Effect of Cryotherapy vs Loop Electrosurgical Excision Procedure on Cervical Disease Recurrence Among Women With HIV and High-Grade Cervical Lesions in Kenya

Abstract

recommends cryotherapy or loop electrosurgical excision procedure (LEEP) for histologically confirmed cervical intraepithelial neoplasia (CIN) grade 2 or higher regardless of HIV status. Cryotherapy is more feasible in resource-limited settings but may be less effective for women living with HIV.OBJECTIVE To evaluate whether cryotherapy or LEEP is a more effective treatment for high-grade cervical lesions among women with HIV. DESIGN, SETTING, AND PARTICIPANTS Single-center randomized trial conducted among women with HIV and CIN grade 2 or 3. From June 2011 to September 2016, women with HIV in Kenya underwent cervical screening with Papanicolaou testing and confirmatory biopsy. The final date on which a study procedure was administered was September 7, 2016.INTERVENTIONS Women with HIV infection and CIN grade 2 or 3 were randomized 1:1 to receive cryotherapy (n = 200) or LEEP (n = 200) and were followed up every 6 months for 24 months with a Papanicolaou test and confirmatory biopsy. MAIN OUTCOME AND MEASURESThe primary outcome was disease recurrence, defined as CIN grade 2 or higher on cervical biopsy, during the 24-month follow-up period.RESULTS Among 400 women who were randomized (median age, 37.4 [interquartile range, 31.9-43.8] years), 339 (85%) completed the trial. Over 2 years, 60 women (30%) randomized to cryotherapy had recurrent CIN grade 2 or higher vs 37 (19%) in the LEEP group (relative risk, 1.71 [95% CI, 1.12-2.65]; risk difference, 7.9% [95% CI, 1.9%-14.0%]; P = .01). Adverse events occurred in 40 women (45 events, including change in pathology and death due to other causes) in the cryotherapy group and in 30 women (38 events, including change in pathology and unrelated gynecological complications) in the LEEP group. CONCLUSIONS AND RELEVANCEIn this single-center study of women with HIV infection and CIN grade 2 or 3, treatment with LEEP compared with cryotherapy resulted in a significantly lower rate of cervical neoplasia recurrence over 24 months. Cost-effectiveness analysis is necessary to determine whether the additional benefit of LEEP represents an efficient use of the additional resources that would be required.

Antiretroviral Therapy and Detection of High-grade Cervical Intraepithelial Neoplasia (CIN2+) at Post-CIN Management Follow-up Among Women Living With Human Immunodeficiency Virus: A Systematic Review and Meta-Analysis

“…Four hundred and four records were identified, of which 128 duplicates were removed, and 230 records were excluded after title/abstract review, leaving 43 articles for full-text review (Figure 1). Of these, 8 articles [21][22][23][24][25][26][27][28] , representing 9 discrete populations and 1,452 women, met the inclusion criteria. One study [24] provided separate effect estimates for two populations: WLHIV who received cryotherapy and WLHIV who received excisional therapy.…”

“…Of the three populations that studied the association of ART and CIN2+ detection at follow-up in HMICs [22,25,28] , excisional management methods were used in one [28] and a combination of excision and ablative methods were used in two, although most women were treated using excisional methods (77% and 85%) [22,25] . Of the five populations evaluated in LMICs, excision and ablative methods were used in two [24,26] and three [23,24,27] populations respectively (Table 1).…”

The impact of scaling up cervical cancer screening and treatment services among women living with HIV in Kenya: a modelling study

“…The sensitivity and specificity of screening tests and the efficacy of treatment options replicated reported parameters from recent Kenyan studies among WHIV in care (table 1). Also, rates of individuals refusing CC screening services and LTFU reflect those observed in programmatic evaluations within HIV care facilities in Kenya 9 10 20–23. Individuals for whom treatment was effective and who recovered were assumed to remain cervical disease free for 24 months and, as above, go back to susceptible thereafter and be at risk of new HPV infections accounting for their age and ART status.…”

Loop electrosurgical excision procedure (LEEP) plus top hat for HIV‐infected women with endocervical intraepithelial neoplasia in Kenya

“…The present cross‐sectional, prospective study was performed at the Coptic Hope Center for Infectious Diseases, an HIV treatment clinic in Nairobi, Kenya, between June 2011 and August 2016, 12 and was nested within a randomized controlled trial (RCT) comparing the recurrence of cervical lesions among women infected with HIV with CIN2/3 randomized to LEEP and cryotherapy 13 . The Hope Center offers free antiretroviral treatment (ART) with support from the President's Emergency Plan for AIDS Relief (PEPFAR) 12 .…”