Cynthia Firnhaber1, Avril Swarts, Bridgette Goeieman, Ntombi Rakhombe, Masangu Mulongo, Anna-Lise Williamson, Pam Michelow, Sibongile Ramotshela, Mark Faesen, Simon Levin, Timothy Wilkin. 1. *Cervical Cancer Screening and Treatment Research Department, Right to Care, Johannesburg, South Africa; †Clinical HIV Research Unit, Faculty of Health Sciences, Department of Clinical Medicine University of the Witwatersrand, Johannesburg, South Africa; ‡Division of Medical Virology, Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; §National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa; ‖Cytology Unit, Department of Anatomical Pathology, Faculty of Health Sciences, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa; and ¶Division of Infectious Diseases, Weill Cornell Medicine, New York, NY.
Abstract
BACKGROUND: HIV-infected women are at an increased risk of cervical cancer, especially in resource-limited countries. Cervical cancer prevention strategies focus treating cervical high-grade squamous intraepithelial lesions (HSIL). The management of low-grade squamous intraepithelial lesions (LSIL) in HIV-infected women is unknown. SETTING: HIV treatment clinic in Johannesburg, South Africa. METHODS: We randomized HIV-infected women with histologic cervical LSIL to cervical cryotherapy vs. no treatment (standard of care). Cervical high-risk human papillomavirus testing (hrHPV) was performed at baseline. All women underwent cervical cytology and colposcopic biopsies 12 months after enrollment. The primary end point was HSIL on histology at month 12. Chi-square was used to compare arms. RESULTS: Overall, 220 HIV-infected women were randomized to cryotherapy (n = 112) or no treatment (n = 108). Median age was 38 years, 94% were receiving antiretroviral therapy; median CD4 was 499 cells per cubic millimeter, and 59% were hrHPV positive. Cryotherapy reduced progression to HSIL: 2/99 (2%) in the cryotherapy arm and 15/103 (15%) in the no treatment arm developed HSIL, 86% reduction (95% confidence interval: 41% to 97%; P = 0.002). Among 17 HSIL end points, 16 were hrHPV+ at baseline. When restricting the analysis to hrHPV+ women, HSIL occurred in 2/61 (3%) in the cryotherapy arm vs. 14/54 (26%) in the no treatment arm, 87% reduction (95% confidence interval: 47% to 97%; P = 0.0004). Participants in the cryotherapy arm experienced greater regression to normal histology and improved cytologic outcomes. CONCLUSIONS: Treatment of cervical LSIL with cryotherapy decreased progression to HSIL among HIV-infected women especially if hrHPV positive. These results support treatment of LSIL in human papillomavirus test-and-treat approaches for cervical cancer prevention in resource-constrained settings.
RCT Entities:
BACKGROUND:HIV-infectedwomen are at an increased risk of cervical cancer, especially in resource-limited countries. Cervical cancer prevention strategies focus treating cervical high-grade squamous intraepithelial lesions (HSIL). The management of low-grade squamous intraepithelial lesions (LSIL) in HIV-infectedwomen is unknown. SETTING: HIV treatment clinic in Johannesburg, South Africa. METHODS: We randomized HIV-infectedwomen with histologic cervical LSIL to cervical cryotherapy vs. no treatment (standard of care). Cervical high-risk human papillomavirus testing (hrHPV) was performed at baseline. All women underwent cervical cytology and colposcopic biopsies 12 months after enrollment. The primary end point was HSIL on histology at month 12. Chi-square was used to compare arms. RESULTS: Overall, 220 HIV-infectedwomen were randomized to cryotherapy (n = 112) or no treatment (n = 108). Median age was 38 years, 94% were receiving antiretroviral therapy; median CD4 was 499 cells per cubic millimeter, and 59% were hrHPV positive. Cryotherapy reduced progression to HSIL: 2/99 (2%) in the cryotherapy arm and 15/103 (15%) in the no treatment arm developed HSIL, 86% reduction (95% confidence interval: 41% to 97%; P = 0.002). Among 17 HSIL end points, 16 were hrHPV+ at baseline. When restricting the analysis to hrHPV+ women, HSIL occurred in 2/61 (3%) in the cryotherapy arm vs. 14/54 (26%) in the no treatment arm, 87% reduction (95% confidence interval: 47% to 97%; P = 0.0004). Participants in the cryotherapy arm experienced greater regression to normal histology and improved cytologic outcomes. CONCLUSIONS: Treatment of cervical LSIL with cryotherapy decreased progression to HSIL among HIV-infectedwomen especially if hrHPV positive. These results support treatment of LSIL in human papillomavirus test-and-treat approaches for cervical cancer prevention in resource-constrained settings.
Authors: Anne Jeffries; Consuelo M Beck-Sagué; Ariel Bernardo Marroquin-Garcia; Michael Dean; Virginia McCoy; Diego Aurelio Cordova-Toma; Eric Fenkl; Purnima Madhivanan Journal: Int J Environ Res Public Health Date: 2021-11-25 Impact factor: 3.390