Background We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe COVID-19 using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard-of-care. Methods GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed SARS-CoV-2 infection, were hospitalized, had oxygen saturation 94% or lower on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard-of-care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results After the inverse probability of treatment weighting procedure 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio 2.03: 95% confidence interval 1.34–3.08, p<0.001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (adjusted odds ratio 0.38, 95% confidence interval: 0.22–0.68, p=0.001). Conclusions In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19.

Background Remdesivir is FDA approved for the treatment of hospitalized patients with COVID-19 and has been shown to shorten time to recovery and improve clinical outcomes in randomized trials. Methods This was the final day 28 comparative analysis of data from a phase 3, randomized, open-label study comparing 2 remdesivir regimens (5 vs 10 days, combined for this analysis [remdesivir cohort]) and a real-world retrospective longitudinal cohort study of patients receiving standard-of-care treatment (non-remdesivir cohort). Eligible patients, aged ≥18 years, had confirmed SARSCoV-2, oxygen saturation ≤94% on room air or required supplemental oxygen, with pulmonary infiltrates. Propensity score matching (up to 1:10 ratio) was used to ensure comparable populations. We assessed day 14 clinical recovery (determined using a 7-point ordinal scale) and day 28 all-cause mortality (coprimary endpoints). Results Altogether, 368 (remdesivir) and 1399 (non-remdesivir) patients were included in the matched analysis. The day 14 clinical recovery rate was significantly higher among the remdesivir versus the non-remdesivir cohort (65.2% vs 57.1%; OR 1.49, 95% CI 1.16–1.90; P = .002). The day 28 mortality rate was significantly lower in the remdesivir cohort versus the non-remdesivir cohort (12.0% vs 16.2%; OR 0.67, 95% CI 0.47–0.95; P = .03). Conclusions Remdesivir was associated with significantly higher rates of day 14 clinical recovery, and lower day 28 mortality, compared with standard-of-care treatment in hospitalized patients with COVID-19. Collectively, these data support the use of remdesivir to improve clinical recovery and decrease mortality from SARS-CoV-2 infection.

People living with human immunodeficiency virus (PLHIV) are at high risk of developing non-HIV related comorbidities, particularly at older ages. In a retrospective claims database analysis, we compared PLHIV to a matched, non-HIV cohort to assess the prevalence of comorbidities and healthcare costs in PLHIV and the general non-HIV population in Germany. In total, 2,132 adult patients with HIV were identified in the InGef research database with HIV ICD-10 diagnosis within each year from 2011 to 2014. Of these, 1,969 could be matched to a control cohort of 3,938 individuals (1:2 ratio). Matching criteria included age, gender and socio-economic variables. The prevalence of acute renal disease (0.5% vs. 0.2%, p = 0.045), bone fractures due to osteoporosis (6.4% vs. 2.1%, p<0.001), chronic renal disease (4.3% vs. 2.4%, p<0.001), cardiovascular disease (12.8% vs. 10.4%, p = 0.006), Hepatitis B (5.9% vs. 0.3%, p<0.001) and Hepatitis C infection (8.8% vs. 0.3%, p<0.001) was significantly higher in PLHIV compared to the matched non-HIV cohort. Mean costs excluding costs for antiretroviral therapy (ART) were significantly higher in the HIV cohort (8,049€ vs. 3,658€, p<0.05). On average, PLHIV incurred excess costs of 16,441€ for ART, 2,747€ for pharmaceuticals excluding ART (p<0.05), 1,441€ for outpatient care (p<0.05) and 321€ for inpatient care (p<0.05). Devices and remedies’ costs were significantly higher in the control cohort with excess costs of 113€ (p<0.05). Considering mean total costs, excluding ART, excess costs for PLHIV amounted to 8,049€ (p<0.05). This analysis demonstrated an increased comorbidity and economic burden of PLHIV compared to matched controls. Our findings suggest that HIV remains an area of high unmet medical need. To improve patient outcomes, adequate HIV management including regular monitoring, screening for comorbidities and optimal ART selection throughout the life course of PLHIV are of key importance.

Objectives The management of HIV disease is complicated by the incidence of a new spectrum of comorbid noncommunicable diseases (NCDs). It is important to document changes in the prevalence of NCDs over time. The aim of the study was to describe the impact of ageing on HIV markers and on the prevalence of NCDs in people living with HIV (PLWHIV) in the Italian Cohort of Individuals, Naïve for Antiretrovirals (ICONA) seen for care in 2004–2014. Methods Analyses were conducted separately for a closed cohort (same people seen at both times) and an open cohort (all people under follow‐up). We used the χ2 test for categorical factors and the Wilcoxon test for quantitative factors to compare profiles over time. Results The closed cohort included 1517 participants and the open cohort 3668 under follow‐up in 2004 and 6679 in 2014. The median age of the open cohort was 41 [interquartile range (IQR) 37–46] years in 2004 and 44 (IQR 36–52) years in 2014. Analysis of the closed cohort showed an increase in the prevalence of some NCDs [the prevalence of dyslipidaemia increased from 75% in 2004 to 91% in 2014, that of hypertension from 67 to 84%, and that of cardiovascular disease (CVD) from 18 to 32%] and a decrease in renal function (5% with eGFR < 60 mL/min per 1.73 m2 in 2004 versus 30% in 2014); the percentage of people in the high‐risk group for the Framingham CHD score more than tripled (from 13 to 45%). Results in the open cohort were similar. Conclusions The burden of NCDs in our PLWHIV population markedly worsened over a 10‐year time‐span, which is likely to be a result of the effects of both ageing and HIV infection as well as their interaction. Special attention must be given to the management and prevention of NCDs.

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