The purpose of this study was to assess HPV infection associated with the development of external genital lesions (EGL), specifically, condyloma (genital warts) and penile intraepithelial neoplasia (PeIN), in healthy men aged 18–70 residing in São Paulo (Brazil), within the multinational HIM Study. We assessed the incidence of pathologically confirmed condyloma and PeIN and determined the rate of HPV infection progression to EGL. Factors associated with each of these outcomes were assessed.
The Brazil HIM Study participants are men aged 18-70 years living in São Paulo (Brazil) enrolled between July 2005 and June 2009. At each visit, visually distinct EGLs were biopsied, subjected to pathological evaluation, and categorized by pathological diagnoses. Genital swabs and biopsies were used to identify HPV types using PCR and the Linear Array genotyping method for swabs and INNO LiPA for biopsies. Condyloma and PeIN incidence was determined among 1,118 men aged 18-73 years with two or more visits.
Among the Brazil cohort, 73 men developed an incident EGL during the study period. Men could develop multiple types of EGLs primarily diagnosed as condyloma (n=36), PeIN (n=6), and non-HPV related EGL (n=20). Men that developed an EGL were younger in age (p=0.006) and were single (p=0.01) compared to men that did not develop an EGLs.
During follow-up of 815 men with an HPV infection, 4% progressed to an EGL with the same HPV type detected in the lesion. Genital HPV-6 progression to an HPV-6-positive condyloma was 15.7% (18/115) with a median time from infection to condyloma of 9.0 months. Similar results were obtained for HPV-11 infections. Less than 1% (0.2%,4 of 2232) of any genital HPV infections progressed to PeIN with the same HPV type detected in the lesion, with a median time from infection to PeIN of 24.9 months. Approximately 1% of genital HPV-16 infections progressed to an HPV-16-positive PeIN with a median time from infection to PeIN of 25.6 months. The quadrivalent HPV vaccine types were detected in 82.3% and 83.3% of condyloma and PeIN respectively.
EGL incidence in Brazilian men was associated with young age and being single. Most EGLs develop following infection with HPV types 6, 11, or 16, one to two years from HPV detection. This study emphasizes the need to ensure that strong HPV immunity, such as that obtained through vaccination, is available to males to reduce the overall burden of infection and diseases caused by HPV.