Genital Herpes
Conditions
Keywords
Recurrent genital herpes, Black population
Brief summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Interventions
DRUGFamciclovir
oral; two 500 mg tablets twice a day; single day treatment
DRUGPlacebo
oral; two tablets twice a day; single day treatment
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Black men or women 18 years or older * History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy * Documented herpes simplex virus type 2 (HSV-2) seropositivity * Willingness to discontinue suppressive therapy during study, if applicable * Willingness and ability to comply with the study protocol
Exclusion criteria
* Pregnant or breastfeeding women * Women of childbearing potential not using accepted methods of contraception * Hypersensitivity to famciclovir or drugs with similar chemical structures * Renal dysfunction * Known or suspected to have decompensated liver disease * Known to have gastrointestinal malabsorption * Known to be immunocompromised * Known to be hypersensitive to ingredients in study medication * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 21 days | Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | 21 days | Kaplan-Meier estimation. |
| Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | 72 hour after initiation of study medication up to 21 days | Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. |
| Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | 6 months | Number of participants with a second recurrence of genital herpes in the follow-up period. |
| Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | 21 days | — |
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Baseline, Day 2 | The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. |
| The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Baseline, Day 2 | The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase) |
| Time to Second Recurrence of Genital Herpes | 6 months | Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. |
Countries
South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Famciclovir 1000 mg Famciclovir 1000 mg; twice a day for one day for treatment. | 201 |
| Placebo Comparator Placebo twice a day for one day for treatment. | 98 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Problems | 39 | 15 |
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Discontinued prior to taking study drug | 106 | 53 |
| Overall Study | Lost to Follow-up | 15 | 4 |
| Overall Study | Protocol Violation | 7 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Famciclovir 1000 mg | Placebo Comparator | Total |
|---|---|---|---|
| Age Continuous | 37.5 years STANDARD_DEVIATION 10.35 | 38.5 years STANDARD_DEVIATION 10.34 | 37.8 years STANDARD_DEVIATION 10.34 |
| Genital herpes recurrence in last 12 months | 6.0 Genital herpes recurrences STANDARD_DEVIATION 3.26 | 5.8 Genital herpes recurrences STANDARD_DEVIATION 2.72 | 5.9 Genital herpes recurrences STANDARD_DEVIATION 3.09 |
| Number of Years: recurrent genital herpes | 6.9 Years STANDARD_DEVIATION 6.75 | 7.0 Years STANDARD_DEVIATION 6.5 | 7.0 Years STANDARD_DEVIATION 6.66 |
| Sex: Female, Male Female | 127 Participants | 69 Participants | 196 Participants |
| Sex: Female, Male Male | 74 Participants | 29 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 206 | 11 / 98 |
| serious Total, serious adverse events | 2 / 206 | 1 / 98 |
Outcome results
Primary
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).
Time frame: 21 days
Population: Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Famciclovir 1000 mg | Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 5.38 Days |
| Placebo Comparator | Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions | 4.79 Days |
Comparison: Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)p-value: 0.416195% CI: [-0.4, 0.98]Hodges-Lehman Shift Model
Comparison: Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants 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 censored at the time of the last clinical lesion observation.p-value: 0.937295% CI: [0.74, 1.39]Kaplan-Meier & Cox Regression
Secondary
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
Kaplan-Meier estimation.
Time frame: 21 days
Population: ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants 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 as having non aborted lesions in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Famciclovir 1000 mg | Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | 4.13 Days |
| Placebo Comparator | Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions | 4.06 Days |
Secondary
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
Number of participants with a second recurrence of genital herpes in the follow-up period.
Time frame: 6 months
Population: Intent to Treat Population: participants who completed the first recurrence.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Famciclovir 1000 mg | Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | 141 Participants |
| Placebo Comparator | Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period | 75 Participants |
Secondary
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
Time frame: 21 days
Population: Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Famciclovir 1000 mg | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Percentage with aborted lesions (n=49,20) | 24.4 Percentage of Participants |
| Famciclovir 1000 mg | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Percentage with non-aborted lesions (n= 152,78) | 75.6 Percentage of Participants |
| Placebo Comparator | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Percentage with aborted lesions (n=49,20) | 20.4 Percentage of Participants |
| Placebo Comparator | Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period | Percentage with non-aborted lesions (n= 152,78) | 79.6 Percentage of Participants |
Secondary
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)
Time frame: Baseline, Day 2
Population: 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Placebo (n=92) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Placebo (n=72) | 3 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Famciclovir (n=190) | 2 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Famciclovir (n=196) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Placebo (n=90) | 1 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Famciclovir (n=182) | 16 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Placebo (n=90) | 5 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Placebo (n=92) | 1 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Famciclovir (n=190) | 4 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Famciclovir (n=192) | 1 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Placebo (n=93) | 1 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Placebo (n=95) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Famciclovir (n=152) | 6 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Famciclovir (n=183) | 3 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Famciclovir (n=183) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Placebo (n=90) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Placebo (n=72) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Placebo (n=92) | 2 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Placebo (n=90) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Placebo (n=92) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Famciclovir (n=190) | 3 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Placebo (n=93) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Famciclovir (n=196) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Famciclovir (n=152) | 2 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Famciclovir (n=190) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Placebo (n=95) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Famciclovir (n=192) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Famciclovir (n=182) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Placebo (n=92) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Famciclovir (n=196) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Placebo (n=90) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Famciclovir (n=192) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Placebo (n=93) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Famciclovir (n=152) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Placebo (n=72) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Famciclovir (n=190) | 1 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Placebo (n=90) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Famciclovir (n=183) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Famciclovir (n=190) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Placebo (n=92) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Placebo (n=95) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Famciclovir (n=182) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Placebo (n=90) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Famciclovir (n=196) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Placebo (n=92) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Placebo (n=92) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Famciclovir (n=190) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGOT(AST)-Famciclovir (n=190) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | SGPT(ALT)-Famciclovir (n=183) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Blood Urea Nitrogen-Placebo (n=95) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Placebo (n=72) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Lipase-Placebo (n=90) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Amylase-Famciclovir (n=152) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Creatinine-Famciclovir (n=182) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Placebo (n=93) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment | Bilirubin(total)-Famciclovir (n=192) | 0 Participants |
Secondary
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.
Time frame: Baseline, Day 2
Population: 304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Famciclovir (n=177) | 6 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Famciclovir (n=183) | 2 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Famciclovir (n=184) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Placebo (n=88) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Placebo (n=87) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Placebo (n=83) | 0 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Placebo(n=98) | 6 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Famciclovir (n=163) | 15 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Placebo(n=88) | 3 Participants |
| Famciclovir 1000 mg | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Famciclovir (n=186) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Placebo (n=83) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Famciclovir (n=163) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Famciclovir (n=184) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Placebo(n=98) | 1 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Placebo (n=88) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Famciclovir (n=183) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Placebo (n=87) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Placebo(n=88) | 0 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Famciclovir (n=177) | 2 Participants |
| Placebo Comparator | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Famciclovir (n=186) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Placebo(n=98) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Placebo (n=88) | 1 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Famciclovir (n=163) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Placebo(n=88) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Placebo (n=83) | 1 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Famciclovir (n=184) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Famciclovir (n=186) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Famciclovir (n=177) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Placebo (n=87) | 0 Participants |
| Grade 3 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Famciclovir (n=183) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Placebo (n=88) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Placebo (n=87) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Placebo (n=83) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Placebo(n=98) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haematocrit-Famciclovir (n=186) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Famciclovir (n=183) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Haemoglobin-Placebo(n=88) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Absolute Neutrophils-Famciclovir (n=177) | 1 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | WBC(total)-Famciclovir (n=163) | 0 Participants |
| Grade 4 Toxicity | The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment | Platelet count-Famciclovir (n=184) | 0 Participants |
Secondary
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
Time frame: 72 hour after initiation of study medication up to 21 days
Population: Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Tingling (n=141,70) | 2.0 Days |
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Tenderness (n=147/74) | 3.4 Days |
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | All symptoms (n=195/98) | 4.5 Days |
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Pain (n=141,69) | 3.0 Days |
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Burning (n=126,65) | 2.3 Days |
| Famciclovir 1000 mg | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Itching (n=168,86) | 3.2 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Burning (n=126,65) | 2.5 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Tingling (n=141,70) | 2.3 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Pain (n=141,69) | 2.6 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Tenderness (n=147/74) | 2.9 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | Itching (n=168,86) | 3.5 Days |
| Placebo Comparator | Time to Resolution of Symptoms Associated With Recurrent Genital Herpes | All symptoms (n=195/98) | 5.7 Days |
Secondary
Time to Second Recurrence of Genital Herpes
Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
Time frame: 6 months
Population: Intent to Treat Population: participants who completed the first recurrence.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Famciclovir 1000 mg | Time to Second Recurrence of Genital Herpes | Time from healing of non-aborted lesion | 63.0 Days |
| Famciclovir 1000 mg | Time to Second Recurrence of Genital Herpes | Time from initiation of treatment | 69.0 Days |
| Placebo Comparator | Time to Second Recurrence of Genital Herpes | Time from healing of non-aborted lesion | 75.0 Days |
| Placebo Comparator | Time to Second Recurrence of Genital Herpes | Time from initiation of treatment | 81.0 Days |