2-day versus 5-day famciclovir as treatment of recurrences of genital herpes: results of the FaST study*
Neil Bodsworth A J , Mark Bloch B J , Anna McNulty C , Ian Denham D , Nicholas Doong E , Sylvie Trottier F , Michael Adena G , Mary-Ann Bonney H , James Agnew H andA Taylor Square Private Clinic, Darlinghurst, NSW 2010, Australia.
B Holdsworth House Medical Practice, Darlinghurst, NSW 2010, Australia.
C Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW 2000, Australia.
D Melbourne Sexual Health Centre, Carlton, Vic. 3053, Australia.
E Burwood Clinic, Burwood, NSW 2134, Australia.
F Infectious Disease Research Centre, Quebec, Canada.
G Covance Pty Ltd, Braddon, ACT 2612, Australia.
H Novartis Pharmaceuticals, North Ryde, NSW 2113, Australia.
I Members listed in appendix.
J Joint first authorship. Email: neilb@tspc.com.au; MarkBloch@holdsworthhouse.com.au
Sexual Health 5(3) 219-225 https://doi.org/10.1071/SH08013
Submitted: 12 February 2008 Accepted: 11 March 2008 Published: 6 August 2008
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.
Additional keywords: episodic treatment, short course.
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* *Statement on prior presentation: These data were presented to the Australian Sexual Health Conference, Melbourne, Australia in October 2006 (Bloch M, et al. Bonney M, et al.) and the International Herpes Management Forum meeting, Prague, Czech Republic in October 2006 (Bloch M, et al. Bonney M, et al.). The results have also appeared in summary form in Corey L, Bodsworth N, Mindel A, Patel R, Schacker T, Stanberry L. An update on short-course episodic and prevention therapies for herpes genitalis. Herpes 2007; 14: 5A–11A.
Appendix: Members of the FaST Study Group
Investigators – Australia
Abdurahman I, Ajam A, Alexander R, Aung A, Barry S, Becker B, Belbin M, Bishop C, Bisshop F, Bloch M, Bodsworth N, Bourne C, Brett T, Brown K, Butler A, Carmody C, Chan D, Chuah J, Conway D, Daly C, Davies S, Davis C, Davis B, Dayan L, D’Bras L, Denham I, Dever N, Donovan B, Doong N, Eisen D, Eliades C, Elisha B, Fairley C, Feiglin A, Freeman A, Furner V, Garland S, Genn W, Giannakopoulos J, Glass F, Gold J, Goswami J, Gowers A, Grech J, Hackney P, Hanson B, Hartnell K, Harvey C, Hasan M, Hawkins S, Heley S, Herbst D, Hespe C, Irlicht M, Isaacs A, Katahanas L, Kelly M, Komarowski P, Kostic G, Kozminsky M, Lagios K, Lee D, Lewis P, Liang T, Lyttle H, Mackellar-Michelmore H, Macleod H, Marsh L, Marshall L, McCloskey J, McCurdy D, McEvoy P, McFarlane R, McKeegan P, McMurchie M, McNamee K, McNulty A, Medland N, Menon A, Meyerowitz C, Michaels W, Mobbs M, Montague A, N Nicola, Nurcombe C, O’Connor C, Ooi C, Ostrowskyl O, O’Sullivan M, Owen L, Papp K, Patten J, Panopoulous D, Pell C, Quan D, Quin J, Rhodes D, Rowles S, Rowling D, Ryan S, Sasadeusz J, Shanahan J, Sherwin P, Sim Y, Singer C, Sloan D, Smith D, Smyth L, Staunton-Smith T, Stepankova E, Stephens N, Steward J, Szwarcberg M, Taylor R, Taylor K, Tee B, Thind G, Towner B, Waddell R, Webster J, White J, Wilcox G, Williams H, Wils E, Workman C, Wright R, Yeong W, Zaverdinos T
Investigators – Canada
Aoki F, Brassard A, Diaz-Mitoma F, Lynde C, Papp K, Shafran S, Trottier S
Study Coordinators
Adolphe K, Agrawal S, Allen A, Bourke B, Braybook P, Corradin L, Dinning S, Doughty S, Gagnon H, Giourouki M, Goodyear W, Houlihan N, Hudson J, Kent H, Kenchington P, Lillie C, Martin C, Nagel R, Pollard C, Prone I, Quezdea M, Rees V, Richardson R, Ryan M, Sarangapany J, Schmidt T, Silvers J, Toohey T
Clinical Research Organisations
Adena M (Covance); Margie S, Jaar V, Hurford D, Monitors & data staff (Quintiles); Monitors (Integrated Research); McKenna S, Meads D (Galen Research)
Novartis
Agnew J, Bonney M, Binette M, Cole J, Deutsch G, Frost B, Giagodi A, Gray S, Kirkman M, Kowalczyk I, Plouffe B
