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News

November 15, 2019

November ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

NOVEMBER 2019

New or Updated Treatment Guidelines

New for H. pylori Treatment

  • The US FDA has approved the three-drug combination of rifabutin, amoxicillin, and omeprazole (Talicia*) for the treatment of Helicobacter pyloriinfection in adults. Each capsule contains rifabutin 12.5 mg (immediate-release), amoxicillin 250 mg (immediate-release), and omeprazole 10 mg (delayed-release). Recommended dosage is four capsules q8h for 14 days, with food. US product launch is expected in the first quarter of 2020.

Intron A Discontinued

  • Based on an evaluation of clinical use and the availability of alternative therapies, Merck is discontinuing recombinant interferon alfa-2b (Intron A), in all strengths. Supply availability should continue over the next 1-2 years depending on product formulation and dose strength.

CABP Indication for Delafloxacin

  • Delafloxacin* is now indicated in adults for the treatment of community-acquired bacterial pneumonia due to S. pneumoniae, MSSA, K. pneumoniae, E. coli, P. aeruginosa, H. influenzae, H. parainfluenzae, C. pneumoniae, L. pneumophila, and M. pneumoniae. This is the drug's second FDA-approved indication.

Baloxavir Indication Expanded to High-Risk Patients

  • Baloxavir* is now indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for ≤48 hours and are 1) otherwise healthy, or 2) at high risk of developing influenza-related complications. High risk factors include underlying asthma or chronic lung disease, diabetes, heart disease, morbid obesity, and age ≥65 years.

Second Drug Approved for PrEP

  • Descovy (emtricitabine 200 mg + TAF 25 mg) is the second drug to be approved by the US FDA for HIV-1 pre-exposure prophylaxis (PrEP)*. It is indicated in at-risk adults and adolescents weighing at least 35 kg to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must be screened for HIV-1 infection immediately prior to starting PrEP, and then at least once every three months. The recommended dosage is one tablet orally once daily, with or without food. The first drug to be approved for PrEP was Truvada (emtricitabine 200 mg + TDF 300 mg) in 2012.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 8, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list since October 17]: None
    • [Shortage recently resolved]: Erythromycin lactobionate injection
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin 0.5% ophthalmic ointment
      • Nitrofurantoin oral suspension
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline hyclate injection
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment (unavailable), Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection, Griseofulvin oral tablets and suspension, Nystatin oral suspension
      • Antiparasitic drugs: Pentamidine isethionate
      • Antiretroviral drugs: None
      • Antiviral drugs: Acyclovir injection, Cidofovir injection, Letermovir injection (unavailable)
      • Vaccines: Hepatitis B vaccine recombinant, Rabies vaccine (and immune globulin), Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Interferon alfa-2b (Intron A, in October 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
  • For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
October 8, 2019

October ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

OCTOBER 2019

New or Updated Treatment Guidelines

Improved Access to IV Artesunate

  • IV artesunate* is the first-line, WHO-recommended treatment for severe malaria but is neither FDA-approved nor commercially available in the United States. Obtaining the drug from CDC has been problematic due to limited supply and other issues, but recent efforts have improved drug accessibility for those who need it. As of April 2019, CDC will release artesunate for all cases of severe malaria, any case of malaria where the patient is not tolerating oral medications, or any highly suspected case of severe malaria. The drug is pre-positioned at 18 locations nationally, and the hospital will need to send someone to the receiving airport or quarantine station to retrieve it. Call the CDC Malaria Hotline, (770) 488-7788, Mon-Fri, 9 am to 5 pm US EST. After hours, or on weekends or holidays, call the CDC Emergency Operations Center at (770) 488-7100 and ask to page the person on call for the Malaria Branch.

Practice Pearl

  • DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) is a T-cell-mediated hypersensitivity reaction characterized by fever, facial edema, maculopapular rash, lymphadenopathy, eosinophilia, mononucleosis-like atypical lymphocytosis, and multiorgan involvement (hepatitis, nephritis, arthritis, pneumonitis, carditis). The latency period is 2-8 weeks, and mortality approaches 10%. Recognized drug triggers include anticonvulsants, allopurinol, and antibiotics, including vancomycin. There are well-known HLA associations with drug hypersensitivity reactions, such as HLA-B*57:01 and hypersensitivity to abacavir; could variation within HLA predispose to vancomycin-associated DRESS? In 23 patients with vancomycin-associated DRESS, 82.6% carried the HLA-A*32:01 allele compared to 0% of 46 matched vancomycin-tolerant control patients (p=1 x 10-8). The patients with vancomycin-associated DRESS were primarily of European ancestry. In a larger cohort of 54,249 patients, the HLA-A*32:01 allele carriage rate was 6.3%, matching the carriage rate in other cohorts of mainly European ancestry. The authors estimate that approximately 75 patients started on vancomycin would need to undergo HLA-A*32:01 testing to prevent one case of vancomycin-associated DRESS. If validated, the association of HLA-A*32:01 carriage with vancomycin-associated DRESS could be useful not only for the prediction and prevention of the hypersensitivity reaction, but also for monitoring and risk stratification (J Allergy Clin Immunol 2019;144:183).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 7, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list since August 30]: Acyclovir injection, Rabies Immune Globulin, Rabies vaccine
    • [Shortage recently resolved]: Erythromycin lactobionate injection
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin 0.5% ophthalmic ointment
      • Nitrofurantoin oral suspension
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline hyclate injection
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment (unavailable), Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection, Griseofulvin oral tablets, Nystatin oral suspension
      • Antiparasitic drugs: Pentamidine isethionate
      • Antiretroviral drugs: None
      • Antiviral drugs: Cidofovir injection, Letermovir injection (unavailable)
      • Vaccines: Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
September 10, 2019

September ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

September 2019

New Antimicrobial Drug Approvals

  • Xenleta (lefamulin*), a systemically-administered pleuromutilin, approved for the treatment of adult with community-acquired pneumonia caused by susceptible strains of S. pneumoniae, MSSA, H. influenzae, L. pneumophila, M. pneumoniae, and C. pneumoniae. Pleuromutilins inhibit bacterial protein synthesis by binding to the peptidyl transferase center of the 50S bacterial ribosome, thereby preventing the binding of tRNA for peptide transfer. Recommended dosage: 150 mg IV q12h x5-7 days (switching to oral therapy to complete the course if appropriate), or 600 mg po q12h x5 days. Product availability: injection, 600 mg tablets.
  • Pretomanid* Tablets, a nitroimidazooxazine antimycobacterial drug, approved as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary MDR-TB or XDR-TB. Recommended dosage: 200 mg po once daily for 26 weeks (with bedaquiline and linezolid). The combination regimen should be taken with food. Product availability: 200 mg tablets.

Drug Safety Communications

  • The US FDA has issued a warning about worsening liver function or liver failure occurring in chronic hepatitis C patients with moderate to severe liver impairment who are treated with glecaprevir/pibrentasvir (Mavyret), elbasvir/grazoprevir (Zepatier), or sofosbuvir/velpatasvir/voxilaprevir (Vosevi). All three contain a NS3/4A protease inhibitor (the drug ending in -previr) and are not indicated for use in patients with moderate to severe liver impairment.  In most patients, symptoms resolved or new-onset worsening of liver function improved after stopping treatment. The full Drug Safety Communication can be found here.

From CDC

  • The recommendations of the Advisory Committee on Immunization Practices (ACIP) concerning the use of seasonal influenza vaccines in the US for the 2019-2020 season have been released (MMWR Recomm Rep 2019;68(No. RR-3):1–21). U.S. trivalent vaccines will contain hemagglutinin (HA) derived from an A/Brisbane/02/2018 (H1N1)pdm09–like virus, an A/Kansas/14/2017 (H3N2)–like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain HA derived from these three viruses and from an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage). This composition includes updates in the influenza A(H1N1)pdm09 and influenza A(H3N2) components of the vaccine. The full report is available on the MMWR website.

New or Updated Treatment Guidelines

  • Clinical practice guidelines for microbiological laboratory testing used in the diagnosis of fungal infections commonly encountered in pulmonary and critical care practice, from the American Thoracic Society (Am J Respir Crit Care Med 2019;200:535). The guidelines are available for download on the journal website.
  • Revised guidelines for the management of HHV-6 infections in patients with hematological malignancies and after hematopoietic stem cell transplantation, from the 2017 European Conference on Infectious in Leukemia (Haematologica 2019 August 29 [Epub ahead of print]). The guidelines are available for download on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 30, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list since August 1]: None
    • [Shortage recently resolved]: Hepatitis A vaccine inactivated, Letermovir tablets
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection, Erythromycin 0.5% ophthalmic ointment
      • Nitrofurantoin oral suspension
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline hyclate injection
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment (unavailable), Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection, Griseofulvin oral tablets, Nystatin oral suspension
      • Antiparasitic drugs: Pentamidine isethionate
      • Antiretroviral drugs: None
      • Antiviral drugs: Cidofovir injection, Letermovir injection (unavailable)
      • Vaccines: Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
September 10, 2019

Sanford Guide Announces Integration with Wise Diagnostic Systems


 
Sperryville, VA – Sanford Guide® announces the availability of its industry-leading infectious diseases guidelines through lab reports generated by Wise Diagnostic Systems. This new integration, facilitated by Sanford Guide’s content delivery API, links to pertinent Sanford Guide content directly from the report to help guide appropriate antimicrobial selection and dosing.
 
Wise Diagnostic Systems, a state-of-the-art molecular laboratory focused on infectious disease testing, offers comprehensive panels that detect a broad range of pathogens and common antibiotic resistance using PCR technology. The new interface with Sanford Guide content ensures clinicians quickly receive accurate results that include the most up to date pathogen information and therapy options for infectious diseases.
 
The Wise Diagnostic Systems interface with Sanford Guide represents the next logical iteration in laboratory diagnostics. By providing accurate and rapid PCR based results coupled with Sanford Guide recommendations, Wise Diagnostic Systems results provide not only clear, concise and actionable lab results, but also the most current antimicrobial therapy guidelines to support sound clinical decisions. “Coupled together, these facilitate better patient outcomes while fostering antibiotic stewardship,” notes Scott Brady, CEO and Founder of Wise Diagnostic Systems.
 
The growth in real-time integrations with Sanford Guide demonstrates the ease with which trusted guidelines can be incorporated into the clinical workflow using the Sanford Guide API. Since releasing the API in 2017, Sanford Guide content has been made available to tens of thousands of practitioners through clinical surveillance platforms and laboratory information systems. Providing information that is accessible, concise, and reliable, the API furthers Sanford Guide’s mission by reducing time-to-answer and providing guidance when it is needed most.
 
About Wise Diagnostic Systems
Veteran owned and operated, Wise Diagnostic Systems offers practical diagnostics to help clinicians achieve better patient outcomes. Through its state-of-the-art laboratory, Wise Diagnostic Systems provides FDA approved molecular testing platforms that achieve better sensitivity and specificity than conventional methodologies. 
 
About Sanford Guide
Since 1969, Sanford Guide has been a leader in point-of-care recommendations for the treatment of infectious diseases. Widely used by pharmacists, physicians, physician assistants, and nurses, Sanford Guide helps to improve patient care by providing carefully curated recommendations based on the latest evidence. Sanford Guide takes pride in responsiveness to customers, the development of innovative solutions, and providing content that is unparalleled in quality and clinical applicability.

 

August 14, 2019

August ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

August 2019

From CDC

  • Updated recommendations from the CDC Advisory Committee on Immunization Practices (ACIP) regarding prevention of Japanese encephalitis (JE) among US travelers and laboratory workers (MMWR Recomm Rep 2019;68(No. RR-2):1-33). The report summarizes the epidemiology of JE, describes the JE vaccine that is licensed and available in the US, and provides recommendations for its use. These recommendations update the 2010 release and are available on the CDC website.

Practice Pearls

  • Sofosbuvir/velpatasvir (Epclusa) is a pangenotypic, fixed-dose combination of sofosbuvir (NS5B RNA polymerase inhibitor) and velpatasvir (NS5A inhibitor) used for the treatment of chronic HCV. Velpatasvir is a lipophilic weak base with pH-dependent solubility (its solubility decreases as pH increases). Therefore, drugs like proton-pump inhibitors (PPI) impair velpatasvir absorption by raising gastric pH, and coadministration of sofosbuvir/velpatasvir with PPIs is generally not recommended. If it is medically necessary, the manufacturer recommends that sofosbuvir/velpatasvir be administered with food and taken four hours before omeprazole (20 mg). In a recent open-label, randomized, 3-arm crossover study, 11 healthy volunteers were administered a single dose of sofosbuvir/velpatasvir a) alone, b) with omeprazole (at steady-state concentrations), or c) with omeprazole combined with 250 mL of Coca-Cola. Pharmacokinetic sampling was performed on days 5-7 of each arm (see chart below). The data suggest that taking sofosbuvir/velpatasvir with Coca-Cola can overcome the interaction with proton-pump inhibitors, presumably by temporarily lowering gastric pH and thus enhancing velpatasvir solubility and absorption (Clin Pharmacol Ther 2019 Jul 17 [Epub ahead of print]).
    Study arm (seven days per arm, 7 days washout between arms) Velpatasvir AUC
    (geometric mean)
    Sofosbuvir/velpatasvir 400/100 mg on day 5 + 250 mL water 3742 mcg*hr/L
    Sofosbuvir/velpastavir 400/100 mg on day 5 + 250 mL water, omeprazole 40 mg qd (days 1-6) 2705 mcg*hr/L
    Sofosbuvir/velpastavir 400/100 mg on day 5 + 250 mL Coca-Cola, omeprazole 40 mg qd (days 1-6) 5981 mcg*hr/L

 

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 1, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list since July 17]: Bacitracin ophthalmic ointment, Griseofulvin oral tablets, Letermovir tablets
    • [Shortage recently resolved]: Amphotericin B injection, Nelfinavir tablets, Valganciclovir oral powder for solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection, Erythromycin 0.5% ophthalmic ointment
      • Nitrofurantoin oral suspension
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline hyclate injection
      • Topical (miscellaneous) antibacterials: Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection, Nystatin oral suspension
      • Antiparasitic drugs: Pentamidine isethionate
      • Antiretroviral drugs: None
      • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection (unavailable)
      • Vaccines: Hepatitis A vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)
  • For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages