Authors' objectives:

To assess the potential benefit of HPV testing in primary screening of precancerous and cancerous lesions of the cervix.

Authors' results and conclusions: Prevalence and history of cervical cancer: It is the 8th most common cancer in women in France. In 2000, the incidence was 3400 women, with 1000 deaths a year. A relationship has been established between HPV infection and cervical cancer. High-risk HPVs have been identified (types 16 and 18 classified as carcinogens). Risk factors: HPV is a sexually transmissible infection. Prevalence decreases after age 30-35. Age is therefore a variable that can be used to select a population for screening. Persistent infection with high-risk HPV is a major risk factor for progression to cancer. Disease management: When abnormalities are detected in a cervical smear (CS), a diagnostic and management strategy is implemented. There is no treatment for HPV infection. HPV tests: Tests using molecular hybridization (Hybrid Capture 2 (HC2)) or gene amplification (PCR) are available. The HC2 test is simple to use. The design quality of the 11 studies selected in our review was not high (2 cross-sectional studies, only 1 of which was randomised, and 2 cohort studies). The results, however, suggest that the HPV tests are more sensitive and less specific than CS. Implementation of HPV testing: No studies support using the HPV test instead of CS as a first-line test. The high negative predictive value (99-100%) of the combination 'HPV test + CS' could lead to spacing tests out, but the performance of tests repeated at different intervals has not been assessed. Test timing, intervals, and the level of population coverage have to be taken into account in the assessment of the efficacy of a screening programme. The psychological impact of HPV testing has not been assessed. Only the FDA has approved 'HC2 + CS' for primary screening; the algorithms for management are based on expert opinion. Three randomised trials and three cohort studies are in progress.

Authors' recommendations: HPV testing instead of a CS is not justified. The medical and economic benefit of 'HPV test + CS' has to be reassessed after the results of ongoing studies are available and after a cost-efficacy model has been constructed. HPV testing should be compared with a strategy for optimising the level of cover obtained with CS.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.has-sante.fr/

Year Published: 2004

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: L'Agence Nationale d'Accreditation d'Evaluation en Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: sh.leerobin@has-sante.fr

Contact Email: sh.leerobin@has-sante.fr

Copyright: L'Agence Nationale d'Accreditation d'Evaluation en Sante (ANAES)