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November '23 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD on Nov 13th 2023

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 Web Edition and All Access clients. All other links are available without a Sanford Guide subscription. To receive monthly updates via email, sign up now. 

NOVEMBER 2023

SARS-CoV-2 / COVID-19

Vaccine for Chikungunya Virus*

  • Single dose, live attenuated virus vaccine (Ixchiq, Valneva) for age >18 years now FDA approved.
    • Vaccine efficacy trial to be done in Phase 4 with readouts by 2027.
    • Recommended for: Adults with travel to areas with current CDC declared outbreaks.
    • Consider for: Certain persons traveling to transmission areas (within past 5 years as determined by CDC).
      • Long-stay travel (>6 months).
      • All persons age >65 years especially with co-morbidities.
    • FDA specified sero-response rate met in 98.9% of non-endemic subjects with 12-month persistence in pivotal Phase 3 trial (Lancet 2023; 401:P2138).
    • Adverse effects: Headache (31.6%), fatigue (28.5%), myalgia (23.9%), arthralgia (17.2%), fever (13.5%), nausea (11.2%).
    • Severe adverse effects: Chikungunya-like illness in 1.6%. 
    • US CDC ACIP draft proposal (vote in February 2024).

New Meningococcal Vaccine

  • A new combination meningococcal vaccine MenABCWY (Penbraya, Pfizer) has been approved by the US FDA and ACIP recommendations made. Penbraya may be used when both MenACWY and MenB are indicated at the same visit and desired by the patient. Common situations will include:
    • Healthy persons age 16-23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and the person is already due for the age 16 dose of MenACWY.
    • Persons age >10 years at increased risk of meningococcal disease (e.g., due to persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia) due for both vaccines at the same visit.
  • In most situations the second dose of MenB-containing vaccine will need to be with Trumenba (MenB monovalent vaccine). This combination vaccine introduces many complexities into the quite different MenACWY and MenB schedules.

Composition of Future Influenza Vaccine

  • Quadrivalent influenza vaccines protect against four different viruses: one H1N1 virus, one H3N2 virus, one B/Victoria virus and one B/Yamagata virus. All current influenza vaccines in the US are quadrivalent. US CDC and global surveillance data show that B/Yamagata lineage viruses have not been detected since March 2020, perhaps a result of the widespread public health countermeasures imposed during the COVID-19 pandemic. After review of these data, the WHO Influenza Vaccine Composition Advisory Committee and US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) have recommended that B/Yamagata lineage antigens be removed from influenza vaccines used in the US and internationally as soon as reasonably possible. For further information from CDC regarding the 2023-24 influenza season, click here.

Fexinidazole Availability

  • Fully FDA-approved fexinidazole* tablets (Sanofi), the treatment of choice for West African trypanosomiasis due to both Stage 1 and 2 T. brucei gambiense infection, are now available in the US. The fully oral regimen replaces the need for the previous regimen that includes a week of IV Eflornithine (stocked only by CDC). However, with Stage 2 disease with WBC >100/µL in CSF, the older regimen must still be used. Contact Sanofi directly (no commercial distribution) for free drug: Sanofi Medical Affairs at 1-800-372-6634 or customersupport@sanofi.com.

Mpox Update

  • For Mpox prevention, CDC has moved from earlier outbreak-based recommendations to standing recommendations.
  • Persons >18 years of age with risk factors should receive two doses of Jynneos 28 days apart. Jynneos will move to commercial distribution in the next few months.
  • Persons at risk:
    • Gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past six months have had one of the following:
      • At least one sexually transmitted disease
      • More than one sex partner
      • Sex at a commercial sex venue
      • Sex in association with a large public event in a geographic area where mpox transmissions is occurring
    • Sexual partners of persons with the risks described above
    • Persons who anticipate experiencing any of the above
    • Persons deemed at risk by health authorities in outbreak situations
  • Pregnancy: No recommendation at present, but pregnant persons with risk factors as above MAY receive Jynneos.
  • Healthcare workers: Should not receive Jynneos unless they have a sexual risk factor as above.

AMS Pearl: Preventing AMR and C. difficile

  • U.S. Antibiotic Awareness Week and World AMR Awareness Week are November 18-24, 2023, and November is also C. difficile Awareness Month. Among the key messages related to these campaigns is that misuse and overuse of antibiotics can lead to side effects including Clostridioides difficile infection. A recent case-control study evaluated the risk for community-associated C. difficile among 27 different outpatient antibiotics. Clindamycin and later generation cephalosporins were associated with higher risk of C. difficile while the tetracyclines had the lowest risk levels. Open Forum Infect Dis 2023 10: ofad413
  • Antimicrobial stewardship teams can encourage providers to evaluate patient risk factors such as antibiotic exposure, extended length of stay, older age, serious underlying conditions, and previous history of C. difficile. Targeting interventions to agents commonly associated with C. difficile such as clindamycin, fluoroquinolones, and third/fourth generation cephalosporins while working to use the shortest effective duration of therapy may also help minimize risk.
  • On Tuesday, November 14 at 3pm ET, Sanford Guide is hosting a free 1-hour webinar highlighting how AMS programs can be developed and optimized to play a role in reducing AMR. You can register here.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 12, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since October 8, 2023:
      • Ampicillin injection (10/19/2023)
      • Chloramphenicol injection (10/9/2023)
      • Nirsevimab-alip injection (10/24/2023)
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefdinir (all oral formulations)
        • Cefixime 400 mg capsules
        • Cefotaxime injection (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),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/23)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/23)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
      • Nystatin topical powder
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)
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