treatment option for some adults with HIV-1 infection and no history of virological failure who are already virologically suppressed on (and wish to switch from) their current ART regimen.

摘要

多替拉韦/利匹韦林(Juluca)是首个获批用于治疗成人 HIV-1 感染的二联单片复方制剂(STR)。该固定剂量 STR 联合了整合酶链转移抑制剂多替拉韦和非核苷类逆转录酶抑制剂利匹韦林。在两项治疗经验丰富的患者中开展的 III 期非劣效性试验(SWORD-1 和 SWORD-2)中,在当前抗逆转录病毒(ART)方案下已实现病毒学抑制的患者中,转换为每日一次多替拉韦加利匹韦林治疗,可在 48 周时维持病毒学抑制。在真实世界观察性研究中,转换为二联复方制剂多替拉韦加利匹韦林也与较高的病毒学抑制率相关。转换为每日一次多替拉韦加利匹韦林通常具有良好的耐受性,并与维持当前 ART 方案相比,具有更有利的肾功能和骨骼参数。长期来看,多替拉韦加利匹韦林可持久维持病毒学抑制,并且在长达 100 周的时间内通常具有良好的耐受性。因此,多替拉韦/利匹韦林为一些已实现病毒学抑制且无病毒学失败史的 HIV-1 感染成人提供了一种方便的替代治疗选择,这些患者正在接受当前的 ART 方案治疗(并希望从该方案转换)。

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