Original Title: Herpès génital - repérage, diagnostic, usage optimal des antiviraux et suivi

Authors' objectives: Herpes results from infection with the Herpes simplex virus (HSV) type 1 (HSV-1) or type 2 (HSV-2), which can present in different ways (e.g. herpes labialis, genital or ocular involvement). According to the World Health Organization (WHO), an estimated 67% of the population (3.7 billion people under the age of 50) is infected with HSV-1, and 11% of the population (491 million people aged 15-49) is infected with HSV-2. Although the virus can remain inactive for years following initial infection, its episodic reactivation can cause clinical recurrences characterized by ulcerative lesions and intermittent subclinical viral shedding. Considering the absence of a reliable screening test in the asymptomatic population, and the sometimes-significant psychosexual repercussions of a diagnosis of genital herpes, the INESSS deemed appropriate to conduct work, following its usual scientific process, in order to update the recommendations as well as the clinical information contained in its optimal use guide on genital herpes treatments.

Authors' results and conclusions: RESULTS (#1 PROVIDE INFORMATION ON THE LIMITATIONS OF TYPE-SPECIFIC SEROLOGY TO ENCOURAGE ITS CLINICALLY RELEVANT USE): Genital herpes cannot be detected but is rather diagnosed at the time of a symptomatic episode. Since the specificity of serology is low, and the rate of false-positive results is high, this test is of little use in screening for genital herpes in asymptomatic individuals in the absence of a confirmatory test. The use of type-specific serology (HSV-1 and HSV-2) could nevertheless be clinically relevant in helping to establish or exclude the diagnosis of genital herpes when virologic testing cannot be performed or gives a negative result, in the presence of recurrent symptoms, atypical lesions or lesions in the process of healing. It can also be useful for verifying the serological status of infected people's regular partners, supporting diagnosis and guiding counseling in relation to the risk of transmission (in the presence of serodifference). (#2 OPTIMIZING DIAGNOSIS TO REDUCE PSYCHOSEXUAL IMPACT AND NEONATAL TRANSMISSION):During pregnancy, the identification of a primary infection is important because of the increased risk of vertical transmission. Given that a primary infection cannot be distinguished from a recurrence solely on the basis of symptoms and signs, the diagnosis of a primary infection during pregnancy is based on the combination of a viral detection test and a negative serology result or clinical evidence of seroconversion. (#3 CHOOSING AN ANTIVIRAL TREATMENT THAT PROMOTES COMPLIANCE): Valacyclovir, acyclovir and famciclovir are three antivirals that act on viral replication and can be administered to treat different types of herpetic episodes (initial episode, recurrence). In Quebec, valacyclovir has long been the preferred treatment option, mainly because it is administered less frequently than other antivirals. In recent years, however, new dosage regimens favoring better adherence (reduced frequency of administration or low number of tablets) have been studied in different settings and populations. Based on the latest scientific evidence, new dosing options have been identified, notably for episodic treatment of recurrences. (#4 CHOOSING AN ANTIVIRAL TREATMENT THAT PROMOTES COMPLIANCE): Valacyclovir, acyclovir and famciclovir are three antivirals that act on viral replication and can be administered to treat different types of herpetic episodes (initial episode, recurrence). In Quebec, valacyclovir has long been the preferred treatment option, mainly because it is administered less frequently than other antivirals. In recent years, however, new dosage regimens favoring better adherence (reduced frequency of administration or low number of tablets) have been studied in different settings and populations. Based on the latest scientific evidence, new dosing options have been identified, notably for episodic treatment of recurrences. (#5 SUPPORTING FRONT-LINE CARE FOR PEOPLE LIVING WITH HIV AND PREGNANT PEOPLE): In studies of people living with HIV, the proportion of participants whose immune systems are compromised or who take antiretroviral therapy varies, and the antiviral doses studied to treat genital herpes are generally higher. Nevertheless, infectious diseases specialists generally prescribe the same treatment as for the general population if the immune function of the person living with HIV is controlled. However, higher doses are prescribed if immune function is compromised. (#6 REDUCING THE RISK OF NEONATAL INFECTION THROUGH SCREENING DURING PREGNANCY AND AT THE TIME OF DELIVERY): Because of the seriousness of neonatal infection, it's important to ask pregnant people and their partners about the symptoms of genital herpes, and to discuss the associated risks if either partner is infected. (#7 COUNSELING THAT GOES BEYOND SIMPLE FOLLOW-UP): Following a new diagnosis of genital herpes, post-test counseling is used to assess the patient's condition and response to treatment. Subsequently, for people with genital herpes, annual follow-up is used to re-assess the relevance of continuing suppressive therapy, or to assess the effectiveness of episodic recurrence management. (#8 ORGANIZATIONAL ISSUES RAISED DURING THE WORK): A number of organizational issues were identified during the consultations, including confirmation of the diagnosis of genital herpes, and the follow-up required to ensure adequate care for those affected. In order to confirm the genital herpes diagnosis, it is essential to take a sample from active lesions. However, it is sometimes difficult for those potentially affected to access the necessary resources at the right time. In addition, genital HSV infection requires some follow-up visits, which are important for assessing the chronicity of the disease. CONCLUSION : This optimal use guide on sexually transmitted infections is a complementary tool to those developed by the INESSS, the Ministère de la Santé et des Services sociaux and the Institut national de santé publique du Québec. The enhancement and harmonization of practice will, however, depend on: • dissemination of the optimal use guide resulting from the work; • adherence to the changes and adoption of the recommendations by the healthcare professionals involved; • promotion of the tool by public health departments within the network.

Authors' methods: The evaluation questions were formulated to cover the population, clinical and organizational dimensions of the INESSS’s Statement of Principles and Ethical Foundations. In collaboration with a scientific information consultant (librarian), a systematic search of scientific literature published between January 2018 and July 2023 was conducted in more than three bibliographic databases. A manual search of grey literature was also conducted in summer 2023, consulting, among others, the websites of learned societies specializing in infectious diseases, health technology assessment agencies and other organizations that have issued recommendations on genital herpes. The official drug monographs of Health Canada, U.S. and European regulatory agencies were also consulted. A targeted information review of this literature was conducted until June 2024. The bibliographic databases were searched again in December 2023, targeting randomized clinical trials investigating the efficacy of different antiviral regimens for the treatment of both an initial episode of genital herpes or a recurrence. For the systematic review of clinical practice guidelines as well as for the review of the efficacy of different antiviral regimens, document selection, information extraction and methodological quality assessment were conducted independently by two scientific professionals. The GRADE tool was used to assess the scientific evidence on various efficacy parameters of the antiviral dosage regimens.

Authors' identified further research: The relevance of updating the recommendations in this guide will be assessed four years from the date of publication of this work, based on the progress of scientific data, changes in clinical practices, the listing of new drugs or the needs of the health and social services network.

Project Status: Completed

Year Published: 2024

URL for published report: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Outils/Guides_ITSS/INESSS_Herpes_genital_GN.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)