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. 2017 Mar 3;11:575-583.
doi: 10.2147/DDDT.S123340. eCollection 2017.

Human Papillomavirus (HPV): Systemic Treatment With Gene-Eden-VIR/Novirin Safely and Effectively Clears Virus

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Free PMC article

Human Papillomavirus (HPV): Systemic Treatment With Gene-Eden-VIR/Novirin Safely and Effectively Clears Virus

Hanan Polansky et al. Drug Des Devel Ther. .
Free PMC article

Abstract

Purpose: This paper reports the results of a clinical study that tested the effect of systemic treatment with the botanical product Gene-Eden-VIR/Novirin on the clearance rate (also called time to clearance) of the human papillomavirus (HPV). The study compared the clearance rate in treated and untreated individuals suffering from a symptomatic HPV infection. The data on the untreated individuals were obtained by reverse engineering of the Kaplan-Meier figures in five published papers.

Materials and methods: The study included 59 treated participants. All participants were suffering from a symptomatic HPV infection prior to the commencement of treatment. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-12 months. The study included five groups of external controls with diverse characteristics.

Results: The mean time to clearance in Gene-Eden-VIR/Novirin-treated individuals was 5.1 months or 151.5 days (95% CI: 4.2-5.9 months or 95% CI: 125.7-177.3 days, respectively). The median time to clearance was 3.5 months. The mean time to clearance in the five untreated groups ranged from 6.9 to 20.0 months (P<0.0001 for the difference between treatment group and each untreated group). Also, 100% of the participants in the treatment group were HPV free at the end of 12 months vs 53%, 52%, 65%, 20%, and 77% in the untreated control groups. The treated participants reported no adverse experiences.

Conclusion: This clinical study has two major contributions. First, it showed that systemic treatment with the natural Gene-Eden-VIR/Novirin decreased the time to HPV clearance, increased the percentage of HPV-free individuals, and caused no adverse experiences in individuals suffering from a symptomatic HPV infection. Since there are no other systemic treatments for symptomatic HPV infections, this study presents highly valuable information on the clinical effects of the first treatment in this category. Second, the study presents a new method for conducting clinical studies that addresses one of the major deficiencies associated with the practice of the randomized controlled trial method.

Keywords: Gene-Eden-VIR/Novirin; HPV; efficacy; natural treatment; safety.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Reverse-engineered figures (blue curves) vs. original figures (black curves). Notes: The survival distribution curve of each reverse-engineered external control plotted against that of the original figure from the five papers: (A) Liu et al (Reprinted by permission from the American Association for Cancer Research: Liu M, He Z, Zhang C, et al. Prevalence, incidence, clearance, and associated factors of genital human papillomavirus infection among men: a population-based cohort study in rural China. Cancer Epidemiol Biomarkers Prev. 2014;23(12):2857–28659), (B) Moscicki et al (Moscicki AB, Ma Y, Farhat S, et al. Natural history of anal human papillomavirus infection in heterosexual women and risks associated with persistence. Clin Infect Dis. 2014;58(6):804–811, by permission of Oxford University Press19), (C) Munoz et al (Reprinted by permission from Macmillan Publishers Ltd: British Journal of Cancer http://www.nature.com/bjc/index.html. Munoz N, Hernandez-Suarez G, Mendez F, et al. Persistence of HPV infection and risk of high-grade cervical intraepithelial neoplasia in a cohort of Colombian women. Br J Cancer. 2009;100(7):1184–1190, copyright 2009.20), (D) Rosa et al (Reprinted from Am J Obstet Gynecol, 199(617), Rosa MI, Fachel JM, Rosa DD, Medeiros LR, Igansi CN, Bozzetti MC. Persistence and clearance of human papillomavirus infection: a prospec tive cohort study, e1–e7, Copyright (2008), with permission from Elsevier21), and (E) Franco et al (Franco EL, Villa LL, Sobrinho JP, et al. Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer. J Infect Dis. 1999;180(5):1415–1423, by permission of Oxford University Press5). Abbreviation: HPV, human papillomavirus.
Figure 2
Figure 2
Reversed engineered (blue curve) vs. current study (green curve). Notes: The survival distribution curve of the current study against each of the external controls: (A) Liu et al (Adapted by permission from the American Association for Cancer Research: Liu M, He Z, Zhang C, et al. Prevalence, incidence, clearance, and associated factors of genital human papillomavirus infection among men: a population-based cohort study in rural China. Cancer Epidemiol Biomarkers Prev. 2014;23(12):2857–28659), (B) Moscicki et al (Moscicki AB, Ma Y, Farhat S, et al. Natural history of anal human papillomavirus infection in heterosexual women and risks associated with persistence. Clin Infect Dis. 2014;58(6):804–811, by permission of Oxford University Press19), (C) Munoz et al (Adapted by permission from Macmillan Publishers Ltd: British Journal of Cancer http://www.nature.com/bjc/index.html. Munoz N, Hernandez-Suarez G, Mendez F, et al. Persistence of HPV infection and risk of high-grade cervical intraepithelial neoplasia in a cohort of Colombian women. Br J Cancer. 2009;100(7):1184–1190, copyright 2009.20), (D) Rosa et al (Adapted from Am J Obstet Gynecol, 199(617), Rosa MI, Fachel JM, Rosa DD, Medeiros LR, Igansi CN, Bozzetti MC. Persistence and clearance of human papillomavirus infection: a prospective cohort study, e1–e7, Copyright (2008), with permission from Elsevier21), and (E) Franco et al (Franco EL, Villa LL, Sobrinho JP, et al. Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer. J Infect Dis. 1999;180(5):1415–1423, by permission of Oxford University Press5). Abbreviation: HPV, human papillomavirus.

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