Investigation of the safety and efficacy of Amenamevir (Amenalief<sup>®</sup> tablet 200 mg) in patients with herpes zoster (interim report from a Special drug use-result survey,)

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  • 帯状疱疹患者におけるアメナメビル（アメナリーフ<sup>®</sup>錠 200 mg）の安全性と有効性の検討－特定使用成績調査の中間成績－
  • 帯状疱疹患者におけるアメナメビル(アメナリーフ錠200mg)の安全性と有効性の検討 : 特定使用成績調査の中間成績
  • タイジョウホウシンカンジャ ニ オケル アメナメビル(アメナリーフジョウ 200mg)ノ アンゼンセイ ト ユウコウセイ ノ ケントウ : トクテイ シヨウ セイセキ チョウサ ノ チュウカン セイセキ

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Amenamevir (Amenalief® tablet 200 mg, hereinafter AMNV) is a novel anti-herpetic agent that has helicase–primase inhibitor activity and is labeled for herpes zoster. AMNV is currently available only in Japan and a mandatory observational survey is ongoing in order to collect real-world information on the safety and efficacy. This report is an interim cross-sectional analysis of the data at the time of AMNV administration and one month after. There are a total of 1,345 patients in the safety analysis set, and adverse drug reactions have been reported only in 11 patients (0.82%). Abdominal pain upper, diarrhea and pyrexia” were reported in 2 cases. Regarding safety issues related to the important potential risks identified in the Japanese Risk Management Plan, two cases, one of thrombocytopenia and one of gingival bleeding were reported as events associated with “platelets decreased” and one case of palpitation was reported as an event associated with “cardiovascular event”. None of these were serious. There are a total of 1,338 patients in the efficacy analysis set. A 50% reduction in the number of patients with skin lesions (erythema/papules and blisters/pustules) was reached at day８, a 50% reduction in the number of patients who did not achieved full crusting was reached at day 12 and a 50% reduction in the number of patients with pain was reached at day 22. In this report, we discuss patient backgrounds and treatment regimens from an epidemiological perspective and in consideration of the characteristics of AMNV. This study plans to enroll 3,000 patients in total. This interim report evaluates based on data from the earlier 1,446 patients. The full analysis will evaluate a stratified analysis of safety with background information for patients, as well as detailed effectiveness data related to things like lesions and pain.

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