Real-Life Outcomes of TAF/FTC/BIC in HIV Patients in Colombia

Clinical Effectiveness, Adherence, Clinical and Paraclinical Outcomes Associated With Tenofovir Alafenamide/Emtricitabine/Bictegravir (TAF/FTC/BIC) in Patients Diagnosed With Human Immunodeficiency Virus HIV) in Colombia: A Real-Life Study

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.

Study Overview

• Status: Completed
• Conditions: HIV Treatment
• Intervention / Treatment: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Servicios de Salud Ips Suramericana S.A.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the defined selection criteria within the established time frame for the search will be included.

Description

Inclusion Criteria:

• Male or female patients aged 18 years or older.
• Individuals with a confirmed HIV diagnosis.
• Individuals enrolled in EPS SURA during the study period.
• Patients receiving treatment with the TAF/FTC/BIC regimen.

Exclusion Criteria:

• Patients with a concurrent diagnosis of tuberculosis.
• Pregnant patients during the study period.
• Patients with virologic failure.
• Patients who started treatment with TAF/FTC/BIC but changed providers or discontinued treatment before completing six months of therapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Servicios de Salud IPS Suramericana S.A.S

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine
• Other Study ID Numbers: SR-GL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No