ABSTRACT
Background: Recent studies suggest that baricitinib added to dexamethasone may reduce mortality in hospitalized COVID-19 patients requiring supplemental oxygen Methods: In a multicenter open-label, pragmatic, randomized clinical trial in 25 hospitals in Spain we included symptomatic participants with SARS-CoV-2 detected by PCR or antigenic test, with a creatinine clearance >60 mL/min, > 60 years or younger if they had at least two comorbidities (hypertension, obesity, diabetes, cirrhosis, chronic neurologic disease, active cancer, heart failure, coronary heart disease or COPD). Participants were initially randomized to receive or not tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). At any moment during the trial participants with room air 02 saturation < 95% and at least one increased inflammatory biomarker could be randomized to dexamethasone (D) or dexamethasone plus baricitinib (DB). Primary outcome was 28 days mortality. Secondary outcomes were disease progression (increase of O2 requirements, mechanical ventilation or increase in medical therapy: steroid dose, need for starting tocilizumab) Results: Out of the 355 participants included in the trial 287 (80.8%) were randomized to D (n=142) or DB (n=145), 264 (91.9%) simultaneously with the TDF/FTC randomization and 23 (8.1%) later on. Median age 67 years (IQR 62, 73), male (65.5%), with median 8 days of symptoms (IQR 5-10), 28.6% with ≤ 5 days of symptoms, 100% hospitalized, 31.6% with one and 38.7% with ≥ 2 comorbidities (most common: 35.9% hypertension, 9.4% diabetes, 1.7 % obesity), 14.3% receiving remdesivir and 49.1% TDF/FTC. Endpoints in participants treated with D vs. those treated with DB favored DB without achieving statistical significance: mortality 4.9%/2.1%, disease progression 27.5%/24.8%, mechanical ventilation (invasive or noninvasive) 25.4%/23.4%, days since randomization until discharge (median [IQR]) 7 [5, 12]/7 [5, 13.5], discharge before 28 days 89%/94.2%. By Cox regression Hazard Ratio (95% CI) of 28-day mortality was 0.51 (0.13-2.06) for participants treated with DB. Serious adverse events occurred in 9.9%/9.7% of participants treated with D or DB respectively. Adverse events leading to B discontinuation occurred in 3.45% of participants. Conclusion: In this clinical trial of high-risk patients with COVID-19 all disease outcomes favored baricitinb added to dexamethasone but differences did not reach statistical significance. Overall mortality was unexpectedly low.
ABSTRACT
Background: For newly diagnosed persons with HIV (PWH), early initiation of ART is essential in reducing morbidity and mortality and decreasing the risk of transmitting HIV. We have previously reported the trends in linkage to HIV medical care within one month of HIV diagnosis (LC-1Mo) and viral suppression within three months of HIV diagnosis (VS-3Mo) among PWH in Spain from 2004 to 2018. We herein update this information up to 2020. Methods: Longitudinal study based on the Cohort of the Spanish AIDS Research Network (CoRIS). VS was defined as ever having an HIV-RNA <200 copies/mL. We used logistic regression to assess differences by sex, age, country of birth, transmission category, and baseline CD4+ cell count. Results: A total of 13,632 PWH were enrolled in CoRIS in the study period: males 85%, men having sex with men (MSM) 62%, median age 35 (IQR: 28-43) years. LC-1Mo increased from 41% (95% CI, 37%-45%) in 2004 to 83% (79%-87%) in 2020 (P trend <0.001) (Figure). Median CD4+ cell counts at ART initiation increased from < 250/mm3 in 2004-2005 to > 350/mm3 since 2012 (P for trend <0.001). The percentage of initial ART regimens based on integrase strand transfer inhibitors (InSTI) increased from 3% in 2004 to > 70% from 2016 onwards (P trend <0.001). VS-3Mo increased from 6% (4%-8%) in 2004 to 43% (40%-47%) in 2019 with a small decrease to 41% (36%-46%) in 2020 (P trend [for the entire period] <0.001) (Figure). The odds of achieving VS-3Mo was higher among females (aOR, 95% CI: 1.30, 1.12-1.51), among non-Spanish Europeans and Latin Americans compared to native-born Spaniards (1.26, 1.11-1.44 and 1.36, 1.21-1.52, respectively), and among those older than 50 years (1.20, 1.03-1.41). Opposite, the odds of achieving VS-3Mo was lower among IDU compared to MSM (0.53, 0.40-0.70) and those with CD4 counts between 200-500 cells/uL (0.78, 0.69-0.89) and CD4 counts >500 cells/uL (0.51, 0.44-0.60) compared to those with CD4 < 200 cells/uL. Conclusion: Indicators of care have improved among newly diagnosed PWH in Spain over the last 16 years. Elimination of CD4 cell count restrictions for ART initiation and increasing use of InSTI-based regimens was decisive for progress. A slight decrease in VS-3Mo in 2020 compared with 2019 was observed, perhaps because of the COVID-19 pandemic.
ABSTRACT
In this article, we interrogate vergonha alheia (shame on behalf of others;or "vicarious embarrassment"), which is experienced when viewing an embarrassing action from the outside. We question if shame-associated with the worst of human behavior brought about and made visible by the COVID-19 pandemic-can ignite a new kind of cultural sensitivity to the pain of others. Turning to the work of several feminist scholars, we reveal the generative power of shame in artistic and political mobilization. We study examples of artistic activism (i.e., artivism) during the COVID-19 pandemic, as presented by two Brazilian women-Adriana Calcanhotto and Debora Diniz. By intimately engaging with their work and situating it in the context of the popular feminist struggle in Brazil-that is, a luta (the struggle), we discern two performative patterns articulated through distinct symbolic utterances: indignacao and declaracao corporal (indignation and bodily declaration). We contend that these utterances help overcome individual apathy, summon radically different forms of sensitivity and meaning making that may initiate potentially transformative shifts in public perceptions of social justice. We conclude with our reflections on how feminist artivism in Latin America not only questions the validity of the , universal, and modern human being but also reveals new frames of progress.
ABSTRACT
Background: Evidence supports switching DTG/3TC/ABC in patients complaining about insomnia. However, there is unknown if the benefit observed could also apply to non-complaining patients displaying sleep disturbances in self-reported questionnaires used as screening tools, such as the Pittsburg sleep quality index (PSQI). Methods: We designed the DETOX study, as an open label, randomized (1:1), multicenter, pilot clinical trial, to evaluate the reversibility of sleep disturbances detected with the PSQI in well-suppressed patients on DTG/3TC/ABC (>12 weeks) not complaining of insomnia. Participants with a PSQI >5 were randomized either to switch to DRV/c/FTC/TAF for 8 weeks (arm 1) or either to continue 4 weeks on DTG/3TC/ABC and then switch to DRV/c/FTC/TAF for 8 weeks (arm 2). Every 4 weeks, participants self-reported using the PSQI, the Hospital Anxiety & Depression Scale (HADS) and a questionnaire exploring about 11 neuropsychiatric adverse events (AE). Raw scores on PSQI and HADS, along with an average score from adding the grade of each neuropsychiatric AE, were normalized (0-100). Then we compared changes at week 4 (between study arms) and after participants completed 4 and 8 weeks on DRV/c/FTC/TAF. Additional analyses included virological outcomes. Results: The study included 72 participants (arm 1: n=37;arm 2: n=35). Both arms had similar baseline characteristics. Three discontinued prematurely before week 4 (arm 1: none;arm 2: 1 COVID-19, 1 loss of follow up (LFU) and 1 consent withdrawal). At week 4, we observed significant improvements (arm 1 vs. arm 2) in PSQI (mean change±SD: 11.5±10.2 vs. 0.6±8.9;p<0.001), HADs anxiety scale (14±16.9 vs. 1.9±15.6;p=0.003) and AE (13.7±13.3 vs. 1.3±8.6;p<0.001) scores. Sixty-nine participants switched to DRV/c/FTC/TAF: 37 at baseline (arm 1) and 32 at week 4 (arm 2). All except 3 who discontinued prematurely (2 LFU and 1 due to AE nausea) completed 8 weeks of follow up. Pooled analysis showed significant improvements in most neuropsychiatric scores and symptoms (table), with no virologic failures reported. After switching to DRV/c/FTC/TAF, 26 participants (37.7%) reported any AE (all grade 1-2). Most common AE were headache (7.2%) and dyslipidemia (7.2%). Conclusion: Sleep disturbances detected through self-reported screening tools seem to be associated with patients on DTG/3TC/ABC not complaining of insomnia. These disturbances, among other neuropsychiatric symptoms such as anxiety or depression, could improve after switching to DRV/c/FTC/TAF.