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HPV CLEARANCE AND REINFECTION IN 2 YEARS AFTER RANDOMIZATION TO CRYOTHERAPY OR LEEP
Christine J. McGrath1, Anthony Cagle1, Hugo De Vuyst2, Troy Querec3, Elizabeth Unger3, Sharon A. Greene1, Sameh Sakr4, Marleen Temmerman5, Nelly R. Mugo6, Michael H. Chung1
1University of Washington, Seattle, WA, USA,2International Agency for Research on Cancer, Lyon, France,3CDC, Atlanta, GA, USA,4Coptic Hope Center, Nairobi, Kenya,5Aga Khan University, Nairobi, Kenya,6University of Washington in Kenya, Nairobi, Kenya
Women with HIV are at increased risk of high-risk human papillomavirus (hrHPV) infection. We compared hrHPV clearance and reinfection in HIV-infected women randomized to cryotherapy or loop electrosurgical excisional procedure (LEEP) for treatment of cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3).
From June 2011 to July 2014, HIV-infected women enrolled at the Coptic Hope Center in Nairobi, Kenya with CIN2/3 were randomized to receive cryotherapy or LEEP and followed for 2 years with a Pap smear and HPV cervical swab every 6 months. hrHPV was defined as a positive result on at least one of 13 types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) identified by the Roche Linear Array Genotyping Test. Clearance was defined as testing negative for the same hrHPV type/s detected at baseline on ≥2 consecutive visits ≥6 months apart. Time to clearance or duration of hrHPV infection was defined as the time elapsed from intervention to the date of the first negative hrHPV test. Reinfection was defined as new hrHPV infection after clearance. Outcomes were compared between arms using Chi-square tests and log-binomial regression.
Of 400 women randomized to cryotherapy or LEEP, 95% (189 per arm) had baseline hrHPV results. Median age was 37 years [interquartile range (IQR): 31-43], median CD4 count was 380 cells/μl (IQR: 211-525), and median plasma HIV RNA viral load was 1.5 log10/mL (IQR: 1.5-2.8). The majority (88%) of women were on antiretroviral treatment (ART) at baseline, of whom 40% were on ART for ≥2 years. Baseline hrHPV prevalence was 93% in the cryotherapy arm and 92% in the LEEP arm (P=0.83). Clearance of hrHPV was significantly higher in LEEP than cryotherapy both at 6 months following intervention (36% vs 24%; P=0.015) and over two-year follow up (50% vs 39%; P=0.040). Median time to clearance was 6 months in each arm (P=0.16). Those who underwent LEEP were 50% (95% confidence interval (CI), 1.1-2.1; P=0.017) more likely to clear hrHPV than those receiving cryotherapy. The difference in reinfection with hrHPV following clearance of hrHPV in women with LEEP vs cryotherapy was not statistically significant (Relative risk=0.67, 95% CI, 0.4-1.1; P=0.089).
Clearance of hrHPV in HIV-infected women after cervical treatment was limited; 40% experienced hrHPV reinfection within 2 years. However, women receiving LEEP were more likely to clear hrHPV than those receiving cryotherapy adding a reason to consider expanding LEEP in resource-limited settings.