CROI 2016 Abstract eBook

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Poster Abstracts

Methods: We conducted a retrospective chart review of 37 HIV-positive and 35 HIV-negative mothers enrolled in a study evaluating vertical transmission of HR-HPV. Results from vaginal swabs collected 24-72 hours after delivery were reviewed, as well as maternal charts for sexually transmitted infections (STI) and obstetric history. Descriptive statistics and chi square analysis were used. Results: 92% of the mothers were African American and 8% Hispanic. The majority of patients had Medicaid or the County District insurance. Among HIV-positive women, 16 (43%) tested positive for HR-HPV post-partum (PP) compared to 10 (29%) of women without HIV (p=0.23). In addition, among those with a positive HR-HPV PP test, 6 (38%) of HIV-positive women had history of STI during pregnancy and 5 (31%) received no prenatal care, compared to 1 (10%) and 2 (20%) of HIV-negative women, respectively. Among women with no documented history of an abnormal PAP smear, 10/24 (42%) HIV-positive women and 5/29 (17%) HIV-negative women had a positive HR-HPV PP test (p=0.07). Conclusions: We found a higher prevalence HR-HPV in women infected with HIV. Having an STI during pregnancy or no prenatal care could be potential risk factors for HR-HPV PP among HIV-positive women. Of the women positive for HR-HPV PP 15/53 (28%) had not previously been identified; two thirds of these women had HIV. For underserved women where access to care is difficult or limited, testing for HR-HPV during the post-partum period may be a feasible screening tool. 624 Role of p16 Testing in Cervical Cancer Screening Among HIV-InfectedWomen Christine J. McGrath 1 ; Rochelle L. Garcia 2 ; Hugo DeVuyst 3 ; Ritesh Pamnani 4 ; Barbra A. Richardson 2 ; Grace C. John-Stewart 2 ; Evans Nyongesa-Malava 5 ; Samah Sakr 6 ; Nelly R. Mugo 7 ; Michael H. Chung 2 1 Univ of Texas Med Branch at Galveston, Galveston, TX, USA; 2 Univ of Washington, Seattle, WA, USA; 3 Intl Agency for Rsr on Cancer, Lyon, France; 4 Kenyatta Natl Hosp, Nairobi, Kenya; 5 Kenya Rsr Prog at the Univ of Washington, Nairobi, Kenya; 6 Coptic Hosp, Nairobi, Kenya; 7 Kenya Med Rsr Inst, Thika, Kenya Background: We evaluated the utility of p16 staining to screen for cervical intraepithelial neoplasia 2 or 3 (CIN2/3) among HIV-infected women. Methods: Between June and December 2009, 500 HIV-infected women underwent Papanicolau (Pap) smear, visual inspection for acetic acid (VIA), high-risk human papillomavirus (hrHPV) testing, and colposcopy-directed biopsy (gold standard) at the Coptic Hope Center in Nairobi, Kenya. After Pap smears were read for cytology, a portion of samples were de-stained and treated with p16 immunohistochemistry to evaluate for expression of p16 protein by a separate study pathologist. Defining disease as the detection of CIN2/3 by colposcopy-directed biopsy, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of abnormal Pap smear (low-grade squamous intraepithelial lesions or greater [LSIL+]), hrHPV, and positive VIA were compared to the positive detection of p16 protein alone and in combination. Results: Of 500 HIV-infected women who were originally screened, 150 samples had p16 protein expression results available for analysis. On histology, 43 (28.7%) were normal, 65 (43.3%) CIN1, 18 (12.0%) CIN2, 11 (7.3%) CIN3, and 13 (8.7%) indeterminate. On cytology, 52 (34.7%) were normal, 33 (22.0%) ASCUS, 40 (26.7%) LSIL, 17 (11.3%) HSIL, and 8 (5.3%) indeterminate. On VIA, 43 (28.7%) were positive, 102 (68.0%) were negative, and 5 (3.3%) indeterminate. On hrHPV, 78 (52.0%) were positive and 72 (48.0%) were negative. On p16, 40 (26.7%) were positive and 110 (73.3%) were negative. The sensitivity, specificity, PPV and NPV were: 62.1%, 67.8%, 31.6%, and 88.2% for Pap smear; 51.7%, 72.7%, 31.3%, and 86.3% for VIA; 82.8%, 55.4%, 30.8%, and 93.1% for hrHPV; and 41.4%, 76.9%, 30.0%, and 84.6%, for p16. Triaging an abnormal result with a p16 test reduced sensitivity and increased specificity from 62.1% to 31.0% and 67.8% to 90.1% for Pap smear; 51.7% to 24.2% and 72.7% to 93.4% for VIA; and 82.8% to 37.9% and 55.4% to 86.0% for hrHPV. Conclusions: Using cytologic p16 protein expression as an adjunctive test to triage positive results to screen for cervical cancer significantly increases specificity but also decreases the sensitivity of Pap smear, VIA, and hrHPV among HIV-infected women. Use of p16 testing alone as a screening tool has relatively high specificity (76.9%) but lower sensitivity (41.4%). Additional data and analyses are needed to assess the utility of p16 testing to detect CIN2/3 among HIV-infected women. 625 High Prevalence of HR-HPV Infection in HIV-InfectedWomen From Tanzania Tessa Lennemann 1 ; Ruby Mcharo 1 ; Asli Bauer 1 ; LisetTorres 2 ; Mkunde Chachage 1 ; Nice Mwinuka 1 ; Leonard Maboko 1 ; John France 2 ; Christof Geldmacher 3 ; Arne Kroidl 3 1 Natl Inst for Med Rsr Mbeya Med Rsr Cntr, Mbeya, Tanzania; 2 Mbeya Referral Hosp, Mbeya, Tanzania; 3 Univ of Munich, Munich, Germany Background: Cervical cancer caused by high risk human papilloma virus (HR-HPV) is among the leading cancer in sub-Saharan Africa, especially in HIV infected women. Screening programs are based on a screen-and-treat approach including visual inspection with acetic acid (VIA). Alternatively HR-HPV based screening is discussed to have greater sensitivity to detect cancerous and pre-malignant lesions. The objective of our analysis was to investigate the association of HR-HPV genotypes with cervical lesions in HIV+ and HIV- women, risk factors and HPV based screening feasibility. Methods: In our analysis we included HIV+ and HIV- women who received VIA based screening with available cytological/histological (Bethesda criteria) and HPV genotyping results (Linear Array HPV Test, Roche Molecular Systems) from the ongoing, prospective 2H cohort study conducted in Mbeya, Tanzania. Results: Among 376 women screened 203 (54%) were HIV infected (68% on ART, 19%with CD4 counts <200 cells/µl). Cervical cancer, high grade squamous intraepithelial lesions (HSIL), low grade squamous intraepithelial lesions (LSIL) or no lesions were detected in 8.2%, 4.5%, 13.0% and 74.2% of women. HR-HPV genotypes were detected in 65.1% of HIV+ and 34.9% of HIV- women. Risk factors associated with HR-HPV were HIV infection (RR 1.6, 95%CI 1.3 to 1.9, p<0.001), CD4 count <200 cells/µl (RR 1.4, 95%CI 1.1 to 1.6, p=0.001), first sexual intercourse before 18 years of age (RR 1.3, 95%CI 1.2 to 1.6, p=0.013), and age below 30 years (RR 1.4, 95%CI 1.1 to 1.6, p=0.002). In cancer/HSIL cases HR-HPV was detected in 93.8% and HPV16/18 in 60.4%, and proportions were comparable between HIV+ and HIV- women. Of note HR-HPV or HPV 16/18 was also detected in 43.4% (HIV+ 53.7% versus HIV- 33.6, p=0.001) and 21.5% in women without cervical lesions. The sensitivity of HR-HPV as compared to VIA based screening to detect cancer/HSIL in HIV infected women was slightly higher (95.8% versus 89.5%) but low for specificity (36.9% versus 75.9%) and positive predictive values (7.4% versus 16.3). Conclusions: We detected high proportions of cervical HR-HPV infections, especially in HIV infected, young women with low CD4 counts. As expected, HR-HPV infection was prevalent in cancer/HSIL cases, but also frequently detected in HIV infected women without cervical lesions. Low HR-HPV test specificity therefore impacts the feasibility of HPV based screening algorithms, the long term impact of HPV/HIV co-infection without cervical disease needs to be evaluated.

Poster Abstracts

253

CROI 2016