Clinical Study
Once Daily Valacyclovir for Reducing Viral Shedding in Subjects Newly Diagnosed with Genital Herpes
Table 2
Percent of Days with HSV-2 Viral Shedding.
| Population ITTC | Valacyclovir | Placebo | -value | % Reduction | | | () | () | | |
| Period 1 | | 25 | 27 | | | Mean (SD %) | 3.0 (4.6) | 14.3 (16.6) | | | Range | 0–17 | 0–68 | | |
| Period 2 | | 27 | 25 | | | Mean (SD %) | 2.9 (6.5) | 12.6 (17.4) | | | Range | 0–29 | 0–61 | | |
| Overall | | 52 | 52 | | | Mean (SD %) | 2.9 (5.6) | 13.5 (16.9) | | 78 | Range | 0–29 | 0–68 | | |
| ITT Period 1 | | 30 | 35 | | 83 | Mean (SD %) | 2.6 (4.3) | 14.9 (18.3) |
| Other Efficacy Parameters |
| ITTC | Valacyclovir () | Placebo () | -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, (%) | 31 (60) | 15 (29) | .001 | Proportion of subjects recurrencefree, (%) | 41 (79) | 27 (52) | .003 | Median time to first genital herpes recurrencea (days) | 68 | 61 | .010 |
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aFirst treatment period.
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