Helicase-primase inhibitor pritelivir for HSV-2 infection

Update item information
Publication Type pre-print
School or College School of Medicine
Department Ophthalmology
Creator Kriesel, John D.
Other Author Wald, A.; Corey, L.; Timmler, B.; Magaret, A.; Warren, T.; Tyring, S.; Johnston, C.; Fife, K.; Galitz, L.; Stoelben, S.; Huang, M.-L.; Selke, S.; Stobernack, H.-P.; Ruebsamen-Schaeff, H.; Birkmann, A.
Title Helicase-primase inhibitor pritelivir for HSV-2 infection
Date 2014-01-01
Description Background Pritelivir, an inhibitor of the viral helicase-primase complex, exhibits antiviral activity in vitro and in animal models of herpes simplex virus (HSV) infection. We tested the efficacy and safety of pritelivir in otherwise healthy persons with genital HSV-2 infection. Methods We randomly assigned 156 HSV-2-positive persons with a history of genital herpes to receive one of four doses of oral pritelivir (5, 25, or 75 mg daily, or 400 mg weekly) or placebo for 28 days. Participants obtained daily swabs from the genital area for HSV-2 testing, which was performed with a polymerase-chain-reaction assay. Participants also maintained a diary of genital signs and symptoms. The primary end point was the rate of genital HSV shedding. Results HSV shedding among placebo recipients was detected on 16.6% of days; shedding among pritelivir recipients was detected on 18.2% of days among those receiving 5 mg daily, 9.3% of days among those receiving 25 mg daily, 2.1% of days among those receiving 75 mg daily, and 5.3% of days among those receiving 400 mg weekly. The relative risk of viral shedding with pritelivir, as compared with placebo, was 1.11 (95% confidence interval [CI], 0.65 to 1.87) with the 5-mg daily dose, 0.57 (95% CI, 0.31 to 1.03) with the 25-mg daily dose, 0.13 (95% CI, 0.04 to 0.38) with the 75-mg daily dose, and 0.32 (95% CI, 0.17 to 0.59) with the 400-mg weekly dose. The percentage of days with genital lesions was also significantly reduced, from 9.0% in the placebo group to 1.2% in both the group receiving 75 mg of pritelivir daily (relative risk, 0.13; 95% CI, 0.02 to 0.70) and the group receiving 400 mg weekly (relative risk, 0.13; 95% CI, 0.03 to 0.52). The rate of adverse events was similar in all groups.
Type Text
Publisher Massachusetts Medical Society
Volume 370
Issue 3
First Page 201
Last Page 210
Language eng
Bibliographic Citation Wald, A., Corey, L., Timmler, B., Magaret, A., Warren, T., Tyring, S., Johnston, C., Kriesel, J., Fife, K., Galitz, L., Stoelben, S., Huang, M.-L., Selke, S., Stobernack, H.-P., Ruebsamen-Schaeff, H., & Birkmann, A. (2014). Helicase-primase inhibitor pritelivir for HSV-2 infection, New England Journal of Medicine, 370(3), 201-10.
Rights Management (c) Massachusetts Medical Society
Format Medium application/pdf
Format Extent 606,783 bytes
Identifier uspace,18453
ARK ark:/87278/s6351vct
Setname ir_uspace
Date Created 2014-03-21
Date Modified 2021-05-06
ID 711950
Reference URL https://collections.lib.utah.edu/ark:/87278/s6351vct
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