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

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Official Title
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A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes

Conditions
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Genital Herpes

Intervention / Treatment
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* Drug: Famciclovir
* Drug: Valacyclovir
* Drug: Placebo matching famciclovir
* Drug: Placebo matching valacyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old History of at least 4 recurrences of genital herpes in the preceding 12 months Lesions located on the external genitalia or anogenital region Willing to discontinue suppressive treatment Documented positive herpes simplex virus (HSV) General good health, and history of normal renal function Exclusion Criteria: Women of childbearing potential not using approved form of contraceptive Pregnant or nursing women History of hypersensitivity to famciclovir, valacyclovir, or acyclovir Known to be immunosuppressed Known to have renal dysfunction Receiving anti-herpes therapy Known to have other genital tract disorders Known to have condition which could interfere with drug absorption Additional protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famciclovir<br>Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. | Drug: Famciclovir<br>* Famciclovir 500 mg tablet<br>* Other names: Famvir;Drug: Placebo matching valacyclovir<br>* Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.<br>|
| Active Comparator: Valacyclovir<br>Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir. | Drug: Valacyclovir<br>* Valacyclovir 500 mg capsule<br>* Other names: Valtrex;Drug: Placebo matching famciclovir<br>* Famciclovir placebo, matching in size, color and forms of famciclovir tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 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. | 72 hours after initiation of study medication up to Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Aborted Genital Herpes Lesions | 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. | 72 hours after initiation of study medication up to Day 20 | 
| Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions | 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. | 72 hours after initiation of study medication up to Day 20 | 
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 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. | 72 hours after initiation of study medication up to Day 20 | 
| Number of Patients With a Second Recurrence of Genital Herpes | 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. | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | 
| Time to a Second Recurrence of Genital Herpes | 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: From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence. | Up to 6 months after investigator assessed healing of first recurrence of genital herpes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes simplex, genital herpes, famciclovir, valacyclovir, Recurrent genital herpes