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BackgroundAge-specific data on anal, and corresponding cervical, human papillomavirus (HPV) infection are needed to inform female anal cancer prevention.MethodsWe centrally reanalyzed individual-level data from 26 studies reporting HPV prevalence in paired anal and cervical samples by human immunodeficiency virus (HIV) status and age. For women with HIV (WWH) with anal high-grade squamous intraepithelial lesions or worse (HSIL+), we also investigated concurrent cervical cytopathology.ResultsIn HIV-negative women, HPV16 prevalence decreased significantly with age, both at anus (4.3% at 15-24 years to 1.0% at ≥55 years; ptrend = 0.0026) and cervix (7.4% to 1.7%; ptrend < 0.0001). In WWH, HPV16 prevalence decreased with age at cervix (18.3% to 7.2%; ptrend = 0.0035) but not anus (11.5% to 13.9%; ptrend = 0.5412). Given anal HPV16 positivity, concurrent cervical HPV16 positivity also decreased with age, both in HIV-negative women (ptrend = 0.0005) and WWH (ptrend = 0.0166). Among 48 WWH with HPV16-positive anal HSIL+, 27 (56%) were cervical high-risk HPV-positive, including 8 with cervical HPV16, and 5 were cervical HSIL+.ConclusionsAge-specific shifts in HPV16 prevalence from cervix to anus suggest that HPV infections in the anus persist longer, or occur later in life, than in the cervix, particularly in WWH. This is an important consideration when assessing the utility of cervical screening results to stratify anal cancer risk.

Objective The current study aimed to inform the varied and limited research on clinical variables in the context of teletherapy. Questions remain about the comparative quality of therapeutic alliance and clinical outcome in the context of teletherapy compared to in-person treatment. Methods We utilized a cohort design and a noninferiority statistical approach to study a large, matched sample of clients who reported therapeutic alliance as well as psychological distress before every session as part of routine clinical practice at a university counseling center. A cohort of 479 clients undergoing teletherapy after the emergence of the COVID-19 pandemic was compared to a cohort of 479 clients receiving in-person treatment before the onset of the pandemic. Tests of noninferiority were conducted to investigate the absence of meaningful differences between the two modalities of service delivery. Client characteristics were also examined as moderators of the association between modality and alliance or outcome. Results Clients receiving teletherapy showed noninferior alliance and clinical outcome when compared to clients receiving in-person psychotherapy. A significant main effect on alliance was found with regard to race and ethnicity. A significant main effect on outcome was found with regard to international student status. Significant interactions on alliance were found between cohort and current financial stress. Conclusions Study findings support the continued use of teletherapy by demonstrating commensurate clinical process and outcome. Yet, it will be important for providers to be aware of existing mental health disparities that continue to accompany psychotherapy – in person and via teletherapy. Results and findings are discussed in terms of research and clinical implications. Future directions for researching teletherapy as a viable treatment delivery method are also discussed. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical values of extended human papillomavirus (HPV) genotyping in triage of high‐risk HPV‐positive women, focusing on the trade‐off between cervical precancer detections and colposcopy referrals. Methods: A bivariate random‐effects model was used to estimate the diagnostic accuracy of primary HPV screening with following triage strategies to detect cervical precancers: (i) partial genotyping for HPV16/18 combined with cytological testing at atypical squamous cells of undetermined significance threshold (used as the comparator), (ii) genotyping for HPV16/18/58/52, (iii) genotyping for HPV16/18/58/52/33, (iv) genotyping for HPV16/18/58/33/31, (v) genotyping for HPV16/18/58/52/33/31, and (vi) genotyping for HPV16/18/58/52/33/31/39/51. Internal risk benchmarks for clinical management were used to evaluate the risk stratification of each triage strategy. Results: A total of 16,982 women (mean age 46.1 years, range 17–69) were included in this analysis. For CIN3+ detection, triage with HPV16/18/58/33/31 genotyping achieved lower positivity (6.85% vs. 7.35%, p = 0.001), while maintaining similar sensitivity (91.35% vs. 96.42%, p = 0.32) and specificity (94.09% vs. 93.67%, p = 0.56) compared with the comparator strategy. Similar patterns were observed for CIN2+ detection. Women with a positive HPV16/18/58/33/31 genotyping test had high enough risk for CIN3+ for colposcopy referral, while the risk for women with a negative test was below the 1‐year return decision threshold according to internal benchmarks. Conclusions: Our findings suggested extended HPV genotyping is of potential to be used as a triage technique integrated into HPV‐based cervical cancer screening, leading to reduced need for colposcopy referral while maintaining similar disease detection and efficient risk stratification. [ABSTRACT FROM AUTHOR]

Accumulating evidence has demonstrated that high‐risk human papillomaviruses (HR‐HPVs) are involved in the etiology of a subset of oropharyngeal squamous cell carcinoma (OPSCC). In this regard, the International Agency for Research on Cancer (IARC) has recommended direct molecular HPV testing. So far, there is no agreement on the most appropriate method for HPV detection on OPSCC formalin‐fixed paraffin‐embedded (FFPE) materials. In this study, we aimed to evaluate the performance of the high‐sensitive SureX HPV assay in OPSCC FFPE tissues compared with LiPA‐25 and p16ink4a immunostaining. A retrospective series of FFPE primary OPSCC cases were diagnosed between 2008 and 2019 and provided by the Henan Cancer Hospital, China. The level of agreement of two assays was determined using Cohen's Kappa (κ) statistics. A total of 230 FFPE OPSCC samples from tumor resections (n = 160) and diagnostic biopsies (n = 70) were detected. Sixty‐six (28.7%) and 70 (30.4%) samples were identified as HPV‐DNA‐positive by LiPA‐25 and SureX, respectively, of which HPV16 was largely the most common type (95.5% vs 94.3%). We found a perfect concordance between LiPA‐25 and SureX for HPV‐DNA status (κ = 0.906, 95% CI: 0.875–0.937) and for HPV16 (κ = 0.925, 95% CI: 0.897–0.953). In addition, SureX and p16ink4a immunostaining had a perfect concordance (κ = 0.917, 95% CI: 0.888‐0.946). Moreover, the HPV‐driven fraction, based on double positivity for HPV‐DNA and p16ink4a, was similar between SureX (63 of 230, 27.4%) and LiPA‐25 (60 of 230, 26.1%). Similar results were found in samples from resections and biopsies. SureX and LiPA‐25 are comparable. SureX could be used for routine HPV‐DNA detection and genotyping on archival OPSCC FFPE tissues. [ABSTRACT FROM AUTHOR]

More evidence from population-based cohort studies is required to confirm the application of methylation-based biomarkers in real-world settings. The cross-sectional and 24-month cumulative triage performance of a novel methylation assay targeting the host gene EPB41LE and HPV16/18 DNA L1/L2 regions among hrHPV-positive women was evaluated based on a population-based cohort study from China. Overall methylation positivity was 12.4% among hrHPV-positive women. Methylation-positive women had significantly higher risks of hrHPV persistence at 12M and 24M follow-up (RR12M = 1.9, 95%CI: 1.5–2.6 and RR24M = 1.7, 95%CI: 1.2–2.5). For CIN2+, cross-sectional triage sensitivity of methylation was similar to HPV16/18 (70.6% vs. 64.7%, pexact = 1.000), but was lower than cytology (94.1%), although not significantly (pexact = 0.213). The specificity (91.2%) of methylation was significantly higher than other triage methods (p < 0.001 for all). The longitudinal sensitivity of methylation over 24M follow-up was 56.0%, lower (but not significantly so) than HPV16/18 (64.0%, pexact = 0.688) and cytology (76.0%, pexact = 0.125). Methylation testing showed high positive predictive values for CIN2+ (41.4% at baseline, 50.0% at 24-month), while the CIN2+ risk of methylation negative women (cNPV) remained considerable (2.5% at baseline, 6.9% at 24-month). Study findings indicate that methylation has better specificity and predictive values for the presence or development of cervical precancer and might therefore be considered for the strategy of HPV screening and methylation triage followed by immediate treatment of triage-positive women and delayed follow-up of hrHPV-positive/methylation-negative women. [ABSTRACT FROM AUTHOR]

Introduction: The pivotal efficacy study assessed efficacy and safety of GSK's AS04‐HPV‐16/18 vaccine in Chinese women aged 18–25 years up to 6 years. The present extension study, performed 4 years later, offered AS04‐HPV‐16/18 vaccination to placebo recipients. Vaccine safety and its long‐term protective effect were assessed at Year 10. Methods: All 6051 women who received AS04‐HPV‐16/18 or the placebo during the initial study (NCT00779766) were invited to phase III/IV, open‐label, partially controlled extension Year 10 study (NCT03629886). Placebo recipients were offered three‐dose AS04‐HPV‐16/18 vaccination and followed up over 12 months to assess the safety. Cervical samples from all women were examined. Vaccine efficacy (VE) against incident infections and cytological lesions associated with HPV‐16/18 and other oncogenic types was assessed as exploratory objective. Results: Among 3537 women (out of 6051) enrolled in the extension study, 1791 women (mean age 32.7 years; standard deviation 1.8 years) received AS04‐HPV‐16/18 and reported no serious adverse events, potential immune‐mediated diseases, or adverse pregnancy outcomes related to vaccination. Among 6051 women, VE against incident HPV‐16, ‐18, and ‐16/18 infections up to Year 10 was 82.8% (95% confidence interval: 72.5–89.7), 79.8% (64.5–89.2), and 80.8% (72.4–87.0), respectively. VE against HPV‐16/18 ASC‐US+, CIN1+, and CIN2+ was 92.7% (82.2–97.7), 94.8% (67.4–99.9), and 90.5% (34.6–99.8), respectively. Conclusion: AS04‐HPV‐16/18 vaccine showed an acceptable safety profile in Chinese women vaccinated at age 26 years or above, and a long‐term protection similar to other efficacy trials worldwide. [ABSTRACT FROM AUTHOR]