Study to assess bone health with bone mineral density, bone microarchitecture and bone tissue quality after switching from a TDF regimen to Bictegravir-TAF-FTC

INTERVENTION: Trade Name: Biktarvy Product Name: Biktarvy Product Code: EMEA/H/C/004449 Pharmaceutical Form: Pastille INN or Proposed INN: BICTEGRAVIR Current Sponsor code: BIC Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Concentration number: 50‐ INN or Proposed INN: TENOFOVIR ALAFENAMIDE CAS Number: 379270‐37‐8 Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Concentration number: 25‐ INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: Bq/mg becquerel(s)/milligram Concentration type: equal Concentration number: 200‐ Trade Name: Atripla Pharmaceutical Form: Tablet INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138‐50‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ INN or Proposed INN: Efavirenz Other descriptive name: EFAVIRENZ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Trade Name: Stribild Product Name: Stribild Pharmaceutical Form: Tablet INN or Proposed INN: Elvitegravir CAS Number: 697761‐98‐1 Other descriptive name: ELVITEGRAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ INN or Proposed INN: COBICISTAT CAS Number: 1004316‐88‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ INN or Proposed INN: TENOFOVIR DISOPROXIL Other descriptive name: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: EVIPLERA Pharmaceutical Form: Tablet INN or Proposed INN: RILPIVIRIN CAS Number: 700361‐47‐3 Other descriptive name: RILPIVIRINE HYDROCHLORIDE Concentr CONDITION: Bone health (bone mineral density, microarchitecture and bone quality) in HIV individuals under antiretroviral treatment with tenofovir disoproxil fumarate (TDF) that change treatment to bictegravir‐tenofovir alafenamide‐emtricitavin (BIC) Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] SECONDARY OUTCOME: Secondary end point(s): ‐ Compare the differences between the two groups with respect to the baseline value in Week 48 in bone mineral density of the lumbar (L2 ‐ L4) and hip.; ; ‐ Compare between the two groups the differences in bone microarchitecture at week 48 by means of Trabecular Bone Score (TBS). Timepoint(s) of evaluation of this end point: Initial visit: treatment change or persistence will be prescribed according to the randomization. Analytical + Densitometry + Microindentation; Week 24: Analytical + Densitometry + Microindentation; Week 48‐ Analytical + Densitometry + Microindentation INCLUSION CRITERIA: ‐ Treated Adult patients for HIV, virologically suppressed during a regimen containing TDF for more than 48 weeks, regardless of the BMD values Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10 PRIMARY OUTCOME: Main Objective: To study three components of bone resistance (density, microarchitecture and microindentation) in HIV patients on antiretroviral treatment who change treatment to Biktarvi against patients who continue in the same treatment. Primary end point(s): The primary endpoint of this study is an assessment of bone quality through microindentation. A decrease of =1% at 24 weeks will be established as a criterion for worsening bone quality. Secondary Objective: 1. Compare the differences in bone tissue quality (BMSi) by microindentation between the group that changes to Biktarvy and the one that follows the pattern prior to week 24 and week 48.; ; 2. Compare the differences between the two groups with respect to the baseline value in Week 48 in bone mineral density of the lumbar (L2 ‐ L4) and hip.; ; 3. Compare the differences in bone microarchitecture to week 48 between the two groups by means of the Trabecular Bone Score (TBS). Timepoint(s) of evaluation of this end point: Initial visit: treatment change or persistence will be prescribed according to the randomization. Analytical + Densitometry + Microindentation; Week 24: Analytical + Densitometry + Microindentation; Week 48‐ Analytical + Densitometry + Microindentation