infectious diseases

The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19. The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia. 206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy. The primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missinmore...

Interferon-based regimens for chronic hepatitis C (HCV) are quite common, just like interferon-free treatments, and are extensively used in Russia because interferon is widely available to most patients. In 2013 the original Russian drug cepeginterferon alpha-2b (cepegIFN alpha-2b marketed as Algeron by Biocad, Russia) was introduced into clinical practice. The aim of this study was to assess effectiveness and safety of cepegIFN alpha-2b as part of the combination therapy with ribavirin in patients with chronic HCV infection. The study was conducted over the period from 2014 to 2016 and recruited 37 patients with chronic genotype 1 HCV infection: 22 men and 15 women (mean age of 42.0 ±5.2 years). All of them received the following combination antiviral therapy (AT): 1.5 pg/kg cepegIFN alpha-2b once a week and 15 pg/kg ribavirin daily over the period of 48 weeks. Effectiveness of AT was assessed by the rate of sustained virological response (SVR), i. e. aviremia achieved 24 weeks after more...