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HIV remains a major global health issue, with 38 million people affected, and significant challenges in diagnosis and treatment due to stigma and socioeconomic factors. In Colombia, the epidemic is concentrated among men who have sex with men, with 165,405 people living with HIV and 14,670 new cases reported in 2023. Barriers to treatment access are exacerbated by social factors and Venezuelan migration. While integrase inhibitors like TAF/FTC/BIC have shown effectiveness, real-world data in Colombia is limited. This study evaluates adherence, effectiveness, and clinical outcomes of TAF/FTC/BIC in 169 patients within the EPS SURA program, contributing context-specific evidence.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIKTARVY 50Mg-200Mg-25Mg Tablet | Drug | Antiretroviral therapy (ART) has advanced with the introduction of integrase strand transfer inhibitors (INSTIs), such as the fixed-dose combination of tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC), known as Biktarvy®. This regimen is preferred for its high genetic barrier to resistance, minimal drug interactions, and once-daily, single-tablet formulation, which enhances adherence and long-term treatment outcomes. While clinical trials have demonstrated its efficacy, real-world data specific to Colombia are lacking. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Virological Suppression | From enrollment to weeks 24 and 48 | |
| Effectiveness: CD4 T-Lymphocytes count | From enrollment to weeks 24 and 48 | |
| Security: Treatment-Related Adverse Events | From enrollment to weeks 24 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile | The lipid profile will be evaluated using HDL and LDL levels before the start of treatment and at 24 and 48 weeks of treatment. | From enrollment to weeks 24 and 48 |
| Adherence to Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the defined selection criteria within the established time frame for the search will be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicios de Salud IPS Suramericana S.A.S. | Medellín | Antioquia | Colombia |
Following the results of the study, they will be analyzed and evaluated by the team designated for this purpose. When the final version of the study product has been obtained and the draft manuscript has been reviewed and approved by the authors, it will be submitted to the journal selected and agreed upon by the principal investigator, according to the impact classification of the publication. In addition, it will be presented at a previously selected scientific event (congresses, symposia, among others).
Publications will comply with the guidelines of the International Committee of Medical Journal Editors (ICMJE). Likewise, all individuals who meet the authorship criteria defined by the ICMJE will be recognized as authors of the publications (http://www.icmje.org).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 | Feb 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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Adherence will be measured using pharmacy claims information with the Proportion of Days Covered (PDC). PDC calculates the proportion of days the patient has access to the medication over a specified period. |
| From enrollment to week 48 |
| Security; Hepatic function | Liver function will be evaluated by AST and ALT enzymes and total bilirubin levels before the start of treatment and at 24 and 48 weeks of treatment. | From enrollment to week 48 |
| Security: Renal function | Renal function will be assessed by serum creatinine levels before the start of treatment and at 24 and 48 weeks of treatment. | From enrollment to weeks 24 and 48 |