HIV Treatment
Conditions
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.
Interventions
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.
Sponsors
Servicios de Salud IPS Suramericana S.A.S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Colombia
Outcome results
None listed