Safety Control Department, ViiV Healthcare K.K., 1-8-1 Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
Medical Affairs Unit, ViiV Healthcare K.K., Tokyo, Japan.
Adv Ther. 2023 Apr;40(4):1884-1898. doi: 10.1007/s12325-023-02459-4. Epub 2023 Feb 25.
Since 2019, for the first time, a two-drug regimen with dolutegravir/lamivudine (DTG/3TC) has been recommended for HIV treatment as initial and subsequent therapy in the international guidelines. However, safety and efficacy data of DTG/3TC in Japanese people living with HIV (PLHIV) in clinical trials are limited and have not been evaluated in clinical practice. In this report, we evaluated safety and effectiveness of DTG/3TC in Japanese PLHIV through post-marketing surveillance.
Post-marketing surveillance was conducted to evaluate the real-world safety and effectiveness of DTG/3TC in Japanese PLHIV. One hundred ninety-seven patients who received oral DTG 50 mg/3TC 300 mg as a single-tablet fixed-dose combination regimen (STR) were registered in clinical practice. The safety was evaluated by incidence of adverse drug reactions (ADRs). The effectiveness was evaluated by plasma HIV RNA and peripheral CD4 cell counts.
This is a 2-year (from 2020 to 2022) report of approximately 6 years of survey, and 187 patients were registered from 21 Japanese sites. The number of antiretroviral therapy (ART)-experienced patients was 178, and > 60% of their previous antiretrovirals (ARVs) were DTG/abacavir (ABC)/3TC. There were only nine ART-naïve patients. Four of 178 ART-experienced patients (2.25%) reported ADRs, and 1 serious ADR of syphilis was reported. There was no clear causal relationship between DTG/3TC and the ADRs. Plasma HIV RNA and peripheral CD4 cell counts maintained the pre-DTG/3TC level in ART-experienced patients.
No new clinical concerns of safety and effectiveness were identified in Japanese ART-experienced PLHIV treated with DTG/3TC. We could not discuss the safety and effectiveness in ART-naïve patients because of the small sample size.
自 2019 年以来，国际指南首次推荐将多替拉韦/拉米夫定（DTG/3TC）二药联合方案作为 HIV 治疗的初始和后续治疗方案。然而，临床试验中关于日本 HIV 感染者（PLHIV）中 DTG/3TC 的安全性和疗效数据有限，且尚未在临床实践中进行评估。在本报告中，我们通过上市后监测评估了 DTG/3TC 在日本 PLHIV 中的安全性和有效性。
我们进行了上市后监测，以评估 DTG/3TC 在日本 PLHIV 中的真实世界安全性和有效性。197 例患者接受了口服 DTG 50mg/3TC 300mg 单片固定剂量复方制剂（STR）治疗，并在临床实践中注册。通过不良反应（ADR）的发生率评估安全性。通过血浆 HIV RNA 和外周 CD4 细胞计数评估疗效。
这是一项为期 2 年（2020 年至 2022 年）的报告，涵盖了大约 6 年的调查，从 21 个日本地点注册了 187 例患者。178 例患者有抗逆转录病毒治疗（ART）经验，其之前的抗逆转录病毒药物（ARV）中超过 60%为 DTG/阿巴卡韦（ABC）/3TC。仅有 9 例患者为初治。178 例有 ART 经验的患者中有 4 例（2.25%）报告了 ADR，其中 1 例为梅毒的严重 ADR。DTG/3TC 与 ADR 之间无明确的因果关系。ART 经验丰富的患者的血浆 HIV RNA 和外周 CD4 细胞计数维持在 DTG/3TC 治疗前的水平。
在接受 DTG/3TC 治疗的日本有 ART 经验的 PLHIV 中，未发现新的安全性和有效性临床问题。由于样本量小，我们无法讨论初治患者的安全性和有效性。
