TY - JOUR
T1 - Valaciclovir for the suppression of recurrent genital herpes simplex virus infection
T2 - A large-scale dose range-finding study
AU - Reitano, M.
AU - Tyring, S.
AU - Lang, W.
AU - Thoming, C.
AU - Worm, A. M.
AU - Borelli, S.
AU - Chambers, L. O.
AU - Robinson, J. M.
AU - Corey, L.
N1 - Funding Information:
The authors and the International Valaciclovir HSV Study Group gratefully acknowledge Glaxo Wellcome for financial support and assistance with the study. We are particularly indebted to R. Toorawa for the statistical analysis, S. Weller for the pharmacokinetic analysis, and A. J. Ingamells, A. R. Bell, and R. J. Crooks for their contributions to both the design and conduct of the study and to preparation of this manuscript.
PY - 1998
Y1 - 1998
N2 - A randomized, double-blind study of valaciclovir for suppression of recurrent genital herpes was conducted among 1479 immunocompetent patients. Patients were randomized to receive valaciclovir (250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily), acyclovir (400 mg twice daily), or placebo, for 1 year. All valaciclovir dosages were significantly more effective than placebo at preventing or delaying recurrences (P < .0001). There was a dose- response relationship (P < .0001) across the once-daily valaciclovir regimens. Twice-daily valaciclovir and acyclovir were similar in effectiveness. Subgroup analysis showed that patients with a history of < 10 recurrences per year were effectively managed with 500 mg of valaciclovir once daily. One gram of valaciclovir once daily, 250 mg of valaciclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with ≤ 10 recurrences per year. Safety profiles of all treatments were comparable. Thus, valaciclovir is highly effective and well tolerated for suppression of recurrent genital herpes. Once-daily regimens offer a useful option for patients who require suppressive therapy for management of genital herpes.
AB - A randomized, double-blind study of valaciclovir for suppression of recurrent genital herpes was conducted among 1479 immunocompetent patients. Patients were randomized to receive valaciclovir (250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily), acyclovir (400 mg twice daily), or placebo, for 1 year. All valaciclovir dosages were significantly more effective than placebo at preventing or delaying recurrences (P < .0001). There was a dose- response relationship (P < .0001) across the once-daily valaciclovir regimens. Twice-daily valaciclovir and acyclovir were similar in effectiveness. Subgroup analysis showed that patients with a history of < 10 recurrences per year were effectively managed with 500 mg of valaciclovir once daily. One gram of valaciclovir once daily, 250 mg of valaciclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with ≤ 10 recurrences per year. Safety profiles of all treatments were comparable. Thus, valaciclovir is highly effective and well tolerated for suppression of recurrent genital herpes. Once-daily regimens offer a useful option for patients who require suppressive therapy for management of genital herpes.
UR - https://www.scopus.com/pages/publications/0031688110
U2 - 10.1086/515385
DO - 10.1086/515385
M3 - Article
C2 - 9728526
AN - SCOPUS:0031688110
SN - 0022-1899
VL - 178
SP - 603
EP - 610
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 3
ER -