CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

763

Trial Comparing Cryotherapy to LEEP in Women With HIV: CIN2+ Recurrence After 9 Years Douglas K. Gaitho 1 , Marleen Temmerman 1 , Evans Nyongesa-Malava 2 , Shahin Sayed 1 , Stephen Hawes 3 , Andrew Nagy 4 , Samah Sakr 2 , Judith Lukorito 4 , Aisha Bwanaali 4 , Dennis Omondi 4 , Nelly R. Mugo 5 , James Kiarie 6 , Michael Chung 7 , Carey Farquhar 3 , Christine McGrath 3 1 Aga Khan University, Nairobi, Kenya, 2 Coptic Hospital, Nairobi, Kenya, 3 University of Washington, Seattle, WA, USA, 4 Coptic Hope Center, Nairobi, Kenya, 5 Kenya Medical Research Institute, Nairobi, Kenya, 6 University of Nairobi, Nairobi, Kenya, 7 Emory University, Atlanta, GA, USA Background: We aimed to determine the long-term risk of recurrent cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in women living with HIV (WLWH) previously treated for cervical disease with loop electrical excision procedure (LEEP) or cryotherapy. Methods: We conducted a long-term follow-up study of WLWH, and CIN2/3 randomized to LEEP or cryotherapy and followed 2-years post-treatment in Kenya between 2011-2016. Former participants were recontacted from January to August 2023 for Papanicolaou (PAP) screening and colposcopy-directed biopsy if indicated to determine presence of CIN2+ in the ≥9 years since initial treatment. Women with PAP results of low grade squamous intraepithelial lesions, high grade squamous intraepithelial lesions (HSIL) or Atypical Squamous Cells, HSIL cannot be excluded (ASC-H), underwent colposcopy directed biopsy. Primary outcome was CIN2+ recurrence (CIN2/3, Carcinoma in-situ or invasive cancer) as determined by colposcopy-directed biopsy at ≥9 years after initial treatment. Log-binomial regression was used to estimate the relative risk of CIN2+ recurrence by treatment arm. Results: Overall, 353 of 400 (88%) former participants were alive at the end of the parent trial, 14 were lost to follow-up with 33 mortalities. Of these, 288 (82%) were recontacted and 213 (74%) agreed to participate in this follow-up study. Fewer women in the LEEP arm (17%) had unsuppressed HIV viral load (≥1000 copies/ml) than the cryotherapy arm (24%). ART duration was similar between arms with a median of 11 years (IQR 10–12). Sixteen (8%) participants had a hysterectomy since the parent trial and were excluded. Of 197 screened, 5 (5%) of 107 in the cryotherapy arm and 3 (3%) of 90 in the LEEP arm had recurrent CIN2+ at ≥9 years since initial treatment. Of these eight with CIN2+, 2 (1 per arm) had a prior CIN2+ recurrence in the 2-years following initial treatment (parent trial). In addition, 48 (31 in cryotherapy and 17 in LEEP) had CIN2+ recurrence in the initial trial but not in this study. There was no difference in CIN2+ recurrence risk at ≥9 years following initial treatment between arms (RR=1.40, 95% CI, 0.34-5.71, p=0.64). In subgroup analysis, the effect of treatment on CIN2+ recurrence did not vary by viral suppression, CD4 count, and ART duration. Conclusion: Recurrence of CIN2+ in WLWH ≥9 years after cryotherapy or LEEP was low (4%) and did not differ between the ablative and excisional therapies after initial 2-year follow-up and may be related to long-term ART use. Prioritizing Anal Cancer Screening in PWH: Not All Are at the Same Risk Raquel Martin-Iguacel 1 , Boris Revollo 2 , Jordi Aceiton 1 , Pere Domingo 3 , Joaquín Burgos 4 , Patricia Sorni 5 , Maria Saumoy 6 , Hernando Knobel 7 , Marta Navarro 8 , Elena Leon 9 , Amat Orti 10 , José M. Miró 11 , Jordi Casabona 1 , Josep M. Llibre 2 , for the PISCIS Cohort Study Group 1 Centre d'Estudis Epidemiològics Sobre les ITS i Sida de Catalunya, Barcelona, Spain, 2 Hospital Germans Trias i Pujol, Barcelona, Spain, 3 Hospital Sant Pau, Barcelona, Spain, 4 Hospital Universitario de la Vall d’Hebron, Barcelona, Spain, 5 Hospital Son Llàtzer, Palma de Mallorca, Spain, 6 Hospital Universitario de Bellvitge, Barcelona, Spain, 7 Hospital del Mar, Barcelona, Spain, 8 Parc Taulí Hospital Universitari, Sabadell, Spain, 9 Hospital Moises Broggi, Sant Joan Despí, Spain, 10 Verge de la Cinta Hospital, Tortosa, Spain, 11 Hospital Clinic of Barcelona, Barcelona, Spain Background: People with HIV (PWH) are up to 100 times more likely to develop anal cancer (AC) compared to the general population, where overall incidence is 1.6/100,000 person-years (PY). Screening programs are efficient in preventing AC but are not accessible to all PWH. Identifying individuals at higher risk is crucial to implement effective and targeted screening strategies Methods: In this cohort study, we included all treatment naïve PWH ≥16 years from 16 hospitals in Catalonia and Balearic Islands, included in the PISCIS HIV cohort from 1998-2022. The primary outcome was the incidence rate (IR) of histologically confirmed AC. We used Poisson regression to identify AC risk factors, including age at AC, risk group, nadir CD4+ count, and period of HIV diagnosis. AC and nadir CD4+ were validated in all cases. Results: We identified 107 AC events among 14,238 PWH, overall IR of 71.5/100,000 PY (95%CI:71.5-71.6), and median follow-up 9.5 years (IQR:4.4 15.7). Of them, 37 died, 65% AC-related deaths. The IR was highest in those with

nadir CD4+ <200 cells/µL (103.0 [95%CI:102.9-103.1]), followed by those with nadir CD4+ 200-350 cells/µL (29.1, [95%CI:29.1-29.2]), and lowest in those with nadir CD4+ >350 cells/µL (2.8 [95%CI:2.8-2.9]). In the same categories, MSM had IR of 211.5 (95%CI:211.2-211.7), 37.6 (95%CI:37.5-37.7), and 4.8 (95%CI:4.8 4.9), respectively. Among PWH with <30 years, there was only 1 AC in MSM and none in the other groups. There were no cases among women or non-MSM men with nadir >350 cells. In the multivariable analysis, nadir CD4+ <200 cells/ µL was associated with the highest risk compared to nadir CD4+>350 cells/µL, followed by nadir CD4+ 200-350 cells/µL (aIRR 29.1 [95%CI:4.1-206.2] and 8.8 [95%CI:1.2-66.2], respectively). Vs those with <30 years, PWH ≥60 had aIRR 27.6 [95%CI:3.7-206.8], and with 45-59 years aIRR 21.6 [95%CI:3.0-156.5]. HIV diagnosis before 1998 (32.9 [95%CI:8.0-135.1]) was also a significant risk factor. Age <45 years was a protective factor against AC with nadir CD4+ <200 cells/µL. Conclusion: PWH with nadir CD4+ count <200 cells/µL exhibit the highest risk of AC, especially among MSM, whereas those with nadir CD4+ count >350 cells/µL had a similar risk to the general population. Tailored approaches for AC screening based on nadir CD4+ count could optimize resources by prioritizing AC screening to those with the highest risk. The figure, table, or graphic for this abstract has been removed. Contribution of HIV to the Burden of Merkel Cell Carcinoma in the US Jacob T Tribble 1 , Karena Volesky-Avellaneda 1 , Qianlai Luo 1 , Michael Sargen 1 , Isaac Brownell 2 , Elizabeth Cahoon 1 , Meredith Shiels 1 , Ruth Pfeiffer 1 , Adrianne Moreno 3 , Brenda Hernandez 4 , Eric Engels 1 1 National Cancer Institute, Rockville, MD, USA, 2 National Institutes of Health, Bethesda, MD, USA, 3 Texas Department of State Health Services, Austin, TX, USA, 4 University of Hawaii, Honolulu, HI, USA Background: Merkel cell carcinoma (MCC) is an aggressive form of skin cancer with a 5-year survival rate of approximately 65%. Risk factors for MCC include advanced age, immunosuppression, Merkel cell polyomavirus, lightly pigmented skin, and UV radiation. People with HIV (PWH) have elevated risk of MCC; however, prior studies had few MCC patients with HIV (ranging from 6 to 20) and did not estimate the MCC burden attributable to HIV. Using population-based cancer registry data collected in 14 US regions, we report the characteristics of MCC patients with HIV and quantify the burden of MCC among PWH during 2001–2019. Methods: We used cancer registries in the HIV/AIDS Cancer Match (HACM) Study to identify MCC (ICD-O3 8247: C44.0–C44.9) cases in the general population and the linked HIV registry data to compare cases in PWH and those without HIV. We calculated standardized incidence ratios (SIRs) to compare MCC incidence in PWH to the general population. To estimate the proportion of MCC cases in the general population due to HIV, we calculated population attributable fractions (PAFs) using the formula Pc*[(RR-1)/RR], where Pc is the prevalence of HIV among MCC patients and RR is the relative risk of MCC associated with HIV (approximated by the SIR). We also report HIV viral load and CD4 counts among PWH in the year leading up to MCC diagnosis. Results: 13,126 MCC cases were diagnosed in HACM registries during 2001– 2019, and 46 (0.4%) were among PWH (see table). Among MCC patients, the median age of diagnosis was 56 years (IQR: 50–67) in PWH, vs. 77 years (IQR: 68–84) in those without HIV. Thirty-one (67.4%) PWH and MCC had an AIDS diagnosis prior to MCC diagnosis. The risk of PWH developing MCC was almost three times higher than the general population (SIR=2.78, CI: 2.01–3.75). Only 0.2% of MCC cases were attributable to HIV; however, the PAF was higher among PWH aged 20–59 (2.0%). Among 24 individuals with a HIV viral load measure in the year before MCC diagnosis, 5 had undetectable levels (<20 copies/ mL), 16 had 20-99,999 copies/mL, and 3 had >100,000 copies/mL. Among 25 individuals with a CD4 count in the year prior to MCC diagnosis, 4 had <200, 10 had 201–499, and 11 had >500. Conclusion: PWH have a higher risk of MCC compared to the general population. While the overall contribution of HIV to the MCC burden is minor, a larger PAF was observed among younger individuals. The majority of PWH and MCC had disease markers indicating moderate to severe immunosuppression leading up to MCC diagnosis.

765

Poster Abstracts

764

CROI 2024 228