ファムシクロビルの再発型単純疱疹患者に対する早期短期治療(1日治療)による第III相臨床試験:-ランダム化プラセボ対照二重盲検並行群間比較多施設共同試験-  [in Japanese] Single-day, patient-initiated Famciclovir treatment for recurrent herpes simplex::A randomized, placebo-controlled, double-blind, parallel-group, multicenter phase 3 study  [in Japanese]

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Abstract

再発型単純疱疹(口唇ヘルペス,性器ヘルペス)患者に対するファムシクロビル(FCV)の1日治療の有効性および安全性について,ランダム化プラセボ対照二重盲検並行群間比較試験で検討した.<br> 本試験では,FCV 1000 mg(FCV錠 250 mgを4錠)又はプラセボを単純疱疹の前駆症状発現から6時間以内に1回目を服薬し,2回目を1回目から12時間後に服薬した.<br> 1134例の患者がFCV群又はプラセボ群にランダム化された後,531例が治験薬を服薬した(Intent-to-treat).主要評価項目はIntent-to-treatからAborted lesion症例を除いた集団373例を対象に解析した.主要評価項目であるすべての病変部位が治癒するまでの時間の中央値は,FCV群で4.7日,プラセボ群で5.7日であり,FCVの1日治療は,治癒までの時間を有意に短縮した(P=0.008).副次評価項目である病変部位のウイルスが消失するまでの時間およびすべての病変部位が完全痂皮化するまでの時間についても,有意に短縮した(それぞれP=0.042,P=0.004).有害事象の発現率はFCV群で19.0%(50/263例),プラセボ群で11.6%(31/268例)であり,重篤な有害事象は発現しなかった.以上より,FCVの1日治療の有効性が検証され,高用量投与による安全性上の問題は認められなかったことから,本治療法は再発型単純疱疹の有用な治療選択肢の一つとなることが示唆された.試験登録番号JapicCTI-163223

Background<br>Orally administerd antiviral therapy for herpes simplex shortens the time to lesion healing. Although the traditional therapy for recurrent episodes in Japanese adults is given three times a day for 5 days, a patient-initiated, single-day regimen has been widely used worldwide. This study was conducted to assess the efficacy and safety of high-dose, short-duration, early Famciclovir (FCV) therapy, compared with placebo, in Japanese adult patients with recurrent herpes simplex (recurrent herpes labialis and recurrent genital herpes).<br>Methods<br>This multicenter, randomized, double-blind, parallel-group, placebo-controlled study compared one-day oral FCV (1000 mg twice) with placebo for the treatment of recurrent herpes simplex. Patients were instructed to initiate therapy within 6 hours after onset of prodromal symptoms, and take the second dose 12 hours later.<br>Results<br>A total of 1134 patients were randomly assigned to receive self-initiated therapy with FCV or placebo. In all, 531 patients had prodromal symptoms of a recurrent herpes simplex, started study medication, and were included in the intent-to-treat (ITT) and safety populations. A total of 373 patients developed vesicles (modified ITT population). FCV shortened the median time to healing of non-aborted lesions (i.e., those that did not progress beyond the erythema/papule stage) from 4.7 to 5.7 days, compared with placebo (P=0.008). The secondary endpoints, time to virus shedding cessation and time to complete crusting, showed similar results (P=0.042 and 0.004, respectively). Adverse events in the FCV group were infrequent overall and of mild severity.<br>Conclusion<br>A single-day regimen of FCV shortened the time to healing of recurrent herpes simplex lesions by approximately 1 day compared with placebo, and was well tolerated and safe. Therefore, this one-day FCV treatment regimen can be regarded as a useful treatment option for herpes simplex.

Journal

  • Journal of the Japan Organization of Clinical Dermatologists

    Journal of the Japan Organization of Clinical Dermatologists 35(3), 488-496, 2018

    Japan Organization of Clinical Dermatologists

Codes

  • NII Article ID (NAID)
    130007411774
  • NII NACSIS-CAT ID (NCID)
    AA1202905X
  • Text Lang
    JPN
  • ISSN
    1349-7758
  • NDL Article ID
    029022020
  • NDL Call No.
    Z19-2095
  • Data Source
    NDL  J-STAGE 
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