Objective To review the first two years of the primary human papillomavirus (HPV) cervical screening programme in an HPV vaccinated population. Design Observational study. Setting Australia. Participants 3 745 318 women with a primary HPV test between 1 December 2017 and 31 December 2019; most women aged <40 years had previously been offered vaccination against HPV16 and HPV18. Interventions Primary HPV screening with referral if HPV16 or HPV18 (HPV16/18) positive and triage with liquid based cytology testing (threshold atypical squamous cells-cannot exclude high grade squamous intraepithelial lesion) for women who were positive for high risk HPV types other than 16/18. A 12 month follow-up HPV test was recommended in triaged women with a negative or low grade cytology result, with referral if they tested positive for any high risk HPV type at follow-up. Main outcome measures Proportion of women who had attended for their first HPV screening test, tested positive, and were referred for colposcopy; and short term risk of detecting cervical intraepithelial neoplasia (CIN) grade 2 or worse, CIN grade 3 or worse, or cancer. Results 54.6% (n=3 507 281) of an estimated 6 428 677 eligible women aged 25-69 had undergone their first HPV test by the end of 2019. Among those attending for routine screening, positivity for HPV16/18 and for HPV types not 16/18 was, respectively, 2.0% and 6.6% in women aged 25-69 (n=3 045 844) and 2.2% and 13.3% in highly vaccinated cohorts of women aged 25-34 (n=768 362). Colposcopy referral (ages 25-69 years) was 3.5%, increasing to an estimated 6.2% after accounting for women who had not yet had a 12 month repeat test. Cervical cancer was detected in 0.98% (456/46 330) of women positive for HPV16/18 at baseline, including 0.32% (89/28 003) of women with HPV16/18 and negative cytology. Women with HPV types not 16/18 and negative or low grade cytology at both baseline and 12 months were at low risk of serious disease (3.4% CIN grade 3 or worse; 0.02% cancer; n=20 019) but estimated to account for 62.0% of referrals for this screening algorithm. Conclusions Colposcopy referral thresholds need to consider underlying cancer risk; on this basis, women with HPV16/18 in the first round of HPV screening were found to be at higher risk regardless of cytology result, even in a previously well screened population. Women with HPV types not 16/18 and negative or low grade cytology showed a low risk of serious abnormalities but constitute most referrals and could be managed safely with two rounds of repeat HPV testing rather than one. HPV16/18 driven referrals were low in HPV vaccinated cohorts. Only aggregated data from the National Cancer Screening Register were supplied for this analysis. Detailed aggregated data tables are provided as supplementary data.

中文翻译：

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澳大利亚 HPV 疫苗接种人群头两年原发性人乳头瘤病毒 (HPV) 宫颈筛查的国家经验：观察性研究

目的回顾 HPV 疫苗接种人群中原发性人乳头瘤病毒 (HPV) 宫颈筛查项目的前两年。设计观察研究。设置澳大利亚。2017 年 12 月 1 日至 2019 年 12 月 31 日期间，3 745 318 名女性进行了初次 HPV 检测；大多数年龄小于 40 岁的女性之前曾接种过 HPV16 和 HPV18 疫苗。干预措施 如果 HPV16 或 HPV18 (HPV16/18) 呈阳性，则转诊进行初步 HPV 筛查，并对 16 型以外的高危 HPV 类型呈阳性的女性进行基于液体的细胞学检测（阈值非典型鳞状细胞 - 不能排除高级别鳞状上皮内病变）进行分类/18。建议对细胞学结果为阴性或低级别的分诊女性进行 12 个月的 HPV 随访检测，如果他们在随访中检测出任何高危 HPV 类型呈阳性，则转诊。主要结果测量 参加第一次 HPV 筛查、检测呈阳性并被转诊进行阴道镜检查的女性比例；以及检测出宫颈上皮内瘤变 (CIN) 2 级或更差、CIN 3 级或更差或癌症的短期风险。结果 到 2019 年底，在 6 428 677 名 25-69 岁的合格女性中，有 54.6% (n=3 507 281) 接受了首次 HPV 检测。在参加常规筛查的人群中，HPV16/18 和 HPV 类型呈阳性在 25-69 岁女性（n=3 045 844）中，非 16/18 的比例分别为 2.0% 和 6.6%，在 25-34 岁女性（n=768 362）的高度接种疫苗队列中分别为 2.2% 和 13.3%。阴道镜转诊（年龄 25-69 岁）为 3.5%，估计增加到 6。占尚未进行 12 个月重复测试的女性的 2%。基线时 0.98% (456/46 330) 的 HPV16/18 阳性女性检出宫颈癌，包括 0.32% (89/28 003) 的 HPV16/18 和细胞学阴性女性。HPV 类型不是 16/18 且在基线和 12 个月时细胞学阴性或低级别的女性患严重疾病的风险较低（3.4% CIN 3 级或更差；0.02% 癌症；n=20 019），但估计占此筛选算法的推荐率为 62.0%。结论 阴道镜转诊阈值需要考虑潜在的癌症风险；在此基础上，发现在第一轮 HPV 筛查中患有 HPV16/18 的女性无论细胞学结果如何都处于更高的风险中，即使是在之前筛查良好的人群中也是如此。HPV 类型不是 16/18 和阴性或低级别细胞学检查的女性表现出严重异常的风险较低，但构成大多数转诊，可以通过两轮重复 HPV 检测而不是一轮来安全管理。HPV16/18 驱动的转诊在 HPV 疫苗接种队列中较低。此分析仅提供了来自国家癌症筛查登记册的汇总数据。详细汇总数据表作为补充数据提供。