Microbicidas tópicos: Nueva esperanza para la Prevención del VIH y otras ITS por métodos diferentes del condón Creación Positiva / gTt En nombre de Campaña.

Presentación del tema: "Microbicidas tópicos: Nueva esperanza para la Prevención del VIH y otras ITS por métodos diferentes del condón Creación Positiva / gTt En nombre de Campaña."— Transcripción de la presentación:

1 Microbicidas tópicos: Nueva esperanza para la Prevención del VIH y otras ITS por métodos diferentes del condón Creación Positiva / gTt En nombre de Campaña Global por los Microbicidas / Please start off by introducing yourself and your organisation. Say why you are making this presentation and why this issue is important to you. Then you could say something like: In an epidemic short on good news, I am always amazed at how little discussion there is of topical microbicides. These are products that have the potential to transform the HIV prevention landscape by giving us a new method of HIV protection that is user-controlled, instead of partner controlled. I think it is clear to all of us that not everyone has the power in their relationships to insist on male condom use during every act of intercourse. So we need to start talking about what IS possible for women and men in this situation -- what can be developed that would enable the receptive partner to protect her or himself when a condom isn’t being used. What I’d like to do today is threefold. 1) Familiarize you with the concept of topical microbicides and how they might fit into an overall program of HIV prevention; 2) Talk a little about how microbicides are being developed, how they would work and what they will look like; and 3) Discuss why we have to develop a vocal and active constituency for microbicides in order to ensure that this vital new technology reaches the market as soon as possible.

2 El desafío global El sida mata a más personas que cualquier otra enfermedad infecciosa en Botswana, un 36% de todos los adultos están infectados. en África Subsahariana, un 67% de los casi 9 millones de jóvenes VIH+ (15-25 años) son mujeres. El VIH se está convirtiendo rápidamente en una “epidemia de mujeres” De cada 10 personas recién infectadas con VIH, 6 son mujeres. Incluso en el mundo desarrollado, las tasas de nuevas infecciones están aumentando en mujeres. If you work in HIV/AIDS or women’s health, you know that we need microbicides here at home. But even if you don’t, you can tell by reading the newspaper or listening to the news how urgently we need more prevention options to fight the spread of this pandemic. The HIV infection rates are horrifying. 58% of the 28 million adults now living with HIV/AIDS in sub-Saharan Africa are women. Young women (indicate 67% on slide) comprise over two-thirds of all HIV positive youth in that region. And the rate is soaring in other parts of the world as well, particularly in China and India. But how can women and girls protect themselves when their risk comes from sex with a boyfriend or husband -- and when insisting on condoms is a cultural impossibility? It’s like asking them to prevent pregnancy without access to any contraceptives. It doesn’t work. One thing we can do to combat the spread of HIV/AIDS globally is to advocate that microbicides be developed and made available worldwide as rapidly as possible. In the Global North, we have the power to demand that our governments invest in this research. We have an obligation to use our voices to speak up for those at highest risk. AIDS is the biggest pandemic the world has seen since the Bubonic Plague hit Europe in the 1300s. While we are making important progress on getting treatment to people who have never had access to it before, we still need to do everything we can to help people protect themselves. Women need tools they can use to prevent infection -- tools they can control without having to rely on their partner’s cooperation. That means microbicides.

3 ¿Qué es un microbicida? Los microbicidas son sustancias que, aplicadas por vía vaginal y, posiblemente, rectal, pueden reducir la transmisión del VIH y otros patógenos por vía sexual. Hoy en día hablamos de productos tópicos formulados como geles o cremas para ser aplicados mediante un aplicador. Formulaciones futuras podrían incluir esponjas, anillos vaginales de liberación lenta o geles combinados con métodos barrera, como diafragmas o dispositivos cervicales. It’s important to understand that there aren’t any proven microbicides on the market yet. What we’re talking about here today are products that are now under development. So what is a microbicide? A microbicide is any substance that can substantially reduce risk of sexually transmitted diseases, including HIV, when it is applied in the vagina or rectum. The first generation of microbicides could be available on the market in as little as five to seven years. They will probably look a lot like the over-the-counter birth control products we already know -- the gel, foam, cream and suppository-type products that have been on the shelves for years. They won’t contain the same chemicals as these birth control products but they will come in some of the same formulations. But scientists are also working on developing new formulations that may make the second generation of microbicides even better than today’s spermicides. For example, they’re working to make formulations that women can use several hours before intercourse, if necessary. One idea on the drawing board is a vaginal ring or sponge-- something that could slowly release the protective substance over time, providing round the clock protection. Another possibility is combining a physical barrier -- such as a diaphragm or cervical cap -- with a microbicide. Since the cervix is generally considered to be more vulnerable to infection than the vaginal walls, this combination might provide highly effective protection.

4 ¿Cómo serán? Algunos servirán también para prevenir el embarazo
Otros serán microbicidas pero no contraceptivos Muchos productos candidatos son de amplio espectro, por lo que reducirán el riesgo de otras ITS además del VIH Some of the microbicides being developed will probably also be contraceptive. And that’s great because many women would like to have a product that can protect them from disease and pregnancy at the same time. But scientists are also working on products that may be microbicidal without being contraceptive. Non-contraceptive microbicides will be very helpful to women and couples who want to conceive a child while still protecting themselves from possible infection --- something that is not possible to do with condoms. Non-contraceptive microbicides will also offer an acceptable protection alternative for women who choose not to use contraceptives for religious or cultural reasons. It is very likely that some of the microbicides approved for distribution will also be “broad spectrum” -- that is, will be able to reduce the risk of some other STDs, in addition to HIV. Right now, each candidate product is being tested for efficacy against HIV and a whole range of common STDs. Several of them appear to reduce risk of at least one or two other STDs -- although we don’t really expect that any one product will be effective against all possible infections. Eventually, though, scientists will probably be able to combine active ingredients so that one product can serve several purposes.

5 Otras ventajas... Disponibles sin receta médica
Podrían ser distribuidos como los condones en supermercados, farmacias o por personas que trabajan en el campo de la prevención. Es probable que sean baratos Podrían utilizarse sin la colaboración de la pareja Algunos ayudarán a potenciar las defensas naturales de la vagina Over 60 potential microbicides have already been identified. Only eleven of these are in human trials right now but several more are ready for human trials. About half of the 60 are still at the pre-clinical, or lab research stage. As you see, these products could offer a number of advantages. A big one is that the woman wouldn’t need to gain her partner’s active cooperation at each act of intercourse – the way she has to with male or female condoms. Many women probably will chose to discuss microbicide use with their partners. But this could be a one time conversation -- and it wouldn’t have to happen right before sex. After that, the woman could manage her own protection without need to “negotiate” or interrupt sexual spontaneity every time. Some of the microbicides are also be developed to help boost the vagina’s own defense mechanisms. Of course, all the candidate microbicides have to be tested to be sure they don’t have a negative effect on the vagina’s natural environment – because we all know that products that kill lactobacilli and other flora can make a woman more vulnerable to infection. Now it appears that they may be able to develop some products that not only aren’t damaging -- but actually have the capacity to strengthen the vagina’s natural environment. This is another promising advantage that some microbicides could have

6 ¿Cómo se usarán los microbicidas?
Junto con el condón para protección adicional Como protección primaria para individuos y/o parejas que no pueden o no desean hacer un uso continuado de preservativos Como enjuague bucal para protección durante el sexo oral Como posible método de bajo coste para reducir la transmisión perinatal mediante lavados vaginales antes del parto There are several useful applications that microbicides could have: We could use them along with condoms for extra protection, or instead of condoms when condom use isn’t possible. How about a product that you could use as a mouthwash for protection during oral sex? The inside of your mouth is made up of the same type of mucosal cells as the vagina, so this isn’t as far fetched as it may seem. Microbicides may also help prevent HIV transmission during child birth by giving us an easy, effective way to reduce the amount of HIV in a positive woman’s vagina right before delivery. This could be especially important in very poor countries where women cannot get access to drugs to prevent perinatal transmission.

7 ¿Cómo podrán beneficiar a las mujeres VIH+?
Reduciendo el riesgo de reinfección con otras cepas de VIH Ayudando a proteger a sus parejas, es decir, efecto bidireccional Reduciendo el riesgo de otras ITS, hongos e infecciones de la vejiga Aumentando la probabilidad de embarazo seguro y de tener bebés negativos al VIH Microbicides are not something just for HIV negative women. A lot of HIV positive women want them, too. By neutralizing pathogens in both semen and vaginal secretions, they will give HIV positive women a way of reducing their partners’ risk of HIV exposure during sex -- as well as a way of reducing their own risk of re-infection. That’s what “bi-directional” means -- that the product can reduce risk in both directions, for both partners. Some products will also be able to reduce a woman’s risk of getting other STDs, bladder infection or yeast infections. For women with compromised immune systems, this could be an important advantage. Some products might help HIV positive women who are trying to get pregnant. Using a non-contraceptive microbicide could help a positive woman realize that dream without endangering her partner if he is HIV negative. It could also enhance her chances of having an HIV negative baby. Eventually, it might even be possible to develop a microbicide that would help an HIV positive man to father a baby without risk of infecting his partner if she is negative. But that one may not be a “near future” option

8 Microbicidas & sexo anal
La dificultad biológica de crear un microbicida rectal es mayor Mucha gente (mujeres y hombres) necesita microbicidas para la práctica de sexo anal Debemos asegurar que los microbicidas vaginales están adecuadamente etiquetados, ya que algunas personas pensarán que pueden utilizarlos por vía rectal Formulating a microbicide for rectal use is a little more challenging than making one for vaginal use just because the rectum is a very different environment. First of all, it’s an open ended cavity. The vagina is a closed pouch. You can coat the inside of the vagina with only about 3-5 ml. of product. Since the rectal cavity isn’t closed, it could require significantly more product to protect the rectal walls where they need protection. One of the key questions scientists are trying to answer now is exactly how much product it will take and what areas have to be covered to get a good protective effect. Rectal tissue is also more fragile than the tissue lining most of the vagina. Its cells have a lot of CD4 receptors that are especially vulnerable to HIV infection. Research has begun to start developing rectal microbicides, however. They are urgently needed -- not only by gay men but also by the many women who engage in anal intercourse. And -- until effective rectal microbicides are developed -- we have to insist that all vaginal microbicides be labeled appropriately to let the public know that they are not designed for rectal use and should not be used that way. We know from experience that as soon as a product is marketed for vaginal use, some people will use it rectally if they think it could give them some protection. So we need to make sure that the vaginal microbicides are labeled very clearly to indicate what the consequences could be of using such products rectally.

9 ¿Cuál será su nivel de eficacia?
Los primeros microbicidas tendrán una capacidad de protección del 40-60% La de los productos de segunda generación puede ser del 60-80% Deberían ser promocionados como complemento del preservativo, no como una sustitución Usar con mensajes de reducción de riesgos, como: Usa un condón masculino o femenino siempre que tengas relaciones sexuales: si no puedes utilizar condón, usa un microbicida Usa un microbicida con el preservativo para aumentar el placer mejorando la protección Microbicides will help people reduce risk of infection -- but we need to be clear about the fact that they aren’t going to eliminate risk. Microbicides will probably never be as effective as condoms. It’s safer to keep a virus out of your body than it is to try to kill or disable it once it’s there. That’s common sense. But remember, we’re talking about microbicides as an option for people who can’t or don’t use condoms. The first microbicides are only likely to be 40-60% protective against HIV. That doesn’t sound very good compared to a condom effectiveness, does it? But it’s a whole lot more protection than people get when they’re using nothing. The second generation microbicides are likely to be 60-80% effective against HIV and, by the third generation, they may be as high as 90% effective. But for now, we should only be talking about microbicides as part of a harm reduction approach. We need to encourage people to continue to use condoms if they possibly can. Many folks may want to use microbicides with their condoms for back-up protection and added pleasure. Microbicides will give us something to suggest when a woman says “I just can’t make him use a condom. Isn’t there something else I can do to protect myself?” Once microbicides become available, we’ll be able to answer by explaining clearly that these new products aren’t as effective as condoms -- but they’re way better than nothing. And, as we all know, a lot of women are getting infected because “nothing” is all they have.

10 Situación de los microbicidas en el espectro de la prevención
Previa a la exposición Momento de la transmisión Tratamiento Cambio de conducta Vacunas Profilaxis pre-exposición (PPreE) Condones masculinos y femeninos Terapias antirretrovirales (Madre-hijo) Microbicidas Terapias antirretrovirales Tratamientos para infecciones oportunistas Atención/nutrición básica If microbicides were available right now, how would we change the HIV and STD prevention messages we give out? Condoms will remain the option of choice in terms of effectiveness --- provided they are used correctly every time. But, as you see here, microbicides also have a natural place as one option in the Prevention Spectrum. Behavior change will remain an important way for people to protect themselves prior to being exposed to HIV. When an effective HIV vaccine becomes available, it will substantially strengthen our ability to take effective action in this pre-exposure phase. Microbicides will also not replace condoms or the protocols used to prevent mother-to-child transmission of HIV – essential strategies to help prevent infection from occurring at “point of transmission” phase of prevention. Instead, they will add another valuable option to the array we already have – an option that will give people who can’t or don’t use condoms (for whatever reason) a way to reduce their infection risk. So, to present them fairly, we will have to adopt a hierarchical prevention message – one that looks like a ladder. We will need to put male and female condoms at the top and strongly encourage condom use for those who can achieve it. But microbicides would give us a second-best option for when condom use isn’t possible. Los microbicidas ofrecen un método controlado por las mujeres para reducir la transmisión.

11 ¿Por qué una prevención diferente del condón?
Los métodos existentes -- condones y monogamia mutua – dependen de la cooperación de la pareja masculina. Violencia, coerción y dependencia económica en las relaciones dificultan la “negociación” del preservativo o que la mujer abandone a la pareja que la pone en situación de riesgo. In this presentation, I am talking mainly in terms of the risk women experience when their male partners won’t use condoms. I realize that some gay men also have this problem and may also need new tools to protect themselves. But, for the sake of simplicity, I’m going to just say “women’s risk” here -- and ask you to bear in mind that some gay men also need more options. Most of the time, women are at greater risk of STD or HIV infection as a result of their partners’ sexual and drug-using behavior than they are as a result of their own. In many countries, the primary “risk factor” shared by most HIV-infected women is marriage. Women may influence -- but they certainly can’t control -- their men’s sexual or drug-using behavior. In many parts of the world, women also don’t have control over when and how they have sex. Asking her partner to use a condom may result in a woman being beaten, threatened, or abandoned by her partner. The possibility of a violent response is especially high if a man believes that a condom means 1) a lessening of male pleasure, 2) that promiscuity or infidelity is going on or 3) that the woman has “inappropriate” knowledge of sexual practices. In studies done all over the world, women report that even suggesting condom use can put them in danger-- because it raises the question of whether one partner or the other has been unfaithful.

12 10 20 30 40 50 60 70 80 90 100 Burkina Faso Camerún Costa de Marfil Etiopía Guinea Kenia Malawi Mozambique Ruanda Sudáfrica Tanzania Togo Uganda Zambia Zimbabwe País Porcentaje % utilizó condón con la última pareja pareja estable Mujeres en edad reproductiva en África Subsahariana que declararon haber usado el preservativo en su último acto sexual

13 Uso del condón con la pareja habitual tras la intervención
Lugar Población Uso de Condón Notas 5 ciudades EEUU ♀ alto riesgo 17% Uso continuado Nicaragua Pob. general 7% Ruanda Mujeres casadas 22% Camerún Juventud 24% Última pareja Zimbabwe Trabajadoras sexuales 26% EEUU Clientes de clínicas ITS 39% Ucrania UDI Uso muy continuado Bangladesh 23% Siempre uso en la última semana Indonesia 34% De actos sexuales protegidos Tanzania ♀ paradas de camiones 43% 100% uso en los últimos 5 actos

14 ¿Qué pasa con la “migración del condón”?
¿Cambiarán las personas del condón a los microbicidas porque son más fáciles de usar? Tres líneas de evidencia sugieren que la introducción de los microbicidas conllevará una mayor protección en lugar de menor Experiencia de planificación familiar Datos de la investigación Puntos de vista para elaborar el modelo Some people are concerned that, if we introduce microbicides, people may stop using condoms altogether and just rely on the microbicides. The term “condom migration” is often used to describe regular condom users shifting away from condoms to another method- such as microbicides. The possible impact of this effect is being studied and what the research is turning up is pretty interesting Rather than just drifting away from condom use, people appear to be more likely to supplement their condom use with additional new methods. In other words, most people keep using condoms when they can -- but select other methods when they can’t use condoms. Three lines of evidence suggest that this is the case. They include data from the family planning field, existing research data, and insights from mathematical modeling specifically designed to examine this question.

15 Experiencia de planificación familiar
La adición de cada nuevo método aumenta el número total de actos protegidos y disminuye los embarazos no deseados. La adición de un nuevo método contraceptivo a los ya existentes en un programa aumenta el uso global en un 12% aprox., y disminuye el índice de nacimientos en 5,3 puntos. (Ross,J & E. Frankenberg.1993 Hallazgos de Dos Décadas de Investigación en Planificación Familiar. Population Council) Decades of programmatic experience with family planning indicate that, when you add a new method to the mix of contraceptive methods available, the overall number of protected sex acts INCREASES and the number of unintended pregnancies DECREASES. So, for example, women who have access to birth control pills, diaphragms, condoms, the patch and the IUD, for example, are likely to have fewer numbers of unprotected sex acts and fewer unintended pregnancies than women who only have access to one or two of those methods. A review of several decades of family planning research showed that the addition of each new contraceptive method to the existing menu of options increased overall contraceptive use by about 12 percentage points, and decreased the crude birth rate by 5.3 percentage points. If you think about it, it makes perfect sense. The more options available, the more likely it is that a woman will be able to find one she can use easily, comfortably and consistently.

16 Investigación existente sobre el uso del condón
9 estudios existentes – dos diseños: 1) Sólo condón comparado con el condón más el gel o 2) Sólo condón comparado con una jerarquía de opciones preventivas (incluyendo el condón femenino y masculino); Todos menos uno se centran en clientes de las clínicas de ITS o trabajadoras sexuales 6 observaron que la disponibilidad de opciones de protección adicional tuvo como resultado un aumento global del uso continuado del condón 3 observaron alguna evidencia de migración 3 destacaron que las mujeres que no usaban condones podían tener un uso continuado de microbicidas Here’s what the existing research from the condom literature shows us: Nine studies have been done so far that offer some insight into possible condom migration patterns. Most of these studies were not designed specifically to answer the question of condom migration -- but they do shed some light on this issue. We should also note that all these studies -- except for one -- focused on STD clients or sex workers --- individuals that we would identify as having high risk and who would generally be the target of intense condom promotion programs. Six of the nine studies showed that when study participants had access to condoms and additional prevention options, they increased their overall level of consistent condom use and, consequently, their level of protection. Three of the studies showed some evidence of migration. The highest level was among sex workers in Colombia, who shifted from using condoms 95% of the time to using them 78% when they were offered a second prevention option. And, finally, three studies showed that women who weren’t consistently using condoms COULD manage consistent use of an alternative, non-condom prevention method. [If asked: explain that the “gel” referred to in these studies was a spermicidal gel containing Nonoxynol-9. These studies were done before we knew that using N-9 for disease prevention was inadvisable].

17 Un modelo matemático sugiere….
En la mayoría de circunstancias, los niveles probables de migración del condón no aumentan el riesgo de transmisión del VIH de individuos de subpoblaciones La migración del condón es un posible problema sólo donde el uso del condón es alto (> 70%) y el uso continuado de microbicidas alcanzada es bajo (< 50 % de actos sexuales en los que no se usa condón) (Foss et al, Cambios en el uso del condón tras la introducción de microbicidas: ¿Deberíamos preocuparnos? AIDS 2003, 17: ) Scientists use computerized mathematical models to understand, given available data, what is likely to happen in a specific set of circumstances. Building a mathematical model enables researchers to explore how different factors influence trends in the data under consideration – and use that information to inform policy. The London School of Hygiene and Tropical Medicine, working in conjunction with the Global Campaign for Microbicides, has developed a mathematical model for looking at the question of condom migration and what impact it could have on individual and population-level risk of HIV infection. They based their model on the assumption of a 50% efficacious microbicide and did calculations to see what would happen if such a product were accessible to people who were already using condoms with varying degrees of frequency. What they found was that, under most circumstances, the probable levels of condom migration would not increase risk of HIV transmission, either among individuals or within sub-populations. The model showed that condom migration was only likely to be a problem in groups with: 1) high rates of condom use (greater than 70% of the time) AND 2) inconsistent microbicide use (where people used the microbicide in fewer than 50% of their non-condom protected sex acts -- i.e. times when they had sex without condoms.)

18 Punto de reflexión: ¿Cuándo afecta al riesgo la migración del condón?
SI un microbicida 50% eficaz se usa en un 50% de actos no protegidos por condones Uso continuado del condón ANTES del uso de un Microbicida 30% 50% 70% 90% Uso continuado del condón DESPUÉS del uso de un Microbicida 5% 32% 59% 86% Let’s look at these numbers piece by piece. There are two critical factors here (1) how effective the microbicide is at preventing HIV/STD transmission and (2) how frequently microbicide is used when the condom isn’t being used (i.e. how many sex acts are saved from being totally unprotected by use of the microbicide) Let’s start at the bottom of the chart here by looking at a woman who has a high degree of protection now. If her condom consistency drops even slightly (from 90% to 86%) her overall level of risk increases. That’s because she has very good protection already. But what about the woman is only protected by a condom 50% of the time now? She is already having unprotected sex 50% of the time. So if she starts using a microbicide during just half of the sex acts when her partner isn’t using a condom, her overall protection profile improves because now she’s having fewer totally unprotected sex acts. Her overall level of risk won’t increase unless her partner drops to using a condom only a third of the time or less (indicate 32% figure on chart) while she’s still using the microbicide half the time. Now let’s look at the woman whose partner rarely uses condoms (only about 30% of the time). She is in a high risk situation -- one that can really be improved by access to a microbicide. As long as she uses her microbicide for at least half of the sex acts that aren’t protected by a condom, her overall risk won’t go up unless he totally stops using condoms. And even that scenario can be changed if she starts using the microbicide more often.

19 Punto de reflexión: ¿Cuándo afecta al riesgo la migración del condón?
SI un microbicida 50% eficaz se usa en un 100% de actos no protegidos por condones Consistencia del condón ANTES del uso de un Microbicida 30% 50% 70% 90% Consistencia del condón DESPUÉS del uso de un Microbicida 0% 0% 37% 79% Now let’s think for a minute about what happens to these same ladies if they use the 50% efficacious microbicide every time they have sex without a condom. The previous slide was what happened if they only used it half the time– but what if they use it every time he’s not using a condom? Once again we see at the bottom of the chart that the lady whose partner uses a condom 90% of the time will be increasing her risk if her partner reduces his condom use more than a little bit. Even if she uses the microbicide every time, he has to continue to use the condom at least 79% of the time or her overall risk of infection increases. But what about our other two ladies – the one whose partners used condoms half the time or a third of the time? If these two ladies used the 50% effective microbicide every time, their partners could stop using condoms entirely and they would still be getting as much protection as they were getting with his occasional condom use. These are the people for whom we think access to microbicides could make a really huge difference. Now let’s think back to the slide we saw earlier about the frequency of condom use in primary relationships. It was hardly ever higher than 30%, right? So we know that a lot of women are at high risk already. Even if condom migration occurs, these women will be better of with a partially effective microbicide – provided that they use it consistently -- than they are now without one.

20 ¿Usarán microbicidas las mujeres?
En un estudio realizado en EEUU, aprox. 21,3 millones de mujeres muestran interés en usar un microbicida (Darroch & Frost, 1999) Incluso en países con escasos recursos, las mujeres en riesgo estarían dispuestas a pagar el doble (o más) del precio local de un condón (EU study, 1998; Hardy, et al 1998) Las mujeres tienen necesidades y preferencias de presentación del producto muy diversas por lo que será crucial la existencia de múltiples productos para difundir la aceptación y el uso Would women really want to use a microbicide if one were available? Market research says YES! Although it is difficult to predict uptake and use for a product that doesn’t exist, the research done so far show that substantial numbers of women are interested in microbicides. It indicates that millions of women from all kinds of economic and cultural backgrounds would buy such products if they were available and effective. A study done by the Alan Guttmacher Institute in the US showed that approximately 21.3 million American women are likely to be interested in using a microbicide. Those expressing the greatest interest were the younger and poorer women -- the exact demographic groups at highest risk of HIV infection in the US. An international market study was also funded by the European Union in 11 countries around the world. These included resource-poor as well as affluent countries. What they found was a women were so interested in getting access to microbicides that many said they would pay more for a microbicide, if necessary, than they pay for condoms. I think we’d all agree that microbicides will need to be very inexpensive -- and free to those who can’t pay. But the fact that women say they would pay more for a microbicides really speaks to how urgently they need prevention alternatives.

21 ¿Cómo funcionan los microbicidas?
Matan o inactivan el patógeno Rompiendo la superficie de la membrana Creando un entorno inhóspito para el patógeno Crean una barrera entre el patógeno y el tejido vulnerable Revistiendo las membranas mucosas con gel So how are microbicides developed? It’s quite a challenge to make something gentle enough for daily use but effective enough to knock out HIV and other pathogens entering the vagina. The 60 products now in the pipeline fall into five basic categories -- defined by how they work. These are called their ”mechanisms of action”. So far, all the potential microbicides work by using one of five basic mechanisms of action. (Say the following sentence if you have provided the handout). Examples of products in each category are shown on the “Microbicide Research and Development: What’s in the Pipeline” fact sheet we have here. The first category is products that work by simply killing or disabling the pathogen. They do that by disrupting its surface membrane or coat. Spermicides work by breaking up the outer coat of the sperm. Now microbicides have been developed that do the same thing to HIV and other pathogens. Others in this category make the vaginal environment inhospitable to HIV. The second approach involves creating a barrier to protect vulnerable tissue. HIV has to attach to a cell in order to infect it. So, if you can coat the cells with something that keeps virus or bacteria from being able to attach, you should be able to prevent infection. That’s how the “barrier” microbicides that have been developed propose to work. For example, you may have heard of a potential microbicide called Carraguard, made with a gel called carrageenan. Has anyone here ever heard of carrageenan? (if so, ask where she or he has seen that word. The answer is usually on food labels). Carrageenan is a very common thickener made from red algae – a seaweed. It has been used for years as an food additive to make things thick and creamy. Now we’ve learned that carrageenan has the ability to cover cell walls like a coat of paint, forming a temporary barrier that keeps HIV from being able to attach. Carraguard has been shown to be safe and will be going into a large Phase III trial soon to see if it works in the real world to prevent infection.

22 Mecanismos de acción Interferencia con la fusión del virus en la célula diana A third way that a microbicide could work is by preventing the virus from being able to fuse with target receptors. You probably know that HIV has very specific target receptors on its outside shell, or coat. It has to match these up with receptors on the outside of a human cell in order to latch on, or fuse, with the cell and infect it. The picture here gives us some idea of how this shape-matching works. The HIV has to find an empty CCR5 receptor, a CD4 receptor or a CXCR4 receptor to attach to (point to these on the slide if you can) It’s like finding a parking space in a parting lot. If you fail to find an open space, you can’t stay in the lot. Eventually you have to give up and drive somewhere else. The “fusion inhibitor” microbicides are designed to work by taking up all the available parking spaces. They are harmless molecules have the same kind of receptor shapes on their outsides as HIV does. So, if they are inserted in the vagina before sex, they can spread out and take up all the available CCR5, CD4 and CXCR4 receptor spaces. Then, if HIV then enters the vagina, there are no receptors left for it to attach to. It dies for lack of a parking space.

23 Mecanismos de acción Prevenir la replicación del virus una vez que ha entrado en la célula Antirretrovirales de uso tópico Potenciar las defensas naturales de la vagina Defensinas, anticuerpos Estrategia de combinación The fourth strategy for creating a microbicide involves reformulating the anti-retroviral drugs developed to treat HIV-infected individuals. These drugs are designed to stop HIV from being able to replicate. Researchers are now experimenting to see if some of the drugs – re-formulated to be used as topical gels or creams – could stop localized HIV replication just in the vagina. The fifth strategy is based efforts to enhance the vagina’s own defense mechanisms. Our bodies contain a variety of natural defense mechanisms such as antibodies and defensins. These are cells designed to fight off infections that enter the body. Is it possible to supplement these naturally occurring mechanisms and, thus, to boost the body’s ability to protect itself from infection? Developers are experimenting with a number of synthetic and organic antibodies and other molecules in an effort to do just that. The first microbicides to come onto the market may operate with just one mechanism of action. It is very likely, however, that the second and third generation microbicides will be combination products -- using two or more mechanism of action to enhance their effectiveness. It makes sense that, if each product is only 50%-60% effective on its own, you might be able to get higher effectiveness by using them together. The trick, of course, will be figuring out which products actually have the ability to complement each other while still being safe to use in combination.

24 ¿Qué pasó con el Nonoxynol-9?
Estudiado en los 80 y los 90 para comprobar si productos ya existentes eran eficaces contra el VIH Estudio previos en humanos había apuntado que ofrecía cierta protección frente a la gonorrea, la clamidia y el VIH En julio de 2000, los resultados de los estudios mostraron que trabajadoras sexuales que usaban bajas dosis del producto tenían índices más altos de seroconversión que las que usaban placebo, posiblemente debido al aumento de la abrasión vaginal causada por el N-9 Of course, we can’t really talk about the future of microbicide research without talking a bit about the past. You have probably heard or read reports in the news about Nonoxynol-9 and HIV prevention. I’d like to give you a little more background on that. You probably know that N-9 is the active ingredient in almost all of the over-the-counter birth control products like the jellies, creams, foams and suppositories sold in the North America. Women have been using N-9 contraceptives for the last fifty years. Research on N-9 as a possible microbicide started in the 1980s, when scientists found that in the test tube, it killed HIV and several other STD pathogens. N-9 falls into in the first category of products we just discussed. It kills sperm and HIV by destroying the outer coats. In July, 2000, research on N-9 as a microbicide stopped because of data showing that Advantage-S, a low-dose over-the counter spermicide, didn’t protect women against HIV. Even though the product contains a small amount of N-9, the study showed that it could actually increase risk of HIV infection if used too frequently. It appears to do this by causing small lesions or breaks in the vaginal wall, making it easier for HIV to enter the bloodstream. The participants in this study (all sex workers) reported having an average of 3.6 partners per day and about 70 coital acts per month during the study. Even though most women wouldn’t use the product this frequently, researchers decided to take N-9 off the table as a potential microbicide because of the risk it posed. So research on N-9 has stopped and none of the potential microbicides under consideration contain N-9.

25 La Organización Mundial de la Salud establece
N-9 no ofrece protección frente al VIH u otras ITS bacterianas como gonorrea y clamidia. En vagina, el uso frecuente (más de una vez al día) puede causar disrupción epitelial, posiblemente aumentando el riesgo frente al VIH. No deberían usarse productos con N-9 por vía rectal, incluso con condones o lubricantes. El recto es frágil y puede verse lesionado por el N-9. Las mujeres en riesgo frente al VIH o que tengan coitos más de una vez al día no deberían usar espermicidas con N-9, aunque siguen siendo una opción contraceptiva segura para mujeres que no estén en riesgo. In 2001, the World Health organisation (WHO) held a technical consultation on N-9 in Geneva, Switzerland. Researchers and experts from around the world came together to discuss all the data accumulated from all the studies on N-9 and to reach some conclusions about it. After the meeting, WHO issued this guidance: They concluded that N-9 is NOT effective in preventing the transmission of HIV or other STDs and should not be used or promoted for disease prevention. We now have proof that, when used frequently, even low doses of N-9 may cause irritation and increase HIV risk. N-9 products should never be used for anal sex. The rectum is more fragile than the vagina. Even the small amount of N-9 in condoms and lubes can damage the rectum, raising HIV risk. The experts recognized, however, that N-9 contraceptive products still offer an important birth control option for some women who don’t want to use hormonal methods of birth control like the pill, the patch or injectable methods. Since infrequent use of low dose N-9 products seems to be well tolerated by most women, they agreed that women who aren’t at risk of HIV infection can safely continue this level of contraceptive use. But they stressed that N-9 products should NOT be used for birth control by women who have multiple acts of intercourse in a day OR by women who are at risk of HIV infection

26 Proceso de investigación clínica
In vitro (Sólo principio activo) Actividad frente a patógeno Perfil de toxicidad celular En animales (P. activo frente a placebo) Eficacia en la prevención de la infección Seguridad En humanos (clínica) (P. activo frente a placebo) Seguridad en individuos de bajo riesgo (Fase 1) Seguridad en población representativa (Fase 2) Eficacia (Fase 3) Now let’s talk a little about how these products are actually tested. The first testing is done in labs and is called pre-clinical research. Using lab and animal studies, developers have to show that the product is active against the pathogen – that is, capable of stopping it – and that it isn’t toxic, as far as they can tell. Product don’t go into human trials unless lab and animal testing shows that they’re probably safe and have a reasonable chance of being effective in humans. Once a product gets the go-ahead for human trials, it goes first into a Phase I Safety trial. In Phase I, a few volunteers use the product for a short period of time (usually a few weeks) and are monitored very closely to see how their bodies react. If a product seems safe in Phase I, then a larger number of volunteers use it in a Phase II trial. In Phase II, participants are recruited from the populations that will actually be using the product. This is to see if it is likely to cause irritation or other problems for the “average” woman who will be using it. Both HIV-positive and HIV-negative people participate in Phase I and Phase II trials. Products that do well in Phase II are eligible to go on to Phase III. These are very large trials that are done to see if the product actually works in “real life” use. In Phase III microbicide trials, all the participants are given free condoms as well as the product or a placebo (a “fake” that looks like the product but doesn’t contain active ingredient). They are urged to use both condoms and the other product they received for every sex act. The condoms are essential because we don’t know if the product is protective. Then the women report back on each time they had sex -- did they use the condom? The product? The condom and the product together? Or nothing at all? The researchers then look at whether the women who received the active product and condoms had fewer HIV sero-conversions than the women who received the placebo and condoms. The difference between the two arms is the measure of the effectiveness, if any, of the microbicide.

27 Centros de ensayos clínicos en 2003
Amberes, Bélgica Londres, Reino Unido Nueva York, EEUU Cincinnati, EEUU Washington, EEUU Providence, EEUU Filadelfia, EEUU Los Ángeles, EEUU Baltimore, EEUU Houston, EEUU Norfolk, EEUU Ghana Birmingham, EEUU Costa de Marfil Miami, EEUU India Chiang Rai, Tailandia This slide is to give you a sense of where microbicide trials are taking place. As you see, there are lots of trial sites in North America and Europe. Most of these sites are doing Phase I and II trials -- the safety trials done to see if a candidate product causes irritation, damage or other problems when inserted on a regular basis. Phase I and II trials are also done in the Global South, because it is important to see if the candidate product can can also be safely used by people less developed countries, where nutritional status and overall health profiles may be different. The Phase III trials that measures a product’s effectiveness have to be done in populations at high risk of sexually transmitted HIV, in order to accurately measure how well the product reduces infection risk. The condom promotion efforts that accompany microbicide trials generally increase participants’ condom use -- which is good. But this also means that there are likely to be fewer sero-conversions during the trial than would normally occur -- and that difference between the number of sero-conversions in the product arm and the number in the placebo arm may be small. If you look at this difference against a background sero-conversion rate that is low, it may be almost invisible. But if you look at it against a high background rate, as occurs in the red and green countries on the map here, then it is possible to measure the difference accurately. That’s why the Phase III trials have to be done in the Global South. Fortunately, trials can also bring increased health care, prevention services and treatment access into highly-impacted communities. How those services are provided and how well they are continued after the trial is a subject of intense ethical debate among researchers and communities. One of the Global Campaign’s functions is to help community members in trial areas prepare to advocate effectively for their communities during this process. República Dominicana Nigeria Uganda Yaoundé, Camerún Tanzania Malawi Zambia Zimbabwe Brasil Botswana Sudáfrica Alliance for Microbicide Development

28 Análisis de Laboratorio
Cronología Análisis de Laboratorio 2-6 Años Fase 1 1 Año Fase 2 2 Años Fase 3 3,5 Años Fases 1 y 2: estudios en pene y recto, VIH+, etc. 10 + Años As you see, this kind of research isn’t exactly quick to do. It’s not uncommon for the whole process to take a decade. The pre-clinical phase in the laboratory can take from 2-6 years. Then the Phase I safety trial takes about a year and the Phase II expanded safety trial takes about two years. The Phase III effectiveness trial can take 3-4 years, because such a large number of participants are enrolled and they generally receive a year or two of follow up services, to see if the product has any effects after extended use. While the Phase II and III trials are going on, researchers also undertake penile safety trials to see if the product causes irritation on the penis. I’ll say more about that in a minute. They may also do rectal safety trials, to see how the body will react if the product is inserted rectally, and expanded safety trials involving HIV positive people to make sure the product is safe for their use and to see what impact it has on HIV shedding. This is the time line you have to think about when we say that -- at the earliest -- we could have a product on the market in five to seven years. If one of the products now entering Phase III turns out to be effective, we should have proof of its effectiveness in the next 3-4 years. It will then take another year or two for the product to be considered by regulatory authorities and, if approved, to go on the market. But this is a “best case” scenario. If none of products now going into Phase III proves to be effective, we will wait longer. How long it takes depends, in part, on how fast we can keep new products advancing in the pipeline. Fuente: Centro Tufts para el estudio del desarrollo de fármacos

29 ¿Se prueban sólo en mujeres?
Se incluye a hombres en algunos ensayos: Estudios de base sobre el impacto del coito anal en el cuerpo Estudios de “tolerancia masculina” (impacto de los productos candidatos sobre el pene y la uretra) Se están diseñando estudios de seguridad rectal Most microbicide research is now focused on vaginal use of candidate products. But, as I mentioned, some rectal studies and other studies enrolling men are also underway. Two federally funded studies are happening in the US to measure baseline levels of rectal injury and inflammation that typically occur during anal intercourse. Since no candidate products are used, these have been called “Phase 0” trials. They just tell us what’s “normal” during anal sex and set parameters for researchers to use in future trials. Using these parameters, researchers will be able to tell if the rectal irritation or damage they may see when testing a product is caused by the product itself, or is an effect that might have occurred anyway, without the product. These Phase 0 data give us essential background for designing effective safety trials for rectal microbicides. "Male Tolerance" trials are also done to see if a candidate microbicide causes irritation on the penis or within the male urethra. Most women and gay men are NOT going to insert a product that irritates a partner’s penis. So, of course, we have to know if they do or not. We know from experience that --as soon as a product is marketed for vaginal use -- some people will use it rectally if they think it will protect them. So even products designed for vaginal use must be tested rectally to find out if they are likely to be harmful when used in the rectum. Trials can be done to assess rectal safety, it will be important for vaginal products to be issued with warning labels cautioning people not to use them rectally.

30 Situación de los productos actuales
Total preclínicos 50 Total clínicos 17 Fase I 10 Fase I/II Fase II Fase II/III 1 Fase III 1 Here’s a summary of what we currently have in the microbicides research pipeline. As you see, there are 50 pre-clinical trials and 17 clinical trials going on right now. Some candidate products are being used in more than one trial. That explains how we can have eleven different products are in human trials -- but 17 clinical trials in all going on. Fifteen of the 17 trials are Phase I and Phase II level testing. One product is in Phase I and scheduled to go straight from there to a Phase II/III trial (point to the Phase I/III line). And one product is now in a Phase III trial that started in early 2004. The Phase III candidate is Carraguard -- the product I mentioned earlier that is made from carrageenan. Here is a picture of Carraguard. It is a gel and, as you see, it’s designed to be inserted directly from the packet, so it doesn’t need a separate applicator. The Carraguard trial expects to enroll at least 6000 women. If all goes well, we should have an answer regarding Carraguard’s effectiveness by about 2007. Fuente: Alliance for Microbicide Development

31 ¿En dónde nos encontramos?
This slide just shows you the same information in graph form. This clearly illustrates the large number of products in pre-clinical development. Some of these are actually ready to go into human testing but the developers either don’t have the money to fund the trials or are delayed because not enough trials sites are available to do the testing. It takes substantial funding to develop new trial sites capable of enrolling and following thousands of women. Costs include: the development of laboratory infrastructure, recruiting and training local research and community liaison staff and establishing or expanding counseling and treatment facilities to provide services to trial participants. It is also essential to do outreach, networking and education work in the community where the trial is happening to help people understand what the trial is about and generate interest among potential participants. Making sure that the rights of participants are protected by establishing Community Advisory Boards and other mechanisms is also vital. All of these components have to be in place in order for an ethical, scientifically rigorous clinical trial to be conducted. When you take all this into consideration, you can see why significant investment is needed to move products from the pre-clinical research stages into human trials.

32 El desarrollo exigirá una significativa inversión gubernamental
Las grandes compañías farmacéuticas tienen relativamente poco interés en llevar adelante los microbicidas Baja percepción de los beneficios posibles Dudas sobre fiabilidad Falta de expertos disponibles Entorno regulador incierto Durante los últimos 20 años, casi toda la financiación para el desarrollo de anticonceptivos e investigación relacionada provino de gobiernos y fundaciones. Now we need to talk about the political and economic situation surrounding microbicide trials. We have plenty of potential products in the pipeline and the research is being done. The problem is that it isn’t moving forward as rapidly as it could be and the reason for the delay is, to a large extent, money. There just isn’t enough being invested right now to keep the pipeline moving along efficiently. New drug development is usually funded by the major pharmaceutical companies who have enough money to pay for large clinical trials and other costly research processes. Unfortunately, none of the Big Pharma companies are investing in microbicide research yet. They are reluctant for a variety of reasons including: liability concerns, lack of in-house expertise, and an uncertain regulatory environment. Their main concern, however, is that the new products may not be profitable enough to justify the cost of developing them. They aren’t convinced that the potential market for microbicides is large enough -- especially among women in affluent countries -- to assure that they will get a good return on the investment. Actually, this isn’t unusual. Pharmaceutical corporations are driven by economic self-interest so they aren’t motivated to invest in a product just because it is needed. There are lots of products—like malaria vaccines, new contraceptives, or microbicides -- that would yield huge returns to society in terms of productivity and health benefits but that hold little profit potential for private investors. Such products are known collectively as “public health goods” and they are developed only when governments and foundations invest in creating them.

33 El Universo de los Microbicidas
35 compañías biotecnológicas 44 entidades de investigación sin ánimo de lucro 4 entidades del sector público You may wonder who, if not the big pharmaceutical corporations, is developing the new microbicides? Most of the work was originally started by small groups of academic researchers who used their university labs and resources to unravel the question of how to make a safe, effective microbicide. Since then, many of these groups of researchers have formed themselves into small bio-tech companies to continue this work. But, for the most part, these are still start-up companies funded by grants and, in a few cases, small venture capital investments. (If you have provided the “What’s in the Pipeline” fact sheet, hold it up again here.) BufferGel, for example, was developed by a group of scientists at Johns Hopkins University who later started their own biotech company. And the Invisible Condom was created by a scientist at Laval University in Quebec, Canada. Carraguard is an example of a product developed by a non-profit organisation, the Population Council, rather than by academic researchers. But the resources that these entities have been able to mobilize are insufficient. Money is now the limiting factor in how rapidly microbicide research can proceed. That is why activism is needed to make more resources available and keep the research pipeline moving.

34 Realidad y necesidades de financiación
El análisis farmacoeconómico demostró: El descubrimiento a través de la fase II cuesta unos 10 millones de dólares Los ensayos de fase III pueden costar millones más Si el actual activo fuera de una única farmacéutica, necesitaría invertir unos 775 millones en los próximos cinco años para asegurar el éxito PERO, en 2002 sólo había 230 millones procedentes de fondos gubernamentales y filantrópicos Por tanto, faltan por lo menos ¡500 millones de dólares! Here’s how the economics of all this works: According to an analysis released by the Rockefeller Foundation in 2002, it costs about $10 million (US dollars) to get a product from discovery through the Phase II safety trials. It costs another $46 million, on average, to get it through the huge Phase III efficacy trials, which can involve as many as ,000 participants. The Rockefeller Foundation analysis concluded that, if all microbicide research leads were being managed by a single pharmaceutical company, that company would have to invest $775 million over the next five years to ensure success. They defined “success” as getting one effective product out on the market. And $775 million is a “bare bones” scenario that covers only the costs directly related to development. It doesn’t include the cost of other necessities like basic research, following new leads and working to assure that products will be acceptable and accessible to users. But even so, let’s look at these numbers and see where they go. The Rockefeller analysis also said that, if 2002 funding levels continued, a total of $230 million would be spent on microbicide research worldwide between 2001 and 2005. The math is easy: $775 million needed and $230 million available. That’s a shortfall of AT LEAST a $500 million between need and available resources. Despite the recent generosity of some philanthropists, notably the Gates Foundation, we still have nowhere near enough to keep the research pipeline moving forward efficiently.

35 El mensaje de l@s activistas
Hay una amplia y demostrable demanda de métodos de prevención que puedan controlar La inversión norteamericana y de la Unión Europea en investigación y desarrollo de microbicidas debería ser: sustancialmente superior en el próximo año, y aumentando anualmente hasta que los productos alcancen el mercado Sin esa inversión no podremos tener herramientas de prevención del VIH de este tipo en esta década. We can’t force the big pharmaceutical companies to invest in microbicides, although they are very likely to do so once the first generation of products reach the market. Research on pharmaceutical company attitudes suggests that they are waiting for Phase III trial data to be produced. Once we know which products may actually work, some of the Big Pharma companies are very likely to buy up the most promising leads and get involved in developing the second and third generation products. In the mean time, the only thing we, as citizens, can do to close the gap between what’s needed and what’s available is to pressure our governments to increase their investment. Public funds have to step in where private funds are lacking. So we need to demand that: 1) the widespread, urgent need for user-controlled HIV prevention methods be recognized and treated like the public health priority it really is; and 2) the US, Canada and European Union substantially increase their current investment in microbicide research and development in the coming year and 3) they continue to increase it annually until the first generation of microbicides become available. Without substantially increased support, we may not see an effective microbicide reach the market within this decade. We have to keep the pipeline moving to assure that, even though some leads will fail, the odds are good that some will succeed.

36 Campaña Global por los Microbicidas
Actúa como paraguas unificador para el activismo de las ONG y la interacción con la comunidad científica 25 organizaciones asociadas activas; 200 grupos de apoyo en todo el mundo Gestionadas por dos secretarías con un pequeño grupo central, una en Washington y otra en Londres Búsqueda de financiación centralizada y apoyo financiero a grupos asociados Comité de vigilancia Internacional Enter the Global Campaign for Microbicides -- a broad-based, international effort initiated in 1998 to build support among policy makers, opinion leaders, and the general public for increased research into microbicides and other user-controlled HIV prevention methods. The Global Campaign actually isn’t an NGO, itself, but rather a conduit through which the huge international demand for microbicides, largely latent and unexpressed in the past, is being collectively mobilized and articulated. The Campaign links participants together in shared advocacy efforts by recommending unified strategies and provide a growing body of resources and materials that are freely and publicly available to anyone wishing to use them. The work of the Campaign is coordinated by its secretariats, housed at NGOs in Washington DC, London and (soon, we hope) South Africa. But, in essence, the Campaign is just a shared idea -- the idea that receptive sex partners must have a way to protecting themselves that they can control and that civil society actors can play an essential part in determining when, how and in what fashion this technology becomes available to all who need it. With 25 active NGO partners and 200 endorsing organisations worldwide to date, the power of this shared idea is growing. Together, we are working effectively to accelerate product development, facilitate widespread access and use, and protect the needs and interests of users, especially women, at every step in the development process.

37 La Campaña Global HERRAMIENTAS OBJETIVOS Visibilidad Impulso Acceso
Responsabilidad HERRAMIENTAS Organización de base Políticas de activismo Presión política (lobbying) Movilización política Investigación en ciencia social Capacitación de las ONG One of the Global Campaign’s primary functions is to mobilize increased resources that will accelerate the process of microbicide research and development. But people can’t demand what they have yet to envision. So our first goal has to be raising awareness -- helping the public see microbicides as a possible tool that they have the right to demand. In addition to working on awareness and acceleration through resource mobilization, we’re also vitally concerned about access -- making sure that the approved products will be widely available and introduced in a way that helps people understand them and use them correctly. This means we also have to focus on issues of pricing, accessibility, stigma, gender bias and women’s empowerment, as well as product development and approval. Our fourth “A” is accountability. A cornerstone of our mission is to ensure that, as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Since microbicides are going to be user-controlled, we must make sure that the developers really listen to needs and perspectives of those who will be using them. New drugs are often developed to fit the prescribing patterns of physicians -- not necessarily the needs, skills, and attitudes of potential consumers. We need to reverse that pattern by insisting that consumer voices be heard throughout the microbicide development process -- to make sure that the products we get are ones that people, especially those at highest risk, really want and can use. In collaboration with our partners, the Global Campaign uses a range of tools to work on achieving the “four A’s”. Our tools include (run through the list of tools on the slide)

38 En la actualidad: colabora con…
Colaboradores globales en el norte: Canadá Reino Unido Irlanda Estados Unidos Colaboradores globales en el sur: Kenia Ghana Uganda India Sudáfrica Tailandia Desarrollando colaboración y apoyos en muchos otros países This slide is just to give you an idea of where the Global Campaign has already established advocacy nodes, or sites, in cooperation with partner organisations. These nodes are hosted by one or more local NGOs and staffed almost entirely by volunteer effort. They work to engage key interest groups, including – women’s health advocates, gay men's health advocates, international development organisations, gender equality organisations, HIV/AIDS service providers and Individuals living with HIV/AIDS, among others – in activities that educate the public, donors and policymakers about microbicides. They then work with these allies to highlight the urgency of the issue and generate local and national action. Groups in the Global South also work to with local opinion-makers in the communities in which clinical trials are taking place -- supporting them in taking an active role in assuring that the rights of trial participants are protected throughout the process. The nodes receive sub-grants from the Campaign and guidance from Campaign staff. But each pursues its own locally developed strategies. They also help raise visibility of microbicides through their local and national media and by participation in key AIDS, STD, reproductive health and international development conferences and meetings.

39 Qué puedes hacer como individuo…
Averiguar dónde está actuando la Campaña Global en tu zona en: / o escribir a / 2) Solicitar nuestra revista bimensual, GC News (en inglés) 3) Procurar que organizaciones o grupos comunitarios en los que trabajes incluyan un programa sobre microbicidas. 4) Firmar la petición de la Campaña Global y ayudar a la obtención de firmas. I don’t want you to leave here today thinking that you, as an individual can’t make much of a difference on this issue. You can. You can find out if there are Global Campaign partner organisations active in your area by looking on our web site or sending us an inquiry at If there is a Global Campaign node near you, you can get in touch with them and they will welcome your involvement -- even if you just want to be on their mailing list to find out more about what’s going on locally. You can sign up to receive our bi-weekly e-newsletter and find additional information about what’s happening with microbicides at the Global Campaign’s web site at You can urge community groups, organisations and service providers in your community to host a free program on microbicides. We’ll be glad to work with you on organizing those programs and finding presenters for you. Finally, you can help out by signing the Global Campaign petition, taking blank Petition forms and collecting signatures, yourself. The petition serves as both an educational and an advocacy tool. It’s a great way to start conversations with your colleagues and people in your community about why this issue is important to you.

40 Tu organización puede apoyar a la Campaña Global
Es gratis. Sólo tienes que rellenar el formulario y: Transmitir información a tu entidad (miembros, personal, colegas, junta, etc.) Situar el tema en la agenda de activismo de tu grupo Hablar de ellos en tu revista o en los medios de comunicación locales Cualquier cosa que convenga a tu organización If you’re here on behalf of an NGO, you can go back to your office and urge your organisation to endorse of the Global Campaign for Microbicides. Currently, over 200 partner organisations and endorsers worldwide are working together under the Global Campaign umbrella. This work is funded by public money from donors and foundations. The Campaign accepts no funding from product developers or private corporations. There are no fees involved in endorsing or participating in the Campaign. In fact, the Campaign can supply you with training, materials and speakers at no cost to help you educate your community about microbicides. We realize that virtually every NGO is over worked and under-funded -- and that asking you to add another issue to your agenda is asking a lot. That’s why the Global Campaign tries to make it as easy as possible -- by giving you access to materials such as pre-drafted newsletter articles, fact sheets and standardized presentations just like this one. All these have been created to help you do whatever you can do to raise awareness on the need for microbicides. If you join the Campaign, you will be working hand-in-hand with a network of large and small organisations all over the world that have made non-condom HIV and STD prevention a high priority on their advocacy agendas. Here are some things that other partner groups are doing (review list on slide).

41 Posible impacto en la salud pública
Si un producto ……….….60% eficaz se ofreciera a.…..73 países de bajos ingresos y fuera utilizado por % de las personas con acceso a un centro de salud durante…… …50% actos sexuales no protegidos = 2,5 millones de infecciones por VIH se evitarían en 3 años (incluyendo mujeres, hombres y niños) Let me close with a quick illustration of the impact microbicides could have. These figures are from an analysis conducted by researchers at the London School of Hygiene and Tropical Medicine. Their computer modeling exercise shows that: if a 60% effective microbicide is introduced in 73 low income countries with high HIV rates and gets used by only 20% of the people with easy access to existing services and those people use it only 50% of the time when they’re not using condoms it could avert 2.5 million new HIV infections among women, men & children over three years. Just Think! That’s equivalent to the total number of women infected with HIV in 2002*. I’m not suggesting that this impact would be immediate but just trying to show how substantial it could be over time. And, as you see, these calculations are on relatively modest estimates of effectiveness, uptake and use. A more effective microbicide, used by a larger number of people, would have an even greater effect. Microbicides are not a magic bullet. But they could save a lot of lives and make an enormous difference in the spread of the pandemic. Most importantly, they will put protection into the hands of millions of women who, right now, can’t convince their partner’s to use condoms. ___________________________ * According to WHO, 5 million people became HIV infected in half of them women.

42 ¿Cuándo esperamos disponer de un microbicida?
Si dependiera de Con la suficiente inversión y voluntad política podríamos tener una nueva opción de prevención en 5-7 años El lema de nuestra campaña El mejor momento para plantar un árbol es hace 20 años; el siguiente mejor momento es ahora. Probervio africano Everyone asks --- so when will microbicides be on the market? The answer is -- that depends. How much do we want them and how willing are we to demand that our government invest in developing them NOW? Let me close with a little story. In the 1940s, the pharmaceutical companies wouldn’t invest in proposals to develop oral contraceptives. They certainly didn’t believe that women would ever want to take pills to prevent pregnancy! After years of trying to change their minds, Margaret Sanger (the founder of Planned Parenthood) got her friend Kathryn McCormick (who was heir to the American Harvester fortune) to write a big check. That money supported the tiny research efforts that led to development of the very first birth control pill. We’re in the same position today as those women were in the 1940s and 50s. Microbicides could change the landscape of sexual risk today as dramatically as the pill did forty years ago. They could literally save millions of lives worldwide. But it won’t happen any time soon unless we act. No one’s going to advocate for us but us. We all wish we’d had access to non-condom prevention tools 20 years ago. AIDS would present a very different picture worldwide today if we had -- especially for women. But we can’t change twenty years ago. We can only change today. As the proverb observes, the second best time to act is now. Thank you for your attention. Questions? Comments?