Single-day, patient-initiated Famciclovir treatment for recurrent herpes simplex:

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  • 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
  • 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
  • ファムシクロビル ノ サイハツガタ タンジュンホウシンカンジャ ニ タイスル ソウキ タンキ チリョウ(1ニチ チリョウ)ニ ヨル ダイ Ⅲ ソウ リンショウ シケン : ランダムカ プラセボ タイショウ ニジュウ モウケンヘイコウグン カン ヒカク タシセツ キョウドウ シケン
  • －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－
  • A randomized, placebo-controlled, double-blind, parallel-group, multicenter phase 3 study

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Abstract

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.

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