New Science, New Hope: South Africa Radio Interview Transcript

IPM CEO Dr. Zeda Rosenberg spoke with SAfm Radio in South Africa on August 14, 2010, for its Science Matters program about the milestone findings from the CAPRISA 004 trial showing proof-of-concept for microbicides. In the interview, Dr. Rosenberg speaks about the future of microbicides in the wake of the promising results. Listen to the show at our Multimedia page or read the transcript below.

SAfm Radio:  Well, first up on the show today, we heard about the breakthrough on the prevention of the spread of HIV infection as it was announced earlier this week at the AIDS conference currently under way in Vienna.  Well earlier today, I spoke once again to Dr. Zeda Rosenberg from the International Partnership for Microbicides.   I spoke to her earlier this year, in fact, when the trials had just begun.  But following this good news—most especially good news for women—I asked what the response was at the conference when the news was announced. 

IPM's CEO Dr. Zeda Rosenberg (ZR):  The response was amazing.  First of all, Professors Salim and Quarraisha Karim, who conducted the study, received several standing ovations and cheering, which was, I think everyone said, was the first time they have ever seen investigators receive such a response in a very large plenary room here in Vienna at the International AIDS Conference.  And there were also tears in the room from many microbicide advocates who have been and researchers who have been working for 20 years to try to get to this point and to have such a proof of concept that a microbicide can prevent infection, so it was amazing.

SAfm:  Tears, I imagine, perhaps for all the women who might have been saved if it had happened earlier and tears of joy for all those who are going to be saved.

ZR: Exactly.

SAfm: The implications are enormous specifically for women.

ZR: Well yes, and as you know, this is one study and it showed a 39 percent protective effect, so it is the beginning of an effort to create a very highly effective microbicide and these results are just groundbreaking in the sense that this is the first time there has been seen protection after many, many trials that showed no protection.  And this was the twelfth microbicide efficacy study, so as you can imagine, there have been 11 disappointments and these trials are very intense and take a long time, so to have this result at the end is really wonderful.  And the results do have to be confirmed or should be confirmed. This was one study in one population and we need to make sure that the results work in other populations and I know that many people are now planning on what those studies should be and get them done as rapidly as possible. And at the same time, there is a great deal of effort going into looking to see how the manufacturing of the gel can be put in place in large enough quantities in South Africa. There’s been an agreement between CONRAD, one of the co-license holders of tenofovir gel, with the South African Technology Innovation Agency and other partners to scale up for manufacturing of the gel. So, these efforts—confirmatory data and scaling up for manufacturing—should go hand in hand so  that the product, if confirmed, can be launched as rapidly as possible once the government has approved it.   

SAfm: You mentioned that it’s just one population on whom it has been tried and it was, in fact, a South African population of nearly 900 women.

ZR: Yes, it was. And this was an entirely South African effort so all of the researchers were in South Africa and the South African government did support it along with the United States Agency for international Development. And there were partners that helped in study design and analysis, monitoring, and in the provision of the product.  But the trial was done there and it was done with all of the creativity and design ingenuity of the South African investigators.

SAfm:  And we’re going to need all sorts of creativity and ingenuity to get it out there.  I suppose the next big step will be in terms of education —because scientists know a great deal about microbicides—getting it out there for the use of the average woman, is it going to require a lot of education?

ZR: Absolutely. Because even within the trial, the way the trial was conducted, there was ongoing, consistent educational messages and a huge amount of effort went into working with the women in the trial, and so to translate that now to a general population is going to require, as you said, a lot of creativity. And this will require bringing in people, people who understand marketing and education, and so it’s going to require a big team of people to make sure that its introduction goes as smoothly and as successfully as possible.

SAfm: And the introduction is likely to be when?  Ballpark figure?

ZR:  Well, that’s a really hard question to answer, and everyone has been trying not to get pinpointed on those date, and I would think that I could probably tell you maybe the earliest that it could happen, although the South African government will really be the determining force in this. But if, depending on what kind of confirmatory results are needed and how quickly it needs to scale up, but by sometime in 2013, early 2014 could be feasible.

SAfm: There’s been much euphoria, tears, all sorts of excitement.  Just on a cautionary note—side effects? Downsides? 

ZR: In this study, the product was very safe as tested.  There were no side effects that were noted.  There was a small increase in self-limited diarrhea—it came and it went—but other than that, there were no side effects.  Sometimes confirmatory studies are useful as well because then you have more people taking the product and if there’s a rare side effect, it might be picked up. But so far there have been a lot of studies with tenofovir—and as you know, it’s a proven treatment for HIV—and so, there is an extensive safety database on that and there also is the use of tenofovir for oral prevention, and those studies are going on right now in many, many countries throughout the world, and so there is a lot of safety that is being reported there as well.  But with vaginal application, you get even much, much lower exposure to the drug. 

SAfm: So there’s even more hope ahead.  Easy to use?

ZR: Yes.  These are gels and the regimen, the dose that was used in the study, was up to 12 hours before sex and up to 12 hours after sex.  So on the day that a woman was to have sex, she was to use two applicators of gel: up to 12 hours before and then as soon as possible but up to 12 hours after.  There was a lot of counseling and education and support for the women in the trial to help them use the regimen. In the study, although there was an overall 39 percent protection, in the women who reported and brought back the most applicators that they used, they had a 54 percent protection, so it’s clear that the more you can use the product, the greater its effectiveness will be. And so some women in the trial didn’t have as good an ability to use the product every time they had sex. So one thing that many researchers and product developers are looking at are different formulations that may be useful for women, some that can be used once a day — and in fact there is a trial, called the VOICE trial, that is going on right now in South Africa and in other African countries, that is looking at using tenofovir gel once a day and every day, so that you don’t have to plan for when you’re having sex, you just use it at the same time every day. And that might make it easier for women so they don’t have to plan ahead.  And then there are many people who are trying now to develop vaginal rings and I remember speaking with you not too long ago about the work that we are doing on a vaginal ring with another antiretroviral drug, dapivirine, and there are safety studies right now going on in South Africa of both dapivirine ring and gel and the ring would go in once every 28 days and stay in place. And so I think we learned from the contraception field that there is not one specific form of contraception that every woman wants.  People need choices — women need choices — and throughout their life they need different choices, depending on their status, and so, it is very important that we make sure there is a robust choice for women of different kinds of microbicides with different active drugs and different ways of delivering them.

SAfm: Well, there you have it. Dr. Zeda Rosenberg from the International Partnership for Microbicides.  And if you’d like more information on all of that, you can check their website and I think you’ll find links there—www.ipmglobal.org—ipmglobal.org.  Incidentally, I also asked her about the shelf life for the gel and it is apparently up to 2 years and it needs no refrigeration, making it even more user-friendly than before.