Cobicistat Versus Ritonavir as a Pharmacoenhancer of Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV Type 1-Infected Patients: Week 48 Results

Background. Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity in vitro. Methods. An international, randomized, double-blind, double-dummy, active-controlled trial was conducted to evaluate the efficacy and safety of COBI versus ritonavir (RTV) as a pharmacoenhancer of atazanavir (ATV) in combination with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in treatment-naive patients. The primary end point was a human immunodeficiency virus type 1 (HIV-1) RNA load of 100 000 copies/mL, rates were similar (86% vs 86%). Similar percentages of patients in both groups had serious adverse events (10% of COBI recipients vs 7% of RTV recipients) and adverse events leading to discontinuation of treatment with the study drug (7% vs 7%). Median increases in the serum creatinine level were 0.13 and 0.09 mg/dL, respectively, for COBI and RTV recipients. Conclusions. COBI was noninferior to RTV in combination with ATV plus FTC/TDF at week 48. Both regimens achieved high rates of virologic success. Safety and tolerability profiles of the 2 regimens were comparable. Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor ATV. Clinical Trials Registration. NCT0110851

Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial

Idiopathic pulmonary fibrosis is a fatal disease for which no effective treatment exists. We assessed whether treatment with interferon gamma-1b improved survival compared with placebo in patients with idiopathic pulmonary fibrosis and mild-to-moderate impairment of pulmonary function

Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results

BACKGROUND:  Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity in vitro. METHODS:  An international, randomized, double-blind, double-dummy, active-controlled trial was conducted to evaluate the efficacy and safety of COBI versus ritonavir (RTV) as a pharmacoenhancer of atazanavir (ATV) in combination with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in treatment-naive patients. The primary end point was a human immunodeficiency virus type 1 (HIV-1) RNA load of <50 copies/mL at week 48 by the Food and Drug Administration snapshot algorithm; the noninferiority margin was 12%. RESULTS:  A total of 692 patients were randomly assigned to a treatment arm and received study drug (344 in the COBI group vs 348 in the RTV group). At week 48, virologic success was achieved in 85% of COBI recipients and 87% of RTV recipients (difference, -2.2% [95% confidence interval, -7.4% to 3.0%]); among patients with a baseline HIV-1 RNA load of >100 000 copies/mL, rates were similar (86% vs 86%). Similar percentages of patients in both groups had serious adverse events (10% of COBI recipients vs 7% of RTV recipients) and adverse events leading to discontinuation of treatment with the study drug (7% vs 7%). Median increases in the serum creatinine level were 0.13 and 0.09 mg/dL, respectively, for COBI and RTV recipients. CONCLUSIONS:  COBI was noninferior to RTV in combination with ATV plus FTC/TDF at week 48. Both regimens achieved high rates of virologic success. Safety and tolerability profiles of the 2 regimens were comparable. Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor ATV

Epidemiology and clinical features of emergency department patients with suspected and confirmed COVID-19: a multisite report from the COVID-19 Emergency Department Quality Improvement Project for July 2020 (COVED-3)

Objective:The aim of the present study was to describe the epidemiology and clinical features of patients presenting to the ED with suspected and confirmed COVID‐19.Methods:The COVID‐19 ED (COVED) Project is an ongoing prospective cohort study in Australian EDs. This analysis presents data from eight sites across Victoria and Tasmania for July 2020 (during Australia's ‘second wave’). All adult patients who met criteria for ‘suspected COVID‐19’ and underwent testing for SARS‐CoV‐2 in the ED were eligible for inclusion. Study outcomes included a positive SARS‐CoV‐2 test result and mechanical ventilation.Results:In the period 1 July to 31 July 2020, there were 30 378 presentations to the participating EDs and 2917 (9.6%; 95% confidence interval 9.3–9.9) underwent testing for SARS‐CoV‐2. Of these, 50 (2%) patients returned a positive result. Among positive cases, two (4%) received mechanical ventilation during their hospital admission compared to 45 (2%) of the SARS‐CoV‐2 negative patients (odds ratio 1.7, 95% confidence interval 0.4–7.3; P = 0.47). Two (4%) SARS‐CoV‐2 positive patients died in hospital compared to 46 (2%) of the SARS‐CoV‐2 negative patients (odds ratio 1.7, 95% confidence interval 0.4–7.1; P = 0.49). Strong clinical predictors of a positive SARS‐CoV‐2 result included self‐reported fever, non‐smoking status, bilateral infiltrates on chest X‐ray and absence of a leucocytosis on first ED blood tests (P Conclusion:In this prospective multi‐site study from July 2020, a substantial proportion of ED patients required SARS‐CoV‐2 testing, isolation and enhanced infection prevention and control precautions. Presence of SARS‐CoV‐2 on nasopharyngeal swab was not associated with death or mechanical ventilation