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
Conditions: HIV Treatment
Sponsor: Servicios de Salud IPS Suramericana S.A.S

 
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Date of Writing/Update: Octuber 2024 
Project version: 1.0 
 
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 
 
Research Question 
What are the clinical effectiveness, adherence, and clinical and paraclinical outcomes 
associated with Tenofovir Alafenamide/Emtricitabine/Bictegravir (TAF/FTC/BIC) in 
patients diagnosed with HIV in a Colombian EPS? 
• P (Population): Patients aged 18 years and older diagnosed with HIV. 
• I (Intervention): Treatment with TAF/FTC/BIC. 
• C (Comparison): N/A. 
• (Outcomes): Clinical effectiveness, adherence, and clinical and paraclinical 
outcomes. 
 
 
Summary 
HIV remains one of the most serious global pandemics, affecting 38 million people, with 
the highest prevalence in sub-Saharan Africa. Stigma and discrimination continue to 
hinder diagnosis and treatment, impacting marginalized populations most significantly. In 
Latin America, prevalence remains stable at approximately 0.4%, though Colombia faces 
unique challenges, with an epidemic concentrated among men who have sex with men. 
Recently published high-cost data from Colombia indicate that there are currently 165,405 
people living with HIV (PLHIV), with 14,670 new cases reported in 2023. Social and 
economic factors, along with Venezuelan migration, complicate access to treatment in 
Colombia. 

 
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Advances in ART have been made with the use of integrase inhibitors such as 
TAF/FTC/BIC, which has demonstrated effectiveness across various populations. 
However, real-world studies specific to Colombia are lacking. In this study, we aim to 
evaluate adherence, effectiveness, and clinical outcomes of TAF/FTC/BIC treatment in a 
cohort of 169 patients within a larger group of 15,300 HIV patients under the EPS SURA 
program, generating evidence that is relevant to the Colombian context. 
 
 
Problem Statement and Relevance 
HIV remains one of the most significant global pandemics, with approximately 38 million 
people living with HIV worldwide, according to medical literature. The prevalence is 
particularly high in sub-Saharan Africa, which accounts for 70% of infections (1-3). 
Additionally, HIV is a leading cause of disability-adjusted life years (DALYs), ranking as 
the fifth leading cause globally in 2010 (4). 
 
Stigma and discrimination remain major barriers to the diagnosis and treatment of HIV, 
disproportionately affecting marginalized populations such as sex workers, people who 
inject drugs, men who have sex with men, and transgender individuals (5). Despite 
advances in treatment, HIV remains a chronic condition that requires lifelong drug therapy 
to suppress viral load and prevent transmission (6). 
 
In Latin America, HIV infection is recognized as a public health issue with unique 
epidemiological characteristics and challenges that vary across the region. HIV 
prevalence is relatively stable in Latin America, averaging 0.4% in the general population, 
though significant differences exist both between and within countries. Brazil, Mexico, and 
Colombia have the highest number of cases (7,8). In the Caribbean, for example, 
prevalence among adults exceeds 1% in several countries, where a decrease in new 
infections has also been observed (8). 

 
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HIV infection in Colombia poses a significant public health challenge, as the country has 
the fourth highest incidence rate of HIV/AIDS in Latin America, which has been rising 
since the 1980s (9). The epidemic is concentrated within key populations, such as men 
who have sex with men, who bear a high HIV burden in the country's major cities, with 
prevalence ranging from 6% to 24% (10). In 2023, 14,603 new cases were reported, 
marking a 13.5% increase compared to 2022. Of these cases, 34% were diagnosed at 
the AIDS stage. This trend of rising incidence and late diagnoses has been observed since 
the COVID-19 pandemic, likely due to delayed healthcare access. In 2023, new diagnoses 
in men accounted for 83% of cases compared to women. 
 
HIV transmission in Colombia is influenced by social and economic factors, including 
social inequalities and sex tourism, particularly in cities like Cartagena (11). Co-infection 
with the hepatitis C virus is also becoming a growing issue among people living with HIV. 
Of the 1,058 new cases of hepatitis C reported in Colombia in 2023, 69.47% were co-
infected with HIV (12). Additionally, hepatitis C is emerging as a significant problem among 
people who inject drugs (13). While access to antiretroviral therapy (ART) has improved, 
significant barriers to early diagnosis and timely treatment remain, exacerbated by social 
stigma, limited access to healthcare, and the impact of large-scale migration from 
Venezuela. This migration has placed added pressure on the Colombian healthcare 
system and disrupted the continuity of care for migrants living with HIV (14,15). 
 
Current recommendations for the initiation of antiretroviral therapy (ART) include the use 
of an integrase strand transfer inhibitor (INSTI), such as bictegravir or dolutegravir, in 
combination with a nucleoside reverse transcriptase inhibitor (NRTI). These options have 
proven to be effective, with a high genetic barrier and potent activity in infected patients 
(16,17). Bictegravir/Emtricitabine/Tenofovir Alafenamide (TAF/FTC/BIC) is a single-tablet 
combination therapy developed for the treatment of HIV. Its mechanism of action 
combines the INSTI bictegravir with the NRTIs emtricitabine and tenofovir alafenamide, 

 
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demonstrating efficacy in both treatment-naïve patients (those without prior exposure to 
ART) and patients previously exposed to ART (18). 
 
As of January 2024, EPS SURA manages a cohort of approximately 15,300 HIV patients. 
The control, evaluation, and follow-up of these patients are primarily conducted by 
specialized healthcare institutions (IPS), with a smaller proportion monitored by affiliated 
IPS providers. Program indicators include treatment abandonment rates, virological 
success rates, virological success with ART in the last 3 months, HIV viral load, and CD4 
T-lymphocyte levels in the past 6 months for patients with HIV. To assess patient 
adherence, regular weekly evaluations are conducted, which include laboratory 
monitoring and attendance at medical appointments. In cases of non-compliance, a strict 
follow-up plan is established by a designated physician and a pharmaceutical chemist to 
verify medication intake and evaluate risk factors associated with non-adherence on an 
individual basis. From 2020 to 2023, 169 patients within the HIV program were prescribed 
TAF/FTC/BIC treatment. 
 
To date, few studies have been conducted in real-life conditions (19-22) to evaluate the 
effectiveness, safety, and clinical outcomes of TAF/FTC/BIC initiation, especially in 
patients at later stages of HIV, in everyday contexts. These outcomes are influenced by 
factors such as timely access to healthcare, follow-up, and proper adherence. No real-life 
studies have been conducted in Colombia, despite integrase inhibitors being the first-line 
treatment in the country and widely available as part of the mandatory health plan. 
Therefore, it is essential to evaluate the effectiveness, adherence, and clinical outcomes 
within our cohort. Generating our own data will allow us to create evidence with significant 
population impact. 
 
 
Theoretical framework 
Human Immunodeficiency Virus (HIV) is a retrovirus from the Retroviridae family, 

 
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specifically an enveloped positive-stranded RNA virus (5). There are two main types: HIV-
1, the most common worldwide, and HIV-2, which is more prevalent in West Africa (23). 
The virus is transmitted through bodily fluids such as blood, semen, vaginal secretions, 
and breast milk. Once inside the body, HIV primarily targets CD4+ T lymphocytes of the 
immune system, binding to CD4 receptors and one of the chemokine co-receptors, CCR5 
or CXCR4, to enter the host cell (6). This process of viral entry and replication leads to 
the progressive destruction of CD4+ T lymphocytes, resulting in severe immunodeficiency 
if not treated promptly (6,24). 
 
The molecular structure of HIV includes several key proteins. The virus is enveloped by a 
lipid membrane containing envelope glycoproteins (Env), specifically gp120 and gp41, 
which form a functional trimer. These glycoproteins are crucial for binding and fusion with 
host cells. Gp120 binds to the CD4 receptor on the surface of T lymphocytes, causing 
conformational changes that allow it to interact with the CCR5 or CXCR4 co-receptors, 
facilitating viral entry (25-27). 
 
Its genome is RNA-based and encodes 15 distinct proteins, including structural Gag 
proteins (MA, CA, NC, p6), Pol enzymes (protease, reverse transcriptase, integrase), and 
accessory and regulatory proteins such as Tat, Rev, Nef, Vif, Vpr, and Vpu (28). These 
proteins play critical roles in the viral life cycle, from entry to replication and assembly 
(26,28). While HIV-1 and HIV-2 share structural similarities, they also exhibit significant 
differences in their envelope glycoproteins, which influence their pathogenicity and 
immune response. For example, HIV-2 has lower pathogenicity and a greater capacity to 
induce neutralizing antibodies (29,30). These structural and functional characteristics are 
crucial for understanding the mechanism of infection and for developing therapeutic and 
prevention strategies, such as vaccines (25,26). 
 
Pathophysiology of HIV 
The pathophysiology of HIV involves a series of complex mechanisms that result in 

 
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progressive immunosuppression (31-33). The process begins with the binding of the HIV 
envelope glycoprotein to the CD4 receptor on the surface of CD4+ T lymphocytes and 
other cells, such as macrophages (31). This facilitates virus entry and replication within 
host cells. During primary infection, acute viremia occurs with extensive viral shedding, 
and the virus is sequestered in the germinal centers of lymphoid tissues (34). There is 
massive destruction of memory CD4+ T lymphocytes early in the infection, although this 
does not initially lead to overt immunodeficiency. However, over time, the regeneration of 
these cells proves insufficient, resulting in the failure of immune homeostasis and 
progression to AIDS (Acquired Immunodeficiency Syndrome) (32,33). 
 
In addition, chronic immune activation and immune dysfunction contribute significantly to 
the pathogenesis of the virus. Inappropriate activation of the immune system and the 
elevated secretion of proinflammatory cytokines regulate HIV expression in tissues (34). 
Infection of progenitor cells in the bone marrow and thymus also contributes to the 
impaired regeneration of immunocompetent cells (34). Furthermore, HIV causes direct 
damage to various tissues, such as the gut, brain, and lungs, through infection and 
activation of mononuclear cells (24). Systemic immune response activation and the 
destruction of lymphoid follicle integrity are hallmark features of pathogenic infection (35). 
 
Clinical Manifestations of HIV 
The clinical manifestations of HIV are varied and affect multiple systems due to the 
progressive immunosuppression and chronic immune activation that characterize the 
infection. HIV can be divided into several clinical phases, each with distinct characteristics: 
1. Acute infection: This phase occurs within the first few weeks after exposure to the 
virus. Symptoms may include fever, adenopathy, pharyngitis, rash, myalgias, and 
arthralgias. This phase resembles an acute viral syndrome and is often 
underdiagnosed (36,37). 
2. Chronic asymptomatic phase: Many patients enter a clinical latency phase that can 
last for several years. During this time, the virus continues to replicate and destroy 

 
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CD4+ T cells, but patients may remain asymptomatic (36,37). 
3. Advanced Immunosuppression and AIDS: As the infection progresses and CD4+ 
T-lymphocyte counts decline, patients become increasingly susceptible to 
opportunistic infections and neoplasms. Common opportunistic infections include 
Pneumocystis jirovecii pneumonia, esophageal candidiasis, cytomegalovirus 
disease, cerebral toxoplasmosis, and pulmonary or disseminated tuberculosis, 
among others. The prevalence of these infections varies depending on the degree 
of immunosuppression and the geographical region. Some neoplasms associated 
with HIV include Kaposi's sarcoma, non-Hodgkin's lymphoma, and invasive 
cervical cancer (24,36,37). 
4. Non-Infectious Manifestations: HIV is also linked to a range of non-infectious 
complications due to chronic immune activation and systemic inflammation. These 
include cardiovascular, hepatic, renal, bone, and neurological diseases. 
Cardiovascular disease in HIV patients may manifest as coronary artery disease, 
dilated cardiomyopathy, pulmonary hypertension, and endothelial dysfunction. 
Liver complications may involve virus-associated viral hepatitis and drug-induced 
hepatotoxicity, while renal dysfunction can present as HIV-associated nephropathy 
(37-39). 
5. Hematological Manifestations: These are common and may include anemia, 
leukopenia, and thrombocytopenia. These conditions may result from the direct 
infection of hematopoietic progenitor cells, bone marrow dysfunction, and 
activation of the reticuloendothelial system (40). 
6. Immune Reconstitution Inflammatory Syndrome (IRIS): In patients initiating ART, 
a paradoxical exacerbation of underlying infections may occur due to partial 
recovery of the immune system. IRIS can complicate clinical management and 
requires careful monitoring (24,41). In some cases, ART initiation should be 
postponed for a few weeks, especially when diagnosing opportunistic infections 
such as cytomegalovirus disease or meningeal cryptococcosis, to avoid 
exacerbation or worsening of symptoms, which can lead to considerable morbidity 

 
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and mortality. 
 
Diagnosis of HIV 
HIV diagnosis is performed using a combination of tests that detect viral RNA, p24 
antigen, and HIV-specific antibodies. This approach allows for the identification of both 
acute and chronic infections: 
1. HIV RNA: Detection of viral RNA is possible approximately 10-12 days after 
exposure to the virus, making this test particularly useful in the acute phase of 
infection, when antibodies are not yet detectable (23). 
2. p24 Antigen: The p24 antigen appears in serum or plasma about 15-17 days after 
exposure. Detection of p24 antigen is a key feature of fourth- and fifth-generation 
tests, which allow for the identification of infection before antibodies develop (5,23). 
3. Specific Antibodies: HIV antibodies (IgM and IgG) are detectable in serum or 
plasma approximately 21 days after exposure. Today, fourth-generation tests 
combine antibody detection with p24 antigen detection, improving sensitivity and 
enabling earlier detection of infection (5,42,43). 
 
The diagnostic algorithm recommended by the CDC in the United States begins with a 
laboratory antigen/antibody (Ag/Ab) combination test. If this test is reactive, it is followed 
by an antibody differentiation test to distinguish between HIV-1 and HIV-2. If the 
differentiation test is negative or indeterminate, a nucleic acid amplification test is 
conducted to confirm acute infection (43,44). In Colombia, there is also a diagnostic 
algorithm that begins with a first rapid test (ELISA, chemiluminescence, or molecular test). 
If the first test is reactive, a second test should be performed to confirm the diagnosis. In 
cases of discordance, a molecular test for RNA detection or the Western Blot technique 
can be used (45). 
 
HIV Treatment 
It is critical that HIV treatment be initiated as early as possible (45). There is substantial 

 
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medical evidence that early initiation of ART prevents complications related to 
immunosuppression and reduces mortality. Treatment requires lifelong ART, which has 
transformed a fatal disease into a manageable chronic condition. Modern ART consists of 
combinations of at least three drugs from two or more different classes, providing long-
lasting virologic suppression and improving clinical outcomes (46,47). Regimen selection 
is based on factors such as virologic efficacy, adverse effect profiles, pill burden, dosing 
frequency, drug-drug interactions, resistance test results, comorbidities, and cost (46). 
 
In low- and middle-income countries, access to this therapy remains uneven due to 
economic constraints, inadequate health infrastructure, and social stigmatization (48,49). 
Despite these challenges, global efforts have enabled millions of people in these regions 
to access life-saving treatment (49). However, significant barriers to achieving universal 
coverage remain, including the need for improved early detection and timely initiation of 
treatment (50). 
 
Recent innovations in ART include the development of drugs with improved safety and 
resistance profiles, as well as combination therapies that enhance adherence, such as 
single-tablet regimens and long-acting ARVs (46,47). These advances are particularly 
promising for improving adherence and reducing treatment burdens in low- and middle-
income countries (50). Additionally, research into curative therapies, such as latency 
reversal agents and gene therapy, is ongoing, although their implementation faces 
challenges due to differences in host genetics and viral subtypes (48,51). 
 
Bictegravir is a second-generation integrase strand transfer inhibitor (INSTI) used in HIV 
treatment. It is a key component of BikARVTy®, a fixed-dose regimen combining 
bictegravir, emtricitabine, and tenofovir alafenamide in a single daily tablet (52,53). This 
drug is notable for its high genetic barrier to resistance, meaning the virus is less likely to 
develop resistance to it compared to other INSTIs such as raltegravir and elvitegravir 
(54,55). It also has a limited drug-drug interaction profile, making it suitable for use in 

 
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combination with other antiretrovirals (52,56). 
 
In phase 3 clinical trials, the bictegravir/emtricitabine/tenofovir alafenamide regimen has 
been shown to be non-inferior to dolutegravir-based regimens in both treatment-naïve and 
treatment-experienced patients, achieving effective virologic suppression without the 
emergence of resistance (53,57,58). Additionally, it is well tolerated and does not require 
prior HLA-B*5701 testing, which facilitates its rapid initiation in HIV treatment (53,57). 
 
The most common adverse effects reported in clinical trials include diarrhea, nausea, and 
headache, with an incidence of at least 5% in treated subjects (59). Other less frequent 
adverse effects (≥2%) include fatigue, abnormal dreams, dizziness, insomnia, and 
abdominal distension (59). Regarding laboratory abnormalities, increases in serum 
creatinine, which stabilized throughout treatment, and increases in total bilirubin, mainly 
grade 1 and 2, were observed. Most adverse events were grade 1, and discontinuations 
due to adverse events were uncommon (59). Psychiatric events, such as suicidal ideation 
and depression, have also been reported, particularly in subjects with a history of 
psychiatric conditions. In subjects with end-stage renal disease, serious adverse events 
such as pneumonia and fluid overload were observed (59). 
 
 
Objectives 
General Objective: To estimate the clinical effectiveness and safety of HIV-positive 
patients on TAF/FTC/BIC treatment within an EPS in Colombia. 
Specific Objectives: 
• To characterize the sociodemographic and clinical profile of patients with HIV who 
initiate antiretroviral therapy with TAF/FTC/BIC. 
• To identify the proportion of patients who have been on different pretreatment 
regimens before initiating TAF/FTC/BIC therapy. 
• To assess the proportion of patients achieving virologic suppression at weeks 24 

 
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and 48 following the initiation of TAF/FTC/BIC therapy. 
• To determine the proportion of patients with effective access to TAF/FTC/BIC 
therapy. 
• To describe the impact of TAF/FTC/BIC treatment on CD4+ T-lymphocyte count, 
renal function, and lipid profile at weeks 24 and 48 after starting therapy. 
• To determine the proportion of patients with a rapid onset of TAF/FTC/BIC therapy. 
• To characterize the proportion of treatment-related adverse events at weeks 24 and 
48 after initiating TAF/FTC/BIC therapy. 
• To identify the proportion of patients meeting the criteria for adherence to 
TAF/FTC/BIC therapy. 
 
 
Methodology 
Study Design 
This is an observational, retrospective cohort study that will include adult patients who 
received treatment with TAF/FTC/BIC between January 2020 and December 2023. The 
study will include both treatment-naïve patients and those who have been previously 
exposed to other treatments. The index date will correspond to the initiation date of the 
drug, at which point baseline demographic and clinical characteristics will be recorded. 
 
Data Collection Plan/Source Documents 
SURA is one of Colombia's leading insurers and has an integrated network of care 
centers. The clinical and administrative records of all its affiliates are stored in a 
centralized digital information system, which includes both structured and unstructured 
data. Data collection will be conducted through a retrospective review of electronic 
medical records, using a pre-designed Excel database (with an institutional Office 
license). This database will include the variables defined in the project. The study will 
utilize secondary data collected from the electronic records generated for each patient 
during the provision of health services. The conversion of unstructured data into structured 

 
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data during the execution of the protocol will be done solely through automated/algorithmic 
methods on a computer. To ensure consistency and standardization, the template will be 
parameterized with predefined answers or options for each variable. These will be defined 
based on medical experience, the availability of information, and in accordance with the 
protocol’s guidelines. 
 
All data will undergo a cleaning process, evaluating four key aspects: consistency, 
completeness, validity, and uniformity. Consistency is checked to ensure that the data are 
coherent and that harmonized codes and labels are used. Completeness ensures that the 
data are fully filled out and ready for use. Validity verifies that the data meet the required 
standards and fall within the established range. Uniformity ensures that the data are not 
duplicated and cannot be confused with other entries. 
 
Subsequently, all relevant information will be extracted, creating a copy of the original 
record, which will be sent to the requester in tabular format (Microsoft Excel). The principal 
investigator or their delegate will import the Excel file into RStudio and Jamovi. 
Unstructured data will be obtained through a manual search of the patients' medical 
records, ensuring that the information is accurate, authentic, attributable, complete, 
consistent, legible, timely, and durable. These will be manually recorded in a flat file 
(Microsoft Access) and subsequently transferred to RStudio and Jamovi for analysis. 
 
The following ICD-10 codes are considered key data for searching patient medical 
records: 
• B200: HIV disease resulting in mycobacterial infection. 
• B201: HIV disease resulting in other bacterial infections. 
• B202: HIV disease resulting in cytomegalovirus disease. 
• B203: HIV disease resulting in other viral infections. 
• B204: HIV disease resulting in candidiasis. 
• B205: HIV disease resulting in other mycoses. 

 
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• B206: HIV disease resulting in Pneumocystis carinii pneumonia. 
• B207: HIV disease resulting in multiple infections. 
• B208: HIV disease resulting in other infectious or parasitic diseases. 
• B209: HIV disease resulting in unspecified infectious or parasitic disease. 
• B210: HIV disease resulting in Kaposi's sarcoma. 
• B211: HIV disease resulting in Burkitt's lymphoma. 
• B212: HIV disease resulting in other types of non-Hodgkin's lymphoma. 
• B213: HIV disease resulting in other malignant tumors of lymphoid, hematopoietic, 
and related tissues. 
• B217: HIV disease resulting in multiple malignant tumors. 
• B218: HIV disease resulting in other malignant tumors. 
• B219: HIV disease resulting in unspecified malignant tumors. 
• B220: HIV disease resulting in encephalopathy. 
• B221: HIV disease resulting in lymphoid interstitial pneumonitis. 
• B222: HIV disease resulting in cachectic syndrome. 
• B227: HIV disease resulting in multiple illnesses classified elsewhere. 
• B230: Acute HIV infection syndrome. 
• B231: HIV disease resulting in generalized lymphadenopathy (persistent). 
• B232: HIV disease resulting in immunologic and hematologic abnormalities, not 
elsewhere classified. 
• B238: HIV disease resulting in other specified conditions. 
• B24X: Human immunodeficiency virus (HIV) disease, not otherwise specified. 
• F024: Dementia in human immunodeficiency virus (HIV) disease (B22.0†). 
• Z21X: Asymptomatic human immunodeficiency virus (HIV) infection status. 
 
All information on the variables of interest will be extracted from the clinical records. The 
process of data collection and form completion will be carried out by personnel from the 
Clinical Research Unit, following training to ensure standardized data capture. Quality 

 
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control of the data will be performed, including the review of codes, missing data, and any 
incorrect or improperly transcribed characters, according to the variable, by the 
researchers before the dataset is purified for analysis. 
 
Study Population 
All patients who meet the defined selection criteria within the established time frame for 
the search will be included: 
• Inclusion Criteria: 
o Male or female patients aged 18 years or older. 
o Individuals with a confirmed HIV diagnosis. 
o Individuals enrolled in EPS SURA during the study period. 
o Patients receiving treatment with the TAF/FTC/BIC regimen. 
• Exclusion Criteria: 
o Patients with a concurrent diagnosis of tuberculosis. 
o Pregnant patients during the study period. 
o Patients with virologic failure. 
o Patients who started treatment with TAF/FTC/BIC but changed providers or 
discontinued treatment before completing six months of therapy. 
 
Variables 
Variable Name 
Definition 
Nature 
Measuring Level 
Primary diagnosis of HIV 
Patient with primary ICD-10 diagnosis of: 
B200, B201, B202, B203, B204, B205, B206, 
B207, B208, B209, B210, B211, B212, B213, 
B217, B218, B219, B220, B221, B222, B227, 
B230, B231, B232, B238, B24X, F024 or 
Z21X 
Qualitative 
Text 
Diagnosis date 
Date of first confirmed repeat HIV diagnosis 
recorded in the medical record 
Quantitative, 
continuous 
dd/mm/yyyy 
Date of birth 
Patient's date of birth 
Quantitative, 
continuous 
dd/mm/yyyy 
Sex 
Sex defined by patient's medical history 
Qualitative 
0: Female; 1: 
Male. 
Race 
Race defined by patient's medical history 
Qualitative 
Texto 

 
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Type of insurance 
Insurance from the health system to whom 
the patient is covered. 
Qualitative 
0: Public 
1: Private 
Residence department 
Department of Colombia where the patient 
lives 
Qualitative 
Text 
AHT 
Patient with hypertension marked in 
electronic medical record 
Qualitative 
0: No  
1: Yes 
Diabetes Mellitus 
Patient with diabetes marked in electronic 
medical record 
Qualitative 
0: No  
1: Yes 
Chronic kidney disease Patient with chronic kidney disease marked in 
electronic medical record 
Qualitative 
0: No  
1: Yes 
Hepatitis B co-infection 
Patient with repeated confirmed ICD-10 
diagnosis of B181 Chronic type B viral 
hepatitis, no delta agent from the date of HIV 
diagnosis to the end of follow-up. 
Qualitative 
0: No  
1: Yes 
Hepatitis C co-infection 
Patient with repeated confirmed ICD-10 
diagnosis of B182 Chronic viral hepatitis type 
C from the date of HIV diagnosis to the end 
of follow-up. 
Qualitative 
0: No  
1: Yes 
Major depressive disorder 
Patient with confirmed ICD-10 repeat 
diagnoses: F320, F321, F322, F323, F328, 
F329, F330, F331, F332, F333, F334, F338, 
F339, F340, F341, F348, F349, F380, F381, 
F388 or F39X from the date of HIV diagnosis 
to the end of follow-up  
Qualitative 
0: No  
1: Yes 
Start date TAF/FTC/BIC 
Medication start date TAF/FTC/BIC 
Quantitative, 
continuous 
dd/mm/yyyy 
End date TAF/FTC/BIC 
Medication end date TAF/FTC/BIC 
Quantitative, 
continuous 
dd/mm/yyyy 
NAIVE for TAF/FTC/BIC 
Patient whose first HIV treatment is 
TAF/FTC/BIC 
Qualitative 
0: No  
1: Yes 
ARVT scheme prior to 
TAF/FTC/BIC  
Name of ARVT scheme immediately 
preceding TAF/FTC/BIC used for HIV 
treatment 
Qualitative 
Text 
HIV viral load at baseline 
The patient has HIV viral load results at 
baseline (+ or - 4 weeks) of TAF/FTC/BIC 
therapy. 
Qualitative 
0: No  
1: Yes 
BHIV viral load at baseline 
value 
HIV viral load value at baseline (+ or - 4 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
HIV viral load at week 24 The patient has HIV viral load results at week 
24 (+ or - 2 weeks) of TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
HIV viral load value at 
week 24 
HIV viral load value at week 24 (+ or - 2 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
HIV viral load at week 48 The patient has HIV viral load results at week 
48 (+ or - 2 weeks) of TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
HIV viral load value at 
week 48 
HIV viral load value at week 48 (+ or - 2 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
CD4 Lymphocyte count at 
baseline 
The patient has CD4 Lymphocyte count 
results at baseline (+ or - 4 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
CD4 Lymphocyte count at 
baseline value 
CD4 Lymphocyte count value at baseline (+ 
or - 4 weeks) of therapy with TAF/FTC/BIC 
Cuantitativa, 
continua 
1, 1.5, 1.8, 2,… n 

 
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CD4 Lymphocyte count at 
week 24 
The patient has CD4 Lymphocyte count 
results at week 24 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
CD4 Lymphocyte count 
value at week 24 
CD4 Lymphocyte count value at week 24 (+ 
or - 2 weeks) of therapy with TAF/FTC/BIC 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
CD4 Lymphocyte count at 
week 48 
The patient has CD4 Lymphocyte count 
results at week 48 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
CD4 Lymphocyte count 
value at week 48 
CD4 Lymphocyte count value at week 48 (+ 
or - 2 weeks) of therapy with TAF/FTC/BIC 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
HDL at baseline 
The patient has high-density lipoprotein 
results at baseline (+ or - 4 weeks) of 
TAF/FTC/BIC therapy 
Qualitative 
0: No  
1: Yes 
HDL value at baseline 
High-density lipoprotein value at baseline (+ 
or - 4 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
HDL at week 24 
The patient has high-density lipoprotein 
results at week 24 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
HDL value at week 24 
High-density lipoprotein value at week 24 (+ 
or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
HDL at week 48 
The patient has high-density lipoprotein 
results at week 48 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
HDL value at week 48 
High-density lipoprotein value at week 48 (+ 
or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
LDL at baseline 
The patient has low-density lipoprotein 
results at baseline (+ or - 4 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
LDL value at baseline 
Low-density lipoprotein value at baseline (+ 
or - 4 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
LDL at week 24 
The patient has low-density lipoprotein HDL 
results at week 24 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
LDL value at week 24 
Low-density lipoprotein HDL value at week 
24 (+ or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
LDL at week 48 
The patient has low-density lipoprotein 
results at week 48 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
LDL value at week 48 
Low-density lipoprotein value at week 48 (+ 
or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
AST at baseline 
The patient has aspartate aminotransferase 
results at baseline (+ or - 4 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
AST at baseline value 
Aspartate aminotransferase value at baseline 
(+ or - 4 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
AST at week 24 
The patient has aspartate aminotransferase 
results at week 24 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
AST value at week 24 
Aspartate aminotransferase value at week 24 
(+ or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 

 
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AST at week 48 
The patient has aspartate aminotransferase 
results at week 48 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
AST value at week 48 
Aspartate aminotransferase value at week 48 
(+ or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
ALT at baseline 
The patient has alanine aminotransferase 
results at baseline (+ or - 4 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
ALT value at baseline 
Alanine aminotransferase value at baseline 
(+ or - 4 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
ALT week at 24 
The patient has alanine aminotransferase 
results at week 24 (+ or - 2 weeks) of 
TAF/FTC/BIC therapy. 
Qualitative 
0: No  
1: Yes 
ALT value week at 24 
Alanine aminotransferase level at week 24 (+ 
or – 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
ALT week at 48 
The patient has alanine aminotransferase 
results at week 48 (+ or - 2 weeks) of therapy 
with TAF/FTC/BIC. 
Qualitative 
0: No  
1: Yes 
ALT value at week 48 
Alanine aminotransferase value at week 48 
(+ or - 2 weeks) of therapy with 
TAF/FTC/BIC. 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Total bilirubin at baseline 
The patient has total bilirubin results at 
baseline (+ or - 4 weeks) of therapy with 
TAF/FTC/BIC. 
Qualitative 
0: No  
1: Yes 
Total bilirubin value at 
baseline 
Total bilirubin value at baseline (+ or - 4 
weeks) of therapy with TAF/FTC/BIC. 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Total bilirubin at week 24 
The patient has total bilirubin results at week 
24 (+ or - 2 weeks) of therapy with 
TAF/FTC/BIC. 
Qualitative 
0: No  
1: Yes 
Total bilirubin value at at 
week 24 
Total bilirubin value at week 24 (+ or - 2 
weeks) of therapy with TAF/FTC/BIC. 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Total bilirubin at week 48 The patient has total bilirubin results at week 
48 (+ or – 2 weeks) of TAF/FTC/BIC therapy 
Qualitative 
0: No  
1: Yes 
Total bilirubin value at 
week 48 
Total bilirubin value at week 48 (+ or – 2 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Serum creatinine at 
baseline 
The patient has baseline serum creatinine 
results (+ or – 4 weeks) of TAF/FTC/BIC 
therapy 
Qualitative 
0: No  
1: Yes 
Serum creatinine value at 
baseline 
Baseline serum creatinine value (+ or – 4 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Serum creatinine at week 
24 
The patient has serum creatinine results at 
week 24 (+ or – 2 weeks) of TAF/FTC/BIC 
therapy 
Qualitative 
0: No  
1: Yes 
Serum creatinine value at 
week 24 
Serum creatinine value at week 24 (+ or – 2 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Serum creatinine at week 
48 
The patient has serum creatinine results at 
week 48 (+ or – 2 weeks) of TAF/FTC/BIC 
therapy 
Qualitative 
0: No  
1: Yes 
Serum creatinine value at 
week 48 
Serum creatinine value at week 48 (+ or – 2 
weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 

 
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Glomerular filtration rate 
at baseline 
The patient has the estimated glomerular 
filtration rate (eGFR) by CKD-EPI at baseline 
(+ or - 4 weeks) of TAF/FTC/BIC therapy 
Qualitative 
0: No  
1: Yes 
Value of glomerular 
filtration rate at baseline 
Value of estimated glomerular filtration rate 
(eGFR) calculated by CKD-EPI at baseline (+ 
or - 4 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Glomerular filtration rate 
at week 24 
The patient has an estimated glomerular 
filtration rate (eGFR) calculated by CKD-EPI 
at week 24 (+ or - 2 weeks) of TAF/FTC/BIC 
therapy 
Qualitative 
0: No  
1: Yes 
Glomerular filtration rate 
value at week 24 
Value of estimated glomerular filtration rate 
(eGFR) calculated by CKD-EPI at week 24 (+ 
or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Glomerular filtration rate 
at week 48 
The patient has the estimated glomerular 
filtration rate (eGFR) calculated by CKD-EPI 
at week 48 (+ or - 2 weeks) of TAF/FTC/BIC 
therapy 
Qualitative 
0: No  
1: Yes 
Glomerular filtration rate 
value at week 48 
Value of estimated glomerular filtration rate 
(eGFR) calculated by CKD-EPI at week 48 (+ 
or - 2 weeks) of TAF/FTC/BIC therapy 
Quantitative, 
continuous 1, 1.5, 1.8, 2,… n 
Number of medication 
claims 
Number of TAF/FTC/BIC medication claims 
during the 48-week follow-up 
Quantitative, 
discrete 
1, 2, 3,… n 
Headache emergency 
The patient visited the emergency 
department during the period of 
TAF/FTC/BIC use for ICD-10 codes G444 
and/or G448 
Qualitative 
0: No  
1: Yes 
Diarrhea emergency 
The patient visited the emergency 
department during the period of 
TAF/FTC/BIC use for ICD-10 code A09X: 
Diarrhea and gastroenteritis of presumed 
infectious origin 
Qualitative 
0: No  
1: Yes 
Nausea and vomiting 
emergency 
The patient visited the emergency 
department during the period of 
TAF/FTC/BIC use for ICD-10 code R11X: 
Nausea and vomiting 
Qualitative 
0: No  
1: Yes 
Termination of health 
insurance coverage 
The patient terminated their health insurance 
with EPS SURA. 
Qualitative 
0: No  
1: Yes 
Date of termination of 
insurance coverage 
Date of termination of health insurance with 
EPS SURA 
Quantitative, 
continuous 
dd/mm/yyyy 
Death 
The patient passed away after the index date Qualitative 
0: No  
1: Yes 
Date of death 
Date of patient's death 
Quantitative, 
continuous 
dd/mm/yyyy 
 
Sample Size 
No sampling will be conducted, as data from the entire population (census) that meets the 
eligibility criteria for this study will be used. 
 

 
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Statistical Analysis 
The database created in Access will be transferred to RStudio and Jamovi for the 
corresponding descriptive analysis. 
 
Characterization of the Sociodemographic and Clinical Profile 
Absolute and relative frequencies will be calculated for categorical variables. For 
numerical variables, normality will be assessed using the Shapiro-Wilk test. 
Variables with a p-value greater than 0.05 will be considered to follow a normal 
distribution and will be represented by means and standard deviations. For variables 
that do not follow a normal distribution, medians and interquartile ranges will be used. 
 
Proportion of Pretreatment Regimens 
The proportion of patients who have received different combinations of ART prior to 
starting TAF/FTC/BIC will be calculated. Frequency tables will be used to display the 
proportion of each pretreatment regimen, supplemented by bar charts reflecting the 
frequencies of the most common treatments. 
 
Virologic Suppression at 24 and 48 Weeks 
Virologic suppression is defined as a viral load of <50 copies/mL at weeks 24 and 
48 of treatment. The proportion of patients achieving this threshold will be calculated 
at both time points, and the results will be compared between weeks 24 and 48 using 
McNemar’s test for related samples. 
 
Effective Access to Treatment 
Effective treatment is defined as the initiation of therapy within a reasonable time 
after prescription. The time between prescription and the initiation of treatment will 
be calculated (mean or median, depending on the normality test), and patients will 
be classified into two categories: those who initiate treatment effectively (within a 
short period, generally defined as initiation within 7-14 days of HIV diagnosis) and 

 
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those who experience delays. 
 
Paraclinical Results: CD4 T-Lymphocytes, Renal Function, and Lipid Profile 
To describe changes in clinical markers at weeks 24 and 48, the summary measure 
(mean or median, depending on the normality test) of baseline values will be 
compared with the values of these biomarkers at the two time points. Paired-samples 
t-tests or Wilcoxon tests will be used if the data distribution is non-normal. 
 
Rapid Onset of Therapy 
The frequency of patients meeting this criterion will be calculated, and the 
characteristics of those with rapid onset versus those without will be compared using 
the chi-square test. 
 
Treatment-Related Adverse Events 
Treatment-related adverse events at weeks 24 and 48 will be characterized and 
classified according to type and severity. The proportion of patients experiencing 
these events will be calculated and compared between the two time points. 
Contingency tables and chi-square tests will be used to analyze the relationship 
between adverse events and other clinical and sociodemographic variables. 
 
Adherence to Treatment 
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 (64,65). In this study, patients with 
a PDC of 80% or higher will be considered to have adequate adherence. However, 
studies have shown that even lower adherence levels can still result in a high rate of 
viral suppression. 
 
 

 
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Biases 
The following biases are considered potential risks in this study: 
• Information Bias: This refers to errors introduced during the measurement of 
exposure, events, and other variables in the study population, which, if present, 
may lead to erroneous conclusions regarding the hypothesis being investigated. In 
this study, data obtained from secondary sources such as medical records may not 
fully or accurately capture the information of interest. To control for this bias, a 
random review of at least 10% of the clinical histories will be conducted, and the 
information recorded in the database will be cross-referenced with that found in the 
clinical records. 
• Loss to Follow-up Bias: Loss of participants throughout the study may introduce bias, 
as the selection of participants is not random. 
 
 
Statement on the Application of Ethical Principles in Research 
In accordance with Resolution 8430 of 1993, this study is classified as risk-free: it involves 
retrospective documentary research techniques and methods, with no intervention or 
intentional modification of the biological, physiological, psychological, or social variables 
of individuals. The study will be conducted through the review of medical records and will 
be submitted for approval to the SURA Ethics Committee. 
 
The use of medical records will be in compliance with Resolution 1995 of 1999, ensuring 
data protection and confidentiality of the information collected. Furthermore, a 
confidentiality agreement has been signed for academic projects, establishing compliance 
with legal provisions. This agreement confirms that access to personal data and 
confidential information from medical records will be provided, data which are considered 
sensitive under the "habeas data" law. The dissemination of this information could affect 
the privacy of the data owner. Therefore, all provisions outlined in this document will be 
strictly adhered to. 

 
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Timeline 
 
Activity/Month 
1 
2 
3 
4 
5 
6 
Phase 1: 
Research protocol 
writing 
 
 
 
 
 
 
Phase 2: 
Submission to IRB 
 
 
 
 
 
 
Phase 3: Execution 
(analysis and 
structuring of 
results and 
discussion) 
 
 
 
 
 
 
Phase 4: 
Technical report 
writing and closing 
to IRB 
 
 
 
 
 
 
Phase 5: Writing of 
publication-type 
manuscript and 
submission to 
journal and 
conference 
 
 
 
 
 
 
 
 
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