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December '24 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD. on Dec 10th 2024

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board and our AMS Program Manager. Links marked with a * are available to Sanford Guide All Access & Sanford Guide for Web clients. All other links are available without a Sanford Guide subscription. To receive monthly updates via email, sign up now.

Article of the Month (Editors' Choice)

  • Pre-exposure prophylaxis (PreP) is an effective strategy to prevent HIV infection. Current US CDC guidelines recommend PreP for HIV-negative sexually active adults and adolescents and persons who inject drugs at substantial risk of acquiring HIV infection. Approved regimens are oral emtricitabine*/tenofovir disoproxil fumarate* (F/TDF) or oral emtricitabine*/tenofovir alafenamide* (F/TAF) administered once daily or cabotegravir* administered intramuscularly every eight weeks. Efficacy of these regimens is high, approximately 75-90% effective in preventing HIV infection. Lack of adherence to the prescribed regimen is a major reason for failure in preventing HIV infection. A phase 3, multicenter, randomized double-blind controlled trial (PURPOSE 1; N Engl J Med 2024; 391:1179) comparing lenacapavir* administered subcutaneously twice-yearly to F/TDF or F/TAF, administered orally once daily, for prevention of HIV infection in cis-gender women in South Africa and Uganda found 0 infections among 2134 participants in the lenacapavir group, 39 infections among 2136 participants in the F/TAF group, and 16 infections among 1068 participants in the F/TDF group. The rates of HIV infection with lenacapavir were significantly lower from background rates of new HIV infection, whereas rates for F/TAF and F/TDF were not. Lack of efficacy with F/TAF and F/FDF was largely attributable to poor adherence to these once daily oral regimens. Twice-yearly subcutaneous lenacapavir is a highly efficacious option for PreP for prevention of HIV infection in women, and probably in other high-risk groups as well.

    A second phase 3, multicenter, randomized trial (PURPOSE 2; New Engl J Med on line 27 Nov 2024 https://www.nejm.org/doi/full/10.1056/NEJMoa2411858) evaluated cisgender men, transgender women, transgender men, and gender-nonbinary persons, randomized 2:1 to receive lenacapavir every 26 weeks or F/TDF. Among 3,265 participants HIV infection occurred in 2 / 2183 individuals assigned to lenacapavir (0.1 per 100 person-years) and 9 / 1088 individuals assigned to F/TDF (0.93 per 100-person years). The incidence of HIV in the lenacapavir group was significantly lower than the F/TDF group (incidence rate ratio 0.11, 95% CI 0.02 – 0.51; p < 0.002). A total of 26 participants (1.2%) discontinued lenacapavir owing to injection site reactions (vs 0.3% in the F/TDF group). No other safety concerns were identified.

    Taken together, twice yearly SQ lenacapavir is a highly efficacious PrEP regimen that performed better than daily oral therapy in 2 large RCTs. It is currently under review by the US Food and Drug administration for approval.

  • Authors: Henry F. Chambers, MD and Michael S. Saag, MD
  • An earlier version of this section misnamed the clinical trials as PROMISE. The correct name is PURPOSE.

CDC Routine Immunization Schedules (2025)

  • The official recommendations were published online on November 21. Updated links are now live on our page Master Immunization Schedules (CDC & WHO)*.
  • All Sanford Guide vaccine pages were updated in conjunction with 2024 ACIP meetings as they occurred. The following points of clarification were, however, added by CDC with the publication of the 2025 recommendations:
    • Heplisav-B is now recommended as acceptable during pregnancy.
    • HIV infection of any severity is a contraindication for use of ProQuad (MMRV; Merck). The criteria for MMR or varicella alone have not changed.
    • Additional doses of RSV vaccine are not recommended in subsequent pregnancies.
    • Fluzone HD and Fluad influenza vaccine are an option in persons aged 18 through 64 years who are solid organ transplant recipients receiving immunosuppressive medications. 

Mpox - LC16m8 Vaccine

  • LC16-Kaketsuken (LC16m8; KM Biologics, Japan) is a minimally replication-competent vaccinia-virus vaccine approved and available in Japan for both children ≥1 year of age and adults.
    • Limited published human data but similar to other vaccinia based vaccines with robust "takes" in vaccinees.
    • Administered percutaneously using a bifurcated needle.
    • WHO EUL issued in November 2024 for deployment to the African outbreak including children ≥1 year of age.

PreHevbrio Discontinued

  • VBI Vaccines, the manufacturer of the PreHevbrio brand of hepatitis B vaccine, declared bankruptcy and is ending business operations. PreHevbrio is no longer being distributed. The recall is not related to vaccine safety or quality.
  • Customers with the product are asked to destroy or return remaining doses.
  • All properly administered doses of PreHevbrio are valid hepatitis vaccinations and do not need to be repeated.  

New or Updated Practice Guidelines

  • ACG Clinical Guideline: Treatment of Helicobacter pylori Infection (Am J Gastroenterol 2024;119:1730-1753).
    • Recommendations for North America.
    • Preferred regimen (treatment-naive, antibiotic susceptibility unknown, with or without penicillin allergy): bismuth quadruple therapy (PPI, bismuth subcitrate or subsalicylate, tetracycline, metronidazole) x14 days.
    • Suitable empiric alternatives (treatment-naive, non-penicillin allergic): rifabutin triple therapy (omeprazole, amoxicillin, rifabutin) or vonoprazan dual therapy (vonoprazan, amoxicillin) x14 days.
  • Antiretroviral Drugs for Treatment and Prevention of HIV In Adults: 2024 Recommendations of the International Antiviral Society-USA Panel (JAMA 2024 Dec 1. doi: 10.1001/jama.2024.24543. Online ahead of print).

AMS Pearl: Framework for Clinical Decision Support

  • A recent publication describes the development of computerized clinical decision support (CDS) interventions using established frameworks.
  • A single academic medical center applied the “Five Rights” of CDS framework to assess and enhance an existing vancomycin electronic health record alert. The “Ten Commandments of Effective Clinical Decision Support” was used to optimize a new order panel for Clostridiodes difficile.
  • Infection Prevention and Antimicrobial Stewardship Programs should consider using established frameworks to evaluate new or optimize existing electronic health record interventions. Antimicrob Steward Healthc Epidemiol. 2024;4(1):e204. Published 2024 Nov 14. doi:10.1017/ash.2024.448.

Antimicrobial Shortages (US)

  • New shortages:
    • Azithromycin oral suspension, 1 gm packets (20 Nov 2024)
    • Ibrexafungerp 150 mg tablets (3 Dec 2024)
  • Resolved shortages:
    • Acyclovir injection (27 Nov 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 9 December 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Gentamicin injection (22 Feb 2021)
      • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir 300 mg capsules (29 Jun 2023)
        • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
        • Cefotaxime injection (10 Jun 2015)
          • FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details.
      • Chloramphenicol injection (9 Oct 2023)
      • Clindamycin phosphate injection (25 Jun 2015)
      • Fluoroquinolones:
        • Ciprofloxacin injection (13 Jan 2023)
        • Levofloxacin injection in D5W (29 May 2024)
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
        • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Metronidazole injection (20 Oct 2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension (5 Jun 2018)
      • Oxazolidinones:
        • Linezolid injection (16 Oct 2024)
      • Penicillins:
        • Amoxicillin, all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Ampicillin injection (19 Oct 2023)
        • Dicloxacillin 250 mg, 500 mg capsules (18 Aug 2021)
        • Nafcillin injection (20 Mar 2024)
        • Penicillin G benzathine injection (1 Feb 2023) Availability update here
        • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
        • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
        • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
      • Rifaximin 200 mg tablets (11 Apr 2024)
    • Antifungal drugs: 
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Fluconazole injection (9 Aug 2024)
      • Nystatin oral suspension (21 June 2024)
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
    • Antiparasitic drugs:
      • Mefloquine 250 mg tablets (14 May 2024)
      • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
    • Antiviral drugs: 
      • Cidofovir injection (01 Nov 2024)
      • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
      • Oseltamivir powder for oral suspension (1 Nov 2022)
      • Ribavirin for inhalation solution (23 May 2023)
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
    • Ritonavir oral solution 80 mg/mL (Jan 2023)
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