A Test and Treat Strategy in New HIV Diagnosis.

Study Overview
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Brief Summary
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This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.

Official Title
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A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Biktarvy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old. Having confirmed HIV-1 positive test. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months). Clinically stable patients, in the opinion of the investigator, at the time of inclusion. Women of child-bearing potential* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Written informed consent. Exclusion Criteria: Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation. Known hypersensitivity or intolerance of any of the components of Biktarvy®. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication). Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label, single arm, single-centre prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biktarvy<br>This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. | Drug: Biktarvy<br>* Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4 | Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4: Presence of HLA-B* 5701 or lack of HLA test Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment CD4 count < 200 cells/mm3 Viral load > 100.000 copies/mL Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score > 10% at 10 years, Kidney function (eGFR <50mL/min), Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI) Hepatitis B (HBV) coinfection or lack of serology | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit. |  | week 4 | 
| Days since first HIV test was performed until Biktarvy is initiated. |  | week 4 | 
| Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated. |  | week 4 | 
| Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks. |  | week 4, week 12, week 24 and week 48 | 
| Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks. |  | week 24 and week 48 | 
| Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks. |  | week 48 | 
| Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks. |  | week 24 and week 48 | 
| Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks. |  | week 24 and week 48 | 
| Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks. |  | week 48 | 
| Proportion of patients with treatment-related adverse events during the study period. |  | week 48 | 
| Proportion of patients who discontinue study treatment due to adverse events at 48 weeks. |  | week 48 | 
| Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period. |  | week 48 | 
| Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks. |  | week 48 |