Population and study design
virologic failure, VF, neoplasia, chronic kidney disease
NEOPLASIA, MALABSORPTION SYNDROME, BONE DISEASES, LIVER DISEASE
This is a pilot open-label, randomized, unicenter, 24-week clinical trial conducted that was carried out in a university hospital in Barcelona, Spain between July 2019 to June 2020. This study enrolled HIV-1- positive adults who were virologically suppressed on any TDF (tenofovir disoproxil fumarate plus emtricitabine plus a third drug) based approved 3-drug regimen for at least 48 weeks and were randomly assigned (1:1) to receive bictegravir 50mg plus tenofovir alafenamide 25 mg and emtricitabine 200mg (TAF) for 24 weeks or continue their baseline disoproxil fumarate based regimens.Inclusion criteria were age ≥18 years, ≥2 HIV-1 RNA measurements <50 copies/mL within 48 weeks of study entry, and a screening HIV-1 RNA <20 copies/mL. We considered as ineligible a history of virologic failure (VF) after 1 year of treatment, pretreatment reverse transcriptase (RT) resistance mutation, or known integrase resistance mutations, and those individuals who had previously received treatments that might have affected the bone quality, such as systemic glucocorticoids or anti-osteoporotic medications. We also excluded individuals who had previously been diagnosed with chronic kidney disease, chronic endocrine conditions, malabsorption syndrome, advanced liver disease, neoplasia, and bone diseases.