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

September 27, 2024 updated by: Gang Qin, MD, PhD, Affiliated Hospital of Nantong University

Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226006
        • Recruiting
        • Nantong Third Peoples Hospital
        • Contact:
        • Contact:
          • Mei-Yin Zou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV early presenters (TDF+3TC+EFV)
100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.
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).
HIV late presenters (TDF+3TC+EFV)
100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.
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).
HIV early presenters(DTG/3TC)
100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.
Drug: DTG/3TC
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.
Drug: DTG/3TC
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.
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.
HIV late presenters (B/F/TAF)
115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with virologic suppression
Time Frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.
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.
The percentage change in CD4+ T cell count from baseline after initiating ART, stratified by patients with lower versus higher baseline CD4+ levels.
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.
Immune reconstitution is defined as an immunological response in HIV late presenters, characterized by a CD4+ T cell count increase of at least 20% from baseline or reaching at least 350 cells/μL at 48 weeks, accompanied by an undetectable viral load.
At 48 weeks from the initiation of ART.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout the entire follow-up period, there were instances of loss to follow-up or death due to other illnesses. If a subject experiences significant adverse reactions after taking the medication, it is necessary to discontinue the medication.
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.
Adverse events are mainly divided into five categories: central nervous system symptoms, which include headache, dizziness, insomnia, difficulty concentrating, mood changes, or mental confusion; gastrointestinal symptoms, such as nausea, vomiting, diarrhea, abdominal pain, or dyspepsia; hematologic symptoms, which involve low levels of red blood cells or hemoglobin, leading to fatigue, weakness, or pallor; hepatotoxicity, indicated by elevated liver enzyme levels, jaundice, or other signs of liver dysfunction; and dermatitis, which includes rash, itching, erythema, or dry skin.
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.
Quality of Life (QoL) is assessed using the EQ-5D-5L scale, a standardized instrument developed by the EuroQol Group. It measures general health across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity each. The index score ranges from -0.59 to 1, with higher scores indicating better health status.
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.
The HIV Symptom Index (HIV-SI) is used to assess the prevalence and severity of HIV-related symptoms. Scores range from 0 to 80, with higher scores indicating a greater burden of symptoms.
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.
People living with HIV (PLHIV) have a risk of experiencing depressive symptoms that is three times higher than that of the general population. The Patient Health Questionnaire-9 (PHQ-9), a self-administered scale, is used for diagnosing and monitoring depression. Scores on the PHQ-9 range from 0 to 27, with higher scores indicating more severe levels of depression. If a patient presents with moderate depressive symptoms (PHQ-9 score &gt; 9), he or she will be referred to a psychiatrist.
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.
Cardiovascular risk assessment is an essential component of clinical practice for people living with HIV (PLHIV). The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of an individual. Scores range from 0% to 30% or higher, with higher scores indicating a greater cardiovascular risk.
Assessed at baseline, and at 12, 24, and 48 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body weight
Time Frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
This metric represents the percentage change in body weight from the baseline measurement.
At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
Change of LDL
Time Frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
Monitoring changes in low-density lipoprotein (LDL) cholesterol levels helps assess cardiovascular risk and the impact of ART on lipid profiles over time.
At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
Change of eGFR
Time Frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.
Estimated glomerular filtration rate (eGFR) calculated using serum creatinine levels is used to assess kidney function over time and indicates how well the kidneys are filtering waste from the blood. Changes in eGFR can signal improvements or declines in renal function.
At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Collaborators

Nantong Third Peoples Hospital

Investigators

  • Study Chair: Gang Qin, MD, PhD, Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-TDF-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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