Clinical trial NCT06619288: Good-first: B/F/TAF As First-line ART
Official title: Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infection
Keywords: B/F/TAF
TDF+3TC+EFV
DTG/3TC
Cohort study
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Nantong Third Peoples Hospital
First posted: 2024-10-01
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of HIV-infected patients, including those who present in the early stages of infection as well as those with late-stage or advanced presentations. These individuals will encompass a wide range of clinical scenarios to ensure the findings are applicable to diverse patient populations.

Brief summary: 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.

Eligibility criteria: 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 \&amp;lt; 50 mL/min).
2. Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
3. Active tuberculosis (TB).

Primary outcomes:
measure: Rate of participants with virologic suppression
timeFrame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
measure: Change of CD4 count
timeFrame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
measure: Rate of immune reconstitution in late presenters
timeFrame: At 48 weeks from the initiation of ART.
Secondary outcomes:
measure: Rate of treatment discontinuation
timeFrame: 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.
measure: Number of adverse events
timeFrame: 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.
measure: QoL assessment
timeFrame: Assessed at baseline, and at 12, 24, and 48 weeks.
measure: HIV symptom assessment
timeFrame: Assessed at baseline, and at 12, 24, and 48 weeks.
measure: Mental health assessment
timeFrame: Assessed at baseline, and at 12, 24, and 48 weeks.
measure: Cardiovascular risk assessment
timeFrame: Assessed at baseline, and at 12, 24, and 48 weeks.
Other outcomes:
measure: Change of body weight
timeFrame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
measure: Change of LDL
timeFrame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
measure: Change of eGFR
timeFrame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
Locations:
city: Nantong
country: China
facility: Nantong Third Peoples Hospital
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Gang Qin, MD, PhD
role: STUDY_CHAIR
References: