2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study

Neil Bodsworth, Mark Bloch, Anna McNulty, Ian Denham, Nicholas Doong, Sylvie Trottier, Michael Adena, Mary Ann Bonney, James Agnew, Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group

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Abstract

Background: The brief period of viral replication in recurrent genital herpes lesions suggests shorter therapeutic regimens may be as effective as standard 5-day courses. Objective: To demonstrate that a 2-day course of famciclovir 500 mg statim, then 250 mg twice daily was non-inferior to the standard 5-day course of 125 mg twice daily. Methods: Patients were randomly assigned either the 2-day or 5-day famciclovir course and initiated therapy within 12 h of onset of prodromal symptoms. They were instructed to complete daily questionnaires on herpes-related symptoms and functioning and to attend the clinic for assessment of healing 5.5 days after initiating therapy. Results: A total of 873 patients were randomised at least once and 1038 recurrences were treated. The proportion of evaluable recurrences with lesions present at 5.5 days was less in the 2-day arm (24%) than in the 5-day (28%) arm. The upper 97.5% confidence limit (CL) for this difference in favour of the 2-day arm was 2% in favour of the 5-day arm, well within the 10% predefined for non-inferiority. The upper 97.5% CL was similar in the intent-to-treat, evaluable and per-protocol recurrence populations and when adjusted for baseline differences (in gender, age, herpes history and HIV infection) or for clustering of recurrences within patients. Both treatments had similar side-effects; proportion of lesions aborted; time to next recurrence; patient-reported symptoms; and impact on daily functioning. Conclusions: The 2-day course was as safe and effective as the standard 5-day course and can only enhance patient convenience and compliance.

Original languageEnglish
Pages (from-to)219-225
Number of pages7
JournalSexual Health
Volume5
Issue number3
DOIs
Publication statusPublished - 2008

Keywords

  • Episodic treatment
  • Short course

Cite this

Bodsworth, N., Bloch, M., McNulty, A., Denham, I., Doong, N., Trottier, S., ... Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group (2008). 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study. Sexual Health, 5(3), 219-225. https://doi.org/10.1071/SH08013
Bodsworth, Neil ; Bloch, Mark ; McNulty, Anna ; Denham, Ian ; Doong, Nicholas ; Trottier, Sylvie ; Adena, Michael ; Bonney, Mary Ann ; Agnew, James ; Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group. / 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes : Results of the FaST study. In: Sexual Health. 2008 ; Vol. 5, No. 3. pp. 219-225.
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title = "2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study",
abstract = "Background: The brief period of viral replication in recurrent genital herpes lesions suggests shorter therapeutic regimens may be as effective as standard 5-day courses. Objective: To demonstrate that a 2-day course of famciclovir 500 mg statim, then 250 mg twice daily was non-inferior to the standard 5-day course of 125 mg twice daily. Methods: Patients were randomly assigned either the 2-day or 5-day famciclovir course and initiated therapy within 12 h of onset of prodromal symptoms. They were instructed to complete daily questionnaires on herpes-related symptoms and functioning and to attend the clinic for assessment of healing 5.5 days after initiating therapy. Results: A total of 873 patients were randomised at least once and 1038 recurrences were treated. The proportion of evaluable recurrences with lesions present at 5.5 days was less in the 2-day arm (24{\%}) than in the 5-day (28{\%}) arm. The upper 97.5{\%} confidence limit (CL) for this difference in favour of the 2-day arm was 2{\%} in favour of the 5-day arm, well within the 10{\%} predefined for non-inferiority. The upper 97.5{\%} CL was similar in the intent-to-treat, evaluable and per-protocol recurrence populations and when adjusted for baseline differences (in gender, age, herpes history and HIV infection) or for clustering of recurrences within patients. Both treatments had similar side-effects; proportion of lesions aborted; time to next recurrence; patient-reported symptoms; and impact on daily functioning. Conclusions: The 2-day course was as safe and effective as the standard 5-day course and can only enhance patient convenience and compliance.",
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author = "Neil Bodsworth and Mark Bloch and Anna McNulty and Ian Denham and Nicholas Doong and Sylvie Trottier and Michael Adena and Bonney, {Mary Ann} and James Agnew and {Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group} and C. Fairley",
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Bodsworth, N, Bloch, M, McNulty, A, Denham, I, Doong, N, Trottier, S, Adena, M, Bonney, MA, Agnew, J & Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group 2008, '2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study', Sexual Health, vol. 5, no. 3, pp. 219-225. https://doi.org/10.1071/SH08013

2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes : Results of the FaST study. / Bodsworth, Neil; Bloch, Mark; McNulty, Anna; Denham, Ian; Doong, Nicholas; Trottier, Sylvie; Adena, Michael; Bonney, Mary Ann; Agnew, James; Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group.

In: Sexual Health, Vol. 5, No. 3, 2008, p. 219-225.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes

T2 - Results of the FaST study

AU - Bodsworth, Neil

AU - Bloch, Mark

AU - McNulty, Anna

AU - Denham, Ian

AU - Doong, Nicholas

AU - Trottier, Sylvie

AU - Adena, Michael

AU - Bonney, Mary Ann

AU - Agnew, James

AU - Australo-Canadian FaST (Famciclovir Short-Course Herpes Therapy) Study Group

AU - Fairley, C.

PY - 2008

Y1 - 2008

N2 - Background: The brief period of viral replication in recurrent genital herpes lesions suggests shorter therapeutic regimens may be as effective as standard 5-day courses. Objective: To demonstrate that a 2-day course of famciclovir 500 mg statim, then 250 mg twice daily was non-inferior to the standard 5-day course of 125 mg twice daily. Methods: Patients were randomly assigned either the 2-day or 5-day famciclovir course and initiated therapy within 12 h of onset of prodromal symptoms. They were instructed to complete daily questionnaires on herpes-related symptoms and functioning and to attend the clinic for assessment of healing 5.5 days after initiating therapy. Results: A total of 873 patients were randomised at least once and 1038 recurrences were treated. The proportion of evaluable recurrences with lesions present at 5.5 days was less in the 2-day arm (24%) than in the 5-day (28%) arm. The upper 97.5% confidence limit (CL) for this difference in favour of the 2-day arm was 2% in favour of the 5-day arm, well within the 10% predefined for non-inferiority. The upper 97.5% CL was similar in the intent-to-treat, evaluable and per-protocol recurrence populations and when adjusted for baseline differences (in gender, age, herpes history and HIV infection) or for clustering of recurrences within patients. Both treatments had similar side-effects; proportion of lesions aborted; time to next recurrence; patient-reported symptoms; and impact on daily functioning. Conclusions: The 2-day course was as safe and effective as the standard 5-day course and can only enhance patient convenience and compliance.

AB - Background: The brief period of viral replication in recurrent genital herpes lesions suggests shorter therapeutic regimens may be as effective as standard 5-day courses. Objective: To demonstrate that a 2-day course of famciclovir 500 mg statim, then 250 mg twice daily was non-inferior to the standard 5-day course of 125 mg twice daily. Methods: Patients were randomly assigned either the 2-day or 5-day famciclovir course and initiated therapy within 12 h of onset of prodromal symptoms. They were instructed to complete daily questionnaires on herpes-related symptoms and functioning and to attend the clinic for assessment of healing 5.5 days after initiating therapy. Results: A total of 873 patients were randomised at least once and 1038 recurrences were treated. The proportion of evaluable recurrences with lesions present at 5.5 days was less in the 2-day arm (24%) than in the 5-day (28%) arm. The upper 97.5% confidence limit (CL) for this difference in favour of the 2-day arm was 2% in favour of the 5-day arm, well within the 10% predefined for non-inferiority. The upper 97.5% CL was similar in the intent-to-treat, evaluable and per-protocol recurrence populations and when adjusted for baseline differences (in gender, age, herpes history and HIV infection) or for clustering of recurrences within patients. Both treatments had similar side-effects; proportion of lesions aborted; time to next recurrence; patient-reported symptoms; and impact on daily functioning. Conclusions: The 2-day course was as safe and effective as the standard 5-day course and can only enhance patient convenience and compliance.

KW - Episodic treatment

KW - Short course

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U2 - 10.1071/SH08013

DO - 10.1071/SH08013

M3 - Article

C2 - 18771636

AN - SCOPUS:49449103180

VL - 5

SP - 219

EP - 225

JO - Sexual Health

JF - Sexual Health

SN - 1448-5028

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