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

NCT ID: NCT06829082

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-01-17

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

BIKTARVY 50Mg-200Mg-25Mg Tablet

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servicios de Salud IPS Suramericana S.A.S

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Servicios de Salud IPS Suramericana S.A.S.

Medellín, Antioquia, Colombia

Countries

Colombia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SR-GL-003

Identifier Type: -

Identifier Source: org_study_id