APRIL 2025

Article of the Month (Editors' Choice)

By Michael S. Saag, MD

• For decades, routine treatment of the male partner of a patient with bacterial vaginosis (BV) was not recommended. Indeed, the current Centers for Disease Control and Prevention STI guidelines do not recommend treatment of the male partner.
• To further evaluate this issue, a recent randomized clinical trial (by Vodstrcil and colleagues) evaluating the benefits of treating male partners to reduce the recurrence of BV in women was published in the New England Journal of Medicine in early March, 2025 (N Engl J Med 2025;392:947-957). The study showed that treating male partners with a combination of oral metronidazole and topical clindamycin cream reduced the recurrence rate of BV in women over a 12-week period compared to standard care (with no treatment of the male partner). The trial evaluated 150 couples and showed that the recurrence rate in the partner-treatment group was 35%, compared to 63% in the control group.
• In an accompanying editorial in the same issue of the NEJM (N Engl J Med 2025;392:1026-27), Muzny and Sobel state “this trial provides data critical to educating clinicians and patients about the role of sexual transmission of bacterial vaginosis–associated bacteria and the benefit of male-partner treatment.”  They recommend that clinicians educate their patients with BV on the role of sexual transmission of bacterial vaginosis–associated bacteria and begin treating the male partners in the setting of recurrent BV.

Sanford Guide Report from CROI 2025

By Michael S. Saag, MD

The 2025 Conference on Retroviruses and Opportunistic Infections (CROI) took place on March 9-12 in San Francisco, CA. As usual, the conference captured the most cutting-edge data on HIV, its associated complications, and other emerging viral diseases, making it the most important annual meeting for the HIV/AIDS research community. Among the myriad of high quality presentations, these presentations stood out to me:

• The session on Tuesday morning reviewing new anti-HIV drugs.
  • Two studies (Colson, et al, and Orkin, et al) presented results of switch studies of people with HIV (PWH) who were virologically suppressed and were randomly assigned to receive islatravir / doravirine vs. remaining on BIC/ TAF/ FTC or their standard ART regimen. Both studies demonstrated sustained virologic suppression in each group (non-inferiority), stable CD4 counts, and no changes in weight post-switch.
  • An exploratory study evaluated lenacapavir (LEN) plus two broadly neutralizing antibodies, teropavimab (TAB) and zinlirvimab (ZAB), with all drugs administered every 6 months among PWH who were virally suppressed. The 6-month combination regimen was non-inferior to the control arm (continued oral Rx), with only one participant in the injectable group experiencing virologic failure (Ogbuagu, et al).
  • A study of cabotegravir (given monthly) was combined with a broadly neutralizing antibody (N6LS) administered every 4 months (IV or SQ) among PWH with suppressed viral load at baseline. Among 99 participants, 4 developed virologic breakthrough, of whom one developed InSTI resistance (Taiwo, et al).
• In the “BEeHIVe” study (ACTG 5379; Marks, et al), hepatitis B vaccine non-responders received either 2 or 3 doses of HepB-CpG (Hepaslav) vaccination vs standard revaccination with 3 doses of HepB-alum vaccine. Both of the HepB-CpG arms demonstrated superior seroprotective responses (anti-HBsAb >10 mIU/ml) compared to the standard HepB-alum vaccine, with 97.2% and 86.1% of the 3-dose and 2-dose recipients of the HepB-CpG vaccine achieving seroprotective responses, respectively, versus only 57.5% of the HepB-alum vaccine recipients. The study also evaluated vaccine-naïve PWH, where 100% of recipients achieve seroprotective titers after receiving 3-doses of the HepB-CpG vaccine.
• In the STOMP trial (ACTG 5418; Wilken, et al), individuals who had incident Clade 2 Mpox infections (N= 530) were randomized 2:1 to receive tecovirimat versus placebo. Median days from onset of Mpox symptoms was 8 days in each group; 35% of study participants were PWH. There was no significant difference in the treatment group vs placebo in terms of resolution of clinical symptoms or resolution of pain. No difference in outcomes were observed in the subgroups that were treated within 3 or 5 days of onset of symptoms, HIV status, nor among those with prior smallpox vaccination.
• A wonderful mini-symposium on Congestive Heart Failure (CHF) was presented by Matthew Feinstein of Northwestern University. Dr. Feinstein indicated that PWH experience a 1.5 to 2-fold higher risk for development of CHF compared to non-HIV age-matched controls in the general population. The causes of CHF among PWH are highly varied and include hypertension, coronary artery disease, toxic damage to the myocardium, valvular heart disease and arrhythmias. Using a subset of patients from the CNICS cohort (Abstract 814) with adjudicated diagnoses of CHF (N=289; 212 with incident HF), Feinstein and his team showed that higher viral loads, lower CD4 counts, older age, treated hypertension, diabetes, and lower GFR were all associated with significantly higher risk for CHF.

All oral abstract presentations, plenaries, themed discussions, symposia, and the full abstract book will be available to the general public on the CROI 2025 website as of 14 April 2025, at https://www.croiconference.org.

Measles Primer Part 2--Who Needs Vaccination?

By David O. Freedman, MD

• Persons without evidence of immunity should receive 1 or 2 doses of MMR.
• Evidence of immunity:
  • Born before 1957 (except for HCW)
    • Rare breakthrough cases have occurred in epidemics in unvaccinated persons born before 1956.
  • Persons with 2 documented doses of MMR vaccine are considered to be immune, regardless of the results of a subsequent serologic test; commercial serologic tests may not be sensitive enough to reliably detect long-term vaccine-induced immunity.
    • In 2024, 4% of outbreak cases occurred in persons who had had 2 MMR doses but overall immune status of these breakthroughs not known.
  • Laboratory evidence of immunity.
  • Laboratory confirmation of disease (recall or written record of clinical disease without lab confirmation not acceptable).
  • CDC considers 1 lifetime dose of MMR as evidence of immunity in adults at "low risk" but 2 doses needed if "high risk."
    • Most cautious adults would consider themselves high-risk in the current environment.
    • No studies on long-term immunity after a single dose of MMR.
• Post-exposure prophylaxis (PEP)
  • • Non-immune normal hosts, or HIV with CD4 >200 cells/µL, age ≥12 months: MMR vaccine is preferable to IG. Administer within 72 hours of exposure.
      • If IG given, still need MMR later (in 3-6 months).
    • Severely immunocompromised persons (including HIV with CD4 <200 cells/µL): Give IVIG (400 mg/kg) within 6 days of exposure regardless of immunological or vaccination status.
    • Pregnant women without evidence of measles immunity: Give IVIG 400 mg/kg.

Recent Drug Approvals

• Aztreonam-avibactam (Emblaveo)
  
  • Monobactam + beta-lactamase inhibitor co-formulation.
  • Approved by the US FDA in February, 2025 for complicated intra-abdominal infection (in combination with metronidazole) in adults with limited or no alternative treatment options.
  • Previously approved by the European Commission in February, 2024 for multiple indications.
  • Recommended dose: 2.67 gm IV (infused over 3 hours) load, then 2 gm IV (infused over 3 hours) q6h x5-14 days.
  • Note that the product is co-formulated in a 3:1 ratio (e.g., 2.67 gm = aztreonam 2 gm + avibactam 0.67 gm).
• Gepotidacin (Blujepa)
  
  • A first-in-class triazaacenaphthylene antibacterial for oral administration.
  • Selectively inhibits DNA replication by interacting with the bacterial subunits of DNA gyrase and topoisomerase IV.
  • Indicated for the treatment of female patients ≥12 years of age (weight ≥40 kg) with uncomplicated cystitis caused by susceptible strains of E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus, and E. faecalis.
  • Most common adverse effect is diarrhea. Reversibly inhibits acetylcholinesterase. Prolongs QTc interval. CYP3A4 substrate and inhibitor.
  • Dose: 1500 mg (two 750 mg tablets) po q12h x5 days.

First Home Test for Chlamydia, Gonorrhea, and Trichomoniasis

• On March 28 the US FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test, the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that is available OTC and performed entirely at home. This palm-sized, single-use PCR test is intended for females with or without symptoms.
• Unlike existing home-based STI tests that require mailing samples to a lab, results are provided directly to users within 30 minutes. The test includes a collection kit (self-collected vaginal swab) and a powered testing device which communicates with the Visby app and displays the results.
• See FDA News Release.

New or Updated Guidelines

• Australasian Society of Infectious Diseases (ASID) updated guidelines for the management of Clostridioides difficile infection in adults and children in Australia and New Zealand (Intern Med J 2025;55:503-13). These guidelines are an update of the 2016 ASID guidelines.
• 2024 European guidelines for the management of genital herpes (J Eur Acad Dermatol Venereol 2025;39:742-58). This guideline was produced on behalf of the International Union against STI Europe, the European Academy of Dermatology and Venereology, the European Dermatology Forum, and the Union of European Medical Specialists. The European Center for Disease Prevention and Control and WHO-Europe also contributed to their development. For PDF click here.

Antimicrobial Shortages (US)

• Recent shortages:
  • None
• Recently resolved shortages:
  
  • Ampicillin injection (24 Feb 2025)
  • Ofloxacin 0.3% ophthalmic solution (3 Feb 2025)
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 6 March 2025) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Azithromycin oral suspension, 1 gm packets (20 Nov 2024)
    • 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)
    • 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)
      • 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)
    • Ibrexafungerp 150 mg tablets (3 Dec 2024)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
    • Rifapentine 150 mg tablets (25 Feb 2025)
  • 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)
    • Peginterferon alfa-2a (Pegasys) (8 Jan 2025)
    • Ribavirin for inhalation solution (23 May 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/