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• W2186097727 abstract "Future VirologyVol. 10, No. 11 CommentaryOpen AccessNot just HIV: preventing other viral sexually transmitted infectionsJosé A Fernández RomeroJosé A Fernández Romero*Author for correspondence: E-mail Address: jromero@popcouncil.org Population Council, Center for Biomedical Research, 1230 York Avenue, New York, NY 10065, USASearch for more papers by this authorPublished Online:26 Nov 2015https://doi.org/10.2217/fvl.15.82AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinkedInRedditEmail Keywords: herpes simplex virusHIVhuman papillomavirusmultipurpose prevention technologiessexually transmitted infectionsIt is estimated that more than one million people acquire an STI every day. Each STI on its own represents a significant public health burden, but interactions between STIs can further increase their detrimental effect on human health. The classic example is the increased risk of HIV acquisition in the presence of a prevalent STI like herpes simplex virus and human papillomavirus. STIs may facilitate HIV acquisition by recruiting HIV target cells, disrupting mucosal barriers and/or mediating mucosal responses. Targeting these STIs through multipurpose prevention technologies can support indirect efforts to control the HIV epidemic.Multipurpose prevention technologies (MPTs) are single products designed to address multiple reproductive health needs. These products may be used for the simultaneous prevention of different combinations of HIV, different STIs and/or unintended pregnancy, depending on the product. MPTs can deliver a single broad-spectrum active pharmaceutical ingredient (API) or a combination of different APIs through different formulations/devices.The term STI can be applied to curable infections such as trichomoniasis, gonococcal, chlamydial or syphilis infection, as well as to a broad range of incurable infections such as HIV, HPV and HSV. Once established, these persistent infections reside in the host for life. This commentary focuses on the prevention of noncurable, viral STIs.Why target HPV & HSV in MPTs?HPV and HSV constitute two of the most prevalent STIs worldwide. Most of these infections occur in less developed countries. Because many people are not aware of their HPV or HSV status, reported cases of HPV and HSV infection will always underestimate the global burden.HPV is the most common STI worldwide. Approximately 291 million women have an HPV infection at any given time, and a similar number of men are also believed to be HPV-infected [1]. HIV-positive women coinfected with HPV and developing dysplasia can progress to cervical cancer faster than HIV-negative women. Anal cancer, which affects both men and women, is also highly associated to HPV infection. Lower genital tract HPV infection in women increases the risk of anal HPV infection [2]. HIV-positive men practicing receptive anal intercourse are at higher risk for developing anal cancer. HIV-negative men with the same sexual practice history also have an increased risk compared with the general population, but not as high as that of HIV-positive men [3].Approximately 417 million people are affected by genital HSV-2 globally [4]. Although HSV-2 predominates around the world, genital HSV-1 prevalence is on the rise, especially in developed countries. Both viruses can also cause lesions in the anus or perianus. Most people infected with herpes are asymptomatic during both infection and reactivation episodes and the disease can cause considerable morbidity and mortality.Both HPV and HSV have been linked to an increased susceptibility to HIV infection [5,6]. The increased susceptibility could be as high as threefold in the case of HSV and twofold for HPV. In the case of HSV-2, increased susceptibility to HIV infection could be due to mucosal responses that the immune system produces to protect against the virus spread, but that actually serve to facilitate HIV infection. Some animal studies suggest that HSV-2 infection may increase the expression of HIV receptor on the surface of HIV susceptible cells [7]. It has been also proposed that persistence of HIV target cells after HSV reactivation may increase susceptibility to HIV acquisition [8]. The mechanism for increased susceptibility to HIV infection in the presence of HPV infection is not clear. This increased risk to HIV acquisition is similar or higher than the potential risk attributed to the DMPA injectable contraceptive [9].Why develop other HPV prevention approaches if we already have vaccines with excellent efficacy?While no vaccine is available to prevent HSV infection there are currently three highly effective vaccines against HPV: the bivalent vaccine targeting HPV 16 and 18, the quadrivalent vaccine targeting HPV 6, 11, 16 and 18 and the recently approved nonavalent (Gardasil 9) vaccine to protect against HPV 6, 11, 16, 18, 31, 33, 45, 52, 58. These vaccines target the most prevalent anogenital HPV types with the nonavalent vaccine including seven high-risk HPV types. While these vaccines are valuable tools in the effort to curb the global HPV epidemic, additional strategies are called for. There are more than 100 different HPV types of which more than 30 are linked to anogenital infections and 13 are the high-risk HPV types responsible for most HPV-caused cancers. We cannot discard the possibility that after controlling the most prevalent types included in these vaccines, the incidence of those that are not targeted could increase and begin a new epidemic. Although still in discovery phase, ongoing research is looking at prophylactic L2 vaccines with the potential to provide protection against a broader array of HPV types. Similarly, microbicide candidates such as carrageenan have the potential to target a broader array of HPV types.Another issue of concern with the current HPV vaccines is their high cost. GAVI Alliance has taken an important step to introduce the quadrivalent HPV vaccine in low-income countries by negotiating a considerably lower price of less than US$5 per dose and US$15 for the three-dose regimen, but more work is needed to guarantee global access, especially in middle-income countries. Cost is not the only barrier to access, however. While HPV vaccine coverage is relatively high in countries such as the UK, Canada and Australia, there is still a persistent gap in coverage in countries such as the USA, where parental control and lack of government-mandated vaccination programs are major issues.Current status of MPTs targeting HIV, HSV and/or HPVOne very familiar MPT has been available for hundreds of years – condoms. Male and female condoms are excellent tools to prevent many STIs, as long as they are used correctly and consistently. The challenge is that condoms are not accepted among many people at risk. Increased condom accessibility and use could have a positive impact on STI and unintended pregnancy prevention, but other options and choices are still needed to improve sexual and reproductive health outcomes. One such option in development is the use of MPTs for vaginal and/or rectal delivery to target multiple STIs [10].Tenofovir (TFV) and tenofovir disoproxil fumarate alone or combined with other APIs have been formulated in gels, tablets and/or intravaginal rings and may provide protection against both HIV and HSV. The Caprisa-004 trial showed for the first time activity of a 1% TFV gel against HSV-2 (reducing HSV-2 acquisition by 51%) while also reducing HIV acquisition by 39% [11]. The results against HSV-2 were surprising since in vitro and in vivo preclinical evaluation did not predict this activity. The same gel was recently tested in the Phase III trial FACTS 001, where low adherence to gel product in the overall study population contributed to the lack of significant effectiveness against HIV compared with placebo. A reduced glycerin version of the 1% TFV gel is now being tested as a potential rectal microbicide in a Phase II trial (MTN–017).MIV–150, carrageenan and zinc acetate have been formulated in a gel (MZC) to provide antiviral protection against HIV, HPV and HSV. The MZC formulation has passed an extensive preclinical evaluation [12] for safety and efficacy. The first-in-human trial showed that the gel was well tolerated after vaginal daily application for 14 days. MZC is also a dual compartment gel, meaning that it is suitable for both vaginal and rectal application. Extensive preclinical evaluation in cell-based assays and animal models have identified carrageenan as the most potent HPV inhibitor discovered to date [12–16]. Combining carrageenan with zinc acetate results in antiviral synergy against HSV [17]. Additionally, HPV prevalence was lower in highly compliant users of a carrageenan-based formulation during the Carraguard Phase III clinical trial (an HIV prevention study) [18]. Ongoing Phase IIb trials at Albert Einstein College of Medicine of Yeshiva University and McGill University are further exploring the effectiveness of a carrageenan-based formulation to prevent HPV acquisition. A combination prevention approach that includes vaccines, cancer screening and formulations/devices with the potential to block HPV acquisition will be a more effective pathway than vaccines alone to control HPV infections/disease globally.Griffithsin (GRFT), a 25.4 kD lectin (mannose binding protein) with broad-spectrum antiviral activity, is described in the literature as one of the most potent anti-HIV agents ever discovered [19]. In addition to its highly potent anti-HIV activity, GRFT also shows activity against HSV-2 [20] and HCV [21]. The University of Louisville is developing a GRFT-based rectal microbicide. The Population Council is developing a GRFT-based vaginal microbicide that could also contain carrageenan, which would add potent anti-HPV activity to the formulation. Other MPT candidates targeting several STIs, and still in preclinical stage, include poly-[1,4-phenylene-(1-carboxy) methylene] gel targeting HIV, HSV, HPV, chlamydia and gonorrhea as well as Mapp66, where monoclonal antibodies formulated in a film or intravaginal rings will target HIV and HSV.The HIV prevention field is moving toward combination prevention approaches that include behavior change, condom use, male circumcision, treatment for HIV infected people and pre-exposure prophylaxis for high-risk HIV negative individuals. The shifting prevention paradigm is based on the understanding that effective interventions can vary by risk profile and that providing choices in prevention is key to achieving a better effect at the population level. MPTs targeting the STIs that increase the risk of HIV acquisition will provide important, cost-effective and user-friendly new approaches to reducing the global burden of HIV and other STIs, and will become important new tools in combination prevention.Open AccessThis work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/AcknowledgementsThe author would like to thank Mark Aurigemma, Thomas Zydowsky, Lauren Katzen and Erin Kiernon for their insightful review and comments.Financial & competing interests disclosureThe author has a pending patent on griffithsin and carrageenan combination. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.References1 De Sanjose S, Diaz M, Castellsague X et al. Worldwide prevalence and genotype distribution of cervical human papillomavirus DNA in women with normal cytology: a meta-analysis. Lancet Infect. Dis. 7(7), 453–459 (2007).Crossref, Medline, Google Scholar2 Stier EA, Sebring MC, Mendez AE, Ba FS, Trimble DD, Chiao EY. Prevalence of anal human papillomavirus infection and anal HPV-related disorders in women: a systematic review. Am. J. Obstet. Gynecol. 213(3), 278–309 (2015).Crossref, Medline, Google Scholar3 Kreuter A, Wieland U. Human papillomavirus-associated diseases in HIV-infected men who have sex with men. Curr. Opin. Infect. 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Virol. 87(11), 6257–6269 (2013).Crossref, Medline, CAS, Google Scholar21 Takebe Y, Saucedo CJ, Lund G et al. Antiviral lectins from red and blue-green algae show potent in vitro and in vivo activity against hepatitis C virus. PLoS ONE 8(5), e64449 (2013).Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByTopical formulations to prevent sexually transmitted infections: are we on track?José A Fernández Romero, Maria Gabriela Paglini & Thomas M Zydowsky22 August 2019 | Future Virology, Vol. 14, No. 8 Vol. 10, No. 11 STAY CONNECTED Metrics History Published online 26 November 2015 Published in print November 2015 Information© José A Fernández RomeroKeywordsherpes simplex virusHIVhuman papillomavirusmultipurpose prevention technologiessexually transmitted infectionsOpen AccessThis work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/AcknowledgementsThe author would like to thank Mark Aurigemma, Thomas Zydowsky, Lauren Katzen and Erin Kiernon for their insightful review and comments.Financial & competing interests disclosureThe author has a pending patent on griffithsin and carrageenan combination. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download" @default.
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