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

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: HIV Infection

Treatments: Drug: TDF+3TC+EFV; Drug: DTG/3TC; Drug: B/F/TAF

Study type: Observational

Funder types: Other

Identifiers

NCT06619288

2024-TDF-058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 < 50 mL/min).
2. Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
3. Active tuberculosis (TB).

Trial design

630 participants in 6 patient groups

HIV early presenters (TDF+3TC+EFV)

Description:

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

Treatment:

Drug: TDF+3TC+EFV

HIV late presenters (TDF+3TC+EFV)

Description:

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

Treatment:

Drug: TDF+3TC+EFV

HIV early presenters(DTG/3TC)

Description:

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

Treatment:

Drug: DTG/3TC

HIV late presenters (DTG/3TC)

Description:

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

Treatment:

Drug: DTG/3TC

HIV early presenters (B/F/TAF)

Description:

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

Treatment:

Drug: B/F/TAF

HIV late presenters (B/F/TAF)

Description:

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

Treatment:

Drug: B/F/TAF