ROMANOWSKI B, GRANT ZA, TABACK N; Interscience Conference on Antimicrobial Agents and Chemotherapy; THE VALACYCLORIR STUDY GRP.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 265.
Univ. of Alberta, Edmonton, AB, Canada
BACKGROUND: This study was designed to evaluate & test the hypothesis that subjects prefer valacyclovir suppressive therapy versus episodic therapy for the management of recurrent genital herpes (GH).METHODS: A prospective, open-label cross-over study was conducted in 16 centres across Canada in adult subjects with recurrent GH. Subjects with >/= 3 to = 10 recurrences per year were eligible and randomized to either suppressive (valacyclovir 500mg qd) or episodic treatment (valacyclovir 500mg bid x 5 days) and crossed over after 24-weeks. If a recurrence occurred while on suppressive treatment, medication was stopped and 5 days-episodic treatment given. The primary endpoint was subject treatment preference at week 48. The most important secondary endpoint was time to first GH recurrence.RESULTS: Two hundred and twenty-five patients entered the study; 202 patients 18-65 years (mean 38) were analyzed. Seventy-two percent of subjects preferred suppressive therapy (95% CI, [65.6%, 78.0%]). In period 1, 42% had a recurrence while on suppressive therapy versus 91% on episodic therapy (95% CI for the difference, [37.4%, 59.6%]). In period 2, 44% had a recurrence on suppressive therapy versus 74.5% on episodic therapy (95% CI for the difference, [17.6 %, 43.4%]). Time to first clinical recurrence was 176 days in the suppressive group (95% CI, [167.0, 182.0]), versus 39.0 days in the episodic group (95% CI, [27.0, 50.0]). The risk ratio indicates that subjects on episodic therapy are 5.0 (P=0.0001) times more likely to have a GH recurrence relative to subjects on suppressive therapy. Conclusion: Subjects preferred once daily valacyclovir as suppressive therapy to manage their GH outbreaks. The time to first recurrence on suppressive therapy is significantly reduced compared to episodic therapy.KEYWORDS: Preference; Suppressive; Valacyclovir>
Publication Types:
Keywords:
- Acyclovir
- Adult
- Antiretroviral Therapy, Highly Active
- Canada
- Female
- Herpes Genitalis
- Humans
- Longitudinal Studies
- Male
- Recurrence
- Treatment Outcome
- Valine
- drug therapy
- therapy
- valacyclovir
Other ID:
UI: 102247684
From Meeting Abstracts