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OpenTrials
Completed

NCT Number: NCT06829082

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

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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Key information

Conditions

HIV Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servicios de Salud IPS Suramericana S.A.S.

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Effectiveness: Virological Suppression

    Time frame: From enrollment to weeks 24 and 48

  2. Effectiveness: CD4 T-Lymphocytes count

    Time frame: From enrollment to weeks 24 and 48

  3. Security: Treatment-Related Adverse Events

    Time frame: From enrollment to weeks 24 and 48

Secondary outcomes

  1. Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile

    Time frame: 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.

  2. Adherence to Treatment

    Time frame: 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.

  3. Security; Hepatic function

    Time frame: 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.

  4. Security: Renal function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Servicios de Salud IPS Suramericana S.A.S

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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