Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients

Abstract

Introduction. 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. Material and 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.

Clinical efficacy, safety, and subjective experience based on ePRO in HIV-infected individuals administered bicetivir, entatabine, and propofol tenofovir in southwest China

“…After starting antiretroviral therapy, CD4 count increased while CD8 count decreased [16]. In this study, at week 24 of BIC + FTC + TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC + FTC + TAF, corroborating previous studies [12][13][14][15]17].…”

“…In this study, 3 treatment-naïve and 8 treatment-experienced patients had virological failure at week 24; 10 (31.3%) of the 32 treatment-naïve patients had a baseline viral load > 500000 copies/mL, and 7 had a VL < 50 copies/mL at week 24, consistent with previous ndings [12][13][14][15].…”

Clinical efficacy, safety, and subjective experience based on ePRO in HIV‐infected individuals administered Bictegravir/Emtricitabine/Tenofovir Alafenamide in southwest China

“…11 In this study, three ART-naïve and eight ARTexperienced patients had virological failure at Week 24; 10 (31.3%) of the 32 ART-naïve patients had a baseline viral load >500,000 copies/mL, and 7 had a VL < 50 copies/mL at Week 24, consistent with previous findings. [12][13][14][15] After starting ART, CD4 count increased while CD8 count decreased. 16 In this study, at Week 24 of BIC/FTC/ TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies.…”

“…16 In this study, at Week 24 of BIC/FTC/ TAF treatment, CD4 count in patients increased, indicating improved immune function after ART with BIC/FTC/TAF, corroborating previous studies. [12][13][14][15]17 In patients with HIV and associated comorbidities, simplified medication regimens can reduce drug interactions and decrease the risk of renal dysfunction. In this study, 84.4% of patients with no previous ART and 78.5% of those with ART experience were younger than 45 years old.…”

Temporal evolution of antiretroviral therapy (2017-2021): analysis of treatment change and its economic impact

“…Como se ha mencionado anteriormente, en este año apareció bictegravir/ emtricitabina/tenofovir alafenamida, un nuevo coformulado como pauta preferente, este fármaco no solo cobró importancia como prescripción de 1ª línea, sino que representa el esquema preferente de cambio en el periodo de años 2019-2022. En el estudio de Guitérrez-lorenzo M et al [ 18 ], llevado a cabo entre 03/2019-10/2020, destacan como el cambio a BIC/ FTC/TAF supuso un aumento económico del 9,3%. En nuestro estudio el aumento observado en 2019 podría justificarse por los cambios realizados a BIC/FTC/TAF, así como al coformulado DRV/c/FTC/TAF, que apareció a mediados del 2018 y el cual, a pesar de no ser una pauta preferente, parece la preferida cuando se quiere cambiar a un esquema basado en inhibidores de la proteasa como se observa en la tabla 2 .…”