Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities
Year: 2019
Type: article
Abstract: OBJECTIVE: We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities. DESIGN: Secondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE). METHODS: Data from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population. RESULTS: Cervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24). CONCLUSION: These findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.
Source: AIDS
Authors: Krishnaveni Reddy, Cliff Kelly, Elizabeth R. Brown, Nitesha Jeenarain, Logashvari Naidoo, Samantha Siva, Linda-Gail Bekker, Gonasagrie Nair, Bonus Makanani, Lameck Chinula, Nyaradzo Mgodi, Zvavahera Chirenje, Flavia Matovu Kiweewa, Jeanne Marrazzo, Katherine Bunge, Lydia Soto-Torres, Jeanna Piper, Jared M. Baeten, Thesla Palanee-Phillips
Institutions: University of the Witwatersrand, University of Washington, Fred Hutch Cancer Center, South African Medical Research Council, University of Cape Town, Johns Hopkins University, Queen Elizabeth Central Hospital, University of Zimbabwe, MUJHU Research Collaboration, University of Alabama at Birmingham, UAB Medicine, University of Pittsburgh, Magee-Womens Research Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Microbicide Trials Network, Statistical and Data Management Center (SDMC): Microbicide Trials Network, Leadership and Operations Center (LOC): Microbicide Trials Network, UZ-UCSF Clinical Trials Unit, South African Medical Research Council Clinical Trials Unit (MRC CTU), Laboratory Center (LC): Microbicide Trials Network, UZ-UCSF CTU, University of Washington/Fred Hutch Center for AIDS Research, Rustbelt Center for AIDS Research (Case/UHC-Pitt CFAR), The Johns Hopkins University-Blantyre Clinical Trials Unit, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication
OpenAlex ID: W2990363881