2-day versus 5-day famciclovir as treatment of recurrences of genital herpes: results of the FaST study.
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.
Bodsworth
Neil
N
Taylor Square Private Clinic, Darlinghurst, NSW 2010, Australia. neilb@tspc.com.au
Bloch
Mark
M
McNulty
Anna
A
Denham
Ian
I
Doong
Nicholas
N
Trottier
Sylvie
S
Adena
Michael
M
Bonney
Mary-Ann
MA
Agnew
James
J
D015075:2-Aminopurine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000077595:Famciclovir; D005260:Female; D006558:Herpes Genitalis / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D011355:Prodrugs / Q000008:administration & dosage* / Q000494:pharmacology; D055502:Secondary Prevention; D016896:Treatment Outcome; D017201:Virus Shedding / Q000187:drug effects
D000998:Antiviral Agents; D011355:Prodrugs; D015075:2-Aminopurine; D000077595:Famciclovir