Good-first: B/F/TAF As First-line ART
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B/F/TAF, TDF+3TC+EFV, DTG/3TC.
- Who it may be relevant to
- Registry conditions: HIV Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - 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). - Drug DTG/3TC
Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.
Primary outcome measures
- Rate of participants with virologic suppression [Time frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.]
- Change of CD4 count [Time frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.]
- Rate of immune reconstitution in late presenters [Time frame: At 48 weeks from the initiation of ART.]
Secondary outcome measures (6)
- Rate of treatment discontinuation [Time frame: 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 [Time frame: 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 [Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.]
- HIV symptom assessment [Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.]
- Mental health assessment [Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.]
- Cardiovascular risk assessment [Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- Severe renal impairment (creatinine clearance \< 50 mL/min).
- Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
- Active tuberculosis (TB).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nantong Third Peoples Hospital — Nantong
Identifiers
NCT: NCT06619288 · 2024-TDF-058