Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Rate of participants with virologic suppression
研究概览
简要总结
This is a multicohort study conducted at Affiliated Hospital of Nantong University, and Nantong Third Peoples Hospital (Designated Hospital for HIV/AIDS Treatment of Nantong City), China. The study would involve 630 patients initiating HIV treatment, divided into six cohorts. The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
详细描述
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is recommended for initiating antiretroviral therapy (ART) in newly diagnosed HIV patients, including those with advanced disease. However, clinical data for this group is limited, and the high cost of B/F/TAF may hinder its widespread use as a first-line treatment.
This study aim to gather real-world evidence on the clinical practice of B/F/TAF as a first-line ART and address the knowledge gap regarding its cost-effectiveness. A multicohort study at the Designated Hospital for HIV/AIDS Treatment of Nantong City, China, involves 630 patients initiating HIV treatment, divided into six cohorts. There are 230 prospective patients on B/F/TAF (115 late presenters with CD4; 350 cells/μL or an AIDS-defining event, and 115 early presenters). Additionally, there are 400 retrospective patients on either tenofovir+lamivudine+efavirenz (TDF+3TC+EFV, 100 for each presentation group) or dolutegravir/lamivudine (DTG/3TC, 100 for each presentation group). The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
Data will be collected at baseline and at specific intervals over 48 weeks using electronic health records and patient-reported outcomes. Clinical data include time from diagnosis to ART initiation, plasma viral load (VL), CD4 count, adverse events, treatment adherence, and quality of life (QoL). QoL improvements will be assessed through questionnaires. Cost data will be collected following healthcare reporting standards. A microsimulation model will be adapted. The cost-effectiveness of B/F/TAF, compared to the other regimens, will be evaluated using clinical cohort data and modeling techniques to project long-term economic outcomes.
This study was approved by the ethics committee of Nantong Third Peoples Hospital. Consent will also be obtained from the participants during the study process.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective).
- •Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC.
- •Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs).
排除标准
- •Severe renal impairment (creatinine clearance < 50 mL/min).
- •Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
- •Active tuberculosis (TB).
研究组 & 干预措施
HIV early presenters (TDF+3TC+EFV)
100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.
干预措施: TDF+3TC+EFV (Drug)
HIV late presenters (TDF+3TC+EFV)
100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.
干预措施: TDF+3TC+EFV (Drug)
HIV early presenters(DTG/3TC)
100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.
干预措施: DTG/3TC (Drug)
HIV late presenters (DTG/3TC)
100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.
干预措施: DTG/3TC (Drug)
HIV early presenters (B/F/TAF)
115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025.
干预措施: B/F/TAF (Drug)
HIV late presenters (B/F/TAF)
115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025.
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Rate of participants with virologic suppression
时间窗: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.
Change of CD4 count
时间窗: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
The percentage change in CD4+ T cell count from baseline after initiating ART, stratified by patients with lower versus higher baseline CD4+ levels.
Rate of immune reconstitution in late presenters
时间窗: At 48 weeks from the initiation of ART.
Immune reconstitution is defined as an immunological response in HIV late presenters, characterized by a CD4+ T cell count increase of at least 20% from baseline or reaching at least 350 cells/μL at 48 weeks, accompanied by an undetectable viral load.
次要结局
- Rate of treatment discontinuation(From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.)
- Number of adverse events(From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.)
- QoL assessment(Assessed at baseline, and at 12, 24, and 48 weeks.)
- HIV symptom assessment(Assessed at baseline, and at 12, 24, and 48 weeks.)
- Mental health assessment(Assessed at baseline, and at 12, 24, and 48 weeks.)
- Cardiovascular risk assessment(Assessed at baseline, and at 12, 24, and 48 weeks.)
研究者
Gang Qin, MD, PhD
Associate Professor
Affiliated Hospital of Nantong University