The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection
After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including: * complete physical examination * register concomitant medication * blood test * concomitant medications * assessment od adverse events * assessement of compliance * PSQI and CESTA questionnaire (week 4 and 48) * Recommendation in contraception methods * Stool sample and pregnancy test urine (week 0 and 48) The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL
Hospital Clinic
Barcelona, Spain
RECRUITINGPortion of patients with a VL (viral load)< 50 Copies at week 48
Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL\< 50 copies at 48 week in the intention to treat population determined by PCR
Time frame: 48 weeks
Viral Load at 4,8,12,24 y 48 weeks
Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
Time frame: weeks 4,8,12,24,48
Portion of patients with > 900 cells CD4+
Proportion of patients with \>900 cells CD4+
Time frame: weeks 24 and 48
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation
Time frame: week 48
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL\<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens
Time frame: week 48
AE (adverse event) leading to discontinuation rate
AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
Time frame: week 48
CD4, CD4/CD8 ratio
CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
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Time frame: weeks 4,8,12,24,48
AE rate
AE rate (overall and AE leading to discontinuation)
Time frame: week 48
Number of required regimen changes
Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).
Time frame: week 48
Quality of life and satisfaction: questionnaire
Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period
Time frame: day 0, week 4 and 48
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Time frame: weeks 0,48