Table 6.

Summary of efficacy end points in the current study vs the studies by Douglas et al, Reitano et al, and Mertz et al

Study	Treatment	N	Time to first recurrencea (days)	% with >50% reductionb	Mean monthly recurrence	% recurrence-freeb	Mean % reduction in recurrence
Douglas et al18	Placebo	47	18	58.30%	0.86	0.0%	–
	ACV 200 mg 2×	51	>120 (P<0.001)		0.14 (P<0.001)	27.4% (P<0.001)	–
	ACV 200 mg 5×	45	>120 (P<0.001)		0.13 (P<0.001)	35.6% (P<0.001)	–
	Average (treatment)		120 (Δ=102)		0.135 (Δ=0.725)	31.5% (Δ=31.5%)
Reitano et al12	Placebo	134	–	–	–	5.0%	–
	VACV 250 mg 2×	274	–		–	34.0% (P<0.001)	78%–79%
	VACV 1 g 1×	269	–		–	34.0% (P<0.001)	78%–79%
	VACV 500 mg 1×	266	–		–	28.0% (P<0.001)	71%
	VACV 250 mg 1×	269	–		–	15.0% (P=0.03)	54%
	ACV 400 mg 2×	267	–		–	35.0% (P<0.001)	78%–79%
	Average (treatment)					27.8% (Δ=22.8%, VACV; Δ=30.0%, ACV)	72.1%
Mertz et al19	Placebo	64	82	–	0.27	6.3%	–
	FCV 125 mg 1×	60	114 (P=0.22)		0.22	No significant increase	–
	FCV 125 mg 2×	65	>120 (P=0.03)		0.16	23.1% (P<0.04)	–
	FCV 250 mg 1×	61	>120 (P=0.07)		0.23	21.3% (P<0.05)	–
	FCV 250 mg 2×	64	>120 (P<0.001)		0.08 (P=0.002)	47.0% (P<0.001)	–
	FCV 500 mg 1×	61	>120 (P=0.06)		0.15	No significant increase	–
	Average (treatment)		118.8 (Δ=36.8)		0.168 (Δ=0.102)	30.5% (Δ=24.2%)
Current study	GEV/NV pretreatment	55	38	69.10%	1.02	0.0%	66%
	GEV/NV treatment	55	238 (P<0.0001) (Δ=200)		0.35 (P<0.0001) (Δ=0.67)	27.3% (P<0.0001) (Δ=27.3%)

Notes: In all studies, the subjects had at least six genital herpes outbreaks per year.

^aUsing Kaplan–Meier.

^bAdjusted from 4 months to a full year for the studies by Douglas et al and Mertz et al. The P-values are taken from the original study.

Abbreviations: ACV, acyclovir; VACV, valacylovir; FCV, famciclovir; GEV/NV, Gene-Eden-VIR/Novirin.