Table 7.
Summary of efficacy end points in the current study vs the study by Patel et al
| Study | Treatment | N | Time to first recurrencea (days) | % recurrence-freeb | % with decrease in recurrencec |
|---|---|---|---|---|---|
| Patel et al20 | Placebo | 94/66d | 20 | 0.0% | 85% |
| VACV 500 mg 1× | 288/198a | >112 (P<0.0001) (Δ=92) |
33.0% (Δ=33.0%) | ||
| Current study | GEV/NV pretreatment | 38 | 28 | 0.0% | 89% |
| GEV/NV treatment | 38 | 145 (P<0.0001) (Δ=117) |
24.0% (P<0.001) (Δ=24.0%) |
Notes: In all studies, the subjects had at least eight genital herpes outbreaks per year.
a
Using Kaplan–Meier.
b
Adjusted from 4 months to a full year for the Patel et al study.
c
Note that 85% is for a 4-month period and 89% is for a 12-month period.
d
Patel et al used 94 (placebo) and 288 (treatment) for calculating the percentage of recurrence-free subjects and percentage of subjects with a decrease in recurrence, respectively. In contrast, Patel et al used 66 (placebo) and 198 (treatment) subjects for calculating the median time to first recurrence.
Abbreviations: GEV/NV, Gene-Eden-VIR/Novirin; VACV, valacyclovir.