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It is a mouse-model study. Mice are going to be infected with SARS-CoV-2 virus and we will examine the mortality change and other parameters with and without AHCC administration,” says Homma. This was the first double-blind, placebo-controlled clinical study to demonstrate that the nutritional supplement, AHCC, is effective in eliminating persistent, high-risk HPV infections with durable response in those patients who achieved an IFN-β level below 20 pg/ml. Overall, AHCC was well tolerated and had comparable adverse effects as compared to placebo. Previously, the two pilot studies evaluating AHCC supplementation in women with persistent HR-HPV infections identified that IFN-β levels of less than 20 pg/ml correlated with the elimination of HR-HPV ( 17). This phase II study confirmed the correlation between suppressed IFN-β levels to less than 20 pg/ml with an increase in T lymphocytes and IFN-γ, which ultimately resulted in clearance of HPV infections in women who received AHCC supplementation. In those patients who were HPV RNA/HPV DNA negative after 6 months of AHCC supplementation but had a mean IFN-β level greater than 20 pg/ml, two remained HPV RNA negative but HPV DNA positive, and three were both HPV RNA and HPV DNA positive 3 months later after supplementation had been stopped. This identified the opportunity for future research to optimize and personalize the duration of supplementation on both HPV infection status and the target IFN-β level. In addition, the data from this study identified the potential opportunity to employ monitoring IFN-β levels, which could be used for both men and women with HPV infections. While this study did focus on women with HR-HPV infections, in the absence of effective testing tools for HPV status in men and with a safety profile comparable to placebo, the use of AHCC supplementation for men with known exposure to HR-HPV (i.e., partners of women with HR-HPV) as well as those with LR-HPV infections could consider AHCC supplementation to clear the HPV infection. After 12 weeks of supplementation, the percentage change in alanine aminotransferase (ALT) levels was significantly different between the placebo and both AHCC groups (1 g of AHCC ® and 3 g of AHCC ®). Serum levels of tumor necrosis (p < 0.05) and interleukin-1β ( p < 0.01) were significantly lower, while those of adiponectin were higher in both AHCC ® groups than in the placebo group (p < 0.01). AHCC ® supplementation for 12 weeks may improve the levels of liver enzymes and circulating pro-inflammatory and anti-inflammatory cytokines in patients with alcohol-induced mildly elevated liver enzyme levels. The liver enzyme levels, lipid profiles, insulin resistance, and scores on fatigue and stress-related questionnaires did not show significant differences between the groups (p < 0.05); however, cytokine levels did show significant differences (TNF-α, IL-1β, and adiponectin, p < 0.05). Comparing the percentage changes at 12 weeks as analyzed by a paired t-test, a decrease in liver enzymes in both AHCC groups and a change in IL-1β and adiponectin in the 1-g AHCC ® group were found to be statistically significant. When analyzed with ANOVA, the percentage changes of serum levels of inflammatory cytokines, such as TNF-α (p < 0.05) and IL-1β (p < 0.01), were lower in the AHCC ® supplementation groups than in the placebo group. Serum levels of adiponectin were higher in both AHCC ® groups than in the placebo group (p < 0.05). Methods: Cervical cancer cells, CaSki (HPV16 +), HeLa(HPV18 +), SiHa(HPV16/18 +), and C-33A(HPV −), were treated in vitro with AHCC 0.42 mg/mL daily x7 days then observed x7 days with daily sample collection. A confirmatory study in cervical cancer mouse models, SiHa(HPV16/18 +) and C-33A(HPV −), was conducted: mice were divided into three groups per cell line then dosed with AHCC 50 mg/kg/d ( N = 10), or vehicle alone ( N = 10), or no supplementation ( N = 10) for a total of 90 days followed by 30 days of observation. Tumors were measured 3x/week and blood samples collected bi-weekly to evaluate interferon (IFN) alpha(α), beta(β), and gamma(γ) and immunoglobulin G(IgG) by immunoassays. Tumors were evaluated for HR-HPV expression by PCR. Two pilot studies of 10 patients each were conducted in women with confirmed persistent HR-HPV+ infections. The 1 st study evaluated AHCC 3g from 5 weeks up to 6 months and 2nd study evaluated AHCC 1g < 8 months. HR-HPV DNA status and the immune panel were monitored at each visit.
AminoUp’s leading supplement, AHCC, was launched in 1987, following an evaluation of more than 100 different mushroom species, and systematically tested for optimized manufacturing. VEGAN WITH NO FILLERS, BINDERS OR ADDITIVES. At Time Health we believe in clean nutrition which is why you won’t find any nasty stuff in our products including any binders, fillers or additives, unlike some of our competitors. Patients of childbearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.
Author Contributions
The presented bench-to-bedside research provides step-wise data to support the hypothesis that AHCC supplementation modulates host immune system, specifically via suppression of elevated IFNβ levels, to effectively clear chronic, persistent HR-HPV infections. After observing elimination of HR-HPV in vitro in the panel of human cervical cancer cell lines, animal studies were completed that also demonstrated successful, durable elimination of HR-HPV after completing AHCC supplementation. Finally, in two “proof of concept” pilot studies of daily AHCC supplementation successful elimination of HR-HPV was achieved that was durable response. Both the animal and human data suggests the mechanism AHCC supplementation supports the host immune system to clear HPV infections is attributed to the modulation of the expression and signaling of IFNβ that is known to be elevated in chronic viral infections (16, 17). The human papillomavirus (HPV) is classified as a non-enveloped, double-stranded DNA virus that generally infects the epithelial layer of cells including cutaneous and mucosal surfaces and is associated with benign warts, carcinoma in situ, and malignant lesions ( 1, 2). There are over 100 HPV strains identified in humans, 40 low-risk HPV (LR-HPV) strains associated with genital warts/lesions, and fifteen high-risk HPV (HR-HPV) strains associated with cancer. When HR-HPV infections persist over time, patients have an increased risk of developing cancer ( 3). However, it should be noted that having a persistent high-risk HPV infection does not cause cancer by itself; rather, it is a contributing co-factor in the risk for development of cancer when it occurs in combination with other insults such as poor nutrition, smoking, physiological stress, or immune dysfunction/suppression. In the United States, there are an estimated 85,890 cases of cancer caused by persistent high-risk HPV infections, and an estimated 79 million Americans are infected with HPV today ( 4, 5).
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Results: HR -HPV clearance was observed in vitro and confirmed in the animal studies as a durable response. Four of six (66.7%) patients had confirmed HR-HPV clearance after 3–6 months of AHCC 3g. Similarly, 4 of 9 (44%) patients had confirmed HR-HPV clearance after 7 months of AHCC 1g. Suppression of IFNβ<25 pg/mL was observed in those clearing the HR-HPV infection.
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