Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.

Time frame: 72 hours after initiation of study medication up to Day 20

Population: Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.

Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.

Time frame: 72 hours after initiation of study medication up to Day 20

Population: ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero.

Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.

Time frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

Population: ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.

Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.

Time frame: 72 hours after initiation of study medication up to Day 20

Population: ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis.

Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows: 1. From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or 2. From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.

Time frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes

Population: ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median.

Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.

Time frame: 72 hours after initiation of study medication up to Day 20

Population: ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms.