title: Will dapivirine redeem the promises of anti-HIV microbicides? Overview of product design and clinical testing.
abstract: Microbicides are being developed in order to prevent sexual transmission of HIV. Dapivirine, a non-nucleoside reverse transcriptase inhibitor, is one of the leading drug candidates in the field, currently being tested in various dosage forms, namely vaginal rings, gels, and films. In particular, a ring allowing sustained drug release for 1month is in an advanced stage of clinical testing. Two parallel phase III clinical trials are underway in sub-Saharan Africa and results are expected to be released in early 2016. This article overviews the development of dapivirine and its multiple products as potential microbicides, with particular emphasis being placed on clinical evaluation. Also, critical aspects regarding regulatory approval, manufacturing, distribution, and access are discussed.
authors.affiliation: i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Porto, Portugal; INEB - Instituto de Engenharia Biomédica, Universidade do Porto, Porto, Portugal; CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde & Instituto Universitário de Ciências da Saúde, Gandra, Portugal. Electronic address: j.dasneves@ineb.up.pt.
authors.forename: José
authors.initials: J
authors.lastname: das Neves
authors.affiliation: i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Porto, Portugal; INEB - Instituto de Engenharia Biomédica, Universidade do Porto, Porto, Portugal.
authors.forename: João Pedro
authors.initials: JP
authors.lastname: Martins
authors.affiliation: i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Porto, Portugal; INEB - Instituto de Engenharia Biomédica, Universidade do Porto, Porto, Portugal; CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde & Instituto Universitário de Ciências da Saúde, Gandra, Portugal.
authors.forename: Bruno
authors.initials: B
authors.lastname: Sarmento
mesh_terms: D019380:Anti-HIV Agents; D003274:Contraceptive Devices, Female; D015195:Drug Design; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D011743:Pyrimidines / Q000737:chemistry / Q000494:pharmacology
chemical_list: D019380:Anti-HIV Agents; D011743:Pyrimidines; C481671:Dapivirine
keywords: ASPIRE; Dapivirine (PubChem CID: 214347); Darunavir (PubChem CID: 213039); Maraviroc (PubChem CID: 3002977); Pre-exposure prophylaxis; Tenofovir (PubChem CID: 464205); The Ring Study; Vaginal film; Vaginal gel; Vaginal ring