Efficacy of oral 20-hydroxyecdysone (BIO101), a MAS receptor activator, in adults with severe COVID-19 (COVA): a randomized, placebo-controlled, phase 2/3 trial.

Background: SARS-CoV-2 binding to ACE2 is potentially associated with severe pneumonia due to COVID-19. The aim of the study was to test whether Mas-receptor activation by 20-hydroxyecdysone (BIO101) could restore the Renin-Angiotensin System equilibrium and limit the frequency of respiratory failure and mortality in adults hospitalized with severe COVID-19. Methods: Double-blind, randomized, placebo-controlled phase 2/3 trial. Randomization: 1:1 oral BIO101 (350 mg BID) or placebo, up to 28 days or until an endpoint was reached. Primary endpoint: mortality or respiratory failure requiring high-flow oxygen, mechanical ventilation, or extra-corporeal membrane oxygenation. Key secondary endpoint: hospital discharge following recovery (ClinicalTrials.gov Number, NCT04472728). Findings: Due to low recruitment the planned sample size of 310 was not reached and 238 patients were randomized between August 26, 2020 and March 8, 2022. In the modified ITT population (233 patients; 126 BIO101 and 107 placebo), respiratory failure or early death by day 28 was 11.4% lower in the BIO101 (13.5%) than in the placebo (24.3%) group, (p = 0.0426). At day 28, proportions of patients discharged following recovery were 80.1%, and 70.9% in the BIO101 and placebo group respectively, (adjusted difference 11.0%, 95% CI [-0.4%, 22.4%], p = 0.0586). Hazard Ratio for time to death over 90 days: 0.554 (95% CI [0.285, 1.077]), a 44.6% mortality reduction in the BIO101 group (not statistically significant). Treatment emergent adverse events of respiratory failure were more frequent in the placebo group. Interpretation: BIO101 significantly reduced the risk of death or respiratory failure supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. Funding: Biophytis.

[HIV and hepatitis B virus co-infection: prevalence and risk factors]. / Co-infecção HIV e vírus da hepatite B: prevalência e fatores de risco.

The objective of this study was to assess the prevalence of hepatitis B virus and possible risk factors for this disease in 401 patients infected with the human immunodeficiency virus, followed at the University Hospital of the Ribeirão Preto Medical School, São Paulo State University. Each participant was submitted to a specific questionnaire and had a blood sample tested for the serologic markers HBsAg, total anti-HBcAg, anti-HBsAg and anti-HCV, using ELISA technique. The overall prevalence of hepatitis B markers was 40.9%, with 8.5% for HBsAg, 39.7% for total anti-HBcAg and 5.5% for anti-HBsAg. The variables that showed association with HBV were: age, higher education level, history of jaundice, time spent in prison, having a homosexual partner and positive markers for anti-HCV. Co-infection HBV/HCV was present in 20.4% of the participants.

Co-infecção HIV e vírus da hepatite B: prevalência e fatores de risco / HIV and hepatitis B virus co-infection: prevalence and risk factors

Este trabalho objetiva estimar a prevalência da infecção pelo vírus da hepatite B e analisar possíveis fatores de risco em 401 pacientes infectados pelo vírus da imunodeficiência humana, atendidos no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo. Os participantes responderam a um questionário que visava levantar variáveis gerais e fatores de risco para hepatite B. Os resultados dos exames sorológicos para os marcadores HBsAg, anti-HBcAg total, anti-HBsAg e anti-HCV foram obtidos dos prontuários dos pacientes. A prevalência global dos marcadores para o HBV foi 40,9 por cento, com valores de 8,5 por cento para o HBsAg, 39,7 por cento para o anti-HBcAg total e de 5,5 por cento para o anti-HBsAg. As variáveis que mostraram associação com a infecção pelo HBV foram: idade, nível superior de escolaridade, antecedente de icterícia, tempo passado como presidiário, existência de parceiro homossexual e positividade para o anti-HCV. A co-infecção HBV/HCV esteve presente em 20,4 por cento dos participantes deste estudo.