Kevin Kunzmann

 who underwent a hematopoietic stem cell transplant (HSCT) also benefitted from frontline medications fidaxomicin or oral vancomycin, according to a recent study.

However, the new research—presented at the Making A Difference in Infectious Disease (MAD-ID) 2021 Annual Meeting—would infer one provides significantly lower risk of treatment failure over the other in such adult patients, according to the researchers.

Investigators from Atrium Health’s Carolinas Medical Center, led by Bliss Green, PharmD, sought to retrospectively evaluate clinical outcomes among patients with initial 

infection within 100 days after their stem cell transplant, treated with either fidaxomicin or oral vancomycin.

, the 2 agents provided similar outcomes in initial short and short-term mortality among adults with 

, but fidaxomicin provided a lower risk of infection recurrences at 1 month following treatment.

As Green and colleagues noted, hematopoietic stem cell transplant is generally associated with increased 

infection risk, without any specific treatment recommendations existing for the patient population.

“Fidaxomicin has been shown to have potential benefits over oral vancomycin, including decreased recurrence rates and the preservation of the intestinal microbiota,” they wrote, “however, there are limited data comparing therapies in HSCT recipients.”

Their single-center, retrospective cohort study of all adult transplant recipients diagnosed with initial 

infection episodes within 100 days of their procedure ran from March 11, 2014 to October 1, 2020. All observed patients had been treated with either agent.

infection diagnosis was based on the presence of at least 3 unformed stools within 24 hours, and/or physician-expressed concern for diarrhea, plus a positive test for infection on institutional protocol.

infection, a prior infection within 90 days of HSCT, fulminant 

infection, or mortality prior to completion of initial treatment were excluded from the cohort.

Investigators sought a primary outcome of recurrence at 30 days from therapy completion, and secondary outcomes including 

infection recurrence at 60 and 90 days, as well as clinical cure of infection, sustained clinical response, treatment failure, acute graft versus host disease (aGVHD) occurrence, and vancomycin-resistant enterococci (VRE) infection occurrence within 90 days after completing therapy.

Their assessment included 61 patients from 159 screening; of them, 22 received fidaxomicin and 39 received vancomycin.

Green and colleagues observed no differences in 30-day infection recurrence among patients receiving fidaxomicin (0%) versus those receiving vancomycin (10.3%; 

 = .287). They similarly observed similarity in clinical cure (100% vs 92.3%, respectively; 

 = .547), as well as sustained clinical response at 30 days (100% vs 84.6%, respectively; 

GVHD occurrence (50% vs 45.5%, respectively; 

 >.99) and VRE infection (0% vs 2.6%, respectively; 

 >.99) were similar in the fidaxomicin and vancomycin treatment arms.

However, treatment failure incidence was more frequent in the oral vancomycin group (38.5%) than the fidaxomicin group (4.6%; 

 = .005), in which patient diarrhea persisted enough to require a change in therapy regimen. Median therapy duration was 14 days with oral vancomycin, versus 10 days with fidaxomicin (

In their conclusion, investigators stressed the primary outcome similarities among the front-line agents in treating HSCT patients with 

“The rates of recurrence, clinical cure, and sustained clinical response in adult HSCT recipients with initial CDI treated with fidaxomicin or oral vancomycin were similar,” they wrote. “Fidaxomicin was associated with significantly lower rates of treatment failure compared to oral vancomycin.”

This article was originally published in ContagionLive.

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Frontline Drugs Vancomycin, Fidaxomicin Found to Benefit Transplant Patients With C Difficile

New data from an unreviewed, preprint research article indicates first-dose immunization efficacy from Pfizer-BioNTech coronavirus 2019 (COVID-19) vaccine BNT162b2 is improved 51% after 13-24 days among Israel residents given the vaccine. The retrospective cohort assessment, pending review and publication, is among the first real-world indications of first-dose efficacy of the currently authorized mRNA vaccines for the pandemic.

Israel is currently the most vaccinated country against COVID-19, per capita, worldwide. According to Our World in Data, more than one-third of the total population has received at least 1 COVID-19 vaccine dose as of Thursday—or, nearly 3 million people. Off the strength of phase 3 results for BNT162b2&mdash;which was used to support its approved Emergency Use Authorization (EUA) under the FDA last month, and showed COVID-19 prevention efficacy of greater than 90% among adults after their second dose&mdash;the current understanding is that the Pfizer-BioNTech product is among the most promising prophylaxes for the pandemic virus.

That said, investigators wrote, real-life vaccine effectiveness evaluation during the rollout phase is “urgently needed, especially given the global disease surge.”

New data from an unreviewed, preprint research article indicate first-dose immunization efficacy of the Pfizer-BioNTech coronavirus 2019 vaccine improves by 51% 13-24 days post administration. 

Preprint Research on Pfizer COVID-19 Vaccine Shows Greater Efficacy Two Weeks Post Administration

Sanofi, one of the largest drug and vaccine producers in the world, has agreed to bottle and package at least 125 million doses of 

 BNT162b2 from Pfizer and BioNTech. The France-based company will use its Frankfurt facilities to aide in late-stage production for the vaccines from their pharmaceutical rivals, for distribution in the European Union, beginning this summer, according to an announcement made Wednesday.

In the meantime, Sanofi remains engaged in the development of its own COVID-19 vaccine, in collaboration with partner GlaxoSmithKline (GSK). The group most recently delayed its vaccine production and real-world assessment after observed failure to produce a strong immune response in older participants of a phase 1/2 trial.

The UK had originally ordered 60 million doses of the Sanofi and GSK vaccine, which investigators reported last month as having a low immune response in participants aged ≥50 years old, likely due to “insufficient concentration of the antigen.” This setback, combined with shortcomings in Pfizer-BioNTech production and delays from the AstraZeneca-University of Oxford vaccine—as well as a highly transmissible SARS-CoV-2 variant first observed in southeast England&mdash;has put significant strain on the region’s immunity-building efforts.

Sanofi has agreed to bottle and package at least 125 million doses of the COVID-19 vaccine BNT162b2 from Pfizer and BioNTech.

Sanofi to Aid in Production of Pfizer-BioNTech Vaccine

The FDA has approved atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) for the treatment of adult and pediatric patients with Zaire ebolavirus​ (Ebola virus) infection. With the indication, the monoclonal antibody cocktail from Regeneron Pharmaceuticals becomes the first drug approved to treat Ebola virus. The 3-drug combination therapy is designed to target the glycoprotein located on the virus' surface, and inhibit its attachment to the cell receptor, stopping the virus from entering cells.

Its efficacy and safety was observed the PALM trial, a 382-adult and -pediatric patient assessment led by the US National Institutes of Health (NIH) and DRC's Institut National de Recherche Biomédicale as part of the expanded access program conducted in the Democratic Republic of the Congo (DRC) during an outbreak in 2018-2019. The multi-center, open-label, randomized controlled study compared 154 patients administered 50 mg of each monoclonal antibody in Inmazeb intravenously in a single infusion, versus 168 patients on investigational control therapy. Primary efficacy endpoint was 28-day mortality.

One-third (33.8%) of patients treated with Inmazeb died after 28 days, versus 51% of control patients. Investigators provided the therapy to another 228 patients in the expanded access program. The most common symptoms reported among treated patients included fever, chills, tachycardia, tachypnea, and vomiting—symptoms also closely associated with Ebola virus infection.

Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb), a monoclonal antibody cocktail ffor the treatment of adult and pediatric patients with Ebola virus infection, becomes the first drug approved to treat Ebola virus.