The Follow-on African Consortium for Tenofovir Studies (FACTS) is a newly-created South African research consortium established to conduct clinical studies to determine whether tenofovir gel is safe and effective at protecting women from HIV and herpes simplex virus (HSV-2). On 25 January 2012, the Consortium held its first annual workshop at Birchwood Hotel in Johannesburg.
Prof. Helen Rees, Wits Reproductive Health and HIV Research Unit
Prof Glenda Gray, Wits Perinatal HIV Research Unit
Dr Steven Becker, Bill and Melinda Gates Foundation
Mr David Stanton, UNAIDS
Honoured guests
Representatives of various organisations
It is my great pleasure to be at this inaugural annual meeting of the Follow-on African Consortium on Tenofovir Studies. FACTS has become one of the Department of Science and Technology's flagship projects in the fight against HIV/Aids. It is appropriate that we collectively assess activities related to FACTS 001 to ensure that the study is contributing critical data to the tenofovir gel development pipeline.
As Donald Rumsfield has said: "There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don't know. But there are also unknown unknowns. There are things we don't know we don't know." The development of an effective microbicide still presents us with challenges and there are many unanswered questions, as we saw last year when it was announced that the VOICE trial had found that the daily use of tenofovir gel did not show efficacy in preventing HIV infection.
Naturally, this was a disappointing setback, particularly in the context of other tenofovir gel clinical trials currently under way. This has shown us, once again, that scientific research and innovation can be difficult and unpredictable, and we must constantly keep in mind that the vast majority of interventions that begin the development process may not make it to commercialisation.
But we must remain optimistic that our concerted efforts will ultimately generate success, which is why the department of Science and Technology has decided to forge ahead with providing support for the FACTS 001 clinical trial, a study that still holds great promise and hope for women in South Africa. We are hoping that more information will emerge and shed some light on the lack of effect seen in the VOICE trial. This provides us with more than sufficient justification for the continuation of the ongoing FACTS clinical trial, which is investigating a different dosing regimen and adherence ration.
The department of Science and Technology will continue to invest in research and development to develop new products, such as microbicides, and keep hoping for a breakthrough for vaccine research and other necessary interventions. The case for the department's involvement in the field of HIV/Aids is clear. HIV is not only a major threat to the realisation of the Millennium Development Goals, but also a serious obstacle to all forms of human development.
I do not really need to give you the hard figures on HIV. You already know them. With an estimated 5,6 million people living with HIV, South Africa's epidemic remains the largest in the world. While advances in treatment have greatly improved the lives of thousands of HIV-infected South Africans, HIV remains a serious and fatal disease. In sub-Saharan Africa, women account for 59% of all infected adults, and women aged 15 to 24 with HIV represent 76% of the total cases in that age group, outnumbering their male peers by three to one. You know that this year, just like last year and the year before, there will be a significant number of new HIV infections, and that the resulting human suffering will affect not only those infected but also their families.
The newly developed strategic plan on HIV/Aids for South Africa has the bold aim of reducing the rate of new HIV infections by 50% in the next five years. All of us involved in the fight against HIV/Aids will therefore have to scale up HIV prevention efforts through science, research and innovation in order to decrease the rate of new HIV infections. In addition, we need to apply what we know about how to tackle the HIV/Aids epidemic on a large scale. In this regard, prevention efforts such as the use of condoms, male circumcision and the increased use of antiretroviral treatments are of critical importance.
The department of Science and Technology's contribution with regard to HIV/Aids research not only addresses microbicides but also includes a comprehensive range of interventions necessary to address the HIV epidemic, such as vaccines, antiretroviral therapies, and the research and development of diagnostics for HIV/Aids. The very high burden of HIV in our country makes it imperative for us to be in the front line in the battle against the epidemic, finding solutions through research and development. With the spread of Aids growing around the globe, we must also encourage the development of new tools to combat this virus, which means a renewed commitment to research. Research is the foundation on which all of our HIV efforts are built.
The latest UNAIDS report tells us that young women aged 15 to 24 in sub-Saharan Africa are as much as eight times more likely than men to be HIV positive. Tools to protect women and girls have to be developed in response to this alarming statistic, which is why the department of Science and Technology provided support for the CAPRISA 004 trials. These provided evidence for the first time that it may be possible to reduce the risk of HIV infection with a microbicide. We are also fully committed to continuing support for the FACTS 001 clinical trials currently under way at a number of sites in South Africa. We are hopeful that FACTS 001 will provide the required confirmation of the safety and effectiveness of 1% tenofovir gel against HIV and Herpes Simplex Virus type 2 observed in the CAPRISA 004 clinical trial, and thus pave the way for licensure and eventual product availability and use by women in South Africa and across the globe.
Given the strategic importance of tenofovir gel studies to South Africa, we are also providing support for CAPRISA to initiate studies to investigate appropriate implementation models for tenofovir gel in the country. These studies will ensure that we are adequately prepared to roll out tenofovir gel to those women who need it the most should the FACTS 001 confirmatory studies provide the necessary evidence for licensing of the gel.
It is also critical that we continue to provide treatment and care to those women who acquire HIV during participation in tenofovir gel clinical trials. Consequently, we are in the process of finalising the necessary logistics and support for CAPRISA in its endeavours to define the optimal treatment for women who become infected using tenofovir gel. This will ensure that research conducted locally continues to inform policies required to turn the tide on the South African HIV/Aids epidemic. All these studies are critical in ensuring that women, who account for the majority of HIV infections worldwide, have a tool that they can use to protect themselves against HIV. We are clear that prevention is the cornerstone of an effective and sustainable response to the HIV epidemic and we are proud to be at the forefront of this agenda.
Ladies and gentlemen, action against HIV/Aids will only be successful if we all work together to build an effective partnership to tackle the threat of the epidemic. With 300 000 deaths from Aids each year in South Africa alone, we need exceptional global efforts to develop and deliver better HIV prevention and treatment tools and strategies. Consequently, South African-led initiatives such as FACTS are imperative in ensuring the research and development of new, safe and affordable HIV prevention and treatment technologies for our local communities. We also acknowledge that this is a global challenge that requires greater effort and collaboration at international level. We cannot do it on our own, and our efforts must be part of the global effort.
The collaborative relationships that have been developed with partners like the United States Government, the Bill and Melinda Gates Foundation and CONRAD are very valuable in this process. This is why we believe a close interaction among the participants that are here today will enable the meeting to take stock of how best to advance HIV prevention research in the context of FACTS 001 and other related tenofovir studies.
In July last year, we officially launched the FACTS 001 clinical trial with the United States Ambassador to South Africa, Donald Gips. It was a momentous occasion for my department and the country as a whole. We in the department also embraced and celebrated the critical milestone when the very first participant was enrolled to the study in October 2011. We are delighted to be part of this journey with the entire FACTS team, and I would like to take this opportunity to confirm the department of Science and Technology's commitment to the study. I would also like to express the department's gratitude to Prof. Helen Rees and her team, and to international partners for their collaboration in making this study possible.
Finally I would like to pay a special tribute the volunteers who are participating in the FACTS 001 trial. Without them, we would not be able to determine whether tenofovir gel is effective. They are the unsung heroes, who have dedicated their all to the fight against HIV/Aids by helping to find answers to critical questions about tenofovir gel.
With these thoughts, I wish you a most productive meeting that will provide inspiration and practical ideas on how to advance the research and development of tenofovir gel.
We look forward to the constructive recommendations that will come from these two days of discussions.
Thank you.
Deputy Minister Derek Hanekom Addresses the FACTS Annual Inaugural Workshop
