Ward Cates2013-05-22T15:29:04-04:00Ward Cateshttp://www.huffingtonpost.com/author/index.php?author=ward-catesCopyright 2008, HuffingtonPost.com, Inc.HuffingtonPost Blogger Feed for Ward CatesGood old fashioned elbow grease.Cascade Helps Keep People Coming Back for HIV Treatmenttag:www.huffingtonpost.com,2012:/theblog//3.21709622012-11-27T11:22:50-05:002013-01-27T05:12:01-05:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/
Last year, we celebrated 30 years of progress in the fight against AIDS. This year, let's celebrate World AIDS Day by looking forward. We've challenged ourselves by setting an ambitious goal of an AIDS-free generation. Let's examine where we are on our way to that goal.
A recent model known as the HIV treatment cascade helps identify the key opportunities to improve services to stop the spread of HIV (see figure). Getting into the treatment cascade begins with HIV testing, because knowing whether one is infected or not determines the next course of action.
We have evidence that helping people to complete each step in this cascade is crucial both to assuring the individual's health and to achieving the public health goal of an AIDS-free generation. We can use the cascade model to help gain accurate assessments of the "leakage points" in the HIV care and treatment system. By knowing where in the cascade we need to focus, we can provide additional incentives for patients and resources for providers to improve retention.
At the individual level, this means everyone needs to take the initiative to learn his or her HIV status. At the population level, health systems need to make universal HIV testing the norm. Determining HIV status is the first step to applying prevention and treatment technologies that have maximum public health impact.
If diagnosed with HIV infection, the individual continues down the cascade to referral for HIV care, receiving HIV therapy, adhering to HIV treatment and finally lowering the viral load level to immeasurable -- essentially non-transmissible -- levels.
So what stands in our way? Health-care providers hear all the time that people don't get tested because they think their risk of HIV infection is low. Overburdened health-care facilities sometimes drop the ball in referring people for testing. Creative approaches to overcoming these barriers are being imagined every day -- for example, make testing the norm, with opt-out procedures instead of opt-in. The clinical study known as HPTN 065 is using this approach as part of its evaluation of the feasibility of an enhanced community-level test and link to care. Other strategies include offering incentives for being tested, mobile HIV testing outlets with rapid diagnosis, using mass communication to emphasize the importance of early treatment and to encourage people to return for their test results, and utilizing new home HIV test kits.
A person who tests positive must be linked to HIV service delivery points. More barriers appear at this stage. Because they feel healthy, people don't begin treatment. Even more critical, many fear their HIV status leaves them vulnerable to stigma. New policies and social change are needed to relieve more of this vulnerability. Often, the benefits of early treatment -- for both themselves and others -- have not been communicated, particularly when it comes to the newer idea of treatment as prevention. Many have questions about starting treatment early and dealing with potential side effects. These are important questions that we need to address.
More creative and sensitive approaches can help overcome some of these barriers: promotion of the benefits of immediate enrollment through digital reminders, hotlines for clients and targeted communications to those who have just been tested. At the facility level, strengthen the links between testing and care centers. Provide performance incentives for achieving referral quotas. Let's encourage those in treatment to remain adherent by sending reminders through mobile phones, delivering care or medicine to their homes, and establishing peer support.
Different countries are using the cascade approach to improve their HIV service delivery among the populations at highest risk. In Zambia for example, where heterosexual transmission is the dominant mode, the rate of transmitting HIV from mother to child dropped more than three-fold when combining HIV testing with administering antiretroviral drugs to both mothers and newborns.[1] In Vietnam, where injecting drug use has driven the epidemic, finding and treating drug users who have HIV has been a focus for the cascade approach.
We've come so far in the battle against this virus. Today, for those who have access to antiretroviral treatment, HIV can be managed as a chronic illness. Better still, with encouraging scientific breakthroughs in HIV prevention tools, fewer people have to go through the trauma of getting that diagnosis at all. In many places, especially in Africa, men are voluntarily receiving medical circumcisions, proven to help reduce transmission of the virus.[3],[4] Others -- some with the virus, some without -- are taking antiretroviral drugs to prevent HIV spread. Both of these strategies have achieved "proof of concept status," meaning there's good scientific evidence that they work.[5-7] We continue searching for a vaccine to prevent the virus and a cure for those who already have it.
As we pause to reflect on 2012's World AIDS Day, let's resolve to get everyone on board to make the most of the tools we have. We can conquer this disease.
References:
[1] Stringer JS, Sinkala M, Goldenberg RL, Kumwenda R, Acosta EP, Aldrovandi GM, Stout JP, Vermund SH: "Universal nevirapine upon presentation in labor to prevent mother-to-child HIV transmission in high-prevalence settings." AIDS 2004, 18:939-9423.
[2] Vietnam AIDS Response Progress Report 2012. National Committee for AIDS, Drugs and Prostitution Prevention and Control. March 2012.
[3] Auvert B, Taljaard D, Lagarde E, et al. "Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 Trial." PLoS Med. 2005; 2:e298.
[4] Bailey RC, Moses S, Parker CB, et al. "Male circumcision for HIV prevention in young men in Kisumu, Kenya: A randomised controlled trial." Lancet. 2007;369: 643-656.
[5] Grant, Robert, Javier R. Lama, Peter L. Anderson et al. "Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men." New England Journal of Medicine, 363;27. December 30 2010
[6] Baeten JM, Donnell D, Ndase P, et al. "Antiretroviral prophylaxis for HIV prevention in heterosexual men and women." N Engl J Med 2012;367:399-410
[7] Cohen MS, Chen YQ, McCauley M, et al. (2011). "Prevention of HIV-1 Infection with Early Antiretroviral Therapy." N Engl J Med. 365:493-505 August 11, 2011
For more healthy living health news, click here]]>New Contraceptive Approaches Needed Now More Than Evertag:www.huffingtonpost.com,2012:/theblog//3.20456822012-11-02T14:22:46-04:002013-01-02T05:12:01-05:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/major price drop for the contraceptive implant, Jadelle, it has been a banner year for media attention, political will and global resources on family planning and women's and girls' rights and empowerment. As part of these efforts, increasing access to safe, effective and affordable contraceptives will have a profound impact on the lives and health of women and their families throughout the world. To achieve the ambitious goals set forth by these international initiatives, however, the global health and development community must act on the current political momentum and not lose sight of the challenges that remain.
The task ahead is large. Over 220 million women living in low-resource countries do not want to become pregnant and yet are not using an effective contraceptive method. This may seem strange when we have so many contraceptive choices available to prevent unintended pregnancy. However, not only is access to contraception limited for many of these women, but also the currently available methods do not always meet their needs, preferences or budgets. Approximately two-thirds of all women with an unmet need do not use modern contraception for reasons including side effects, perceived harm to health and desire to preserve future fertility. Along with our current method mix, we need to consider new contraceptive approaches that address these concerns.
Women who are using less-reliable contraceptives often find themselves with an unintended pregnancy. Developing new, highly effective methods that improve consistent use could reduce unintended pregnancies in sub-Saharan Africa, South Central Asia and Southeast Asia by nearly 60 percent. In far too many instances, an unplanned pregnancy can lead to unsafe abortion, maternal mortality or other serious health effects for the mother, her baby and her family. Deaths related to pregnancy and childbirth are decreasing globally, but approximately 800 women a day still die from preventable causes related to pregnancy and childbirth. These deaths would be reduced by one-third simply by providing women who have a desire to avoid pregnancy with appropriate methods to plan their families.
We need to expand contraceptive choices for women and couples. Adding new innovative methods to the current method mix and making them affordable and accessible in the poorest countries and settings will address many of the existing limitations. For example, FHI 360 is evaluating approaches to extend the length of effectiveness of injectable contraceptives to six months and to develop a biodegradable implant that would not have to be removed. Moreover, if new methods could offer additional health benefits beyond contraception, such as protection from sexually transmitted infections including HIV, they would appeal to an even broader market and have an even greater public health impact. Current research is evaluating multipurpose technologies such as vaginal rings containing both a steroid contraceptive and an antiretroviral agent.
Unfortunately, global investment required to support research and development for the next generation of contraceptives remains limited. Given the profitability of the existing products and the cost and complexity of developing new products, multinational pharmaceutical companies have largely stopped investing in contraceptive research. Changes in market dynamics may be necessary to attract the pharmaceutical industry back as a source of innovation, especially for low-cost, long-acting methods that meet the expressed needs and realities of the world's poorest women.
Some manufacturers based in developing countries are investing in contraceptive R&D activities. These companies in the global South offer the potential of lower-cost options that will ensure women everywhere -- not just in the developed world -- have access to the newest technologies. However, new product development is a complex, long-term process requiring a long-term investment, which some of these manufacturers cannot afford. Navigating the requirements of stringent regulatory authorities presents another challenge.
Many countries have stepped to the plate to address their family planning situation. Bangladesh remains an inspiration for the world, having confronted and improved women's family planning choices for more than a quarter century. Kenya's national family planning guidelines are a model for their neighbors. At the London Family Planning Conference, 24 nations from the developing world committed more than $2 billion over the next eight years to improving contraceptive choices and access for their populations.
Over the next decade, we owe it to women and couples everywhere to present them with more family planning options. We must infuse the field of contraceptive research and development with the same focus that has been applied to other therapeutic areas. Let's build on the recent family planning momentum and market-shaping mechanisms to ensure that all women are able to achieve their goals to plan their families and their futures.]]>London Family Planning Summit: A Call to Focus on Women's Empowerment and Gender Equalitytag:www.huffingtonpost.com,2012:/theblog//3.16597542012-07-10T09:54:33-04:002012-09-09T05:12:04-04:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/ London Family Planning Summit. Co-hosted by the Bill & Melinda Gates Foundation and the U.K. Department for International Development and supported by the U.S. Agency for International Development and the U.N. Population Fund, the event is intended to elevate family planning as a global health and development priority and generate much-needed financial commitments for family planning supplies and programs.
Given the theme of the Summit, one would expect issues of reproductive rights and gender equality to be front and center. But let's not make assumptions. The conversation often focuses on the new and exciting, like the latest contraceptive technologies and delivery innovations. In the Summit dialogue and subsequent commitments, those issues need to be balanced with commitments to women's rights, reproductive rights and female empowerment, which are inextricably linked -- one cannot be addressed without the other.
Family planning can have an empowering effect on women and girls. Research has shown that using contraception leads to better prospects for employment and working for pay. For girls, avoiding unintended pregnancies allows them to stay in school. Indeed, the social, political and economic benefits that come from supporting women to control the size of their families and the timing of their pregnancies make family planning one of the most important drivers of modern development efforts.
For women, families and communities to enjoy the far-reaching benefits of family planning, the first step is making contraceptives more widely available. But our efforts cannot end there. Preventing unintended pregnancies requires that women are able make decisions about how many children to have and when, have access to family planning services when pregnancy prevention is desired and can initiate and continue use of a contraceptive method as long as they wish to avoid pregnancy. These can be deceptively complex tasks for many women because of the social and cultural environment in which they live. Restrictions on women's mobility and lack of access to transportation and financial resources may limit their ability to seek contraceptive services. In addition, husbands, who tend to desire more children than their wives, often hold greater decision-making power about childbearing, contraceptive use, and the timing and conditions of sex. Women also may not space or limit births because their social and economic status is defined by their ability to bear children.
In short, many women are often unable to use contraception for a variety of reasons rooted in gender inequality.
Even when highly effective biomedical interventions that are focused on the individual -- like contraception -- are available, factors beyond individual control often pose obstacles to their use. Gender inequality and harmful gender norms -- including those that that pressure men and boys to be violent and dominate sexual decision-making -- have long been recognized as obstacles to family planning use and better reproductive health and development outcomes. Structural interventions focused on transforming these norms, upholding women's rights, and promoting greater gender equality must accompany our efforts to strengthen family planning services and increase availability of contraceptive methods. While contraceptive technologies and family planning programs have the potential to empower women, their impact will be greater if underlying structures contributing to women's vulnerability and risk of unintended pregnancy -- including discriminatory social norms, rights violations and economic dependency -- also are addressed.
How will the impact of the London Summit be measured? Certainly, the amount of funds committed for global family planning efforts will be one immediate measure of success. A bit farther down the road, the impact of the Summit might be viewed in terms of increases in contraceptive prevalence and reductions in unmet need for family planning that are achieved from these additional program investments. Ultimately, we will want to know if our commitments have had a transformative effect on women, families, communities and societies -- improving the lives of citizens. Achieving these outcomes will require that women's and girls' rights and gender equality are the foundation of the discussions at the event and the actions that follow.]]>Who Gets the HAART? Policy Implications for a Limited Resourcetag:www.huffingtonpost.com,2011:/theblog//3.11219562011-12-01T07:40:21-05:002012-01-31T05:12:02-05:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/estimates we currently have 6.6 million HIV-infected people on antiretroviral agents (ARV), a number that was inconceivable less than a decade ago. Moreover, the rate of new infections has decreased substantially, by more than 25% in 33 countries, many in Africa. Finally, maternal-to-child transmission has dropped from an annual estimated 500,000 in 2001 to 390,000 in 2010.
Recently, the use of antiretroviral drugs for HIV prevention has commanded center stage.
The HPTN 052 landmark trial provided a jolt of optimism about how effectively ARVs can prevent HIV transmission. HIV-infected participants who received HAART had a 96% lower risk of transmitting HIV to their uninfected partner than those who delayed receiving HAART. Moreover, treated participants also suffered fewer HIV-related complications than those who delayed therapy. Talk about a win-win for both prevention and treatment.
So shouldn't we immediately ramp up access to HAART for everyone in the world who needs it? Of course we should. However, that's easier said than done. Providing universal ARV therapy globally will be expensive. By 2031, an estimated total of $35 billion will be needed to support HIV treatment services in low-resource settings. Even in the next three years, we will need another $6 billion (for a total of $22 billion) to meet the UNAIDS goal of universal access. Yet, in 2010, global AIDS funding was down nearly 10% from the previous year. In addition, the Global Fund for AIDS, TB, and Malaria just suspended awarding any new projects for 2011 because its coffers are low.
While resources dwindle, demand for ARVs continues to rise. Based on current WHO guidelines, nearly 8 million additional persons worldwide could benefit from being treated now. This implies that some form of implicit ARV rationing is already occurring. Our colleagues in resource-limited settings are currently facing ARV stock outs, and health systems are straining under the burden of caring for an increasing patient load. While we continue our utopian calls for universal access to ARV for all HIV-infected people, the world is faced with the grim realities of meeting the demands of present day clinical care.
So who gets the HAART? Right now, decisions are frequently made on a first-come, first-served basis. Many people learn they are HIV-infected when they already have HIV-related illness. They are put on treatment if the supply of drugs allows it. However, where supply is limited, we currently have no explicit guidelines to define criteria about who should be treated.
Thinking of ARV as prevention helps us establish such criteria. To optimize the impact of a limited supply of ARVs, policymakers should consider raising the priority for treatment of those individuals who both qualify clinically for ARV drugs and are most likely to spread HIV infection.
However, this approach raises moral, humanitarian and political problems. Those most likely to transmit HIV infection are frequently the most stigmatized populations in our society -- sex workers with many partners, men having sex with men in high-risk settings, migrant workers with multiple concurrent partners, injecting drug users in high-prevalence HIV injecting networks, and so on. Alternatively, those who society frequently perceive as "innocent" victims -- the HIV-positive monogamous sex partner or the HIV-positive young child -- are not as likely to transmit HIV infection to others.
In a public health model, to optimize limited ARV resources, we must proactively reach out to those HIV-infected persons most likely to transmit. Three specific advances can help achieve this. First, we need to do a far better job of identifying persons already HIV-infected. Second, we need better tools to diagnose acute HIV infection, when people are most infectious. Third, we need better protections for stigmatized, vulnerable HIV-infected populations, so they can play a more active role in prevention.
We must continue to advocate for raising the necessary funding to treat every infected individual. However, if we can't treat everyone, we must make hard choices with explicit criteria to determine who gets the HAART.]]>A Call for Public-Private Partnerships for HIV Preventiontag:www.huffingtonpost.com,2011:/theblog//3.8783492011-06-17T12:26:57-04:002011-08-17T05:12:01-04:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/
During the past year, notable progress has been made in the field of HIV prevention. In July 2010, researchers at the Centre for the AIDS Programme of Research in South Africa (CAPRISA) demonstrated that a topical 1 percent tenofovir gel, administered before and after sexual intercourse, could reduce HIV acquisition by 39 percent in high-risk South African women. The CAPRISA 004 study demonstrates what can happen when women are able to take HIV prevention into their own hands.
Shortly thereafter, the iPrEX study found that a daily pill containing tenofovir and emtricitabine, lowered HIV infection by 44 percent in high-risk men having sex with men. The same pills were used in a third study, FEM-PrEP, but did not find the same encouraging results in high-risk women. However, this research involving 1,951 African women did highlight that product adherence -- how closely people follow directions for taking the drug -- and vaginal drug level are crucial for effectiveness.
A fourth recent study, HPTN 052, showed convincingly that early antiretroviral treatment works as prevention. This study provided antiretrovirals to the HIV-infected partner of couples with different HIV statuses and who would not ordinarily have qualified for medications using World Health Organization guidelines. Those HIV-infected persons who received antiretroviral drugs had a 96 percent lower risk of transmitting to their uninfected partner than those who did not receive drugs. So now we can "kill two birds with one stone" -- first, treat HIV-infected people to improve their personal health, and second, treat them to prevent the spread of the virus to their sexual partners.
As the scientists who led the teams that produced some of these advances, we have seen first-hand the value of close collaboration with our pharmaceutical partners. These achievements were only made possible by the partnership between publicly funded scientists and private drug companies. From the outset of all the studies, drug companies provided their drugs (or the rights to their drugs) at no cost to the study teams. For the studies of antiretrovirals as pre-exposure prophylaxis, Gilead Sciences was the key pharmaceutical player. For the study of treating HIV-infected individuals, study drugs were donated by Abbott Laboratories, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Merck. This collaboration among six companies -- who are usually fierce competitors -- is a testimony to their interest in determining how best to prevent HIV transmission. The planet benefits from such collaboration.
Public-private partnerships are set to deliver even more in the future. For example, Gilead Sciences has made available royalty-free licenses for the gel form of their antiretroviral drug, tenofovir, which has recently been shown to reduce HIV risk in women. In South Africa, which has the world's most severe HIV epidemic, the government has acquired a royalty-free license for tenofovir gel and has partnered with a local pharmaceutical company to produce the gel locally. More governments and pharmaceutical companies must join together to ensure the availability of antiretroviral therapy for HIV treatment and prevention at the lowest possible cost in all resource-poor countries. Providing drugs for governmental use or voluntary licenses for generic versions of patented products, are a way for companies to assure adequate supply.
In addition, governments, non-governmental organizations and the pharmaceutical industry need to collaborate to train health workers to provide HIV treatment and prevention at the community level. Strengthening HIV prevention and treatment services, community outreach and literacy programs, and promoting cross-training among those providing prevention and treatment could be jointly funded by public and private resources.
The recent evidence on the use of ARV drugs for HIV prevention moves us closer than ever before to changing the course of the HIV epidemic in Africa, and indeed, globally. As the world celebrates these scientific findings, we are reminded that the public-private partnership involves being able to both "do good" and also "do well". These win-win examples demonstrate that with effective partnerships, conviction and leadership, overcoming HIV is within our grasp. ]]>On International Women's Day: New Promise for Empowering Womentag:www.huffingtonpost.com,2011:/theblog//3.8308552011-03-08T00:00:00-05:002011-05-25T18:35:25-04:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/Nancy Gibbs in Time magazine, can yield vast returns in terms of health and development impact. But it's a hard battle -- women in many developing societies are deprived of resources and disadvantaged when it comes to protecting themselves from exposure to sexually transmitted disease and having control over their own fertility. As noted by Gibbs, today 1 in 7 girls in the developing world are married by the age of 15.
Empowering women -- making even limited progress in the overall battle -- is a particular challenge when it comes to the dominant global health challenge of the last generation, HIV. Despite increasing investments, more than twice as many persons are newly infected each year as receive treatment. Women represent over half of the currently infected population globally, and as a proportion of new infections, rates among women are still growing in many parts of the world (UNAIDS 2010).
But there is new promise -- for women especially, and for men as well -- when it comes to HIV prevention, promise found in clinical research and mobile technology.
In the past year, two trials have demonstrated that the antiretroviral (ARV) drugs used to treat HIV could also be used to prevent people from contracting the virus in the first place, the Holy Grail of intervention. The first study, conducted among women in South Africa, showed that the use of a topical gel could reduce acquisition of HIV in women by 39% or more. The gel is applied vaginally before and after sex and thereby gives women a tool to protect themselves from infection without having to engage in an often unequal negotiation with partners, as is the case with condom usage.
The second study, this one among men who have sex with men but equally important to women as a proof of concept, showed that use of a pill can reduce HIV acquisition by 44%. The research community is now eagerly awaiting the results of several ongoing trials of this same ARV intervention among women, with the expectation that we will see additional woman-controlled prevention intervention added to our arsenal.
At the same time, the emergence of mobile technologies and social networks is placing power in the hands of women, as they leapfrog traditional communications infrastructures with a minimum of investment, making the networks easier, more widely accessible and less expensive to build out. These mobile technologies have penetrated most rapidly in Asia, the Middle East, and Africa where, by the end of 2011, nearly two-thirds of the population will have access.
Our opportunities as public health professionals, private industry, entrepreneurs, policy-makers, donors and community members to use these tools to improve health outcomes and development efforts are limited mainly by our own creativity. mHealth, the general term applied to all health-focused mobile applications, capitalizes on the acceleration of mobile infrastructure to provide vulnerable people with the information necessary to take a more active role in their own health. The availability of cell phones allows flow of data, access to support networks, appointment reminders. For women, they allow access traditionally denied.
In Kenya and Tanzania, text messaging has already been put to use to distribute schedules for community-based distribution of injectable contraception. Another text-based campaign in Kenya, Mobile for Reproductive Health, gives women access to information about different types of contraception.
Because of its relatively low cost and extraordinary potential for putting women in charge of their health, interest in mHealth has political support at the highest level. Last October, for example, the State Department, together with the Cherie Blair Foundation and GSMA, launched mWomen which aims to cut in half the gender gap in women's access to mobile phones over the next three years.
So where do we go from here in optimizing the benefit of these opportunities for health and development, and in particular, to help women? The first step is to prepare for the rollout of ARV regimens for prevention, ensuring successful delivery to the highest risk populations. Concurrently, we need to hype the proven advantages of mHealth strategies to attract further funding, build infrastructure, and put equipment into the hands of women. This will empower them to live healthy lives, and thereby lay the groundwork for financial stability.
Winning the fight to empower women will require all of us with an interest in global health and development to bring adequate resources, smart and coordinated strategies, and our total commitment to fully developing these HIV-prevention and communications tools. It would be more than a shame not to maximize this moment of opportunity to advance women's empowerment.
]]>New Prevention Advances: Can We Now Imagine a World Without AIDS?tag:www.huffingtonpost.com,2010:/theblog//3.7888602010-11-28T12:33:38-05:002011-05-25T18:15:22-04:00Ward Cateshttp://www.huffingtonpost.com/ward-cates/UNAIDS announced that at least 56 countries have stable or declining incidence of HIV/AIDS. Yet on World AIDS Day this week, there are still two new infections for every person put on antiretroviral therapy. However, a series of promising new scientific results in prevention, including three breakthrough trials in just 16 months, offer the first glimmer of hope that we may finally be able to achieve the "three zeros" -- zero new infections, zero stigma/discrimination and zero AIDS deaths.
Start with male circumcision, which studies in Kenya, South Africa, and Uganda have shown to reduce HIV acquisition by up to 60%. Funders such as the U.S. government, The Bill & Melinda Gates Foundation and several African countries are seizing on these findings -- and WHO's and UNAIDS' conclusion that "the efficacy of male circumcision ... has now been proven beyond reasonable doubt" -- to promote male circumcision actively as part of overall prevention efforts.
Meanwhile, last year's release of the RV144 trial in Thailand, which provided the first evidence of the effectiveness of any vaccine in preventing HIV infection, and the discovery of new broadly neutralizing antibodies have renewed hope in the promise of HIV vaccines in the 21st century.
But perhaps the greatest excitement centers on Pre-Exposure Prophylaxis (PrEP), involving preventive use of antiretroviral drugs already proven in HIV/AIDS treatment. PrEP offers women in particular a prevention strategy for dealing with partners who refuse or are unable to use condoms or whose faithfulness is in question.
The scene was electric in Vienna, Austria, last July when the Centre for the AIDS Programme of Research in South Africa (CAPRISA) - with FHI and CONRAD as collaborating partners - announced that a form of topical PrEP, a vaginal gel containing the antiretroviral agent tenofovir, had been shown to reduce acquisition of HIV infection in women by 39% and of herpes by 51%. An even greater rate of protection -- up to 54% -- was recorded among women able to adhere to the trial regimen.
This CAPRISA 004 trial was the first to show a statistically significant result through use of topical gels -- and subsequent mathematical modeling suggests that tenofovir gel could prevent 1.3 million HIV infections and 800,000 deaths over two decades in South Africa alone.
Next year, the International Partnership for Microbicides will initiate two trials to test another form of topical PrEP, a vaginal ring containing a new antiretroviral drug, dapivirine. In addition, CONRAD recently obtained funding from the U.S. Agency for International Development (USAID) to develop rings containing tenofovir and a contraceptive.
Oral PrEP is also being investigated. Last week, initial results from the IPrEx trial, led by the University of California at San Francisco with funding from the U.S. National Institutes for Health (NIH) and the Gates Foundation, indicated that a once-daily oral dose of Truvada® (tenofovir/emtricitabine) is 44% effective in preventing HIV infection in high-risk men who have sex with men (MSM). As in CAPRISA 004, men who best adhered to the regimen achieved even higher levels of protection.
Results are expected in 2012 from the FEM PrEP trial oral prep trial led by FHI and funded by USAID testing Truvada and in 2013 from the Partners PreEP trial of Truvada and Viread, led by the University of Washington with funding from Gates. The VOICE (Vaginal and Oral Interventions to Control the Epidemic) trial funded by NIH, brings the topical/oral PrEP field together by comparing the effectiveness and practicality of both Viread and Truvada pills and tenofovir gel.
All in all, HIV prevention is on a roll. But major scientific and practical challenges lie ahead. Further PrEP studies are required to validate effectiveness, establish dosage, determine long-term safety, assess impact on sexual behavior and evaluate any effect on HIV drug resistance. But in these days of economic challenges, lack of money for trials is already threatening to slow follow-up research on the CAPRISA 004 and IPrEx successes.
Other practical issues need to be addressed as well once these products are ready for the market. Cultural, marketing and logistical barriers must be overcome to increase demand and, since avoiding development of drug resistance requires PrEP to be used only by people known to be free of HIV, we will need to expand access to education and testing and implement protocols to avoid sharing and theft of prophylactic treatments.
Because the science is so promising, we urge everyone -- from scientists to policymakers to the public -- to use World AIDS Day, Dec. 1 as a catalyst to build on these advances by mobilizing communities to embrace HIV prevention as a social norm and advocate for the funding required for the next round of research. Much work remains to be done, but by building support for these critical next steps, we can also build hope for a future World AIDS Day free of AIDS.
