Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir

Figures & data

Table 1 Demographics and clinical characteristics of the participants

Age average (years)	51
Age (years), number (%)
20–40	26 (21.8%)
41–50	28 (23.5%)
51–60	37 (31.1%)
61–80	28 (23.5%)
Gender, number (%)
Male	64 (53.8%)
Female	55 (46.2%)
Race, number (%)
African American	30 (25.2%)
Caucasian	67 (56.3%)
Hispanic	12 (10.1%)
Other	10 (8.4%)
Years since diagnosis by physician	0.5–40 (range), 10.5 (mean), 5 (median)
Years since initial episode	0.5–48 (range), 13.8 (mean), 9.5 (median)
Percentage diagnosed by physician	80.7%
Percentage who received a blood test (out of those diagnosed by a physician)	65.6%
Symptoms of infection, number (%)
Genital blisters/ulcers	100 (84.0%)
Anal blisters/ulcers	22 (18.5%)
Burning feeling while urinating	28 (23.5%)
Local pain	84 (70.6%)
Genital discharge	12 (10.1%)
General discomfort	62 (52.1%)
Light sensitivity	23 (19.3%)
Genital tingling sensation	78 (65.5%)
Genital itching sensation	81 (68.1%)
Flu-like symptoms	55 (46.2%)
Irritation (including burning)	21 (17.6%)
Redness	18 (15.1%)
Fatigue	4 (3.4%)
Lower extremity pain	10 (8.4%)
Duration of treatment (months), number (%)
2–3	21 (17.8%)
4–6	25 (21.2%)
9–12	29 (24.6%)
16–24	29 (24.6%)
26–48	14 (11.9%)

Table 2 Summary of efficacy end points in the current study

Treatment	N	Mean number of recurrences per year	Time to first recurrencea (days)	% recurrence-free	% with decrease in recurrence	% with >50% reduction
No-treatment control	20	5.5	105.01	0.0%	–	–
Pretreatment control	119	7.27 (3.2b)	103.91	0.0%	90.8%	73.1%
Treatment	119	2.39 (5.7b) (P<0.0001, pretreatment) (P<0.001, no treatment)	537.34 (P<0.0001, both controls)	42.0% (P<0.0001, both controls)

Notes: The participants had at least one genital herpes recurrence per year.

a Using Kaplan–Meier.

b Results from the two questions testing internal consistency (P<0.0001).

Table 3 Summary of dosage effect in participants with two to four genital herpes outbreaks per year pretreatment

Dosage	N	Mean number of outbreaks per year (pretreatment)	Mean number of outbreaks per year (posttreatment)	Mean decrease in number of outbreaks per year (Δ)
GEV/NV 1/day	18	3.11	0.9	–
GEV/NV 2/day	24	3.08	0.5	–
		P=0.45	P=0.08	–
GEV/NV 1/day	36	–	–	4.2
GEV/NV 2/day	61	–	–	5.9 P=0.088

Abbreviation: GEV/NV, Gene-Eden-VIR/Novirin.

Table 4 Summary of duration-of-treatment effect in participants with at least six genital herpes outbreaks per year pretreatment

Duration of treatment (months)	N	Mean decrease in number of outbreaks per year (Δ)
2–6	19	3.8
>6	32	8.5 P<0.01

Table 5 Summary of the effect of self-diagnosis vs diagnosis by a physician on the mean number of recurrences per year

Diagnosis method	N	Mean number of outbreaks per year (pretreatment)	Mean number of outbreaks per year (posttreatment)
Self-diagnosis	23	7.04	2.39 (P<0.001)
Diagnosis by physician	96	7.32	2.40 (P<0.0001)

Figure 1 Graphical presentations of the Gene-Eden-VIR/Novirin effect.

Notes: Kaplan–Meier plots of time to first genital herpes recurrence in the current study from participants with a history of (A) at least one recurrence per year, (B) at least six recurrences per year, and (C) at least eight recurrences per year. (D) Percentage of participants versus frequency of recurrences.

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 al^Citation18	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 al^Citation12	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 al^Citation19	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.

a Using Kaplan–Meier.

b Adjusted 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.

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 al^Citation20	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.

Table 8 Summary of efficacy end point in the current study vs the study by Corey et al

Study	Treatment	N	% recurrence-freea	Mean monthly recurrenceb
Corey et al^Citation10	Placebo	741	23%	0.4
	VACV 500 mg 1×	743	53% (P<0.001) (Δ=30%)	0.11 (P<0.001) (Δ=0.29)
Current study	GEV/NV pretreatment	84	0%	0.32
	GEV/NV treatment	84	49% (P<0.0001) (Δ=49%)	0.11 (P<0.0001) (Δ=0.21)

Notes: In all the studies, the subjects had less than ten genital herpes outbreaks per year.

a Adjusted from 8 months to a full year for the Corey et al study. The P-values are taken from the original study.

b Since the distribution of the number of recurrences per patient is not mentioned in Corey et al, it seems that their sample includes many participants with eight or nine recurrences per year, while our participants include many more participants in the 3–5 range. As a result, their mean monthly recurrence in the placebo group is higher than our mean monthly recurrence in the pretreatment group. This initial condition prevents Gene-Eden-VIR/Novirin from showing its full efficacy in this specific sample.

Abbreviations: GEV/NV, Gene-Eden-VIR/Novirin; VACV, Valacyclovir.

Table 9 Efficacy of Gene-Eden-VIR/Novirin vs ACV, VACV, and FCV

Efficacy end point	Superiority of efficacy	Source
Mean number of recurrences per month	GEV/NV > VACV	Mertz et al^Citation19
	GEV/NV < VACV	Corey et al^Citation10
	GEV/NV = ACV	Douglas et al^Citation18
Percentage recurrence-free	GEV/NV > VACV	Corey et al^Citation8
	GEV/NV > VACV	Reitano et al^Citation12
	GEV/NV = ACV	Reitano et al^Citation12
	GEV/NV < ACV	Douglas et al^Citation18
	GEV/NV > FCV	Mertz et al^Citation19
	GEV/NV < VACV	Patel et al^Citation20
Time to first recurrence	GEV/NV > FCV	Mertz et al^Citation19
	GEV/NV > VACV	Patel et al^Citation20
	GEV/NV > ACV	Douglas et al^Citation18
Mean percent reduction in recurrence	GEV/NV = VACV	Reitano et al^Citation12
Percentage with a >50% reduction in number of recurrences	GEV/NV > ACV	Douglas et al^Citation18
Percentage with a decrease in recurrence	GEV/NV = VACV	Patel et al^Citation20

Notes: In the comparison, we used the average clinical effects of all four Gene-Eden-VIR/Novirin dosages. Therefore, we also used the average clinical effects of all drug dosages in each of the five clinical studies. When the difference between our results and their results was <10%, we considered the results as equal.

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

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