Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nantong Third Peoples Hospital | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV early presenters (TDF+3TC+EFV) | 100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. |
| |
| HIV late presenters (TDF+3TC+EFV) | 100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. |
| |
| HIV early presenters(DTG/3TC) | 100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. |
| |
| HIV late presenters (DTG/3TC) | 100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. |
| |
| HIV early presenters (B/F/TAF) | 115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025. |
| |
| HIV late presenters (B/F/TAF) | 115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants with virologic suppression | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment discontinuation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body weight | 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 | Monitoring changes in low-density lipoprotein (LDL) cholesterol levels helps assess cardiovascular risk and the impact of ART on lipid profiles over time. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Qin, MD, PhD | Contact | +86-189-1228-8106 | tonygqin@ntu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Qin, MD, PhD | Affiliated Hospital of Nantong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantong Third Peoples Hospital | Recruiting | Nantong | Jiangsu | 226006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| TDF+3TC+EFV | Drug | 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). |
|
| DTG/3TC | Drug | Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg. |
|
| Number of adverse events | 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 | 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 | 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 | 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 > 9), he or she will be referred to a psychiatrist. | Assessed at baseline, and at 12, 24, and 48 weeks. |
| Cardiovascular risk assessment | 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. |
| At 12 weeks, 24 weeks and 48 weeks from the initiation of ART. |
| Change of eGFR | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |