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

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.

• Rate of treatment discontinuation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessed at baseline, and at 12, 24, and 48 weeks.]
• HIV symptom assessment [Срок оценки: Assessed at baseline, and at 12, 24, and 48 weeks.]
• Mental health assessment [Срок оценки: Assessed at baseline, and at 12, 24, and 48 weeks.]
• Cardiovascular risk assessment [Срок оценки: Assessed at baseline, and at 12, 24, and 48 weeks.]