ISSUES IN CURRENT RESEARCH
Multipurpose prevention technologies for reproductive and sexual health Alan Stone Medical Scientific Advisory Services Ltd, London, UK. Correspondence: [email protected]
Abstract: Global statistics on unplanned pregnancies, abortions and STIs show that unprotected sex is still widely practised. More needs to be done to provide women and men with a wider choice of convenient protective options. To address this need, international efforts are focusing on developing multipurpose prevention technologies (MPTs) that address two or more indications simultaneously. These technologies would have significant advantages over single-indication products. They include inter alia novel barrier devices, drugs administered either as oral tablets or vaginal/rectal gels, drugs used in combination with medical devices, and genetically engineered organisms which secrete antimicrobial substances. As an example of progress in the MPT field, this paper describes an on-demand contraceptive/antimicrobial vaginal gel, Amphora (previously known as Acidform), now in an advanced stage of development. Clinical trials are currently being planned to find out whether this product’s promising antimicrobial profile translates into protective and preventive choices. © 2014 Reproductive Health Matters Keywords: multipurpose prevention technologies, contraception, sexually transmitted infection prevention, spermicide, microbicide
Voluntary male circumcision, being rolled out in some countries, can be expected to make a
significant impact on some of these figures; clinical trials have shown that the procedure can reduce the risk that a man will acquire HIV from a positive female partner by up to 75%, and also reduces his risk of other STIs.4 Although there is no reliable evidence that male circumcision lessens women’s HIV risk, circumcised men are less likely to infect their female partners with certain other STIs.4 However, a great deal more needs to be done to provide people of all genders with appropriate protective choices, − if necessary without the active cooperation of their partners. Userfriendly products that address two or more indications simultaneously would have significant advantages. The advancement of such products is now the focus of CAMI Health, secretariat to the Initiative for Multipurpose Prevention Technologies (MPTs), an international collaboration of product developers, researchers, funders, health care providers and others.5 MPTs would offer greater convenience and cost efficiency than single-indication products, and users would be protected automatically against more than one indication even if they had obtained the product with respect to a single perceived risk. For example, a woman in a long-term relationship using an MPT for family planning purposes would
Contents online: www.rhm-elsevier.com
Doi: 10.1016/S0968-8080(14)44801-8
Until recently, the development of products to prevent unintended pregnancy and methods to protect against sexually transmitted infections (STIs) have proceeded largely independently of each other. The obvious exception, of course, is the condom which, if used consistently and correctly, provides an effective physical barrier to sperm and can protect both men and women from many STIs.1 Unfortunately, despite vigorous campaigns to promote condoms, they and other protective options are still not used anywhere near as widely as they might be. This is reflected in the global statistics: every year some 80 million women experience an unplanned pregnancy, 45 million of which end in an abortion; an estimated 500 million people acquire at least one of the four primary curable STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and syphilis); there are around 2 million new cases of HIV infection; and many millions are infected with the genital herpes virus, HSV-2.2,3
The rationale for multipurpose prevention technologies
213
A Stone. Reproductive Health Matters 2014;22(44):213–217
also be protected against STIs, the risk of which she may not recognise.
The diversity of MPTs The variety of MPTs being developed will widen protective and preventive choices. CAMI Health’s website provides an up-to-date listing of MPTs under development, their stages of development, and the organisations undertaking the work. 5 Some MPTs are based on single drugs or on drug-drug combinations. For example, the antiretroviral drug tenofovir, when used for pre-exposure prophylaxis (PrEP), reduces the risk of infection by both HIV and HSV-2 when administered as an oral tablet (oral PrEP), either on its own or combined, in Truvada tablets, with another antiretroviral, emtricitabine.6–8 There are also promising indications that tenofovir administered as a vaginal gel (topical PrEP) reduces womens’ risk of HIV and HSV-2, and confirmatory trials are underway.9,10 Some examples of other MPTs under development are intravaginal rings which continuously release a contraceptive hormone and an antiretroviral drug over several weeks or months, cervical barriers and female condoms designed to deliver contraceptive and antimicrobial products, male condoms coated with anti-infective gels, and suppositories that deliver live lactobacilli genetically engineered to secrete an antimicrobial agent.11–17 Given the great number of potential MPTs, the Initiative for Multipurpose Prevention Technologies has prioritised the following dosage forms as those that will best meet the needs of the most vulnerable women: on-demand MPTs, e.g. gels and physical barriers, intravaginal rings, and injectables. The rationale for MPT vaccines in the sexual and reproductive health arena is the same as for the MPTs discussed above, but at present there is a lack of activity to develop these, with work being focused on single-indication vaccines. Anti-STI vaccines are already in use against HPV and hepatitis B, and several others are in the investigational phase (against HIV, HSV-2, C. trachomatis and N. gonorrhoeae), while research on contraceptive vaccines is proceeding.18–22 It is not known how feasible it would be to combine some of these vaccines, although it is worth noting that in the childhood immunisation field there are vaccines which target as many as six pathogens. 214
Amphora: an example of progress A good example of progress in the MPT field is an on-demand contraceptive/antimicrobial vaginal gel, Amphora (previously known as Acidform), now in an advanced stage of development. It inactivates sperm by virtue of its mild acidity and is strongly buffered against the alkalinity of the incoming semen.23 A recently completed Phase 3 clinical trial involving over 3,300 women demonstrated that it is a safe and effective contraceptive, the six-month pregnancy rates for typical use being approximately 10%, as expected for a spermicidal contraceptive (Personal communication, M Rosenberg, CEO, Health Decisions Inc, Raleigh-Durham, NC, USA, 1 May 2014). Submission to the US Food and Drug Administration for marketing approval as a contraceptive is expected early in 2015. Amphora would offer the prospect of immediate, yet rapidly reversible, contraception. It does not contain surfactants or hormones and thus avoids their well-known side-effects, and circumvents the ongoing debate about hormones and a woman’s risk of HIV infection.24,25 The gel’s bioadhesivity and viscosity are designed to minimize leakage of protective product from the vagina and to reduce messiness to the user. Amphora’s activity against STI pathogens has yet to be demonstrated in clinical studies, although laboratory studies are very promising. The gel’s antimicrobial properties are partly due to its acidic pH but, significantly, one of its ingredients, L-lactic acid, unlike other acids at the same pH, is a potent microbicide, whether in the absence or in the presence of cervicovaginal secretions and seminal plasma.26,27 Amphora is active against several STI pathogens, in vitro and in the mouse model. These include HSV-2, the leading cause of genital ulcers and an important co-factor for HIV infection, and N. gonorrhoeae, which is especially significant given that multi-drug-resistant gonococcus strains are now spreading globally.28–31 Laboratory studies have also demonstrated that Amphora inhibits C. trachomatis (Personal communication, S Garg, Professor of Pharmaceutical Science, School of Pharmacy and Medical Sciences, University of South Australia, 30 September 2014) and the protozoal pathogen Trichomonas vaginalis, responsible for an estimated 160 million new infections annually.32,33 Amphora also shows activity against many of the organisms associated with bacterial vaginosis, including Gardnerella vaginalis.32,34 Importantly, it does not affect the beneficial lactobacilli which populate the healthy human vagina.34
A Stone. Reproductive Health Matters 2014;22(44):213–217
Clinical trials are currently being planned to find out whether at least some of these promising antimicrobial findings translate into anti-infective protection for women. Success would mean that as a contraceptive/antimicrobial MPT, Amphora would benefit not only women who use it as their primary method of contraception but also women using other forms of contraception, including hormonal contraceptives, IUDs and sterilisation. These are all popular methods, but they do not protect against genital infections. Work is also proceeding on a combination of Amphora with the antiretroviral drug tenofovir.
Endpiece How many of the diverse MPT products under development will eventually come to market
remains to be seen, but it is generally accepted that giving people a wider choice of affordable technologies increases overall uptake, and this is bound to benefit both individuals and the public health. Accessibility is also a crucial factor, and advocates are pressing for better integration of family planning and HIV/STI services.
Notes The author is a paid consultant to Evofem Incorporated, San Diego, CA, USA, and advises on the development of Amphora. Neither CAMI Health nor the Initiative for Multipurpose Prevention Technologies is a product developer or endorses any specific product.
References 1. Centers for Disease Control and Prevention. Condoms and STDs: Fact Sheet for Public Health Personnel. Updated July 2014. http://www.cdc.gov/ condomeffectiveness/latex.htm. 2. World Health Organization. Sexually transmitted infections (STIs). Fact sheet No.110. Updated November 2013. http://www.who.int/mediacentre/ factsheets/fs110/en/. 3. Holt BY, Kilbourne-Brook M, Stone A, et al. Multipurpose prevention technologies for sexual and reproductive health: gaining momentum and promise. Contraception 2010;81:177–80. Doi: 10.1016/ j.contraception.2009.11.009. 4. Centers for Disease Control and Prevention. Male circumcision. Updated April 2013. http://www.cdc.gov/ hiv/prevention/research/malecircumcision/. 5. www.cami-health.org/. 6. Celum C, Morrow R, Donnell D, et al. Daily oral tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis reduces Herpes Simplex Virus Type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial. Annals of Internal Medicine 2014;161:11–19. Doi: 10.7326/M13-2471. 7. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV-1 prevention among heterosexual men and women. New England Journal of Medicine 2012;367:399–410. Doi: 10.1056/NEJMoa1108524. 8. Grant RM, Lama JR, Anderson PL, et al. Pre-exposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine 2010;363:2587. Doi: 10.1056/NEJMoa1011205.
9. Karim Q, Karim S, Frohlich J, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010;329(5996):1168–74. Doi: 10.1126/science.1193748. 10. FACTS Consortium, 2014. http://www.facts-consortium. co.za/. 11. International Partnership for Microbicides. http://www. ipmglobal.org/publications/ipm-receives-award-usaidadvance-dual-purpose-prevention-ring. 12. Population Council. Developing ARV-based Microbicide and Microbicide/Contraceptive Vaginal Rings. http:// www.popcouncil.org/research/developing-arv-basedmicrobicide-and-microbicide-contraceptive-vaginal-ring. 13. CONRAD. CONRAD’s TFV LNG Intravaginal ring in the news. http://www.conrad.org/news-pressreleases-93.html. 14. PATH. A new kind of diaphragm. http://www.path.org/ projects/silcs.php. 15. PATH. A unique kind of condom: Woman’s Condom expands choices for protection. http://www.path.org/ projects/womans_condom.php. 16. Starpharma. VivaGel® condom receives TGA device certification - Launch preparations to follow. http://www. starpharma.com/news/201. 17. Osel. MucoCept: a Technology Platform. http://oselinc. com/site/research-development/mucocept/. 18. National Institutes of Health. HIV vaccine research. Updated July 2014. http://www.niaid.nih.gov/topics/ hivaids/research/vaccines/Pages/default.aspx. 19. National Institutes of Health. NIH launches trial of investigational genital herpes vaccine. Updated November 2013. http://www.nih.gov/news/health/ nov2013/niaid-08.htm.
215
A Stone. Reproductive Health Matters 2014;22(44):213–217 20. Igietseme JU, Eko FO, Black CM. Chlamydia vaccines: recent developments and the role of adjuvants in future formulations. Expert Reviews of Vaccines 2011;10:1585–96. Doi: 10.1586/erv.11.139. 21. Zhu W, Chen C-J, Thomas CE, et al. Vaccines for gonorrhoea: can we rise to the challenge? Frontiers in Microbiology 2011;2:124. Doi: 10.3389/fmicb.2011.00124. 22. Naz RK. Contraceptive vaccines: success, status, and future perspective. American Journal of Reproductive Immunology 2011;66:2–4. Doi: 10.1111/j.1600-0897. 2011.00999.x. 23. Garg S, Anderson RA, Chany CJ, et al. Properties of a new acid buffering bioadhesive vaginal formulation (Acidform). Contraception 2001;64:67–75. Doi: 10.1016/ s0010-7824(01)00217-724. 24. World Health Organization and Contraceptive Research and Development Program. Technical consultation on nonoxynol-9. Geneva: WHO, 2002. 25. World Health Organization. Sexual and reproductive health: Hormonal contraception and HIV. 2014. http://www.who. int/reproductivehealth/topics/family_planning/hc_hiv/en/. 26. Aldunate M, Tyssen D, Johnson A, et al. Vaginal concentrations of lactic acid potently inactivate HIV. Journal of Antimicrobial Chemotherapy 2013;68: 2015–25. Doi: 10.1093/jac/dkt156. 27. O’Hanlon DE, Moench TR, Cone RA. In vaginal fluid, bacteria associated with bacterial vaginosis can be suppressed with lactic acid but not hydrogen peroxide. BMC Infectious Diseases 2011;11:200. Doi: 10.1186/ 1471-2334-11-200. 28. Tuyama A, Cheshenko N, Carlucci M, et al. Amphora inactivates herpes simplex virus and prevents genital
Résumé Les statistiques mondiales sur les grossesses non désirées, les avortements et les IST montrent que les rapports sexuels non protégés sont très fréquents. Il faut faire davantage pour offrir aux femmes et aux hommes un choix élargi de bonnes options de protection. Pour répondre à ce besoin, les activités internationales privilégient l’élaboration de technologies de prévention polyvalentes qui correspondent simultanément à deux indications ou plus. Ces technologies auraient de nets avantages sur les produits à indication unique. Elles comprennent notamment les nouvelles méthodes barrières, les médicaments administrés comme pilules orales ou gels vaginaux/rectaux, les médicaments utilisés en association avec des dispositifs médicaux et des organismes issus du génie génétique qui sécrètent des substances antimicrobiennes. Pour illustrer les progrès dans ce 216
29.
30.
31.
32.
33.
34.
herpes in a mouse model: optimal candidate for microbicide combinations. Journal of Infectious Diseases 2006;194:795–803. Doi: 10.1086/506948. Spencer SE, Valentin-Bon IE, Whaley K, et al. Inhibition of Neisseria gonorrhoeae genital tract infection by leading candidate topical microbicides in a mouse model. Journal of Infectious Diseases 2004;189:410–19. Doi: 10.1086/381125. Tapsall JW, Ndowa F, Lewis DA, et al. Meeting the public health challenge of multidrug- and extensively drug-resistant Neisseria gonorrhoeae. Expert Review of Anti-infective Therapy 2009;7:821–34. Doi: 10.1586/ eri.09.63. Ndowa F, Lusti-Narasimhan M. The threat of untreatable gonorrhoea: implications and consequences for reproductive and sexual morbidity. Reproductive Health Matters 2012;20(40):76–82. Doi: 10.1016/S09688080(12)40653-X. Tevi-Bennison C, Citron D, Crowell A, et al. Acidform: an acid-buffering and bio-adhesive gel with activity against bacterial vaginosis and Trichomonas vaginalis in vitro. Abstract #MoPeD3659, XIV International AIDS Conference, Barcelona, 7–12 July 2002. Harp DF, Chowdhury I. Trichomoniasis: evaluation to execution. European Journal of Obstetrics and Gynecology and Reproductive Biology 2011;157:3–9. Doi: 10.1016/j.ejogrb.2011.02.024. Keller MJ, Carpenter CA, Lo Y, et al. Phase 1 randomized safety study of twice daily dosing of Acidform vaginal gel: candidate antimicrobial contraceptive. PLOS One 2012;7(10):e46901. Doi: 10.1371/journal.pone.0046901.
Resumen Las estadísticas mundiales sobre embarazos no planeados, abortos e ITS muestran que el sexo sin protección aún es practicado comúnmente. Falta mucho por hacer para ofrecer a mujeres y hombres una gama más amplia de opciones convenientes de protección. Para satisfacer esta necesidad, los esfuerzos internacionales se están enfocando en crear tecnologías de prevención con múltiples propósitos (MPT), que aborden dos o más indicaciones simultáneamente. Estas tecnologías tendrían significativas ventajas sobre productos con una sola indicación. Ejemplos son los métodos de barrera novedosos inter alia, medicamentos administrados ya sea como tabletas orales o jaleas vaginales/rectales, medicamentos utilizados en combinación con dispositivos médicos y organismos modificados genéticamente, que secretan sustancias antimicrobianas. Como
A Stone. Reproductive Health Matters 2014;22(44):213–217
ejemplo de los avances en el campo de MPT, este artículo describe una jalea vaginal anticonceptiva/ antimicrobiana en demanda, Amphora (anteriormente conocida como Acidform), ahora en una etapa avanzada de su desarrollo. Actualmente se están planificando ensayos clínicos para averiguar si el prometedor perfil antimicrobiano de este producto ofrece opciones de protección y prevención.
CAMI HEALTH
domaine, l’article décrit un gel vaginal contraceptif/ antimicrobien à la demande, Amphora (connu précédemment sous le nom d’Acidform) qui en est à un stade avancé de développement. Des essais cliniques sont actuellement prévus pour déterminer si le profil antimicrobien prometteur de ce produit se traduit en choix protecteurs et préventifs.
This Infographic shows the range of multi-purpose technologies being developed. While the graphic centres around a figure saying that women need better protection, which is absolutely true, in fact, everyone who has sex needs protection, and the development of these technologies is taking this into account too. 217
Multipurpose prevention technologies for reproductive and sexual health Alan Stone Medical Scientific Advisory Services Ltd, London, UK. Correspondence: [email protected]
Abstract: Global statistics on unplanned pregnancies, abortions and STIs show that unprotected sex is still widely practised. More needs to be done to provide women and men with a wider choice of convenient protective options. To address this need, international efforts are focusing on developing multipurpose prevention technologies (MPTs) that address two or more indications simultaneously. These technologies would have significant advantages over single-indication products. They include inter alia novel barrier devices, drugs administered either as oral tablets or vaginal/rectal gels, drugs used in combination with medical devices, and genetically engineered organisms which secrete antimicrobial substances. As an example of progress in the MPT field, this paper describes an on-demand contraceptive/antimicrobial vaginal gel, Amphora (previously known as Acidform), now in an advanced stage of development. Clinical trials are currently being planned to find out whether this product’s promising antimicrobial profile translates into protective and preventive choices. © 2014 Reproductive Health Matters Keywords: multipurpose prevention technologies, contraception, sexually transmitted infection prevention, spermicide, microbicide
Voluntary male circumcision, being rolled out in some countries, can be expected to make a
significant impact on some of these figures; clinical trials have shown that the procedure can reduce the risk that a man will acquire HIV from a positive female partner by up to 75%, and also reduces his risk of other STIs.4 Although there is no reliable evidence that male circumcision lessens women’s HIV risk, circumcised men are less likely to infect their female partners with certain other STIs.4 However, a great deal more needs to be done to provide people of all genders with appropriate protective choices, − if necessary without the active cooperation of their partners. Userfriendly products that address two or more indications simultaneously would have significant advantages. The advancement of such products is now the focus of CAMI Health, secretariat to the Initiative for Multipurpose Prevention Technologies (MPTs), an international collaboration of product developers, researchers, funders, health care providers and others.5 MPTs would offer greater convenience and cost efficiency than single-indication products, and users would be protected automatically against more than one indication even if they had obtained the product with respect to a single perceived risk. For example, a woman in a long-term relationship using an MPT for family planning purposes would
Contents online: www.rhm-elsevier.com
Doi: 10.1016/S0968-8080(14)44801-8
Until recently, the development of products to prevent unintended pregnancy and methods to protect against sexually transmitted infections (STIs) have proceeded largely independently of each other. The obvious exception, of course, is the condom which, if used consistently and correctly, provides an effective physical barrier to sperm and can protect both men and women from many STIs.1 Unfortunately, despite vigorous campaigns to promote condoms, they and other protective options are still not used anywhere near as widely as they might be. This is reflected in the global statistics: every year some 80 million women experience an unplanned pregnancy, 45 million of which end in an abortion; an estimated 500 million people acquire at least one of the four primary curable STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and syphilis); there are around 2 million new cases of HIV infection; and many millions are infected with the genital herpes virus, HSV-2.2,3
The rationale for multipurpose prevention technologies
213
A Stone. Reproductive Health Matters 2014;22(44):213–217
also be protected against STIs, the risk of which she may not recognise.
The diversity of MPTs The variety of MPTs being developed will widen protective and preventive choices. CAMI Health’s website provides an up-to-date listing of MPTs under development, their stages of development, and the organisations undertaking the work. 5 Some MPTs are based on single drugs or on drug-drug combinations. For example, the antiretroviral drug tenofovir, when used for pre-exposure prophylaxis (PrEP), reduces the risk of infection by both HIV and HSV-2 when administered as an oral tablet (oral PrEP), either on its own or combined, in Truvada tablets, with another antiretroviral, emtricitabine.6–8 There are also promising indications that tenofovir administered as a vaginal gel (topical PrEP) reduces womens’ risk of HIV and HSV-2, and confirmatory trials are underway.9,10 Some examples of other MPTs under development are intravaginal rings which continuously release a contraceptive hormone and an antiretroviral drug over several weeks or months, cervical barriers and female condoms designed to deliver contraceptive and antimicrobial products, male condoms coated with anti-infective gels, and suppositories that deliver live lactobacilli genetically engineered to secrete an antimicrobial agent.11–17 Given the great number of potential MPTs, the Initiative for Multipurpose Prevention Technologies has prioritised the following dosage forms as those that will best meet the needs of the most vulnerable women: on-demand MPTs, e.g. gels and physical barriers, intravaginal rings, and injectables. The rationale for MPT vaccines in the sexual and reproductive health arena is the same as for the MPTs discussed above, but at present there is a lack of activity to develop these, with work being focused on single-indication vaccines. Anti-STI vaccines are already in use against HPV and hepatitis B, and several others are in the investigational phase (against HIV, HSV-2, C. trachomatis and N. gonorrhoeae), while research on contraceptive vaccines is proceeding.18–22 It is not known how feasible it would be to combine some of these vaccines, although it is worth noting that in the childhood immunisation field there are vaccines which target as many as six pathogens. 214
Amphora: an example of progress A good example of progress in the MPT field is an on-demand contraceptive/antimicrobial vaginal gel, Amphora (previously known as Acidform), now in an advanced stage of development. It inactivates sperm by virtue of its mild acidity and is strongly buffered against the alkalinity of the incoming semen.23 A recently completed Phase 3 clinical trial involving over 3,300 women demonstrated that it is a safe and effective contraceptive, the six-month pregnancy rates for typical use being approximately 10%, as expected for a spermicidal contraceptive (Personal communication, M Rosenberg, CEO, Health Decisions Inc, Raleigh-Durham, NC, USA, 1 May 2014). Submission to the US Food and Drug Administration for marketing approval as a contraceptive is expected early in 2015. Amphora would offer the prospect of immediate, yet rapidly reversible, contraception. It does not contain surfactants or hormones and thus avoids their well-known side-effects, and circumvents the ongoing debate about hormones and a woman’s risk of HIV infection.24,25 The gel’s bioadhesivity and viscosity are designed to minimize leakage of protective product from the vagina and to reduce messiness to the user. Amphora’s activity against STI pathogens has yet to be demonstrated in clinical studies, although laboratory studies are very promising. The gel’s antimicrobial properties are partly due to its acidic pH but, significantly, one of its ingredients, L-lactic acid, unlike other acids at the same pH, is a potent microbicide, whether in the absence or in the presence of cervicovaginal secretions and seminal plasma.26,27 Amphora is active against several STI pathogens, in vitro and in the mouse model. These include HSV-2, the leading cause of genital ulcers and an important co-factor for HIV infection, and N. gonorrhoeae, which is especially significant given that multi-drug-resistant gonococcus strains are now spreading globally.28–31 Laboratory studies have also demonstrated that Amphora inhibits C. trachomatis (Personal communication, S Garg, Professor of Pharmaceutical Science, School of Pharmacy and Medical Sciences, University of South Australia, 30 September 2014) and the protozoal pathogen Trichomonas vaginalis, responsible for an estimated 160 million new infections annually.32,33 Amphora also shows activity against many of the organisms associated with bacterial vaginosis, including Gardnerella vaginalis.32,34 Importantly, it does not affect the beneficial lactobacilli which populate the healthy human vagina.34
A Stone. Reproductive Health Matters 2014;22(44):213–217
Clinical trials are currently being planned to find out whether at least some of these promising antimicrobial findings translate into anti-infective protection for women. Success would mean that as a contraceptive/antimicrobial MPT, Amphora would benefit not only women who use it as their primary method of contraception but also women using other forms of contraception, including hormonal contraceptives, IUDs and sterilisation. These are all popular methods, but they do not protect against genital infections. Work is also proceeding on a combination of Amphora with the antiretroviral drug tenofovir.
Endpiece How many of the diverse MPT products under development will eventually come to market
remains to be seen, but it is generally accepted that giving people a wider choice of affordable technologies increases overall uptake, and this is bound to benefit both individuals and the public health. Accessibility is also a crucial factor, and advocates are pressing for better integration of family planning and HIV/STI services.
Notes The author is a paid consultant to Evofem Incorporated, San Diego, CA, USA, and advises on the development of Amphora. Neither CAMI Health nor the Initiative for Multipurpose Prevention Technologies is a product developer or endorses any specific product.
References 1. Centers for Disease Control and Prevention. Condoms and STDs: Fact Sheet for Public Health Personnel. Updated July 2014. http://www.cdc.gov/ condomeffectiveness/latex.htm. 2. World Health Organization. Sexually transmitted infections (STIs). Fact sheet No.110. Updated November 2013. http://www.who.int/mediacentre/ factsheets/fs110/en/. 3. Holt BY, Kilbourne-Brook M, Stone A, et al. Multipurpose prevention technologies for sexual and reproductive health: gaining momentum and promise. Contraception 2010;81:177–80. Doi: 10.1016/ j.contraception.2009.11.009. 4. Centers for Disease Control and Prevention. Male circumcision. Updated April 2013. http://www.cdc.gov/ hiv/prevention/research/malecircumcision/. 5. www.cami-health.org/. 6. Celum C, Morrow R, Donnell D, et al. Daily oral tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis reduces Herpes Simplex Virus Type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial. Annals of Internal Medicine 2014;161:11–19. Doi: 10.7326/M13-2471. 7. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV-1 prevention among heterosexual men and women. New England Journal of Medicine 2012;367:399–410. Doi: 10.1056/NEJMoa1108524. 8. Grant RM, Lama JR, Anderson PL, et al. Pre-exposure chemoprophylaxis for HIV prevention in men who have sex with men. New England Journal of Medicine 2010;363:2587. Doi: 10.1056/NEJMoa1011205.
9. Karim Q, Karim S, Frohlich J, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010;329(5996):1168–74. Doi: 10.1126/science.1193748. 10. FACTS Consortium, 2014. http://www.facts-consortium. co.za/. 11. International Partnership for Microbicides. http://www. ipmglobal.org/publications/ipm-receives-award-usaidadvance-dual-purpose-prevention-ring. 12. Population Council. Developing ARV-based Microbicide and Microbicide/Contraceptive Vaginal Rings. http:// www.popcouncil.org/research/developing-arv-basedmicrobicide-and-microbicide-contraceptive-vaginal-ring. 13. CONRAD. CONRAD’s TFV LNG Intravaginal ring in the news. http://www.conrad.org/news-pressreleases-93.html. 14. PATH. A new kind of diaphragm. http://www.path.org/ projects/silcs.php. 15. PATH. A unique kind of condom: Woman’s Condom expands choices for protection. http://www.path.org/ projects/womans_condom.php. 16. Starpharma. VivaGel® condom receives TGA device certification - Launch preparations to follow. http://www. starpharma.com/news/201. 17. Osel. MucoCept: a Technology Platform. http://oselinc. com/site/research-development/mucocept/. 18. National Institutes of Health. HIV vaccine research. Updated July 2014. http://www.niaid.nih.gov/topics/ hivaids/research/vaccines/Pages/default.aspx. 19. National Institutes of Health. NIH launches trial of investigational genital herpes vaccine. Updated November 2013. http://www.nih.gov/news/health/ nov2013/niaid-08.htm.
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Résumé Les statistiques mondiales sur les grossesses non désirées, les avortements et les IST montrent que les rapports sexuels non protégés sont très fréquents. Il faut faire davantage pour offrir aux femmes et aux hommes un choix élargi de bonnes options de protection. Pour répondre à ce besoin, les activités internationales privilégient l’élaboration de technologies de prévention polyvalentes qui correspondent simultanément à deux indications ou plus. Ces technologies auraient de nets avantages sur les produits à indication unique. Elles comprennent notamment les nouvelles méthodes barrières, les médicaments administrés comme pilules orales ou gels vaginaux/rectaux, les médicaments utilisés en association avec des dispositifs médicaux et des organismes issus du génie génétique qui sécrètent des substances antimicrobiennes. Pour illustrer les progrès dans ce 216
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Resumen Las estadísticas mundiales sobre embarazos no planeados, abortos e ITS muestran que el sexo sin protección aún es practicado comúnmente. Falta mucho por hacer para ofrecer a mujeres y hombres una gama más amplia de opciones convenientes de protección. Para satisfacer esta necesidad, los esfuerzos internacionales se están enfocando en crear tecnologías de prevención con múltiples propósitos (MPT), que aborden dos o más indicaciones simultáneamente. Estas tecnologías tendrían significativas ventajas sobre productos con una sola indicación. Ejemplos son los métodos de barrera novedosos inter alia, medicamentos administrados ya sea como tabletas orales o jaleas vaginales/rectales, medicamentos utilizados en combinación con dispositivos médicos y organismos modificados genéticamente, que secretan sustancias antimicrobianas. Como
A Stone. Reproductive Health Matters 2014;22(44):213–217
ejemplo de los avances en el campo de MPT, este artículo describe una jalea vaginal anticonceptiva/ antimicrobiana en demanda, Amphora (anteriormente conocida como Acidform), ahora en una etapa avanzada de su desarrollo. Actualmente se están planificando ensayos clínicos para averiguar si el prometedor perfil antimicrobiano de este producto ofrece opciones de protección y prevención.
CAMI HEALTH
domaine, l’article décrit un gel vaginal contraceptif/ antimicrobien à la demande, Amphora (connu précédemment sous le nom d’Acidform) qui en est à un stade avancé de développement. Des essais cliniques sont actuellement prévus pour déterminer si le profil antimicrobien prometteur de ce produit se traduit en choix protecteurs et préventifs.
This Infographic shows the range of multi-purpose technologies being developed. While the graphic centres around a figure saying that women need better protection, which is absolutely true, in fact, everyone who has sex needs protection, and the development of these technologies is taking this into account too. 217
