Healthcare & Laboratory News

Infectious Disease Advisor (6/11, Kuhns) reports a study found that “fecal microbiota, live-jslm (REBYOTA® [RBL]) is effective for preventing recurrent Clostridioides difficile infection (CDI) among high-risk patients in both clinic and at-home settings.” Researchers observed that at “8 weeks following RBL administration, the overall treatment success rate was 83.0%. However, 14.8% of patients experienced CDI recurrence, and 2.2% had missing outcome data. Overall, home-based administration of RBL was associated with significantly higher treatment success rates than clinic-based administration (87.3% and 62.5%, respectively).” Subgroup analyses indicated “no significant differences in treatment success rates in patients stratified by age, antibiotic washout period, number of prior CDI episodes, or prior bezlotoxumab use.” The study was published in Infectious Diseases and Therapy.

Renal & Urology News (6/11, Persaud) reports a study found that “in patients with immunoglobulin A nephropathy (IgAN), higher levels of proteinuria and lower baseline estimated glomerular filtration rate (eGFR) are strongly associated with adverse kidney outcomes – even at proteinuria levels previously considered low-risk.” Researchers observed that “among 655 patients with IgAN from Kaiser Permanente Southern California health system followed for a median of 3.1 years, 36% reached a composite endpoint of a 50% or greater decline in eGFR, kidney failure, or death.” They noted the “risk for the composite endpoint increased markedly with higher levels of proteinuria.” The findings suggest “that proteinuria of 0.5 g/g or higher, not the traditional 1 g/g or higher threshold, may mark the beginning of heightened risk for disease progression.” The study was published in Nephrology Dialysis Transplantation.

Infectious Disease Advisor (6/11, Basilio) reports a study found that “individuals with multiple underlying medical conditions are at increased risk for influenza-associated hospitalization, but the risk can be partially mediated in high-risk populations through annual vaccination.” In an analysis including 870,888 unique patients, researchers saw that “43,326 ARI-associated hospitalizations and 1403 influenza-associated hospitalizations occurred during the study period. Patients aged 65 years and older exhibited the highest prevalence of influenza vaccination, and those with underlying conditions were more likely to report seasonal influenza vaccination than those with none across all age groups.” They observed that “adults with congestive heart failure exhibited the highest overall rates for both ARI- and influenza-associated hospitalizations. In general, the rate of both outcomes increased as the number of underlying conditions increased.” The study was published in Infectious Diseases and Therapy.

The New York Times (6/11, Gay Stolberg) reports that HHS Secretary Robert F. Kennedy Jr. “on Wednesday named eight doctors and researchers, including four who have spoken out against vaccination in some way, to replace roughly half the members he fired from an expert panel that advises the” CDC. The health secretary “made the announcement Wednesday on the social media platform X, two days after he fired all 17 members of the Advisory Committee on Immunization Practices.” Also covering the story are the Washington Post (6/11, Sun, Weber), CNN (6/11, Owermohle), Reuters (6/11, Aboulenein, Steenhuysen, Erman), The Hill (6/11, Choi, Weixel), NBC News (6/11, Bendix, Edwards), and the AP (6/11, Stobbe).

Rare Disease Advisor (6/10, Murphy) reports, “The choice of method used to measure serum levels of neurofilament light chain (NfL) should be considered when using it as a biomarker for transthyretin amyloid polyneuropathy (ATTR-PN), according to a study.” Investigators “found that the Ella automated immunoassay reported higher levels of NfL than the Single Molecule Array (SiMoA) immunoassay in 55 symptomatic and presymptomatic patients with hereditary ATTR-PN.” Rare Disease Advisor adds, “The Ella method reported a mean NfL concentration of 27.5 pg/mL in comparison to a mean concentration of 15.9 pg/mL using the SiMoA method,” while “Bland-Altman analysis found a mean bias of 15.4 pg/mL between the 2 methods.” The findings were published in the European Journal of Neurology.

Bloomberg Law (6/10, Langreth, Subscription Publication) reports Gilead Sciences announced the FDA had “placed on hold trials of a new experimental once-weekly HIV drug combination therapy after white blood cell counts dropped in some of the patients.” The studies involved taking two experimental HIV drugs, GS-1720 and GS-4182, together. Gilead explained the FDA suspended the trials due to a “safety signal” triggered by a decline in lymphocyte levels in some patients given the therapy.

Rare Disease Advisor (6/10, Garlapow) reports, “Neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR) were independent predictors of 1-year mortality in patients with cirrhosis-associated hepatocellular carcinoma (HCC), according to a study.” Investigators found that “NLR outperformed other noninvasive serum-based indices.” The data indicated that “a novel nomogram that integrates these markers alongside clinical variables demonstrated strong prognostic utility, with a concordance index of 0.808...for 12-month mortality.” The findings were published in the Journal of Clinical and Experimental Hepatology.

The AP (6/9) reports that 27 states and the District of Columbia filed a lawsuit on Monday in bankruptcy court to “block the sale of personal genetic data by 23andMe without customer consent.” The lawsuit emerged as Regeneron Pharmaceuticals seeks court approval to acquire the company for $256 million, clarifying that it would comply with 23andMe’s privacy policies and applicable law. Oregon Attorney General Dan Rayfield emphasized the sensitivity of genetic data, saying they should not be sold without each person’s expressed, informed consent. 23andMe has “struggled to find a profitable business model since going public in 2021.” A court-appointed consumer privacy ombudsman will report on the sale’s privacy implications.

Infectious Disease Advisor (6/9, Basilio) reports a systemic review and meta-analysis found that “a 7-day course of antibiotic therapy may be comparable to a 14-day course for reducing the risk of mortality in patients with uncomplicated gram-negative bloodstream infections (GN-BSIs).” A total of four trials were included in the meta-analysis, with 3,729 patients in the intention-to-treat (ITT) population and 3,126 patients in the per protocol (PP) population. Researchers observed that “in the ITT population, the rate of 90-day all-cause mortality was similar between the groups (12.8% and 13.7%), with a high probability of noninferiority (97.8%).” A further analysis of patients in the PP population “who received 7 vs 14 days of antibiotics indicated similar findings for both the between-group risk of 90-day mortality and the probability of noninferiority (95.1%).” The review was published in JAMA Network Open.

The AP (6/9, Ungar, Seitz) reports that HHS Secretary Robert F. Kennedy Jr. “on Monday removed every member of a scientific committee that advises the Centers for Disease Control and Prevention on how to use vaccines and pledged to replace them with his own picks.” CNN (6/9, Owermohle, Tirrell) reports, “The entirety of the 17-member Advisory Committee on Immunization Practices...will be retired and replaced with new members, Kennedy announced in a Wall Street Journal op-ed.” The Washington Post (6/9, A1, Sun, Weber) reports that in the op-ed, “Kennedy said...the panel has been ‘plagued with persistent conflicts of interest’ and has become a ‘rubber stamp’ for vaccines.” Also covering the story are the New York Times (6/9, Mandavilli), Reuters (6/9, Aboulenein, Erman, Steenhuysen), NBC News (6/9, Bendix, Zadrozny, Edwards), Politico (6/9, Gardner, Gardner), and STAT (6/9, Branswell, Cirruzzo, Payne, Subscription Publication).