PracticeUpdate Oncology May 2019

SGO 2019 29

MushroomExtract Supplementation Linked to Over 60% Eradication of HPV The supplement was taken for 6 months or longer. S upplementation with active hex- ose-correlated compound, a mushroom extract, for at least 6

months has been associated with a 60% successful elimination of human papillo- mavirus (HPV) infections in women with positive PAP smears. This outcome of an ongoing randomized, double-blind, placebo-controlled, phase II study funded by the National Institutes of Health was reported at SGO 2019. Judith Ann Smith, PharmD, of the McGov- ern Medical School at the University of Texas Health Science Center in Houston, told Elsevier’s PracticeUpdate , “About the time HPV testing was introduced into clin- ical practice, I was concerned that we had no effective treatment for high risk HPV infections.” She continued, “I was familiar with active hexose-correlated compound (AHCC®) and its benefits in the oncology arena. We were thinking outside the box, and despite criti- cism, we proceeded with bench-to-bedside studies to demonstrate that supplementation with the compound can support the immune system to eradicate high-risk HPV infections.” Dr. Smith and colleagues set out to evalu- ate the efficacy of active hexose-correlated compound 3 g by mouth once daily to eradicate HPV infections in women whose PAP smears were positive for the virus, to observe the durability of response to the supplement, and to define its adverse effects compared with placebo. Patients were randomized to receive either active hexose-correlated compound 3000 mg (taken as six 500-mg capsules) by mouth once daily on an empty stomach for 6 months followed by placebo (six cap- sules) by mouth once daily on an empty stomach, or placebo (six capsules) orally once daily on an empty stomach for 6 to 12 months. High-risk HPV DNA status, HPV RNA sta- tus, and immune panel were monitored at each visit. Power analysis was based on expected 10% eradication in the absence of treatment and 50% eradication with treatment. The planned sample was a maximum of 50 patients (n=25 per group), which led to 94.5% power to detect the hypothesized effect size. A total of 50 patients have been enrolled and had completed the study at the time of analysis.

Preliminary analysis confirmed 63.4% clearance of HPV infection after 6 months, including 64.3% whose eradication has been confirmed >12 months. In all, 2 patients (10.5%) receiving pla- cebo cleared their HPV infection over the 12-month study duration. Supplementation with active hexose- correlated compound has been confirmed to modulate expression and signaling of interferon β, known to be elevated in chronic viral infections such as HPV, to levels <25 pg/mL. This modulation as associated with a correlative increase in interferon γ and eradication of HPV infection. Dr. Smith said, “Supplementation with active hexose-correlated compound was well tolerated, with minimal potential for drug/supplement interactions.” Dr. Smith concluded that the results confirmed data obser ved in pilot studies that supplementation with active hexose-correlated compound for at least

6 months has been associated with 63.4% successful elimination of HPV infection and confirmed interferon β correlates of eradication of persistent HPV infection. “We are very encouraged with the phase II study findings, which are consistent with pilot studies and confirmed our hypothesis of the mechanism of action of supplementation with active hexose- correlated compound.” She added, “The supplement appears to support the host immune system to clear persistent HPV infections effectively.” “These phase II results are a major mile- stone in our research. We now plan to optimize and individualize treatment. The duration of supplementation with the com- pound after the first negative result also needs further evaluation.” “Our hope is that, ultimately, the supple- ment will be used to eradicate HPV in both women and men.” www.practiceupdate.com/c/81365

VOL. 3 • NO. 2 • 2019