ABSTRACT
Introduction: BICSTaR (GS-EU-380-4472/GS-CA-380-4574/GS-IL-380- 5335) is an ongoing, multinational, observational cohort study evaluating real-world effectiveness and safety of B/F/TAF in ART naïve (TN) and ARTexperienced (TE) PLWH. Materials and Methods: This 12M pooled analysis included PLWH starting B/F/TAF in clinical practice from June 2018 to September 2020 (latterly during the COVID-19 pandemic) in Europe/Israel/Canada. Outcomes included virological effectiveness (HIV-1 RNA <50 copies/ml [missing=excluded]), persistence, drug-related adverse events (DRAEs), and laboratory parameters. Results: One-thousand one hundred thirty-five PLWH were included (Table 1). The TE group had older median age than TN. Of TE participants, 65%/20%/16% switched from INSTI/NNRTI/PI-based regimens (36% TDF/46% TAF/13% ABC);12% had prior virologic failure. Baseline resistance was documented in 124/535 participants (NRTI/NNRTI/PI/ INSTI=6%/6%/3%/0.2%). Prevalence of comorbidities (47%/72% TN/TE) and concomitant medication usage was high. At 12M, 97% (149/154) of TN and 96% (771/800) of TE participants had HIV-1 RNA <50 copies/ml, and persistence on B/F/TAF was high [91% (1032/1135)]. In a multivariable analysis, TE participants with neuropsychiatric disorder ongoing at baseline had lower odds for viral suppression (odds ratio=0.45, 95% CI: 0.21-0.96). There was no emergence of resistance to the components of B/F/TAF. DRAEs occurred in 13% (148/1135) of participants;gastrointestinal and neuropsychiatric DRAEs were the most common (3% each). Discontinuations due to DRAEs were low (TN 4%;TE 6%). Serious DRAEs were rare (0.2%;2 TE participants with depression). Lipidchanges are shown (Figure 1). Conclusion: B/F/TAF was associated with high levels of effectiveness and persistence after 12M in this large real-world cohort of TN and TE PLWH with a high comorbidity burden. Effectiveness was demonstrated across key subgroups (females, older participants, late presenters). Importantly, there were no new or unexpected safety findings. Collectively, these real-world data continue to support the use of B/F/TAF in clinical practice.
ABSTRACT
Background and Aim: We evaluated the effect of CoViD-19 on the therapy of type 2 diabetic CoViD-19 inpatients (T2DM) during a 3-month period (between November 2020 and February 2021). Materials and Methods: We evaluated 432 in-patients all affected with CoViD-19 pneumonia and T2DM. They were 337 male (78%) and 95 female (22%) with mean age 70± 5 yrs and HbA1c 9±0.7%. Their diabetic therapy, along with antibiotic and steroid therapy was always switched to a basAl bolus regimen wheter they used at home oral, incretin or insulin therapy. Results: The T2DM CoViD-19 pneumonia inpatients had a BMI 28±3 kg/sm and an average of total insulin daily dosage (TDD) at hospitalization of 54±7 IU/day and at discharge of 77±8 IU/day. Initially at hospitalization we performed an i.v insulin infusion protocol to achieve blood glucose values <200 mg/dl for at least 48 hrs in195 pts (45%). The switch to basal bolus insulin therapy was made on the 3rd day of hospitalization. The major amount of insulin was administered before lunch and supper (both covering 40% of TDD) with 20% of TDD at night as basal. The major cause of this increase (40%) of TDD is in part due to the inflammatory state and partly to steroid therapy. We didn't detect any hypoglycemia. Conclusions: We were forced to use an enormous amount of insulin, both iv and on basal bolus regimen to achieve a slight blood glucose control. The need to further evaluate for inpatients the use of other drugs (GLP1-RA) combined to insulin regimen seems appropriate.
ABSTRACT
A coronavirus disease 2019 (COVID-19) surveillance study was performed in March-April 2020 among asymptomatic healthcare workers (HCWs) at a specialist infectious diseases hospital in Naples, Italy. All HCWs underwent two rounds of molecular and serological testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). One hundred and fifteen HCWs were tested; of these, two cases of infection were identified by reverse transcriptase polymerase chain reaction and two HCWs were SARS-CoV-2 immunoglobulin G seropositive. The overall prevalence of current or probable previous infection was 3.4%. The infection rate among HCWs was reasonably low. Most of the infected HCWs had been asymptomatic for the preceding 30 days, which supports the need for periodic screening of HCWs for COVID-19.