Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information was received from the authors of the published literature article titled as stated above concerning a post-hoc analysis of a noncurrent cohort study evaluated 210 patients without history of anal condyloma and 103 patients with previously-treated anal condyloma recurrence-free to for at least 12 months prior to vaccination/time zero, to determine the rate of anal condyloma development in vaccinated versus unvaccinated patients. Study participants were recruited from a single anorectal surgery practice (SEG). The majority of patients were men who have sex with men (MSM) presenting with HPV related disease. Beginning in June 2006, the three-dose GARDASIL (manufacturer unspecified) series was offered off label to all HIV-negative MSM patients at each clinical visit. There were 694 HIV-negative MSM seen in the practice from 2007 to 2010. Based on chart review, 313 patients were 26 years of age or older without history of anal condyloma or with history of previously-treated anal condyloma recurrence-free for at least 12 months. Their mean age was 42.1 years with standard deviation (SD) 9.8, range 26.1 to 76.0 years. Data on race/ethnicity were missing for 25% (77 of 313) of study patients. Of those whose race/ethnicity was identified 89% (21 0 of 236) were one race. One hundred three patients had history of anal condyloma within 5 years of study entry, all of whom were recurrence-free for at least 12 months prior to study entry. Of 313 eligible participants, 116 (37%) were vaccinated and 197 (63%) were unvaccinated. Vaccinated patients were significantly younger then unvaccinated patients (vaccinated mean age 38.6 years with SD 7.4, unvaccinated mean age 44.3 years with SD 10.3, p<0.001). Vaccinated patients were more likely to smoke cigarettes (21.6% vs 13.2%, p=0.05). The groups were comparable in terms of history of anal condyloma, history of High-grade squamous intraepithelial lesion (HSIL), oncogenic HPV status, and history of Sexually transmitted infections (STIs). Unvaccinated patients had longer follow-up time (median 1039 days compared with 880 days; p=0.07). Rates of gonorrhea, chlamydia, and syphilis after study entry were comparable between groups (0-4%). Among vaccinated patients, 10 developed anal condyloma. This case reports concerns male patient 1 of 10. In statistical analysis, qHPV vaccination was associated with decreased risk of developing anal condyloma (HR 0/49; 95% CI 0.24-0.98; p=0.04). Of 103 patients with history of anogenital condyloma within five days of study study, 41 (40%) patients were vaccinated and 62% (60%) were unvaccinated. Among vaccinated patients, 6 developed anal condyloma. The authors concluded stating that this was the first study to show that qHPV decreases risk of anal condyloma among older MSM. Although the vaccine was currently licensed and recommended for prevention of HPV infection in young person ages 9 to 26 years, if this results were confirmed by a randomized, placebo-controlled trial, the age of the target population should be expanded, especially in high-risk populations like MSM. This is one of several reports from the same source (MARRS case 1405USA014706 and from MARRS case 1405USA01430 to 1405USA014938). A copy of the literature article is attached as further documentation of patient's experiences. Additional information has been requested.