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比克替拉韦、恩曲他滨和丙酚替诺福韦艾拉酚胺联合治疗 HIV 感染者:至 1 年 BICSTaR 研究的通俗易懂报告。

Combined bictegravir, emtricitabine and tenofovir alafenamide for treating people with HIV: a plain language summary of the BICSTaR study up to 1 year.

机构信息

Clinic of Dermatology, Department of Venerology, University Hospital Essen, Essen, Germany.

HIV Unit, Hospital Clinic of Barcelona, Barcelona, Spain.

出版信息

Future Microbiol. 2024;19(15):1273-1282. doi: 10.1080/17460913.2024.2391190. Epub 2024 Sep 4.

Abstract

WHAT IS THIS SUMMARY ABOUT?: This is a summary of an article about an ongoing study called the BICSTaR study.The BICSTaR study includes people with HIV (human immunodeficiency virus) who are taking a medicine called bictegravir/emtricitabine/tenofovir alafenamide (shortened to B/F/TAF). B/F/TAF is a single tablet that contains 3 different drugs for the treatment of HIV. The drugs work together to reduce the levels of HIV so that the virus can no longer be detected by a blood test.People taking part in the study are adults with HIV living in Europe, Canada, Israel, Japan, South Korea, Singapore and Taiwan. People take 1 tablet of B/F/TAF once a day. They are either taking B/F/TAF as their first treatment for HIV, or they have switched to B/F/TAF from another HIV treatment.Researchers looked at how well B/F/TAF worked and how safe it was in people who took B/F/TAF for a year.

WHAT ARE THE KEY TAKEAWAYS?: Researchers found that B/F/TAF worked well in almost all people in the study by reducing levels of HIV in the blood. The virus could not be found in the blood of more than 9 out of 10 (94%) people who were taking B/F/TAF as their first HIV medicine and more than 9 out of 10 people (97%) who had taken another HIV medicine before starting B/F/TAF. This is known as having an 'undetectable viral load' and is a major goal for HIV treatment success. Researchers did not find any evidence of HIV developing resistance to B/F/TAF, which might stop B/F/TAF from working properly.Around 1 out of 10 people (13%) had side effects (any unwanted sign or symptom that people have when taking a medicine that researchers think might be caused by the medicine) that might have been caused by B/F/TAF. Most of these side effects were not classified as serious. Less than 1 out of 100 (0.1%) people had serious side effects that might have been caused by B/F/TAF. Only 6 out of 100 people stopped taking B/F/TAF due to side effects caused by B/F/TAF. As a result, more than 9 out of 10 people (95%) took B/F/TAF for at least 1 year.

WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?: B/F/TAF worked well in people with HIV in this study. Most people (around 9 out of 10) did not have any side effects.

摘要

这是一篇关于正在进行的 BICSTaR 研究的文章摘要。BICSTaR 研究包括正在服用一种名为比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺(简称 B/F/TAF)的药物的 HIV(人类免疫缺陷病毒)感染者。B/F/TAF 是一种含有 3 种不同药物的单片制剂,用于治疗 HIV。这些药物协同作用降低 HIV 水平,使病毒无法通过血液检测到。参与研究的是在欧洲、加拿大、以色列、日本、韩国、新加坡和中国台湾居住的 HIV 感染者成年人。他们每天服用 1 片 B/F/TAF。他们要么首次接受 B/F/TAF 治疗 HIV,要么从其他 HIV 治疗方案转为 B/F/TAF 治疗。研究人员观察了 B/F/TAF 在服用一年的人群中的疗效和安全性。

研究人员发现,B/F/TAF 在研究中的绝大多数人身上效果良好,通过降低血液中的 HIV 水平。接受 B/F/TAF 作为首种 HIV 药物治疗的人群中,有超过 9 成(94%)的人病毒载量无法检测到,而在开始接受 B/F/TAF 治疗前曾接受过其他 HIV 药物治疗的人群中,有超过 9 成(97%)的人病毒载量无法检测到。这被称为“病毒载量不可检测”,是 HIV 治疗成功的主要目标。研究人员没有发现 HIV 对 B/F/TAF 产生耐药性的证据,这可能会导致 B/F/TAF 无法正常发挥作用。约每 10 人中有 1 人(13%)出现了副作用(在服用药物后出现的任何研究者认为可能由药物引起的、不希望出现的体征或症状),可能是由 B/F/TAF 引起的。这些副作用大多不属于严重级别。不到 100 人中就有 1 人(0.1%)出现了严重副作用,可能是由 B/F/TAF 引起的。仅有 6 人(6%)因 B/F/TAF 引起的副作用而停止服用 B/F/TAF。结果,超过 9 成(95%)的人至少服用了 1 年的 B/F/TAF。

研究人员报告的主要结论是什么?在这项研究中,B/F/TAF 对 HIV 感染者效果良好。大多数人(约 9 成)没有任何副作用。

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