Table 3.

Summary of the HPV response.

Outcome	Placebo arm (N = 19)	Blinded AHCC arm (N = 22)	Placebo patients who went onto unblinded AHCC (N = 12)	All AHCC patients (N = 34)
Overall response rate	10.5% (2)	63.6 (14)	50% (6)	58.8% (20)
CR (complete response: HPV negative after 12 months of stopping AHCC)	10.5% (2)	40.9% (9)	50% (6)	44.1% (15)
PR (partial response)	NA	22.7% (5)	NA	22.7% (5)
NR (no response)	89.5% (17)	36.3% (8)	50% (6)	41.1 (14)

The primary endpoint of this study was confirmation of clearance of HPV by both HPV RNA and HPV DNA testing. A complete response (CR) was defined as those patients who were both HPV RNA/DNA negative after 6 months of AHCC supplementation and continued to be both HPV RNA/DNA negative 6 months off AHCC supplementation. A partial response (PR) was defined as those patients who were both HPV RNA and DNA negative after 6 months of AHCC supplementation but after 6 months off AHCC supplementation were no longer HPV DNA negative. No response (NR) was defined as those patients who remained HPV DNA positive throughout the study.

HPV, human papillomavirus; NA, Not applicable.