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

Completed

• Conditions: HIV Treatment

• Registration Number: NCT06829082
• Lead Sponsor: Servicios de Salud IPS Suramericana S.A.S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-15
• Primary Completion: 2025-01-17
• Study Completion: 2025-01-17
• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile	From enrollment to weeks 24 and 48	The lipid profile will be evaluated using HDL and LDL levels before the start of treatment and at 24 and 48 weeks of treatment.
Adherence to Treatment	From enrollment to week 48	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.
Security; Hepatic function	From enrollment to week 48	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.
Security: Renal function	From enrollment to weeks 24 and 48	Renal function will be assessed by serum creatinine levels before the start of treatment and at 24 and 48 weeks of treatment.

Trial Locations

Locations (1)

Servicios de Salud IPS Suramericana S.A.S.; 🇨🇴 Medellin, Antioquia, Colombia