Good-first: B/F/TAF As First-line ART

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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HIV early presenters (TDF+3TC+EFV)

100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.

TDF+3TC+EFV

Intervention Type DRUG

Take five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg).

HIV late presenters (TDF+3TC+EFV)

100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.

TDF+3TC+EFV

Intervention Type DRUG

Take five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg).

HIV early presenters(DTG/3TC)

100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.

DTG/3TC

Intervention Type DRUG

Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.

HIV late presenters (DTG/3TC)

100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.

DTG/3TC

Intervention Type DRUG

Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.

HIV early presenters (B/F/TAF)

115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025.

B/F/TAF

Intervention Type DRUG

Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg.

HIV late presenters (B/F/TAF)

115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025.

B/F/TAF

Intervention Type DRUG

Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg.

Interventions

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B/F/TAF

Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg.

Intervention Type DRUG

TDF+3TC+EFV

Take five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg).

Intervention Type DRUG

DTG/3TC

Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective).
2. Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC.
3. Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs).

Exclusion Criteria

1. Severe renal impairment (creatinine clearance \&lt; 50 mL/min).
2. Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
3. Active tuberculosis (TB).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No