FIFE K, ALMEKINDER J, MADHURA BP, DEETER RG; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. UL-17.

Indiana Univ., Indianapolis, IN.

BACKGROUND: Valacyclovir (VAL) has been shown to be effective for both acute treatment and chronic suppression of recurrent genital herpes (RGH). These treatment strategies have not been studied to determine whether one approach is superior to the other with regard to recurrence. The purpose of this study was to compare the effect of episodic therapy (ET) and suppressive therapy (ST) using VAL 500 mg for RGH. METHODS: In this randomized, open-label trial, 80 otherwise healthy subjects with a history of 4-9 recurrences per year were randomized to either ET or ST for one year. Subjects receiving ET, self-initiated 500 mg VAL BID for 5 days at the first sign of recurrence. Those randomized to ST were given 500 mg VAL daily. Patients maintained daily diaries recording information relating to their herpes outbreaks and were evaluated monthly. RESULTS: 32 ET subjects and 34 ST subjects completed the trial. Demographics and prior history of RGH were similar between the two treatment groups: 63% female, a mean of 6 outbreaks per year, and a history of GH of 7.6 and 6.1 years in each treatment group. The proportions of subjects who were recurrence free in one year were 3% (ET) vs. 41% (ST). The mean number of recurrences in one year was 7.3 (ET) vs. 1.6 (ST). The normalized mean number of days with pain and lesions were 6.5 (ET) vs. 1.1 (ST). Most astonishing, the mean number of days between recurrences was 53 (ET) vs. 179.8 (ST). All four comparisons favored suppressive therapy, with p-values <0.001. CONCLUSIONS: ST with VAL (500mg once daily) for RGH significantly reduces the number of recurrences by 78.1%, the number of days with pain and lesions, and the percent recurrence free in one year as compared to ET with VAL (500mg). The interval between recurrence was significantly different between ET and ST providing patients with clinically significant relief from their disease. Interval between recurrence has not been reported before.

Publication Types:

• Meeting Abstracts

Keywords:

• Acyclovir
• Clinical Trials as Topic
• Female
• Herpes Genitalis
• Humans
• Male
• Pain Clinics
• Placebos
• Recurrence
• Valine
• history
• therapy
• valacyclovir

Other ID:

• GWAIDS0029951

UI: 102269583

From Meeting Abstracts