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11 Diseases |  |
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- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: I'm willing to work with others to address overspend and inadequacies in US healthcare. In meantime, I'm not going to deny my patients if I feel a medicine is going to benefit them. If thoughtful providers don't believe something like fidaxomicin helps their pt, don't give it. (Twitter) - Jun 25, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
HEOR: Another cost effectiveness study by @R_Rajasingham analyzing the 2018 IDSA guidelines of C. difficile similarly favored fidaxomicin, based on the data. https://t.co/eXsbUNrFj7 (Twitter) - Jun 25, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
I truly hope that is the case!!! If I had to guess, I imagine some may go with a “PO vanc while admitted, complete course with fidaxomicin on discharge” approach… though data is certainly lacking for that. (Twitter) - Jun 25, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
large systems & we’re reimbursed less in general. So yes, this is absolutely evidence of a horridly broken system. All I ask for is some advocacy so it doesn’t seem like we aren’t providing the best care [as someone on the thread eluded to] by not using fidaxomicin. (Twitter) - Jun 25, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
The new IDSA guidelines on management of C Diff infection suggests the use of Fidaxomicin over Vancomycin, with Vancomycin as a reasonable alternative. Here a 20 min Podcast summarizing the guidelines with the chair of the guidelines committee: https://t.co/zPzTlSZNHA (Twitter) - Jun 25, 2021
- |||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Observational data: But we need an evidence for this other than from observational trials Also EXTEND trial includes only patients >60y Imo IDSA recommendation should be fidaxomicin not for all Criteria to favor fidaxomicin like Age>60 Pt at high risk of recurrence Transplant etc.. #IDTwitter (Twitter) - Jun 25, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: I don't know, but is it a fair comparison? Patients included (EXTEND trial) @CornelyOliver received an extended pulse fidaxomicin regimen even if it is the same total dose of fidaxomicin as a standard course as IDSA said, it's a different regimen Maybe fidaxomicin better in SOT (Twitter) - Jun 25, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Reimbursement: When was the last time someone saw fidaxomicin paid for with an initial occurrence. Genuinely asking. I expect insurance companies will rely on the ACG guidelines to continue not paying. TOC nightmare. (Twitter) - Jun 24, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
The context of the fidaxo rec is *conditional*. Per their definition, this means "...the majority of individuals in this situation would want [fidaxomicin], but many would not". I'll be hanging with the "would not" group along with 99% of #IDTwitter & #TwitteRx 😉😉😉 (Twitter) - Jun 24, 2021
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Curcumin: A natural derivative with antibacterial activity against Clostridium difficile. (Pubmed Central) - Jun 24, 2021
Our findings suggest that curcumin has potential as an anticlostridial agent. More work is needed to further investigate the efficacy of curcumin as a standalone drug or as a supplement of current drugs of choice, as it has no antagonistic activities but might overcome their drawbacks.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
New CDI treatment guidelines from @IDSAInfo @SHEA_Epi Fidaxomicin now preferred drug even for the first episode Bezlotoxumab recommended for second recurrence and can be considered for first recurrence. CDI treatment got a lot more expensive !! @MayoClinicINFD https://t.co/8icxVsKN4o (Twitter) - Jun 24, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Did some new fidaxomicin data come out that I'm unaware of?? (Twitter) - Jun 24, 2021
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Role of Organic Solute Transporter Alpha/Beta in Hepatotoxic Bile Acid Transport and Drug Interactions. (Pubmed Central) - Jun 22, 2021
Treatment of SCHH with troglitazone and fidaxomicin together under cholestatic conditions resulted in increased hepatocellular toxicity compared to either compound alone, suggesting that OSTα/β inhibition may accentuate DILI. In conclusion, this study provides insights into the role of OSTα/β in preferential disposition of bile acids associated with hepatotoxicity, the impact of xenobiotics on OSTα/β-mediated bile acid transport, and the role of this transporter in SCHH and cholestatic DILI.
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Antimicrobial susceptibilities of Clostridium difficile isolated in 12 Asia-Pacific countries, 2014-15. (Pubmed Central) - Jun 22, 2021
Multi-resistance was common in emerging RTs 369 and QX 239 and the most common strain in Asia, RT 017. Ongoing surveillance is clearly warranted.
- | Nuzyra (omadacycline) / Paratek
Preclinical, Journal: In vitro Activity of Omadacycline, a New Tetracycline Analog, and Comparators Against Clostridioides difficile. (Pubmed Central) - Jun 22, 2021
No difference were observed in MIC based on C. difficile phylogeny. Further development of omadacycline as an intravenous and oral antibiotic directed towards CDI is warranted.
- | OPS-2071 / Otsuka
Preclinical, Journal: In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, Against Clostridioides difficile. (Pubmed Central) - Jun 22, 2021
Furthermore, OPS-2071 showed significant in vivo efficacy at 0.0313 mg/kg/day (50% effective doses), 39.0-fold and 52.1-fold lower than those of vancomycin and fidaxomicin, respectively, in a hamster model of C. difficile infection. OPS-2071 has the potential to become a new therapeutic option for treating C. difficile infection.
- |||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: In general, treatment with metronidazole or oral vancomycin has relapse rate in general population ~25%; fidaxomicin relapse rate ~12%. IBD patient population has a significantly higher relapse rate (~34%) following initial successful infection. (Twitter) - Jun 13, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Review, Journal, HEOR: Economic burden and cost-effectiveness of therapies for Clostridiodes difficile infection: a narrative review. (Pubmed Central) - Jun 10, 2021
Data regarding preferred route of FMT, timing of FMT, and non-conventional therapies such as bezlotoxumab is scant. There is a need for further studies to elucidate the true attributable costs of CDI as well as continued cost-effectiveness research to reduce the economic burden associated with the disease and improve clinical practice.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Review, Journal: The interplay of Clostridioides difficile infection and inflammatory bowel disease. (Pubmed Central) - Jun 10, 2021
Immunosuppression for IBD in IBD patients with CDI should be managed individually, based on a thorough clinical assessment and after weighing the pros and cons of escalation of therapy. This review summarizes the epidemiology, pathophysiology, the diagnosis of CDI in IBD, and outlines the principles of management of both CDI and IBD in IBD patients with CDI.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Reimbursement, Medicare: Interestingly, my grandmother has Medicare (which did not cover her fidaxomicin Rx) and she met the income requirements so Merck ended up approving her application for the assistance program despite technically having Medicare. (Twitter) - Jun 6, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Enrollment closed, Enrollment change: A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections (clinicaltrials.gov) - Jun 3, 2021
P4, N=147, Active, not recruiting, Sponsor: University of Michigan
This review summarizes the epidemiology, pathophysiology, the diagnosis of CDI in IBD, and outlines the principles of management of both CDI and IBD in IBD patients with CDI. Recruiting --> Active, not recruiting | N=250 --> 147
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Clinical, Clinical guideline, Review, Journal: Evolution of clinical guidelines for antimicrobial management of Clostridioides difficile infection. (Pubmed Central) - May 20, 2021
We have also seen the addition of immune boosting treatments, including fecal microbiota transplantation (FMT)/microbiota restoration therapy (MRT) and bezlotoxumab in the more modern recommendations. As the guidelines are evolving with the times, it remains important to understand the differences among them so we can apply this information clinically and optimize patient outcomes.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Treatment of Clostridioides difficile Infection and Non-compliance with Treatment Guidelines in Adults in 10 US Geographical Locations, 2013-2015. (Pubmed Central) - May 15, 2021
Provider adherence to the 2010 treatment guidelines for severe CDI was low. Although the updated 2017 CDI guidelines, which expand the use of oral vancomycin for all CDI, might improve adherence by removing the need to apply severity criteria, other efforts to improve adherence are likely needed, including educating providers and addressing barriers to prescribing guideline-adherent therapy, particularly in outpatient settings.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] AAR100 - Clostridiodes difficile: Antibiotic Resistance Mechanisms and Alternative Therapies () - May 9, 2021 - Abstract #WMF2021WMF_2970;
Treatment of CDI usually involves oral metronidazole or vancomycin as the first-line therapy...The recently approved fidaxomicin has improved efficacy in preventing recurrence...This session will review recent advances in understanding antibiotics resistance of C. difficile and development of alternative therapies against CDI. Upon completion of this Track Hub, the participant should be able to: Recognize diverse mechanisms involved in antibiotic resistance in C. difficile Examine the epidemiology with regard to antibiotic resistance in C. difficile Summarize the strategies for designing alternative therapies against CDI
- OPS-2071 / Otsuka
[VIRTUAL] In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, Against Clostridioides difficile (Poster Hall) - May 9, 2021 - Abstract #WMF2021WMF_1674;
Upon completion of this Track Hub, the participant should be able to: Recognize diverse mechanisms involved in antibiotic resistance in C. difficile Examine the epidemiology with regard to antibiotic resistance in C. difficile Summarize the strategies for designing alternative therapies against CDI OPS-2071 has the potential to become a new therapeutic option for treating C. difficile infection.
- SER-109 / Seres Therap
[VIRTUAL] Characterization of Ribotypes Among Study Participants in a Phase 3 Trial of Investigational Microbiome Therapeutic SER-109 to Reduce Recurrent Clostridioides difficile Infection (Poster Hall) - May 9, 2021 - Abstract #WMF2021WMF_7;
A selective medium was used to isolate C. difficile from stool samples prior to randomization to placebo or SER-109 (after completion of vancomycin or fidaxomicin) and at unscheduled visits for recurrence of diarrhea during 24-weeks of follow-up. In the ECOSPOR III trial, SER-109 demonstrated reduced rates of recurrence compared with placebo across ribotypes and protected against relapse, the dominant mode of recurrence in patients with a history of multiply recurrent CDI.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] Opioid treatment and outcomes of Clostridioides difficile infection () - May 8, 2021 - Abstract #ECCMID2021ECCMID_1000;
The difference in outcomes could possibly be the result of opioid tolerance in the stable group, resulting in a decreased antimotility effect . Until additional information becomes available, we recommend that starting or increasing opioids in patients with CDI be avoided or limited.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] A systematic review and meta-analysis of fidaxomicin and vancomycin for Clostridioides difficile infection () - May 8, 2021 - Abstract #ECCMID2021ECCMID_478;
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Review, Journal: Safety of fecal microbiota transplantation for Clostridioides difficile infection focusing on pathobionts and SARS-CoV-2. (Pubmed Central) - May 8, 2021
The severe acute respiratory syndrome coronavirus-2 is a potential pathogen that could be transmitted via FMT during the COVID-19 pandemic. The challenges faced by clinicians for donor screening, clinical trials, and other aspects of FMT during the pandemic are discussed.
- || hydroxychloroquine / Generic mfg., clarithromycin / Generic mfg.
Clinical, Review, Journal: Management of SARS-CoV-2 Infection: Key Focus in Macrolides Efficacy for COVID-19. (Pubmed Central) - May 4, 2021
Indeed, it has been underlined that azithromycin quickly prevents SARS-CoV-2 infection by raising the levels of both interferons and interferon-stimulated proteins at the same time which reduces the virus replication and release. In this sense, the current review aims to evaluate the applications of macrolides for the treatment of COVID-19.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] Features of Clostridioides difficile infection (CDI) in patients with cancer: A seven-year study. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3845;
Appropriate CDI therapy could have counterbalanced this worse profile during recent years . Our study shows that CDI should be included among the scenarios covered by antimicrobial stewardship programs in oncologic patients.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Diagnostic Modality of Clostridioides difficile Infection Predicts Treatment Response and Outcomes in Inflammatory Bowel Disease. (Pubmed Central) - Apr 29, 2021
Toxin+ compared to Toxin-PCR+ IBD patients had a significantly higher rate of response to antibiotics and lower chances of requiring IBD therapy escalation. Future outcome studies involving CDI in IBD patients should be stratified by modality of diagnosis.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, P3 data, Journal: Safety and efficacy of fidaxomicin and vancomycin in children and adolescents with Clostridioides (Clostridium) difficile infection: a phase 3, multicenter, randomized, single-blind clinical trial (SUNSHINE). (Pubmed Central) - Apr 28, 2021
P3
Future outcome studies involving CDI in IBD patients should be stratified by modality of diagnosis. Fidaxomicin was well tolerated and demonstrated significantly higher rates of GC, compared with vancomycin, in children and adolescents with CDI.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Observational data, Journal: Fidaxomicin versus metronidazole, vancomycin and their combination for initial episode, first recurrence and severe Clostridioides difficile infection-an observational cohort study. (Pubmed Central) - Apr 24, 2021
Fidaxomicin was well tolerated and demonstrated significantly higher rates of GC, compared with vancomycin, in children and adolescents with CDI. Fidaxomicin was superior to metronidazole or vancomycin for the treatment of the initial episode, first recurrence, and non-severe CDI.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
It’s quite something to see this article finally out. I’ve been working on it on and off since 2017 or 2018, ever since @StanDeresinski and I were discussing how to apply the MODIFY results with the existing fidaxomicin data. https://t.co/jbDnPZwyNL (Twitter) - Apr 17, 2021
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Preclinical, Journal: Fidaxomicin has high in vitro activity against Mycobacterium tuberculosis. (Pubmed Central) - Apr 10, 2021
38 fully drug-sensitive Mtb strains and 34 multidrug-resistant tuberculosis (MDR-TB) strains were tested using the microplate alamar blue assay (MABA) method to determine the minimum inhibitory concentrations (MICs) for fidaxomicin and rifampicin. Fidaxomicin has high in vitro activity against Mtb and is a potential drug to treat Mtb, and MDR-TB infections in particular.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Inhibitory effect of fidaxomicin on biofilm formation in Clostridioides difficile. (Pubmed Central) - Apr 7, 2021
In C. difficile UK027 exposed to sub-MICs of fidaxomicin, mRNA expression of biofilm-related flagellin gene fliC was slightly increased compared with that of other biofilm-related genes (pilA1, cwp84, luxS, dccA, and spo0A). In conclusion, this study indicates that sub-MICs of fidaxomicin inhibit C. difficile UK027 biofilm formation by influencing cell growth and fliC transcription.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Genome-based rational engineering of Actinoplanes deccanensis for improving fidaxomicin production and genetic stability. (Pubmed Central) - Apr 7, 2021
Further rational engineering approaches including elimination of a pigment pathway, duplication of the fidaxomicin gene cluster, overexpression of a positive regulator and optimization of the fermentation medium, led to an overall 27-folds improvement in fidaxomicin production. Taken together, the genome-based rational combinatorial engineering strategy was efficient to enhance the fidaxomicin production and ameliorate the genetic stability of YP-1, it can also be widely used in other industrial actinomycetes for strain improvement.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal, HEOR: Cost-effectiveness Analysis of a Fecal Microbiota Transplant Center for Treating Recurrent C.difficile Infection. (Pubmed Central) - Mar 19, 2021
This is crucial for medical jurisdictions making decisions about establishing a FMT unit for the treatment of recurrent CDI. The cost-effectiveness can be generalized in other countries.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Total Synthesis of Tiacumicin B: Implementing H-bond-Directed Acceptor Delivery for Highly Selective β-Glycosylations. (Pubmed Central) - Mar 16, 2021
Ring-size selective macrolactonization provided a compound engaged directly in the noviolysation step with a virtually total β-selectivity. The final efficient removal of all the protective groups (PGs) provided synthetic tiacumicin B.
- SER-109 / Seres Therap
[VIRTUAL] 24-WEEK EFFICACY AND SAFETY DATA FROM ECOSPOR-III, A PHASE 3 DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SER-109, AN INVESTIGATIONAL MICROBIOME THERAPEUTIC FOR TREATMENT OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_3581;
By enriching for Firmicute spores, SER-109 achieves high efficacy, while mitigating risk of transmitting infectious agents and represents a major paradigm shift in the clinical management of patients with recurrent CDI. An open-label study for patients with recurrent CDI is currently enrolling
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Effect of a prospective audit with intervention and feedback on Clostridioides difficile infection management. (Pubmed Central) - Mar 10, 2021
Main outcome measures Percentage of conformity to the protocol, percentage of recovery at 10 days and percentage of relapse, as well as Clostridioides difficile incidence and percentage of Fidaxomicin use...The Clostridioides difficile incidence rate improved significantly to 1.3 per 10,000 patient-days during the observation period. Conclusion This study shows the lasting effect of an educational and Clostridioides difficile-prospective audit with intervention and feedback period on prescribers' adherence to recommendations and a significant impact on clinical outcomes.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Journal: Evolving Strategies to Manage Clostridium difficile Colitis. (Pubmed Central) - Mar 4, 2021
Operative treatment should be reserved for patients with fulminant infection, and early identification of patients who would benefit from an operation remains a challenge. Less invasive surgical options-such as laparoscopic diverting ileostomy with colonic irrigation-may improve survival and other outcomes relative to total abdominal colectomy and represent an attractive alternative particularly for frail patients.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: The Face of Clostriodes Difficile Infections in the Outpatient Setting. (Pubmed Central) - Mar 4, 2021
Of those sample patients who have available markers of severity, patients receiving clinic-based diagnoses were less likely assessed to have severe CDI. Keywords: Cloistriodes difficile infection, ambulatory, severity markers.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Observational data, Journal: Outcome of Clostridioides difficile infections treated in a Swiss tertiary care hospital: an observational study. (Pubmed Central) - Feb 20, 2021
Metronidazole was associated with low recurrence rates at minimal costs in patients with uncomplicated CDI, but had relevant shortcomings in patients with severe CDI and/or a high risk of recurrence, suggesting that these vulnerable patients might better be treated with oral vancomycin and fidaxomicin, according to the latest guidelines. .
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal, HEOR: Cost-effectiveness analysis of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in Japan. (Pubmed Central) - Feb 18, 2021
. Fidaxomicin treatment in patients with CDI following failure of metronidazole improves health outcomes with partial offset of higher drug acquisition costs versus vancomycin.
- ||||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Thanks for e-visiting us @DrJessicaA for @MSHS_IBDCenter #IBD rounds. Lots of great pearls. Biggest take away - treat #IBD pts with cdiff first line with vanc or fidaxomicin. Treat with caution, don’t waste time with flagyl. FMT doesn’t cause #IBD flares. (Twitter) - Feb 16, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Trial completion date, Trial primary completion date: A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections (clinicaltrials.gov) - Feb 9, 2021
P4, N=250, Recruiting, Sponsor: University of Michigan
Fidaxomicin treatment in patients with CDI following failure of metronidazole improves health outcomes with partial offset of higher drug acquisition costs versus vancomycin. Trial completion date: Apr 2021 --> Jun 2021 | Trial primary completion date: Jan 2021 --> Jun 2021
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] FAVOURABLE OUTCOME AND NO INCREASED RISK OF GVHD IN PATIENTS DEVELOPING C.DIFFICILE INFECTION AFTER HEMATOPOIETIC STEM CELL TRANSPLANTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_1872;
Patients with a history of previous abdominal surgery or HCV infection, or those who had received broad spectrum parenteral antibacterial therapy were at major risk for CDI development. CDIs were successfully treated with vancomycin or fidaxomicin after auto-HSCT and allo-HSCT, without impactingo on TRM and OS.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] FAVOURABLE OUTCOME AND NO INCREASED RISK OF GVHD IN PATIENTS DEVELOPING C.DIFFICILE INFECTION AFTER HEMATOPOIETIC STEM CELL TRANSPLANTS (On-Demand Library) - Feb 4, 2021 - Abstract #EBMT2021EBMT_1871;
Patients with a history of previous abdominal surgery or HCV infection, or those who had received broad spectrum parenteral antibacterial therapy were at major risk for CDI development. CDIs were successfully treated with vancomycin or fidaxomicin after auto-HSCT and allo-HSCT, without impactingo on TRM and OS.