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2017 ; 44
(11
): 1219-1227
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Amenamevir, a novel helicase-primase inhibitor, for treatment of herpes zoster: A
randomized, double-blind, valaciclovir-controlled phase 3 study
#MMPMID28681394
Kawashima M
; Nemoto O
; Honda M
; Watanabe D
; Nakayama J
; Imafuku S
; Kato T
; Katsuramaki T
J Dermatol
2017[Nov]; 44
(11
): 1219-1227
PMID28681394
show ga
Amenamevir is a potent helicase-primase inhibitor and a novel class of antiviral
agent other than nucleoside compounds, such as aciclovir, valaciclovir and
famciclovir. This study is the first randomized, double-blind,
valaciclovir-controlled phase 3 study to evaluate the efficacy and safety of
amenamevir in Japanese patients with herpes zoster when treated within 72 h after
onset of rash. A total of 751 patients were randomly assigned to receive either
amenamevir 400 mg or 200 mg p.o. once daily or valaciclovir 1000 mg three times
daily (daily dose, 3000 mg) for 7 days. The primary efficacy end-point was the
proportion of cessation of new lesion formation by day 4 ("day 4 cessation
proportion"). The day 4 cessation proportions for amenamevir 400 and 200 mg and
valaciclovir were 81.1% (197/243), 69.6% (172/247) and 75.1% (184/245),
respectively. Non-inferiority of amenamevir 400 mg to valaciclovir was confirmed
by a closed testing procedure. Days to cessation of new lesion formation,
complete crusting, healing, pain resolution and virus disappearance were
evaluated as secondary end-points. No significant differences were observed in
any of the treatment groups. Amenamevir 400 and 200 mg were well tolerated as
well as valaciclovir. The proportions of patients who experienced drug-related
adverse events were 10.0% (25/249), 10.7% (27/252) and 12.0% (30/249) with
amenamevir 400 and 200 mg and valaciclovir, respectively. In conclusion,
amenamevir 400 mg appears to be effective and well tolerated for treatment of
herpes zoster in immunocompetent Japanese patients.
|Acyclovir/analogs & derivatives/therapeutic use
[MESH]