Abstract
OBJECTIVE: Among the new antiretroviral treatment (ART) regimens, bictegravir (BIC) stands out, a recently incorporated integrase inhibitor. BIC conjugated with emtricitabine (FTC) and tenofovir alafenamide (TAF) has been shown to be non-inferior in efficacy as initiation therapy in a single daily dose regimen compared to other initiation ART. The objective of our study is to evaluate the impact of the inclusion of this new ART scheme in real clinical practice. METHODS: Observational, retrospective and descriptive study that included all adult HIV patients (age ≥18 years) who had been treated with BIC/FTC/TAF for at least 24 consecutive weeks for 1.5 year to evaluate effectiveness, safety and economic impact. RESULTS: A total of 115 patients were included. There were 28 patients without previous treatment, naive, (24.3%). The pretreated patients had a mean of 42±9 months of prior ART. The percentage of patients at week 24 after switching to BIC/FTC/TAF with suppressed plasma viral load was 88% in the naive group and 94.1% in the pretreated group. Adverse events were reported in 8 (7%) patients. The economic impact of the change to BIC/FTC/TAF for these patients was €1,202.63/patient/year, representing an increase of 9.3%. CONCLUSIONS: Our results correlate with the results of two phase 3 non-inferiority clinical trials in naive patients (88% and 84%) and those of a phase 3 non-inferiority clinical trial in pretreated patients (86%). However, we found a large difference between the high percentages of patients reporting an adverse event in three phase 3 clinical trials and our results.