Background and importance Bictegravir (BIC), a second generation integrase strand transfer inhibitor, approved for HIV treatment in fixed dose combination with emtricitabine (FTC) and tenofovir alafenamide (TAF), has potent antiviral activity in vitro to wild-type virus.
Aim and objectives To assess the virological and immunological efficacy and to evaluate safety at 24 weeks of BIC/FTC/TAF in naive patients and patients switching to BIC/FTC/TAF, and to analyse, by subgroup, the results in the switch group.
Material and methods This was a multicentre, observational, retrospective study in naive patients and patients switching to BIC/FTC/TAF in 2019, treated for at least 24 weeks. At the beginning of the study, population data (sex and age) and analytical data were collected at baseline and at 24 weeks: viral load (VL), CD4 lymphocytes and any adverse event (AE) produced by BIC/FTC/TAF.
Results During the study period, 95 patients were included: 25 naive (76% men) with an average of 40 years and 70 patients who switched (66% men) with an average of 43 years.
Results for immunovirological efficacy were
naïve group: median VL and CD4 at the beginning were 764 026 copies/mL and 402 cells/mL, respectively. After 24 weeks, 22 (88%) patients had undetectable VL (<50 copies/mL) and the remaining 12% failed due to poor adherence. Adherence was reinforced for them and in the next analysis they had undetectable VL. The median CD4 with undetectable VL was 736 cells/mL.
switched group: median VL and CD4 lymphocytes at baseline were 120 413 copies/mL and 639 cells/mL, respectively. After 24 weeks, 65 (93%) patients had undetectable VL with median CD4 lymphocytes in these patients of 728 cells/mL.
Results for immunovirological efficacy wereIn total, there were four patients (4.2%) who had insomnia during treatment with BIC/FTC/TAF. Also reported were: 3 (3.2%) patients with headache, 1 (1.1%) patient with osteoarticular pain, 1 (1.1%) patient with increased menstrual bleeding and 1 (1.1%) patient with gastrointestinal pain. None of these AE was a reason for treatment interruption.
Conclusion and relevance BIC/FTC/TAF was safe (mild AE with a low incidence rate) and effective (high percentages of undetectable VL and good results for CD4 lymphocytes).
Conflict of interest No conflict of interest
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