Maddalena Giglia

Introduction. Clinical trials and observational studies of co-formulated regimens bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and doravirine/lamivudine, tenofovir disoproxil fumarate (DOR/3TC/TDF) demonstrated potent efficacy in both antiretroviral therapy-naive and -experienced patients, but data on efficacy in naive people with high-level Human Immunodeficiency Virus (HIV) viraemia are still lacking. Hypothesis. BIC/F/TAF and DOR/3TC/TDF have comparable effectiveness in naive people with high-level viraemia. Aim. To compare the effectiveness of BIC/F/TAF and DOR/3TC/TDF in naive people with high-level viraemia. Methodology. We performed a retrospective cohort study of adult people living with HIV, who were naive to antiretroviral therapy, had baseline HIV-1 RNA > 500,000 copies ml ⁻¹ and initiated the co-formulated regimen BIC/F/TAF or DOR/3TC/TDF. Virological efficacy, changes in immunological parameters and safety profiles after 12 months of treatment were evaluated. Results. Inclusion criteria were met by 78 patients: 43 in the BIC/F/TAF group and 35 in the DOR/3TC/TDF group. Baseline characteristics were similar in both groups: median age was 45.2 years, median HIV RNA was 5.95 log ₁₀ , median CD4 T lymphocyte count was 383 cells mm ⁻³ and 22 patients (28%) had HIV RNA >10 ⁶ copies ml ⁻¹ . After 12 months, virological efficacy was comparable: HIV RNA −1 was obtained in 40 patients (93%) in the BIC/F/TAF group and in 31 (89 %) in the DOR/3TC/TDF group. The median increase in CD4 T lymphocyte count was comparable between groups (+139 and +117 cells mm ⁻³ , respectively), such as incidence of adverse events, while median increase in low-density lipoprotein cholesterol and weight gain was significantly greater in the BIC/F/TAF group (weight change, +1.64 kg vs. +0.85 kg; P =0.013). Conclusion. In this real-life cohort, BIC/F/TAF and DOR/3TC/TDF showed high and comparable virological efficacy in naive patients with baseline HIV RNA above 500,000 copies ml ⁻¹ .

Background: Dual regimen dolutegravir/lamivudine (DOL/3TC) showed potent efficacy and favorable safety in both antiretroviral therapy-naive and therapy-experienced patients, but data from real life about naive people with high-level viremia are still lacking. Methods: We performed a retrospective cohort study of people living with HIV who were naive to antiretroviral therapy, had baseline HIV-1 RNA ranging from 100,000 to 500,000 copies/mL, and initiated DOL/3TC. Virologic efficacy and changes in immunologic parameters after 12 months of treatment were evaluated and compared with highly viremic people living with HIV who started a triple antiretroviral combination. Results: Inclusion criteria were met by 58 patients with median age of 43.4 years. At baseline, mean HIV RNA was 5.4 log₁₀ and mean CD4 T lymphocyte count was 488 cells/mm³. HIV RNA <50 copies/mL was obtained in 45 patients (77.6% in the intention-to-treat analysis) after 6 months and in 53 patients (91.4%) after 12 months. Reasons for treatment failure were virologic failure in 2 cases and adverse events in 3 cases. No significant changes in median value of lipids were reported, while there was a not significant increase in body weight (+1.18 kg). Virologic and immunologic response at month 12 in patients on DOL/3TC was comparable with that observed in 50 naive patients with high-level viremia and starting a triple antiretroviral therapy. Conclusions: In this real-life cohort of naive patients with high-level viremia, DOL/3TC was associated with high virologic efficacy and good tolerability after 12 months, supporting use of this dual regimen also in persons with high initial viremia.

Background: Clinical interpretation of trace results by Xpert MTB/RIF Ultra assay (Ultra) used as an initial diagnostic test for tuberculosis (TB) may be challenging. The aim of the study was to evaluate the frequency and epidemiology of trace readouts in routine clinical practice in a low TB prevalence setting and to propose guidance on how to manage patients with trace calls considering the data available (clinical, radiological, bacteriological etc.).Materials and methods: A retrospective, observational, monocentric study was conducted at IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy between November 2017—December 2020. Presumptive TB patients with at least one Ultra trace result during diagnostic workup before treatment were included in the study. Patients with ongoing anti-TB treatment at the time of the trace call result or with no clinical data available were excluded from the study.Results: Fifty-nine presumptive TB patients with Ultra trace readouts were included in the study (mean age 37.0 years, 61% males). Four patients had a history of TB in the last 2 years. Twenty-five (42.4%) of the 59 samples with trace results were respiratory material. 57/59 (96.6%) patients started anti-TB treatment soon after obtaining trace results, based on clinical, radiological or other information available, while for two patients with a recent history of TB the trace result did not lead to anti-TB treatment. Culture was positive forM.tuberculosisfor 31/59 (52.5%) samples with trace calls: 13/25 (52.0%) were respiratory samples and 18/33 (54.5%) non-respiratory samples. The clinical and/or radiological findings of 47/57 (82.4%) patients given anti-TB therapy improved during treatment.Conclusion: In low TB incidence settings, Ultra trace calls in presumptive TB patients should be considered as true-positive and treatment should be started promptly, except in cases of recent history of TB, where careful evaluation of other diagnostic criteria is necessary before starting anti-TB treatment. A decisional algorithm for clinical management is proposed.

We report the case of a man affected by cystic fibrosis who developed a severe SARS-CoV-2 related pneumonia in March 2020. In addition to lopinavir/ritonavir and hydroxychloroquine, he was treated with two doses of tocilizumab, displaying a significant clinical improvement. This is the first case described in the literature of an adult patient affected by cystic fibrosis who received tocilizumab for COVID-19, with documented total recovery, also assessed by a spirometry.