Table 5.

Low-Grade Squamous Intraepithelial Lesions or High-Grade Squamous Intraepithelial Lesions in the Merck 020 Per-Protocol Placebo Group Compared With the AMC-072 Per-Protocol Naive Vaccinated Group

	Per-Protocol Merck 020 Placebo Groupb				Per-Protocol AMC-072 Naive Vaccinated Group
Endpoint: Anal/ Perianal LSIL/HSILa Related to	No. Included in Analyses	No. of Affected Participants	Person-Years at Risk	Events per 100 Person-Years at Risk	No. Included in Analyses	No. of Affected Participants	Person-Years at Risk	Events per 100 Person-Years at Risk	P c
HPV6	144	10	298.5	3.4	15	0	25.0	0.0	.447
HPV11	144	6	298.2	2.0	35	0	55.2	0.0	.361
HPV16	170	6	341.9	1.8	39	0	65.4	0.0	.350
HPV18	193	4	387.4	1.0	47	0	75.6	0.0	.490
HPV6, 11, 16, or 18d	208	24	411.6	5.8	58	0	93.0	0.0	.008

Abbreviations: AMC, AIDS Malignancy Consortium; HPV, human papillomavirus; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; qHPV, quadrivalent human papillomavirus.

^aAnalyses required having both histology and anal biopsy HPV DNA determination at a given visit. AMC-072 participants with qHPV type–specific AIN1 or perianal condyloma at baseline were removed (HSIL was an exclusion criteria); “baseline” DNA HPV type based on visits 0 and 3. Case counting occurred after month 7 at visits 4, 5, and/or 6.

^bThe per-protocol Merck 020 placebo group were HIV-negative men who have sex with men, were naive for a given qHPV type, and did not have LSIL or HSIL at baseline.

^cMerck placebo and AMC-072 naive group comparison of event rates based on exact Poisson calculation (1-sided test).

^dConsistent with the reported Merck V503-020 combined endpoint, analysis of all participants who were eligible for ≥1 of the individual type-specific analyses. A participant would be counted more than once if multiple lesions of different HPV types developed.