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: Routine medical care was drastically affected by the overwhelming irruption of COVID-19 pandemic. We comprehensively assessed the impact of the COVID-19 pandemic on the prevention and care for HIV and other sexually transmitted infections at a large reference hospital providing preventive and clinical services for HIV infection and other sexually transmitted infections. Methods: We retrospectively compared clinical and laboratory data from March to December 2020 (first ten months of the SARS-CoV-2 epidemics in Spain) vs. the same period 2019 in the setting of Hospital Clínic of Barcelona which provides preventive and clinical services for HIV infection and other sexually transmitted infections for the region of Catalonia and is the largest of its kind in Spain. Monthly clinical data on HIV pre-exposure and post-exposure prophylaxis users and on adults with HIV infection were retrieved from the administrative hospital database. Monthly tests for HIV, hepatitis B and C, Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis, and plasma lipids and glucose were recovered from the laboratory database. De novo HIV, hepatitis B, or hepatitis C diagnosis were considered whenever a person had a first known positive laboratory test. Results: There were less (28% reduction) but more advanced (mean [SD] CD4 cell counts per mm3 at HIV diagnosis 305 [167] vs. 370 [170], P<0.001;26 (18%) persons had AIDS-defining conditions at HIV diagnosis vs. 20 (10%), P=0.03) HIV cases and more gonorrhea (39% increase, P<0.001) and chlamydia (37% increase, P<0.001) infections in 2020 vs. 2019. In people with HIV, rates of viral load above the level of detection remained stable (11% vs 11%, P=0.147) despite less scheduled visits (25% reduction, P<0.001). However, they had less antiretroviral prescription changes (10% reduction, P=0.018), worse plasma lipids (mean total cholesterol 190 vs 185 mg/dL, P<0.001;mean LDL cholesterol 114 vs 110 mg/dL, P<0.001;mean triglycerides 136 vs 125 mg/dL, P<0.001;mean HDL cholesterol 47 vs 48 mg/dL, P=0.006), and an excess of mortality (29 deaths vs 11, 264% increase, P=0.006) due in great part to COVID-19 (n=11) but also to other non-COVID-19 causes. Conclusion: In the setting of a large Spanish reference hospital, SARS-CoV-2 epidemics was associated with an increase of some prevalent sexually transmitted infections, with less but more advanced de novo HIV infections, and with worse non-virologic healthcare outcomes and higher mortality in people living with HIV.