HIV among people who inject drugs in Hungary.

Abstract Background Before 2014 (the year of closure of the two largest needle exchange programs in Hungary, which halved the number of available syringes in the country despite increased injecting risk practices) no HIV was reportedly acquired in Hungary among people who inject drugs (PWIDs) who were not also men who had sex with other men (MSM). In 2014, one and in 2015 two non-MSM PWIDs were newly diagnosed with HIV who supposedly became infected in Hungary, and both incident HIV cases in 2015 were diagnosed in the AIDS stage. In addition, two new (albeit supposedly imported) non-MSM PWID cases were also registered in the first three quarters of 2016, one of which subsequently was diagnosed with and then died of AIDS. At the same time, the prevalence of HCV doubled among PWIDs (from 24% to 49% in Hungary and from 34% to 61% in Budapest). Case presentation The case that we discuss in this paper is a male PWID, who was diagnosed with HIV and AIDS in May of 2015 and then died of AIDS the next month. His HIV infection status was detected with delay, and then appeared in the official statistics as an incident PWID HIV case and an incident PWID AIDS case, but not as an incident PWID AIDS death. No contact tracing followed, even though it would have been relatively easy considering the circumstances. To our knowledge, no HIV post-exposure protocol exists in hospitals, in case of HIV exposure due to an eventual needle-stick injury. Conclusions Our paper draws attention to recently published HIV and AIDS surveillance data, and shows the failure of the system. While sounding the alarm based on three newly detected PWID HIV cases in the past 2 years may be premature, there are definitely serious problems in the HIV detection and tracing system among PWIDs in Hungary

Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients : a randomised controlled trial

Background: Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. Methods: EVADE (NCT02696902) was a phase 2, randomised, parallel-group, double-blind, placebo-controlled study in Europe, Turkey, Israel, and the USA. Subjects ≥ 18 years old, mechanically ventilated, tracheally colonised with PA, and without new-onset pneumonia, were randomised (1:1:1) to MEDI3902 500, 1500 mg (single intravenous dose), or placebo. The primary efficacy endpoint was the incidence of nosocomial PA pneumonia through 21 days post-dose in MEDI3902 1500 mg versus placebo, determined by an independent adjudication committee. Results: Even if the initial sample size was not reached because of low recruitment, 188 subjects were randomised (MEDI3902 500/1500 mg: n = 16/87; placebo: n = 85) between 13 April 2016 and 17 October 2019. Out of these, 184 were dosed (MEDI3902 500/1500 mg: n = 16/85; placebo: n = 83), comprising the modified intent-to-treat set. Enrolment in the 500 mg arm was discontinued due to pharmacokinetic data demonstrating low MEDI3902 serum concentrations. Subsequently, enrolled subjects were randomised (1:1) to MEDI3902 1500 mg or placebo. PA pneumonia was confirmed in 22.4% (n = 19/85) of MEDI3902 1500 mg recipients and in 18.1% (n = 15/83) of placebo recipients (relative risk reduction [RRR]: − 23.7%; 80% confidence interval [CI] − 83.8%, 16.8%; p = 0.49). At 21 days post-1500 mg dose, the mean (standard deviation) serum MEDI3902 concentration was 9.46 (7.91) μg/mL, with 80.6% (n = 58/72) subjects achieving concentration