The primary endpoint was time to healing of primary vesicular lesions. Secondary endpoints included time to healing of all vesicular lesions (primary and secondary [secondary lesions are defined as lesions that developed in addition to and on 1 or more days after primary lesions and that were located at least 1 cm from primary lesions]), time to return to normal skin for all lesions (defined as loss of crust, swelling, and dry flaking), duration of lesion tenderness and pain, and proportion of patients with aborted lesions.
There was a statistically significant decrease in time to healing of primary vesicular lesions by approximately 2 days with both single-dose and single-day famciclovir compared with placebo, with no significant difference between the 2 famciclovir regimens in time to healing of primary vesicular lesions (TABLE 2). There was also a statistically significant decrease in the time to healing of all lesions (primary and secondary) by approximately 2 days with both famciclovir treatments compared with placebo, with no significant differences seen in healing between the famciclovir arms (data not shown).
However, only single-dose famciclovir had a statistically significant decrease in the duration of lesion tenderness and pain and the time to return to normal skin compared with placebo (data not shown). No difference was noted between the famciclovir arms in the percentage of patients with aborted lesions compared with placebo. Adverse events in both famciclovir groups were similar to those in the placebo group.
TABLE 2
Short-course, patient-initiated OAV therapy is effective against recurrent herpes labialis
DRUG | TREATMENT DURATION | TREATMENT DOSE | COMPARATOR REGIMEN | CONTROL | MEDIAN TIME (DAYS) TO LESION HEALING (TREATMENT VS COMPARATOR VS CONTROL)* | MEDIAN EP ISODE DURATION (DAYS) (TREATMENT VS COMPARATOR VS CONTROL)* | PATIENTS WITH ABORTED LESIONS (%)(TREATMENT VS COMPARATOR VS CONTROL)† |
---|---|---|---|---|---|---|---|
Valacyclovir27 | 1 day | 2000 mg 2×daily | valacyclovir 2000 mg 2×daily×1 day 1000 mg 2×daily for a 2nd day | Placebo | study 1 4.3 vs 4.3 vs 5.1 study 2 4.8 vs 4.6 vs 5.4 | study 1 4.0 vs 4.5 vs 5.0 study 2 2 5.0 vs 5.0 vs 5.5 | study 1 44 vs 46 vs 38 study 2 43 vs 43 vs 35 |
Famciclovir30 1 dose | 1 Does | 1500 mg | famciclovir 750 mg 2x daily for 1 day | Placebo | 4.4 vs 4.0 vs 6.2 | 4.5 vs 5.7 vs 7.0 | 33 vs 29 vs 34 |
Lesion healing time measures the duration of a subset of severe or classical herpetic outbreaks, characterized by the formation of vesicles, ulcers, or crusts (also papules in some studies28,29). The endpoint is lesion reepithelialization/loss of crust. Episodes where there were only prodromal symptoms, erythema, and/or papule formation (or only symptoms and/or erythema in some studies28,29) were considered “aborted” or prevented lesions. The occurrence of these favorable episode outcomes is described as a percentage of all episodes. Episode duration, sometimes called healing time of all lesions or time to return to normal skin, is the time to resolution of all episodes, regardless of lesion severity. The definition of normal skin varies among the different studies. | |||||||
*All of the healing time and episode duration values for the active treatment arms in both studies differed statistically significantly from placebo, except for famciclovir 750 mg twice daily for 1 day. | |||||||
†None of the frequencies of aborted lesions in the active treatment arms in either study differed statistically significantly from placebo. |
CORRESPONDENCE
Spotswood Spruance MD Professor of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Room 4B319, 30 North 1900 East, Salt Lake City, UT 84132-2405. E-mail:woody.spruance@hsc.utah.edu