Pritelivir for HSV-2 Genital Infections

January 15, 2014

Pritelivir for HSV-2 Genital Infections

  1. Larry M. Baddour, MD

A novel antiviral reduced both genital HSV shedding and days with lesions in a dose-dependent manner.

  1. Larry M. Baddour, MD

Nucleoside analogues, which inhibit herpes simplex virus (HSV) DNA polymerase following phosphorylation by the viral thymidine kinase, have been a mainstay in the treatment and prevention of genital HSV-2 infections. These agents have limitations, however, including development of resistance and inability to reduce viral shedding.

Pritelivir, the first in a new class of antiviral agents, inhibits HSV replication by targeting the viral helicase–primase complex. It has shown potent in vitro activity, as well as efficacy in infection models; phase I studies have demonstrated no safety issues. Now, in an industry-sponsored, proof-of-concept study conducted at seven sites in the U.S., researchers have evaluated the effect of various doses of pritelivir in reducing the HSV-2 shedding rate.

The researchers enrolled 155 otherwise healthy adults who were seropositive for HSV-2 and had a history of genital herpes. Participants were randomly assigned in a 1:1:1:1:1 ratio to one of the following regimens for 28 days:

  • 20-mg loading dose, then 5 mg daily

  • 100-mg loading dose, then 25 mg daily

  • 300-mg loading dose, then 75 mg daily

  • 400-mg weekly dose

  • Placebo

Participants obtained swabs from the genital area daily for HSV testing by polymerase chain reaction.

The relative risk for HSV-2 shedding was reduced with pritelivir, as compared to placebo, in a dose-dependent manner: 1.11 (95% confidence interval, 0.65–1.87) with the 5-mg daily dose; 0.57 (95% CI, 0.31–1.03) with the 25-mg daily dose; 0.13 (95% CI, 0.04–0.38) with the 75-mg daily dose; and 0.32 (95% CI, 0.17–0.59) for the 400-mg weekly dose. In addition, the proportion of days with genital lesions was significantly reduced for both the 75-mg daily and the 400-mg weekly groups compared to the placebo group (1.2% and 1.2% vs. 9.0%, respectively). Adverse-event rates were similar among the five groups.


Having treatment options that belong to different antimicrobial classes is the ideal situation in individualized patient management. Results from the current investigation suggest that pritelivir may ultimately broaden our antiviral armamentarium for the treatment and prevention of type 2 herpes simplex virus infections.

Editor Disclosures at Time of Publication

  • Disclosures for Larry M. Baddour, MD at time of publication Editorial boards UpToDate Leadership positions in professional societies American Heart Association (Chairman, Rheumatic Fever, Endocarditis, Kawasaki Disease Committee)


Reader Comments (3)

Enrique Rodriguez Other, Other, 5 hospital in Miami dade county

I need to know how I can purchase this medication
And why individuals with history of asma do not show this virus while they have them dorm

gladis celeste badolato Other, gimnasio

está ETS arruina la vida de las personas, yo no entiendo como no ayudan a una vía rápida para aprobar este remedio, si bien está ETS NO suele matar físicamente una ETS que te da riesgo de encefalitis, ceguera, posibilidad de partos con infección que puede ser mortal para un niño, RIESGO DE CONTARER HIV y que hace que la gente olvide su vida sexual para no contagiar, si realmente quieren ser responsables con los otros, por que saben lo limitante que es en el diario vivir físicamente CON HSV 2 Y QUE EL OTRO LUEGO DE CONTRAERLO, NO TIENE UN TRATAMIENTO EFECTIVO PARA PODER LLEVAR UNA VIDA NORMAL Y A LOS QUE SE ANIMAN A UNA RELACION VIVEN CON EL TEMOR DE ARRUINAR LA VIDA DEL OTRO. Una ETS que HACE A MUCHOS SENTIRSE muertos en vida y considerar el suicidio debe ser tomada enserio. yo creo que si hay riesgos no podrían firmar cada uno de lo pacientes que se hacen responsables de estos, antes de recibir la receta si son mayores de edad. por favor ayuden a que la gente viva mejor!

See-Won Other Healthcare Professional

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