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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Hospital Clínic de Barcelona
Barcelona, Spain
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
Time frame: week 4
Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.
Time frame: week 4
Days since first HIV test was performed until Biktarvy is initiated.
Time frame: week 4
Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
Time frame: week 4
Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: week 24 and week 48
Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
Time frame: week 24 and week 48
Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
Time frame: week 48
Proportion of patients with treatment-related adverse events during the study period.
Time frame: week 48
Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
Time frame: week 48
Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
Time frame: week 48
Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.
Time frame: week 48