Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases

Genital herpes is one of the most important public health problems [1]. It is a sexually transmitted infection caused by two viruses: the Herpes Simplex Virus Type 2 (HSV-2), and Herpes Simplex Virus Type 1 (HSV-1) [2]. In the United States, one in four persons 30 years of age or older has HSV-2 [3].

Three drugs are used in the treatment of genital herpes: acyclovir (ACV), valacyclovir (VACV, a prodrug of ACV), and famciclovir (FCV, a prodrug of penciclovir) [4, 5]. ACV was approved by the Food and Drug Administration (FDA) in 1984, VACV in 1995, and FCV in 1994. These drugs use modified nucleosides, or their prodrugs [6]. The drugs inhibit the activity of the viral DNA polymerase, which is the main replication enzyme of the virus.

All three drugs are used in both episodic and suppressive therapy. Episodic therapy uses short term, self-administration of the drug during outbreaks. The main objective of episodic therapy is to decrease the duration of the outbreaks [7]. Suppressive therapy involves long term, daily administration of the drug before the onset of outbreaks. The main objective of suppressive therapy is to decrease the number of outbreaks [8].

All three drugs are associated with known adverse effects. The most frequent ones, according to the product inserts, are nausea, diarrhea, and headache, for ACV, headache, nausea, and abdominal pain, for VACV, and headache, nausea and dizziness, for FCV.

The medical literature also reports non-common adverse events. For instance, Yavuz et al. reported that a 78-year-old female with normal baseline renal function, and no contributing possible nephrotoxic factors, developed irreversible renal dysfunction after oral ACV treatment [9]. Becker et al. reported that a patient developed rapidly progressive acute renal failure with concomitant mental status changes following treatment with high-dose parenteral ACV [10]. Another uncommon, but serious side effect of ACV treatment, is neurotoxicity that may lead to confusion, hallucinations, seizures and obtundation [11].

Le Cleach et al. conducted a meta-analysis of 26 clinical studies that tested the effectiveness and safety of the three oral antiviral drugs [2]. Interestingly, they found that only 8 out of the 26 studies, or less than a third, reported the number of withdrawals due to harms. These 8 studies reported 14 withdrawals due to harms in the placebo or no treatment groups, and 31 withdrawals in the antiviral groups. This is a 121 % increase in the number of withdrawals due to harms. In addition, only four, or 16 % of the 26 studies, reported safety data in the form of the total number of adverse events. These four studies reported 115 adverse events in 291 participants in the placebo or no treatment groups (40 %), including three serious adverse events, two renal signs, and one fatal pneumonia. In the antiviral groups, they reported 331 adverse events in 561 participants (59 %), including three serious adverse events, one hypertension crisis, one intestinal obstruction, and one angor. In other words, the participants treated with the antiviral drugs reported 48 % more adverse events relative to the non-treated or placebo-treated participants.

Lam et al. analyzed a cohort of 76,269 patients who received acyclovir or valacyclovir, and 84,646 who received famciclovir [12]. The results showed that 0.27 % of those treated with ACV or VACV, and 0.28 % of those treated with FCV, were hospitalized with acute kidney injury (AKI).

It is well accepted that adverse effects are dose-dependent. Therefore, to minimize the risk of adverse effects whenever possible, the medical community decided to recommend using these drugs in short term, or episodic therapy, in mild cases, and long term, or suppressive therapy, in severe cases. Clinical studies have shown that episodic treatment with these drugs can shorten the time to lesion healing by 1–2 days [13–15]. Clinical studies also showed that suppressive treatment for a period of 4–12 months can decrease the number of outbreaks, such that about half of patients remain recurrence-free, and the other half show a 70–80 % decrease in the frequency of their outbreaks [16, 17].

It is interesting that this practice is so ingrained that it had a profound effect on the clinical studies that tested these drugs. Surprisingly, most of the clinical studies that tested suppressive treatments measured the effect on the number of outbreaks, but not their effect on the duration of outbreaks [7, 8, 17, 18].

Gene-Eden-VIR/Novirin is a patented botanical product that consists of five natural ingredients: quercetin 100 mg, green tea extract 150 mg, cinnamon extract 50 mg, selenium 100 mcg, and licorice extract 25 mg. Gene-Eden-VIR/Novirin was developed to target latent viruses including HSV, HPV, CMV and EBV, and diminish their deleterious effect on the host, as explained by the Microcompetition theory [19–21].

The scientists who developed the Gene-Eden-VIR/Novirin formula used a unique scientific tool, Computer Intuition, a proprietary psycholinguistic-based, data-mining program that analyzes scientific text [22]. The objective was to identify natural ingredients found in the scientific literature that have a strong antiviral effect against the most common viruses. To achieve the objective, the scientists used the computer program to analyze more than 50,000 papers. The results assisted the developers in selecting the best ingredients and the most effective dosages.

Gene-Eden-VIR/Novirin was introduced in the marketplace at the end of 2009. A post-marketing clinical study conducted at the Center for the Biology of Chronic Disease (CBCD) showed that Gene-Eden-VIR/Novirin is antiviral [22]. Another post-marketing clinical study showed that Gene-Eden-VIR/Novirin safely decreased the feeling of fatigue in individuals infected with a latent virus [23].

Our previous paper showed that suppressive treatment with Gene-Eden-VIR/Novirin decreased the number of genital herpes outbreaks without any side effects [24]. It also showed that the clinical effects of Gene-Eden-VIR/Novirin are mostly better than those reported in the studies that tested acyclovir, valacyclovir, and famciclovir. The current paper tested the effect of suppressive treatment with Gene-Eden-VIR/Novirin on the duration of outbreaks, in severe and mild genital herpes cases.