June ID Upate

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. To sign up for ID updates to your inbox, register here.
 

June 2021
 

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • May 26: FDA EUA for sotrovimab. Healthcare providers fact sheet here.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). Available here.
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021 Mar 10 [Epub ahead of print]). Available at PMC.

New Product Approvals

  • Ibrexafungerp* (Brexafemme) for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis. Ibrexafungerp is the first triterpenoid antifungal to be approved by the US FDA. The recommended dosage is two doses of 300 mg (two 150 mg tablets) administered approximately 12 hours apart, with or without food. Verify pregnancy status in females of reproductive potential prior to initiating treatment.
  • Brincidofovir (Tembexa) for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. Because smallpox is eradicated, the effectiveness of brincidofovir was studied in animals infected with viruses that are closely related to the variola virus. Safety information was derived from clinical trials of the drug for a non-smallpox use. The recommended dosage for adults ≥48 kg is 200 mg (tablets or oral suspension) once weekly for two doses (tablets on an empty stomach or with a low-fat meal, suspension on an empty stomach).

New or Updated Treatment Guidelines

A Brief Review of a New Type of Antifungal

  • Ibrexafungerp* is the first triterpenoid antifungal to be approved by the US FDA. It works by inhibiting the biosynthesis of β-(1,3)-D-glucan, a key component of the fungal cell wall. This mechanism of action is like that of an echinocandin, so (not surprisingly) ibrexafungerp is fungicidal against multiple Candida species and fungistatic against Aspergillus. However, ibrexafungerp and echinocandins do not share the same binding site on the target enzyme (β-(1,3)-D-glucan synthase), so limited cross-resistance is expected. A unique feature of ibrexafungerp is its oral bioavailability. It is highly protein bound, its distribution volume is large, and tissue distribution is generally good (although not the CNS). Activity seems enhanced at low pH. Serum half-life is prolonged (about 20 hours), and elimination is mainly via feces and bile. Ibrexafungerp is a CYP3A4 substrate, so moderate to strong inducers and inhibitors will affect its serum concentration. It also inhibits certain CYP enzymes and transporters, but the short duration of treatment should limit clinical significance. The drug is generally well tolerated, although it is contraindicated in pregnancy because of fetal harm observed in animal studies. Ibrexafungerp is approved for the treatment of vulvovaginal candidiasis at a dose of 300 mg q12h x2 doses, with or without food. Commercial launch in the US is expected sometime this year (J Fungi 2021;7:163).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of June 8, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since May 9, 2021Neomycin tablets
    • Shortage recently resolvedAzithromycin injection, Rifampin injection, YF-VAX
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftazidime-avibactam injection, Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin-sulbactam injection, Piperacillin-tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Clotrimazole 10 mg oral troches
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 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).