Infectious diseases

Top medication spend and medications with greatest change in spend

Infectious diseases (ID) spend is driven by HIV therapy, curative hepatitis C regimens and vaccines. Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) remains the top agent with rising spend and utilization. Hepatitis C therapies, including sofosbuvir/velpatasvir (Epclusa) and glecaprevir/pibrentasvir (Mavyret), still represent high spend but show declining use due to fewer treatable patients. Remdesivir (Veklury) spend also continues to fall as COVID-19 hospitalizations decline (Table 1).

Upcoming infectious disease therapy approvals

Table 2 highlights infectious disease agents with upcoming PDUFA dates. Zoliflodacin, an oral option for gonorrhea, may compete with gepotidacin—approved earlier this year for urinary tract infections and seeking expanded gonorrhea approval by late 2025. Doravirine + islatravir offers a novel HIV approach, with islatravir (an NRTTI) expected to first gain approval in treatment-experienced patients.^2-4 Ensitrelvir, under review as post-exposure prophylaxis for COVID-19, would be the only available option after monoclonal antibody withdrawals.^2,3,5 Cefepime + zidebactam may provide a new antibiotic effective against resistant pathogens in pyelonephritis and complicated UTIs.^2,3

New drug approvals and related guideline updates

Antimicrobials

• Aztreonam and avibactam in combination and gepotidacin are new options for complicated intra-abdominal infections and uncomplicated UTIs in females, respectively.
• Lenacapavir (Yeztugo), the second injectable HIV pre-exposure prophylaxis (PrEP) after cabotegravir (Apretude), offers twice-yearly dosing.⁶ Yeztugo is listed on HIVinfo.NIH.gov but not yet in CDC PrEP guidelines.^7,8

COVID-19 vaccines

Moderna’s next-generation vaccine, mNEXSPIKE, targets two binding domains in the SARS-CoV-2 S1 subunit, compared with the full-length spike protein targeted by other approved vaccines. Nuvaxovid is the FDA-approved trade name for Novavax’s COVID-19 vaccine, previously available only under EUA, with 2025–26 distribution managed by Sanofi.⁹

Key changes to COVID-19 vaccine approvals and recommendations in 2025.

• May 20 – U.S. Food and Drug Administration (FDA) published revised policy: immunogenicity data sufficient for high-risk groups (≥65, ≥6 months with risk factors); randomized controlled trials (RCTs) evaluating clinical outcomes will be required for healthy ages 6 months–64 years.¹⁰
• May 27 – U.S. Department of Health and Human Services (HHS) Secretary announced COVID-19 vaccination removed from recommended schedule for healthy children and pregnant women.¹¹
• May 29 – Centers for Disease Control and Prevention (CDC) updated childhood schedule: shared decision-making for ages 6 months–17 years without immunocompromise; no pregnancy-specific adult guidance.^12,13
• August 19 – American Academy of Pediatrics (AAP) recommended universal vaccination for ages 6–23 months; risk-based or clinician-guided vaccination for ages 2–18 years.¹⁴
• August 22 – American College of Obstetricians and Gynecologists (ACOG) recommended updated COVID-19 vaccination or boosters during pregnancy, preconception, postpartum, or lactation.¹⁵
• September 8 – American Academy of Family Physicians (AAFP) recommended universal vaccination for ages 6–23 months; risk-based or clinician-guided vaccination for ages 2–18 years; universal recommendation for ≥ 19 years.¹⁶
• September 18-19 – Advisory Committee on Immunization Practices (ACIP) recommended individual-based (ie, shared clinical decision-making) for all individuals ≥ 6 months of age (emphasis on risk-based selection in individuals 6 months to 64 years of age).¹⁷

Other vaccines and immunizations

Vimkunya is a new recombinant chikungunya vaccine and now the only option available in the U.S.^9,16

Penmenvy became the second pentavalent meningococcal vaccine approved, following Penbraya.⁹

Clesrovimab (Enflonsia), a monoclonal antibody for RSV prevention in infants during their first season only, has been incorporated into updated guidelines from both ACIP and AAP.^1,19

Other therapies

Zopapogene imadenovec-drba (Papzimeos) is a first-in-class, non-replicating adenoviral vector-based immunotherapy approved for recurrent respiratory papillomatosis, a rare condition caused by HPV infection resulting in benign growths in the respiratory tract.²⁰