CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

620

Long-Term Complications of Radiotherapy For Anal Cancer in HIV Leela Chockalingam ; Michael Gaisa; Matthew Silverstein; Keith M. Sigel Icahn Sch of Med at Mount Sinai, New York, NY, USA

Background: Squamous cell carcinoma of the anus (SCCA) is a leading non-AIDS defining cancer in HIV infected (HIV+) persons. The standard of care for invasive SCCA often includes radiotherapy (RT), but there is limited data about the types and rates of long-term complications of RT for this tumor type. Data regarding long-term complications of RT use in HIV+ populations are needed to better understand the harms and benefits associated with this common SCCA treatment modality. Methods: We identified a cohort of 436 HIV+ SCCA patients from the Surveillance, Epidemiology, and End Results (SEER) database linked to Medicare claims (1991-2011) using relevant diagnostic codes. We used claims and SEER data to identify RT use and then beginning 6 months after cancer diagnosis identified potential complications longitudinally. We ascertained multiple complication types including proctitis, anal fissure and/or bleeding, bowel obstruction, femoral or pelvic fracture, abscess and others. We evaluated the association of these long-term complications with RT use in unadjusted analyses as well as adjusted Cox regression models accounting for age, sex, race and stage of SCCA at diagnosis. Results: In our cohort 76% of HIV+ SCCA patients were treated with RT. Patients receiving RT were older and more likely to have advanced cancer stage than those who did not receive RT. Patients treated with RT compared to those who were not treated with RT were more likely to experience proctitis, anal bleeding, and bowel obstruction (all p<0.05) but not abscesses, fractures or other major complications in unadjusted analyses. In adjusted models, RT use was associated with proctitis (hazard ratio [HR] 1.6; p=0.004) and bowel obstruction (HR 2.8; p=0.03) during long-term follow-up. Conclusions: Treatment of SCCA with RT in HIV+ patients was associated with an increased risk of proctitis and bowel obstruction during long-term follow-up in a population- based cohort. More research is needed to clarify the harms and benefits associated with RT treatment for SCCA in this population. 621 Randomized Trial Comparing HIV-1 Cervical Shedding After Cryotherapy Versus LEEP Sharon A. Greene 1 ; Christine J. McGrath 2 ; Dara Lehman 3 ;T.T.Trinh 1 ; NellyYatich 1 ; Barbra A. Richardson 1 ; Grace C. John-Stewart 1 ; Hugo DeVuyst 4 ; Nelly R. Mugo 5 ; Michael H. Chung 1 1 Univ of Washington, Seattle, WA, USA; 2 Univ of Texas Med Branch at Galveston, Galveston, TX, USA; 3 Fred Hutchinson Cancer Rsr Cntr, Seattle, WA, USA; 4 Intl Agency for Rsr on Cancer, Lyon, France; 5 Kenya Med Rsr Inst, Thika, Kenya Background: Treatment of HIV-positive women to prevent cervical cancer may increase HIV-1 RNA cervical shedding and subsequent transmission of HIV-1. We compared cervical HIV-1 RNA levels among women receiving cryotherapy versus loop electrosurgical excisional procedure (LEEP) for treatment of cervical intraepithelial neoplasia stage 2 or 3 (CIN2/3). Methods: Between June 2011 and July 2014, 400 HIV-positive women diagnosed with CIN2/3 in Nairobi, Kenya were randomized to receive cryotherapy or LEEP. Cervical swabs were collected at baseline and at weekly intervals for three weeks. Samples were tested for HIV-1 RNA using Gen-Probe Aptima HIV-1 assay with a minimum detection level of 60 copies/ml and analyzed using general estimating equations with a log link, accounting for time. Wilcoxon Signed Rank Test compared post-intervention HIV-1 RNA to baseline within each arm. Results: Among 400 HIV-positive women randomized, median age was 37.0 years, median CD4 was 377 copies/ml, and 392 had baseline cervical swabs collected. Median cervical HIV-1 RNA levels at baseline, 7, 14, and 21 days after treatment were below the detection limit in both arms. There was no difference in the proportion of detectable cervical HIV-1 RNA between cryotherapy and LEEP at 7 (29.2 vs.26.0; p=0.502), 14 (31.0 vs. 26.1; p=0.310), or 21 days (25.6 vs. 25.3; p=0.947) after intervention. The lack of a significant difference between the cervical treatments remained after adjusting for baseline cervical HIV-1 RNA and exposure to antiretroviral therapy (ART) (adjusted Incidence Rate Ratio [aIRR]=0.91; 95% CI: 0.74-1.11). Within the LEEP arm there was a significant increase in cervical HIV-1 RNA levels compared to baseline at 7 (p=0.014) and 14 (p=0.011) days after treatment, while there was no significant increase in cervical HIV-1 shedding at any time point within the cryotherapy arm. ART unexposed, HIV-positive women receiving LEEP were more likely to shed HIV-1 RNA from the cervix at 7 [Odds Ratio (OR), 1.52; p=0.048] and 14 (OR, 1.60; p=0.028) days after intervention compared to baseline. Conclusions: There was no significant difference in cervical HIV-1 RNA shedding between cryotherapy and LEEP, supporting the use of see-and-treat cervical cancer screening approaches using cryotherapy in HIV-positive women. However, cervical HIV-1 RNA shedding appears to increase for up to 2 weeks after LEEP, particularly in those not receiving ART, and warrants further investigation. 622 Decline in Annual Pap Testing Among HIV-PositiveWomen in Ontario, Canada Ann N. Burchell 1 ; Claire Kendall 2 ; Stephanie Cheng 3 ;Tony Antoniou 1 ; Ahmed M. Bayoumi 1 ; Rick Glazier 1 ; Aisha Lofters 1 ; Janet M. Raboud 4 ; MarkYudin 1 ; Mona Loutfy 5 1 St Michael’s Hosp, Toronto, ON, Canada; 2 Univ of Ottawa, Ottawa, ON, Canada; 3 Inst for Clinical Evaluative Scis, Toronto, ON, Canada; 4 Dalla Lana Sch of PH, Toronto, ON, Canada; 5 Women’s Coll Rsr Inst, Univ of Toronto, Toronto, ON, Canada Background: In 2012-13, North American cervical cancer screening guidelines were revised to recommend a lengthened 3-year screen interval for HIV-negative, average-risk women. Annual screening remains recommended for HIV-positive women due to heightened cancer risk. To determine whether the changes had unintended effects among women with HIV, we estimated annual rates of Pap testing among screen-eligible women in Ontario, Canada, by HIV status. We also identified prognostic factors for annual testing among HIV-positive women. Methods: We conducted a population-based cohort study using administrative health data. We identified HIV-positive women using validated algorithms and Pap testing using laboratory and procedure codes. Annual proportions of women tested at least once from 2008 to 2013 were compared between HIV-positive and –negative women, adjusted for age, geographic region, immigration status, neighborhood income quintile and comorbidity score using John’s Hopkins’ Aggregated Diagnosis Groups. Among HIV-positive women, prognostic indicators were identified using generalized estimating equations with a log link to calculate adjusted ratios of proportions (ARP). Results: A total of 2,600 HIV-positive and 4,731,760 HIV-negative women were included. From 2008-11, annual proportions tested were constant [2011, HIV+: 32.6% (CI 31.0- 34.3); HIV-: 36.0% (CI 36.0-36.1)] then declined [2013, HIV+: 26.9% (CI 25.6-28.2); HIV-: 19.8% (CI 19.8-19.9)]. In the sub-analysis of HIV+ women, women most likely to undergo cytologic testing were younger (21-29 years cf 50-70: ARP 1.43, 95%CI 1.22-1.67), recent entries to HIV care (>=2008 cf <2000: ARP 1.22, 95%CI 1.04-1.42), immigrants from HIV- endemic countries (cf non-immigrants: 1.19, 95%CI 1.08-1.31), lived in highest income neighbourhoods (cf lowest: ARP 1.19, 95%CI 1.02-1.38), had a higher comorbidity score (RUB 3-5 cf 0-2: ARP 1.58, 95%CI 1.17-2.14), and a female physician (cf male: ARP 1.15, 95%CI 1.04-1.25). In all, 28.7% of HIV+ women had no Pap testing over the 6-year period. Conclusions: There was a concerning drop in annual Pap testing among HIV-positive women following recommendations for less frequent screening for average risk women. A substantial proportion was underscreened even in this setting with universal access to medically-necessary services. As jurisdictions across North America aim to improve guideline adherence for less frequent screening in the general population, care must be taken to ensure that cancer prevention remains a priority among HIV-positive women. 623 Feasibility of Post-Partum Testing for HR-HPV Among HIV-Positive and -NegativeWomen Background: More than 80% of deaths related to cervical cancer occur in developing countries. Lack of access to screening procedures delays diagnosis and contributes to increased morbidity and mortality. Women with HIV have a higher prevalence of HPV infection; HPV is also more likely to persist in HIV-positive women, which contributes to an increased risk of cervical cancer. For underserved women, childbirth may be a woman’s first entry into medical care. Identifying methods of screening for High-Risk Human Papillomavirus (HR-HPV) at delivery could improve detection for high-risk groups. We therefore set out to assess the feasibility of testing a cohort of HIV-positive and negative women for HR-HPV shortly after delivery, and to evaluate associated co-morbid conditions. Erin Dressel 1 ; Gabriela DelBianco 2 ; Gilhen Rodriguez 2 ; James R. Murphy 2 ; Gloria P. Heresi 2 ; Laura J. Benjamins 2 1 Univ of Texas Hlth Sci Cntr at Houston, Houston, TX, USA; 2 Univ of Texas Med Sch at Houston, Houston, TX, USA

Poster Abstracts

252

CROI 2016