Table 2.
Percent of Days with HSV-2 Viral Shedding.
| Population ITTC | Valacyclovir | Placebo | P-value | % Reduction | |
|---|---|---|---|---|---|
| (n = 52) | (n = 52) | ||||
| Period 1 | n | 25 | 27 | ||
| Mean (SD %) | 3.0 (4.6) | 14.3 (16.6) | |||
| Range | 0–17 | 0–68 | |||
|
| |||||
| Period 2 | n | 27 | 25 | ||
| Mean (SD %) | 2.9 (6.5) | 12.6 (17.4) | |||
| Range | 0–29 | 0–61 | |||
|
| |||||
| Overall | n | 52 | 52 | ||
| Mean (SD %) | 2.9 (5.6) | 13.5 (16.9) | <.001 | 78 | |
| Range | 0–29 | 0–68 | |||
|
| |||||
| ITT Period 1 | n | 30 | 35 | <.001 | 83 |
| Mean (SD %) | 2.6 (4.3) | 14.9 (18.3) | |||
|
| |||||
| Other Efficacy Parameters | |||||
|
| |||||
| ITTC | Valacyclovir (n = 52) | Placebo (n = 52) | P-value | ||
|
| |||||
| Percent days with subclinical shedding, Mean (SD %) | 2.4 (4.8) | 11 (15.1) | <.001 | ||
| Percent days with clinical shedding, Mean (SD %) | 0.6 (1.7) | 2.4 (4.4) | .014 | ||
| Subjects with no Shedding, n (%) | 31 (60) | 15 (29) | <.001 | ||
| Proportion of subjects recurrencefree, n (%) | 41 (79) | 27 (52) | .003 | ||
| Median time to first genital herpes recurrencea (days) | >68 | 61 | .010 | ||
aFirst treatment period.