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)