Projets achevés

PrEP-CI ANRS 12361 Étude de faisabilité en vue d’un essai clinique sur une prophylaxie préexposition (PrEP) orale à la demande chez des femmes exposées au VIH en Côte d’Ivoire

Responsables scientifiques

Partenariat

Membres du CEPED participant au projet

Financement

  • Bill & Melinda Gates Foundation
  • ANRS

Résumé

Depuis septembre 2015, l’OMS recommande la prophylaxie pre-exposition (PrEP) aux « individus exposés à un risque substantiel de contracter le VIH », en l’incluant dans les « approches combinées de prévention du VIH » (recommandation forte, données probantes de haute qualité).

Malgré des données probantes de haute qualité émanant des essais PrEP récents, l’étude de la meilleure manière de délivrer la PrEP dans la « vraie vie » parmi différentes populations dans des contextes différents demeure cruciale. La PrEP peut être utilisée de manière quotidienne (« continue ») ou occasionnelle (« à la demande »). L’essai ANRS Ipergay a démontré que la PrEP à la demande (deux cachets d’une combinaison d’Emtricitabine (FTC) et de Tenofovir (TDF) deux heures avant un rapport sexuel à risque, puis un cachet le lendemain et le surlendemain) était hautement efficace parmi les homosexuels masculins européens et canadiens. Cependant, la PrEP à la demande n’a pas encore été étudiée chez les femmes à risque substantiel de contracter le VIH, alors que cette approche pourrait améliorer l’observance. La production de données concernant l’efficacité de la PrEP à la demande chez les femmes à risque est nécessaire et urgente, car ces femmes sont vraisemblablement l’une des cibles les plus importantes de la PrEP en Afrique subsaharienne.

Parmi les lacunes de la recherche pointées par l’OMS dans ses directives de 2015 figure le besoin en recherches opérationnelles menées dans différents contextes. Dans ce projet nous proposons d’étudier certaines de ces lacunes et d’examiner la problématique de la PrEP “à la demande” parmi les femmes professionnelles du sexe (PS) qui sont à risque en Côte d’Ivoire, pays dans lequel prévalence et incidence du VIH sont relativement contenues en population générale et beaucoup plus élevées parmi les populations clés.

Mots-Clés

Travailleuse du sexe, PrEP, prévention, santé sexuelle, VIH.

Zone géographique

Côte d’Ivoire

Calendrier

  • 2016-2017

Note de politique

Publications

2018



  • Larmarange Joseph, Becquet Valentine, Masumbuko Jean-Marie, Nouaman Marcellin, Plazy Mélanie, Danel Christine et Eholié Serge (2018) « Implementing preexposure prophylaxis among key populations: an opportunity for patient-centered services and management of hepatitis B », AIDS, 32 (6) (mars 27), p. 829. DOI : 10.1097/qad.0000000000001749. https://journals.lww.com/aidsonline/Fulltext/2018/03270/Implementing_preexposure_prophylaxis_among_key.17.aspx.
    Résumé : When taken properly, Tenofovir-based oral preexposure prophylaxis (PrEP) has been proven to be efficient to prevent HIV acquisition. Since 2015, PrEP is recommended by the WHO for populations at ‘substantial risk’ of HIV. However, WHO points out the need for additional research on PrEP in ‘real life’ on questions such as demand creation for oral PrEP; best delivery models in different contexts and for different populations; social and behavioral impact of PrEP; or integration of PrEP services with other services. Transitioning from efficacy trials to implementation requires to adapt interventions. Preliminary research (ANRS 12361 PrEP-CI) has been conducted in Côte d’Ivoire (CI) in collaboration with community non-governmental organizations to explore relevance and feasibility of implementing a PrEP program among female sex workers, one of the most exposed populations countrywide (estimated HIV prevalence: 29%). The following observations emerged from that collective work. All efficacy PrEP trials provided a range of sexual healthcare services in addition to PrEP drugs. Such services appeared essential for any PrEP program. By design, they were conditional to PrEP use. However, regardless of their interest in using PrEP, female sex workers interviewed in Côte d’Ivoire, and more broadly key populations worldwide, have many unmet sexual and reproductive health needs: sexually transmitted infections screening and care, contraception and birth control, menstrual management, addictions and risky behaviors… When transitioning to real life, we should not reproduce the service model of efficacy PrEP trials, that is a PrEP program with additional services. Instead, a paradigm shift toward a patient-centered approach should be preferred, that is offering sexual and reproductive health services in which PrEP is an option but not mandatory. In Western and Central Africa, the prevalence of hepatitis B is relatively high. In Cote d’Ivoire, more than 11% of new blood donors were positive for hepatitis B surface antigen in 2008–2012. Tenofovir is also used for hepatitis B treatment. But, currently, treatment is not free for monoinfected hepatitis B patients, whereas it is covered by AIDS programs for HIV-hepatitis B coinfected patients. In such context, it would be ethically unacceptable to provide free HIV PrEP without taking into account patients in needs of hepatitis B treatment. Actually, for those patients, offering Tenofovir-based HIV PrEP constitutes an opportunity to simultaneously treat their hepatitis B. It requires to integrate WHO recommendations on hepatitis B within PrEP guidelines, possibly to simplify hepatitis B care algorithms and to allow hepatitis B care in decentralized sexual health clinics and not only in hospital services. Most efficacy PrEP trials excluded hepatitis B patients. Additional clinical research exploring interactions between HIV PrEP and hepatitis B treatment, in particular the risk of flare if PrEP is stopped, is required. PrEP programs could be built on the existing community services for HIV care and treatment. Providing services for HIV positives and HIV negatives within the same clinics could be a way of minimizing the stigma associated with entry and retention into HIV care. In addition, HIV patients have unmet sexual and reproductive health needs as well. Integrating services together and transforming HIV clinics into sexual health clinics could lead to many health outcomes improvements and also to possible cost sharing and savings. So far, the focus of HIV programs has mainly been on reaching individuals never tested for HIV, identifying new positives and linking them to HIV care and treatment. Transitioning PrEP from trials to implementation constitutes an opportunity for developing people-centered approaches integrating all sexual and reproductive health services together, including hepatitis B. It is crucial to avoid a silo-based perspective in which services are separated from each other. Moving from HIV care clinics to sexual health clinics would allow to globally improve the health of key populations and their partners, beyond HIV outcomes alone. To ensure the success of new prevention programs, we have to take the next step forward. Beyond biomedical innovations, innovations in terms of intervention implementation, delivery models and public health policies are urgently required, in particular in Western and Central Africa. Scaling-up PrEP is a key moment. We should not miss out on this opportunity.
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