 |
|
|
| |
Extensive cervical lesions common in HIV-positive
women screened for ACTG trial
|
| |
| |
CROI 2015, February 23-26, 2015, Seattle, Washington
Mark Mascolini
About 1 in 6 HIV-positive women screened for an AIDS Clinical Trials Group (ACTG) study of cervical cancer had extensive cervical lesions not eligible for treatment with cryotherapy [1]. CD4 counts were high and viral loads low in these women, and neither was associated with lesion detection.
ACTG A5282 compares a human papillomavirus (HPV) test-and-treat strategy with a cytology-based approached to prevent cervical intraepithelial neoplasia (CIN) 2+ in women with HIV [2]. Trial sites are in Haiti, Peru, India, and sub-Saharan Africa. The ACTG investigators noted that screen-and-treat protocols to prevent cervical cancer are common in resource-constrained regions because of challenges in using cytology. Women are screened with visual inspection and acetic acid or with testing for high-risk HPV. Those who screen positive undergo cervical cryotherapy. But cryotherapy may not be appropriate for women with extensive lesions, who need excisional procedures like the loop electro-excision procedure (LEEP).
To inform broader use of screen-and-treat programs, the ACTG investigators determined rates of extensive cervical lesions in women with HIV and factors associated with these lesions. Study participants were being screened for ACTG A5282, a randomized comparison of the screen-and-treat approach and cytology-based management to prevent cervical cancer. All participants got screened with (1) colposcopy (visual inspection after acetic acid wash with magnification and without biopsy), (2) HPV testing, and (3) cytology (Pap smear).
HPV testing detected HPV-16, HPV-18, and the other 12 high-risk HPV types. The researchers classified colposcopy results as (1) no lesions, (2) cryotherapy-eligible lesions, or (3) cryotherapy-ineligible lesions (according to World Health Organization criteria). All women were at least 18 years old. The research team will randomize 280 women with high-risk HPV lesions 1-to-1 to immediate cryotherapy or to the cytology-based strategy. They will follow a subset of high-risk-HPV-negative women with extensive cervical lesions not eligible for cryotherapy.
This screening analysis involved 907 women who had complete results from colposcopy, high-risk HPV detection, and cytology. The group had a median age of 37 (interquartile range [IQR] 32 to 42) and a median CD4 count of 524 (IQR 386 to 712); 70% of these women had a viral load below 40 copies. Two thirds of women (66%) had an abnormal Pap smear result. HPV testing determined that 44% of women were positive for any high-risk HPV type, 10% were positive for HPV-16, and 5% were positive for HPV-18.
Colposcopy detected no lesions in 54% of women, lesions eligible for cryotherapy in 30%, and lesions ineligible for cryotherapy in 16%. Thus about 1 in 6 women had extensive cervical lesions ineligible for cryotherapy.
Cryotherapy-ineligible lesions proved significantly more common in women with high-risk HPV (105 of 403, 26%) than in other women (44 of 504, 9%) (P < 0.001). Such lesions also proved significantly more frequent in women with abnormal cytology (110 of 597, 18%) than in women with normal cytology (39 of 310, 13%) (P = 0.024). Neither CD4 count nor viral load was associated with detection of cryotherapy-ineligible lesions.
The ACTG team noted that "adequate treatment" of cryotherapy-ineligible lesions, "such as loop electrosurgical excision procedure, should be readily available within 'screen-and-treat' implementation programs." But further study is needed to determine the best way to manage such lesions.
Webcast:
http://www.croiwebcasts.org/console/player/25543?mediaType=slideVideo&
References
1. Wilkin TJ, Matining R, Sahasrabuddhe V, et al. Factors associated with extensive cervical lesions among HIV-infected women screening for AIDS Clinical Trials Group (ACTG) protocol A5282. CROI 2015. February 23-26, 2015. Seattle, Washington. Abstract 710.
2. ClinicalTrials.gov. HPV Test-and-treat-strategy versus cytology-based strategy for prevention of CIN2+ in HIV-infected women. ClinicalTrials.gov identifier NCT01315353. https://clinicaltrials.gov/ct2/show/NCT01315353
|
| |
|
|
|
|
|
