FDA Approves New Drug for HSV Lesions in Adults

The FDA approved pritelivir (Hovilpri) oral tablets for the treatment of mucocutaneous lesions from herpes simplex virus (HSV) infection in adults, according to a news release.¹ With many patients showing resistance to common treatments like acyclovir, valacyclovir, or famciclovir, pritelivir’s approval could improve population-wide outcomes for adults with HSV-related lesions.

“Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) are common viral infections that typically cause painful mucocutaneous lesions, or fluid-filled blisters that break open and crust over the infectious site,” wrote the FDA, according to the release. “Once a person has HSV, the infection cannot be cured. The virus can be dormant or can reactivate, leading people to have outbreaks or release contagious viral particles without being symptomatic.”

In the clinical trial evaluating pritelivir, the drug’s efficacy was demonstrated in a randomized superiority study involving 101 immunocompromised adult participants with mucocutaneous HSV infections who failed standard treatments.¹

By day 28 of therapy, complete lesion healing occurred in 63% of patients receiving pritelivir, compared with only 34% of patients receiving alternative investigator-selected antiviral medications. Headache was recorded as the most common adverse reaction among trial subjects.

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Clinical Challenges and Resistance to Standard Antivirals

For pharmacists, understanding why pritelivir represents a key therapeutic development requires examining the limitations of traditional nucleoside analogues. Standard oral regimens using acyclovir, valacyclovir, or famciclovir effectively control outbreaks in immunocompetent hosts, but they frequently fail in severely immunocompromised individuals.^2,3

Clinical guidelines indicate that treatment failure due to viral resistance should be suspected when herpetic lesions do not show signs of resolution within 7 to 10 days after starting therapy. In patients with advanced immunosuppression, such as individuals with HIV or organ transplants, chronic mucocutaneous herpes can persist for longer than 4 weeks and produce extensive ulcerative or verrucous lesions.^2,4

Historically, clinicians managing acyclovir-resistant strains relied on systemic foscarnet or intravenous cidofovir, both of which carry significant risks of kidney toxicity and require intensive laboratory monitoring. In severe refractory cases, medical teams have also used off-label topical imiquimod or surgical excision to manage persistent tissue growth.

Accurate diagnostic testing remains critical when evaluating refractory herpetic lesions in vulnerable populations. Clinical visual inspection alone is insufficient for definitive diagnosis, making polymerase chain reaction testing of lesion swabs the preferred diagnostic method. When treatment failure occurs, viral culture and drug susceptibility testing are necessary to confirm acyclovir resistance and guide secondary treatment choices.^4,5

The Expanding Role of Pharmacists in HSV Management and Patient Care

Pharmacists serve as accessible front-line health care providers who regularly assist patients seeking relief from herpetic outbreaks.^3,5

Although expanded scope-of-practice models in regions like Canada and Idaho permit pharmacists to evaluate and prescribe oral antivirals for uncomplicated cold sores, established clinical protocols enforce strict medical referral rules. Triage guidelines mandate immediate physician referral whenever a patient is immunocompromised, exhibits systemic symptoms such as fever, or presents with lesions that persist past 2 weeks.³

Beyond triage and referral, pharmacists in both community and health-system settings play a crucial role in patient education, symptom relief, and stigma reduction. Pharmacists can recommend supportive nonpharmacological care, including saline bathing, loose clothing, and topical lidocaine, to alleviate localized pain during active outbreaks.⁵

Pharmacy professionals are advised to adopt nonjudgmental communication styles during patient consultations to reduce emotional distress and social stigma associated with HSV infections.

By combining clinical knowledge of emerging antivirals like pritelivir with empathetic patient care, pharmacists can optimize therapeutic outcomes across diverse patient populations.^3,5

“With the appropriate safeguards in place, pharmacists can safely assess and treat patients who have cold sores with oral antivirals as has been the case in several jurisdictions,” concluded authors of a study in Innovations in Pharmacy.³ “Regulatory bodies in the US may consider pharmacist independent prescriptive authority for oral antivirals for the treatment of cold sores as a means to improve access to patient care.”

READ MORE: Infectious Disease Resource Center

REFERENCES

1. FDA approves drug to treat lesions caused by herpes simplex virus. FDA. News Release. October 9, 2026. Accessed October 13, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-lesions-caused-herpes-simplex-virus

2. Calbucci KBCV, Veasey JV. Chronic mucocutaneous anogenital herpes: series of ten cases and literature review. An Bras Dermatol. 2022;97(3):362-365. doi:10.1016/j.abd.2021.03.014

3. Adams AJ, Klepser ME. Pharmacy-based assessment and management of herpes labialis (cold sores) with antiviral therapy. Innov Pharm. 2020;11(3):10.24926/iip.v11i3.1532. Published 2020 Jul 31. doi:10.24926/iip.v11i3.1532

4. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. Clinicalinfo.HIV. March 16, 2026. Accessed October 13, 2026. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/herpes-simplex

5. Barchi W, Katiyar S. Genital herpes: diagnosis and treatment. The Pharmaceutical Journal. May 10, 2024. Accessed October 13, 2026. https://pharmaceutical-journal.com/article/ld/genital-herpes-diagnosis-and-treatment