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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00306787
• Collaborator: (none)
• Enrollment: 1,179
• Locations: 66
• Arms: 2
• Duration (Months): 23.1
• Patients Per Site: 17.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Genital Herpes	Drug: Famciclovir; Drug: Valacyclovir; Drug: Placebo matching famciclovir; Drug: Placebo matching valacyclovir	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Famciclovir 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; Famciclovir 500 mg tablet; Other Names: Famvir ; Drug: Placebo matching valacyclovir; Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Active Comparator: Valacyclovir 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; Valacyclovir 500 mg capsule; Other Names: Valtrex ; Drug: Placebo matching famciclovir; Famciclovir placebo, matching in size, color and forms of famciclovir tablet.

Outcome Measures

Primary Outcome Measures

1. Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions [72 hours after initiation of study medication up to Day 20]

   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.

Secondary Outcome Measures

1. Percentage of Participants With Aborted Genital Herpes Lesions [72 hours after initiation of study medication up to Day 20]

   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.

2. Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions [72 hours after initiation of study medication up to Day 20]

   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.

3. Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [72 hours after initiation of study medication up to Day 20]

   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.

4. Number of Patients With a Second Recurrence of Genital Herpes [Up to 6 months after investigator assessed healing of first 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.

5. Time to a Second Recurrence of Genital Herpes [Up to 6 months after investigator assessed healing of first 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Novartis Investigative Site	Chandler	Arizona	United States	85225
3	Women's Health Research	Phoenix	Arizona	United States	85015
4	Quality of Life Medical & Research Center, LLC	Tucson	Arizona	United States	85712
5	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
6	NEA Women's Clinic	Jonesboro	Arkansas	United States	72401
7	The Woman's Clinic	Little Rock	Arkansas	United States	72205
8	Providence Clinical Research	Burbank	California	United States	91505
9	Dermatology Research Associates	Los Angeles	California	United States	90045
10	Sacramento Research Medical Group	Sacramento	California	United States	95825
11	North California Research Corp.	Sacramento	California	United States	95831
12	Medical Center for Clinical Research	San Diego	California	United States	92108
13	Conant Research	San Francisco	California	United States	94114
14	Barbara Davis Center	Denver	Colorado	United States	80262
15	Cohen & Womack, P.C.	Lakewood	Colorado	United States	80228
16	Visions Clinical Research	Boynton Beach	Florida	United States	33437
17	Women's Medical Research Group, LLC	Clearwater	Florida	United States	33759
18	International Research Association LLC	Miami	Florida	United States	33156
19	Orlando Clinical Research Ctr.	Orlando	Florida	United States	32809
20	Avancia Research	Pembroke Pines	Florida	United States	33024
21	University Clinical Research, Inc.	Pembroke Pines	Florida	United States	33024
22	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
23	Mount Vernon Clinical Research	Atlanta	Georgia	United States	30328
24	Medisphere Medical Research Center, LLC.	Evansville	Indiana	United States	47714
25	Indiana University Infectious Disease Research Group	Indianapolis	Indiana	United States	46202
26	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
27	Common Wealth Biomedical Research	Madisonville	Kentucky	United States	42431
28	SNBL Clinical Pharmacology Center	Baltimore	Maryland	United States	21201
29	Future Care Studies	Springfield	Massachusetts	United States	01107
30	Clayton Research Institute	St. Louis	Missouri	United States	63117
31	Deaconess Billings Clinic Research Center	Billings	Montana	United States	59101
32	Heartland Clinical Research, Inc.	Omaha	Nebraska	United States	68134
33	UNC Clinical Research.	Raleigh	North Carolina	United States	27607
34	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina	United States	27103
35	Providence Health Partners-Center for Clinical Research	Dayton	Ohio	United States	45439
36	Lynne Health Science Institute	Oklahoma City	Oklahoma	United States	73112
37	Westover Heights Clinic	Portland	Oregon	United States	97210
38	Paddington Testing Co. Inc	Philadelphia	Pennsylvania	United States	19103
39	Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
40	S. Carolina Clinical Research Center	Columbia	South Carolina	United States	29201
41	Research Inc.	Florence	South Carolina	United States	29501
42	Palmetto Clinical Trial Services, LLC	Simpsonville	South Carolina	United States	29681
43	Benchmark Research	Austin	Texas	United States	78705
44	Renaissance Clinical Research and Hypertension Clinic	Dallas	Texas	United States	75235
45	Center for Clinical Studies (TX Medical Center)	Houston	Texas	United States	77030
46	Center for Clinical Studies	Houston	Texas	United States	77058
47	University of Utah-School of Medicine (Div. of Inf. Disease)	Salt Lake City	Utah	United States	84132
48	Salt Lake Women's Center/Physician's Research Options	Sandy	Utah	United States	84070
49	Clinical Trials of Virginia, Inc.	Richmond	Virginia	United States	23225
50	University of Washington, Virology Research Clinic	Seattle	Washington	United States	98122
51	Liberty Research Center	Tacoma	Washington	United States	98405
52	Novartis Investigative Site	Darlinghurst	New South Wales	Australia	2010
53	Novartis Investigational Site	Edmonton	Alberta	Canada	T6G 2B6
54	Novartis Investigational Site	Vancouver	British Columbia	Canada	V6Z 2C7
55	Novartis Investigational Site	Winnipeg	Manitoba	Canada	R3E 0W3
56	Novartis Investigational Site	Markham	Ontario	Canada	L3P 1A8
57	Novartis Investigational Site	Ottawa	Ontario	Canada	K1S 0G8
58	Novartis Investigational Site	Laval	Quebec	Canada	H7X 3S5
59	Novartis Investigational Site	Montréal	Quebec	Canada	H2K 4L5
60	Novartis Investigational Site	Montréal	Quebec	Canada	H3H IV4
61	Novartis Investigational Site	Sainte-Foy	Quebec	Canada	G1V 4G2
62	Novartis Investigational Site	Augsburg		Germany	D-86179
63	Novartis Investigational Site	Berlin		Germany
64	Novartis Investigational Site	Freiburg		Germany	79106
65	Novartis Investigational Site	Rostock		Germany	D-18055
66	Novartis Investigational Site	Wolfsburg		Germany	D-38440

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• eRecruitment

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00306787
• Other Study ID Numbers: CFAM810A2308
• First Posted: Mar 24, 2006
• Last Update Posted: Jun 30, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Herpes simplex; genital herpes; famciclovir; valacyclovir; Recurrent genital herpes
• Additional relevant MeSH terms: Herpes Simplex; Herpes Genitalis; Valacyclovir; Famciclovir

Study Results

Participant Flow

Pre-assignment Detail	A total of 1179 patients were randomized in the study and followed to their first genital herpes recurrence. A total of 423 patients did not experience a recurrence within 4 months of randomization therefore, no treatment was initiated and study drug was not taken. A total of 756 patients were randomized and took study drug (safety population).

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Period Title: Overall Study
STARTED	579	600
Received Study Drug (Safety Population)	371	385
Intent to Treat (ITT) Population	370	381
COMPLETED	345	359
NOT COMPLETED	234	241

Baseline Characteristics

Arm/Group Title	Famciclovir	Valacyclovir	Total
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.	Total of all reporting groups
Overall Participants	370	381	751
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.6 (11.6)	41.7 (12.6)	40.7 (12.2)
Sex: Female, Male (Count of Participants)
Female	245 66.2%	243 63.8%	488 65%
Male	125 33.8%	138 36.2%	263 35%

Outcome Measures

1. Primary Outcome

Title	Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	249	253
Median (Inter-Quartile Range) [days]	4.25	4.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Famciclovir, Valacyclovir
	Comments	Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Aborted Genital Herpes Lesions
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	370	381
Aborted Lesions	32.7 8.8%	33.6 8.8%
Non-Aborted lesions	67.3 18.2%	66.4 17.4%

3. Secondary Outcome

Title	Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	370	381
Median (Inter-Quartile Range) [days]	3.07	3.01

4. Secondary Outcome

Title	Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	370	381
Pain (n = 220, 228)	18.0	20.3
Burning (n = 221, 218)	16.1	12.6
Itching (n = 309, 297)	43.9	43.5
Tingling (n = 266, 275)	23.8	23.0
Tenderness (n = 298, 311)	55.2	48.0

5. Secondary Outcome

Title	Number of Patients With a Second Recurrence of Genital Herpes
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	370	381
Patients continued in follow up period	324 87.6%	342 89.8%
Patients with 2nd recurrence in follow up period	226 61.1%	231 60.6%

6. Secondary Outcome

Title	Time to a Second Recurrence of Genital Herpes
Description	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.
Time Frame	Up to 6 months after investigator assessed healing of first recurrence of genital herpes

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Famciclovir	Valacyclovir
Arm/Group Description	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.	Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
Measure Participants	226	231
From treatment initiation	33.5	38.0
From date of healing /confirmation	27.5	32.0

Adverse Events

Time Frame	30 days post last dose of study medication
Adverse Event Reporting Description	Safety Population
Arm/Group Title	Famciclovir		Valacyclovir
Arm/Group Description	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.		Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) 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.
All Cause Mortality
	Famciclovir		Valacyclovir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Famciclovir		Valacyclovir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/371 (0.5%)		1/385 (0.3%)
Cardiac disorders
Myocardial ischemia	1/371 (0.3%)		0/385 (0%)
Psychiatric disorders
Suicide Attempt	1/371 (0.3%)		0/385 (0%)
Substance Abuse	0/371 (0%)		1/385 (0.3%)
Other (Not Including Serious) Adverse Events
	Famciclovir		Valacyclovir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/371 (17.8%)		47/385 (12.2%)
Gastrointestinal disorders
Nausea	23/371 (6.2%)		18/385 (4.7%)
Diarrhea	8/371 (2.2%)		5/385 (1.3%)
Vomiting	5/371 (1.3%)		3/385 (0.8%)
Abdominal pain	1/371 (0.3%)		4/385 (1%)
Nervous system disorders
Headache	29/371 (7.8%)		17/385 (4.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.