Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir.

INTRODUCTION: Integrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC. MATERIALS AND METHODS: Consecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance. RESULTS: Five hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1-2 weight gain. CONCLUSIONS: In ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ART-naïve PLWH, blood lipids increased even though lipid profile did not worsen, and a trend towards normalization of liver enzymes was suggested. FTC/TAF/BIC is well tolerated in the real life setting.

Serial QuantiFERON TB-gold in-tube testing during LTBI therapy in candidates for TNFi treatment.

OBJECTIVES: To evaluate the T-cell interferon (IFN)-γ response to Mycobacterium tuberculosis-specific antigens during latent tuberculosis infection (LTBI) therapy in candidates for tumor necrosis factor-α inhibitors (TNFi). METHODS: 1490 Patients were screened for LTBI. One-hundred and sixty-six of them were treated for LTBI and followed-up with QuantiFERON-TB Gold (QFT-IT) testing at baseline (T0) and therapy completion (T1); 92 subjects were also tested 3-6 months after therapy completion (T2). RESULTS: At T1 the QFT-IT reversion and conversion rates were 24% (27/111) and 18% (10/55), respectively. By multivariate analysis, the likelihood of reversion significantly decreased with older age (>50-60), larger TST size (>15 mm) and higher IFN-γ value at T0 (>1 IU/ml); the likelihood of conversion increased with higher IFN-γ levels at T0 (1 IU/ml) and in female patients. Quantitative data among those who scored QFT-IT-positive at T0 showed a decreasing trend of IFN-γ levels between T0 and T1 that reached statistical significance when T0 was compared to T2, and T1 to T2. CONCLUSIONS: The data confirm the difficulty of interpreting the modulation of IFN-γ levels during LTBI therapy. Currently, there is no evidence to support the use of QFT-IT in the clinical practice of monitoring LTBI treatment in candidates for TNFi.