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

NCT06829082 | Completed

• 1 other identifier: SR-GL-003
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile

  From enrollment to weeks 24 and 48

• Adherence to Treatment

  From enrollment to week 48

• Security; Hepatic function

  From enrollment to week 48

• Security: Renal function

  From enrollment to weeks 24 and 48

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Servicios de Salud IPS Suramericana S.A.S.

Medellín, Antioquia, Colombia

Location

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 17, 2025
• Study Start: November 15, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)