CROI 2015 Program and Abstracts

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Poster Abstracts

Conclusions: Although EC is the standard of care for treating anal dysplasia, almost 50% of patients with HGAIN in our study did not respond or relapse to EC. New treatment strategies are necessary to optime the management of patients with anal dysplasia. 715 Survival and Treatment Trends for Squamous Cell Carcinoma of the Anus in HIV Infection Robert A. Pitts ; Stephen Goldstone; Keith Sigel; Michael M. Gaisa; Carlie Sigel; JuanWisnivesky Icahn School of Medicine at Mount Sinai, New York, NY, US Background: HIV seropositive (HIV+) patients are at increased risk of squamous cell carcinoma of the anus (SCCA). Howevere, there are limited data regarding antiretroviral era survival and treatment trends for HIV+ patients with SCCA. Methods: We used data from the Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare claims to evaluate outcomes among a cohort of male HIV+ and HIV- patients diagnosed with SCCA from 1997 to 2009. Outcomes included all-cause and anal cancer-specific mortality, colostomy placement, and SCCA recurrence. Kaplan-Meier methods were employed to compare outcomes (among the whole cohort and then stratified by cancer stage) by HIV status. We developed Cox regression models to adjust for age, race/ethnicity, modified Charlson comorbidity score, cancer stage and diagnosis year. Initial courses of treatment (surgery, radiotherapy, and chemotherapy) were also identified and compared by HIV status and SCCA stage. Results: 1,000 male patients with incident SCCA were included in our cohort, of whom 370 were HIV+. When compared to HIV- patients, HIV+ subjects were younger (median age 48, p<0.05), had lower comorbidity scores (p <0.05), and were diagnosed with earlier stage cancers (p=0.03). Median survival in HIV+ SCCA patients ranged from 95 months (95% CI: 79 - 125) for stage 1 to 23 months (95% CI: 10 - 56) for stage IV. For early stage SCCA, we observed no difference in the pathologic depth of carcinoma invasion by HIV status (p=0.5). However, initial treatment varied by HIV status and SCCA stage (Table 1). In adjusted analyses, HIV patients had worse overall survival (HR 1.5, %CI: 1.2 - 2.0), but no difference in anal cancer-specific survival, colostomy placement or cancer recurrence.

Conclusions: In our population-based cohort, we found that HIV+ patients with SCCA presented with earlier stage cancers (possibly related to anal cancer screening) and had worse overall survival than HIV- patients. SCCA-specific survival did not differ by HIV status despite discordance in initial treatment, suggesting that overall survival differences were related to HIV-related sources of mortality. 716 Oral HPV Shedding andWarts After Starting Antiretroviral Therapy: ACTG Protocol A5272 Caroline H. Shiboski 1 ; Anthony Lee 2 ; JenniferWebster-Cyriaque 3 ; Huichao Chen 2 ; Malcolm John 1 ; Raphael J. Landovitz 4 ; Mark Jacobson 1 Oral HIV/AIDS Research Alliance and the AIDS ClinicalTrial Group 1 University of California San Francisco, San Francisco, CA, US; 2 Harvard School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA, US; 3 University of North Carolina, Chapel Hill, NC, US; 4 University of California Los Angeles, Los Angeles, CA, US Background: Previous studies have suggested an increase in the incidence of oral warts following antiretroviral therapy (ART) initiation. In addition, there are recent reports of an increasing incidence of human papilloma virus(HPV)-related oral malignancies among the US population living with HIV infection, despite the widespread availability of ART for almost two decades. Therefore, we sought to explore whether ART initiation among treatment-naïve HIV-positive adults was followed by an increase in oral wart incidence or a decrease in oral HPV shedding. Methods: AIDS Clinical Trial Group protocol A5272 was a prospective, observational study of HIV-1 infected ART naïve adults who were initiating ART. Endpoints included detection of HPV DNA in throat washes and diagnosis of oral warts measured at two time points prior to ART initiation as well as at 16 and 24 weeks after ART initiation. An oral exam for warts was also performed at 48 weeks. Results: Among 500 participants enrolled, 390 (78%) were men and 110 (22%) women. Among the 396 participants who had evaluable throat wash HPV DNA results from at least one time point before initiating ART and again after 16 or 24 weeks of ART, 76 (19%) had at least one subtype of HPV DNA present before starting ART and 100 (25%) had at least one subtype present after 16 or 24 weeks of ART. In addition, after 16 or 24 weeks of ART, 80 (20%) had a new HPV subtype present in throat wash that was not identified in the specimens obtained before initiating ART. Also, among those with HPV DNA present before initiating ART, 48 (63%) cleared at least one of the prevalent subtypes during follow-up, while 17 (22%) persisted in shedding at least one of the prevalent subtypes. Oral warts were detected in 3% of participants at study entry. Among those who did not have any warts at entry, only 2.5% had acquired one or more warts by 16, 24, or 48 weeks of ART. Conclusions: Both prevalence and incidence of oral warts were low. However, high proportion of participants shed HPV from the oral cavity both before and after ART initiation. Furthermore, HPV subtypes absent at baseline were detected after ART initiation. The results of this study suggest that effective immune control of HPV replication in the oral cavity is not reconstituted by ART in HIV-infected patients during the first 24 weeks of therapy. The prevalence of HPV-associated oral malignancies may continue to increase in the modern ART era. Supported by NIH/NIAID/NIDCR Cooperative Agreement U01AI068636

Poster Abstracts

440

CROI 2015