Among women with HIV infection, an HPV test-and-treat strategy did not decrease the risk of developing biopsy-confirmed high-grade squamous intraepithelial lesions (HSIL) suggestive of cervical cancer compared with cytology-based screening, according to results of a study published in Clinical Infectious Diseases.
Researchers conducted a study to investigate whether HPV testing followed by cryotherapy results in better HSIL-related outcomes among women with HIV infection.
In this randomized, open-label, phase 2 trial, adult women with HIV infection and high-risk HPV infection with no history of cervical lesions or lesions appropriate for cryotherapy were enrolled from multiple countries. Patients were randomly assigned to either undergo immediate cryotherapy (Group A) whereby cervical biopsy specimens were obtained followed by cervical cryotherapy, or to undergo cytology-based screening (Group B). Patients in Group B with abnormal cytology findings indicating HSIL underwent colposcopy with subsequent loop electrosurgical excision. All patients were followed for 30 months, and the time to detection of biopsy-confirmed HSIL between month 6 and the conclusion of the study was the primary outcome.
Overall, 145 patients were included in group A and 143 were in group B. Among all included patients, the median age was 35 years, 85% were receiving antiretroviral therapy, and the median CD4 count was 501 cells/mm3. At enrollment, 39 (27%) patients in group A had biopsy-proven HSIL. Among those in group B, cytology screening showed abnormalities in 88 (62%) patients, 22 (15%) of whom were subsequently diagnosed with biopsy-confirmed HSIL. Of these 22 patients, 12 (8%) underwent loop electrosurgical excision.
During a follow-up duration of 2.5 years, 30 (21%) and 31 (22%) women in group A and group B developed biopsy-confirmed HSIL, respectively. The time to HSIL detection was similar between groups (P =.94), as was the prevalence of high-risk HPV infection observed at month 6 (61% vs 70%; P =.13). Of 51 patients who were lost to follow-up, 14 withdrew consent or did not adhere to the study protocol, and 11 and 3 patients were lost to follow-up due to site closure and death, respectively.
This study was limited as the biopsied cervical specimens included in the analysis did not undergo central review at a single laboratory.
According to the researchers “these results suggest that [the] optimization of cervical treatments [for use] in HPV test-and-[treat] strategies are needed to achieve desired cervical cancer prevention outcomes.”
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Wilkin T, Chen H, Sahasrabuddhe V, et al. A randomized clinical trial of HPV test-and-treat as compared to cytology-based screening for prevention of cervical cancer among women living with HIV: AIDS Clinical Trials Group Protocol A5282. Clin Infect Dis. Published online March 16, 2022. doi: 10.1093/cid/ciac213