Safety and pharmacokinetics of aciclovir in women following release from a silicone elastomer vaginal ring.

The Journal of Antimicrobial Chemotherapy
M J KellerBetsy C Herold

Abstract

Systemic aciclovir and its prodrug valaciclovir are effective in treating and reducing recurrences of genital herpes simplex virus (HSV) and reducing transmission. Local aciclovir delivery, if it can achieve and maintain comparable intracellular genital tract levels, may be equally effective in the treatment and suppression of genital HSV. Intravaginal ring (IVR) delivery of aciclovir may provide pre-exposure prophylaxis against HSV acquisition. Tolerability and pharmacokinetics were evaluated in six HIV-negative women with recurrent genital HSV who switched their daily oral valaciclovir suppression to an aciclovir IVR for 7 days (n = 3) or 14 days (n = 3). Blood and cervicovaginal lavage (CVL) were collected after oral and IVR dosing to measure aciclovir concentrations and genital swabs were obtained to quantify HSV shedding by PCR. The rings were well tolerated. Median plasma aciclovir concentrations were 110.2 ng/mL (IQR, 85.9-233.5) 12-18 h after oral valaciclovir. Little or no drug was detected in plasma following IVR dosing. Median (IQR) CVL aciclovir levels were 127.3 ng/mL (21-660.8) 2 h after oral valaciclovir, 154.4 ng/mL (60.7-327.5) 12-18 h after oral valaciclovir and 438 ng/mL (178.5-618.5) after 7 days and 393 ng/...Continue Reading

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Citations

Jul 24, 2012·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Marla J KellerBetsy C Herold
Dec 4, 2012·International Journal of Women's Health·R Karl MalcolmIan Major
Feb 2, 2016·Advanced Drug Delivery Reviews·R Karl MalcolmDiarmaid J Murphy
Mar 8, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Scott A ChurchmanMarc M Baum
May 5, 2016·Journal of the International AIDS Society·Randy M StalterUNKNOWN Consortium for Ring Adherence
Feb 5, 2014·Antimicrobial Agents and Chemotherapy·Manjula GunawardanaMarc M Baum
Jan 1, 2014·Journal of Pharmaceutics·Onkar SinghAmit K Goyal
Apr 7, 2017·PloS One·John A MossThomas J Smith
Jun 3, 2021·Pharmaceutics·Louise CarsonRobert Karl Malcolm

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