The following is a question and answer with Dr. Elizabeth Anne Bukusi, Ob/Gyn and chief research officer and deputy director of research and training at the Kenya Medical Research Institute. She is mainly involved in reproductive health research, especially related to HIV prevention and care. Dr. Bukusi travelled to the U.S. to speak at an event discussing how the U.S. can advance global health through new technologies, hosted by the Global health Technologies Coalition Tuesday on Capitol Hill. Dr. Bukusi holds a research associate professorship at the departments of obstetrics and gynecology and global health at the University of Washington.
To watch her video interview responses, please click the play button on the video player images below.
You spoke recently at the Global Health Technologies Coalition event “Sparking innovation to save lives.” Can you tell me the story of the woman you mentioned during your speech?
I told the story about Atieno. Atieno is a common name among the lower Nyanza. It’s a name very often you’d find of a girl who is born at night. At the time of independence, a poem was written about Atieno, a poem that I learned when I was in high school. And this story tells of a young lady who drops out of school, and doesn’t get much schooling, because she’s not a priority for schooling. And she works as a house helper – as a domestic worker in the home that she lives. This happens all over, I believe, sub-Saharan Africa and Kenya. She’s probably related to the people she’s working for, earns very little, and most of the money that she earns probably goes back to help her family back home who don’t have much money, hence the reason for her dropping out of school and not being able to complete her education. She lives in conditions that are less than ideal, probably gets very little to eat, and somewhere in her early teenage years she ends up getting pregnant. As a result of this pregnancy she dies of post-partum hemorrhaging, or bleeding after delivery, and leaves a young daughter who will likely live exactly the same kind of life that she has lived.
And while that was true of Kenya at independence, a good 47 years ago, it’s still true today. Atieno today is not only burdened with the challenge of dying at childbirth, she also has to contend with infectious diseases like HIV. She will likely also have HIV or acquire TB. Her child is likely to die and not even repeat her life because of diarrheal diseases or other infections that will plague this child, especially if born to an HIV-positive mother who may not get care, in which case the child will also be HIV infected. So Atieno’s problems have become worse rather than better despite the fact that so many more years have moved on and we have discovered many more new technologies and are doing a lot of research in the area.
What difference would having a microbicide to prevent HIV infection make in the life of a young woman like Atieno?
Her life could be made different because she would have more choices. She may not have more choices about her education or improve her chances of getting an education. But an effective microbicide will put a tool in the hands of women that lets them protect themselves from possible HIV infection. The female condom has not been made widely available and does still require some element of male cooperation. The male condom is male dependent. Even though a female could initiate or ask for her partner to use it, she doesn’t have control of it. A microbicide could potentially offer women the option of using something that their partner could or could not be aware of. It offers the opportunity for covert use, where negotiation of acceptance of the product is not possible and therefore could provide women with the option to protect themselves from acquiring HIV.
What do you see as the main obstacles to successfully deploying a microbicide in rural and urban communities in sub-Saharan Africa?
I think those challenges would be big, but I think that our greater challenge right now is ensuring we can find a microbicide that does work and that is effective. There will be the challenges of service delivery – how do you make it available, how do you ensure women can actually access it? And then there is the challenge of what we call adherence or compliance. How can people use it consistently and correctly? And that is where technology to some extent comes in. You want to make a product that is acceptable, that is user-friendly, but that also takes away the challenge of maybe the woman having to repeatedly apply it or put it in. Or, if she is in a position where sex was not planned, she still has some kind of protection. That’s where technology and research about technology is so important, making tools that are acceptable, easy to use, and that really do provide protection, perhaps over a long period of time.
What lessons can we learn from the development of microbicides as they relate to the development of other new technologies for the prevention of disease, including and beyond HIV?
I think one of the things that the microbicide field has done well is they’ve really brought a lot of players onto the ground. So, it’s not just first of all let’s find a technology that works, but in that regard how are we going to roll it out. I think right from the start the field of microbicides has been looking at what are the other things that we need to do? How are we going to get the regulators on board? What kind of efficacy would be acceptable to allow registration of the product, and would it be something that has to be done in developing countries, in less-developed countries, would it have to be done in a more developed country for it to be acceptable? Because most regulators want at least two different studies, and they want to look at what setting they were actually done in before they accept registration. And because we expect a very high level of efficacy before it can be acceptable. But, a microbicide that is 60 percent effective – even if we are not talking about a product that is 80 or 90 percent effective like we are talking about with other drugs – a partially effective microbicide could make a world of difference to a whole world of women when you look at it from a public health standpoint. So, the microbicide field has engaged regulators, has engaged governments, has engaged many people to talk about what are the delivery mechanisms. If we have a product that works today, what’s the fastest way to get it out into the field and make it available to women as soon as would be realistically possible. So engage everybody, and make sure there is a wide stakeholder base that is engaged and involved as you develop the product.
The other thing that the microbicide field has done well is talking way ahead of time about the patents and ensuring that the product can be made available at minimum cost to those who need it. Because that’s one of the other things that becomes very prohibitive – when the prices are very high immediately after a product becomes available – that those who really need it can’t afford it, and are not able to access it.
You are currently involved in studies regarding pre-exposure prophylaxis (PrEP) of HIV among discordant couples and a Phase I Dapivirine microbicide trial. Can you tell me about both of these trials?
Let me start with the Dapivirine trial, those have really been early trials, what we call Phase I, looking at safety. Relatively small numbers of sites, looking at safety of the Dapivirine gel and also the Dapivirine ring. Dapivirine is an antiretroviral (ARV) containing microbicide. And for a small number of healthy, HIV-negative women, who we examined these products in just to confirm is it safe, is it acceptable, are they willing to use it, can they tolerate it over the period of time that we ask them to use it. And we have just completed these studies, but the results are not currently available.
[“A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women” is sponsored by the International Partnership for Microbicides, Inc.]
Then you asked about the discordant couples study. There have been a number of PrEP studies that are ongoing – there have been some that have been done with men who have sex with men (MSM), there are others that are focused on injection drug users, there are others that are focused on women that are at high risk that’s the FEM-PrEP study that was recently in the news. The study that I am involved in is focusing on couples that are discordant for HIV – meaning one is HIV-positive, the other is HIV-negative. We are finished enrolling for this particular study. It’s a multi-country, multi-site study (four sites in Kenya, five sites in Uganda) enrolling about 4,700 couples and they’re in follow-up up to next year. The HIV-negative partner is taking a daily pill and they can be one of three arms – a placebo, a drug that has tenofovir, or a drug that has Truvada, which is actually a combination of emtricitabine and tenofovir.
[The “Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples (PartnersPrEP)” study is sponsored by the University of Washington in collaboration with the Bill & Melinda Gates Foundation.]
Are there plans to develop a microbicide ring that is also a contraceptive?
Those are the long-term plans and ideally, a really good microbicide would not only protect someone from HIV but if they wanted, they would be able to also protect from pregnancy. But, we’re still in the early days yet. We first need to find something that protects women from HIV, and the Dapivirine ring will be going in to Phase III trials I believe within the next year. Once we find a microbicide that works, then we want to make it even better. And if contraception is one of the options that a woman would want, the ideal thing would be to make it possible that a woman can have contraception in one device in addition to being protected from HIV.
What does the HIV and TB response look like right now in Kenya – including access to antiretroviral therapy, progress on medical male circumcision, etc?
What we’re seeing right now is there really is a lot of effort to ensure that literally everybody that walks into a health facility has the opportunity to get themselves tested for HIV. Because it’s the point of entry. If you know your status you can make decisions about either ensuring that you stay negative, or if you are positive you can make choices about living positively and accessing treatment at the time you need it.
With regard to tuberculosis, it is very important that every person who is diagnosed with TB also gets tested for HIV, because up to half of those who have HIV will end up also contracting TB, and similarly those who are being treated for TB probably up to half have HIV, whether they are aware of it or not. So it’s really important that people get tested either which way. There are massive efforts to make sure that happens, and that those who get tested for TB know that it’s a treatable condition. So long as they can adhere to the treatment that has been prescribed for them over the duration of time that they need to take it, they can return to health and be declared TB-free.
Kenya I believe right now is at the forefront of providing voluntary medical male circumcision (MC), something that I think government and policymakers and the implementing arms of the ministries offering medical services and public health can be very proud of. We have been able to offer MC to a huge number of men, and I believe we are leading in terms of numbers of men who have been circumcised thus far.
MC also provides a unique opportunity to talk about reproductive health to men of reproductive age. And not only offering the service, but also taking the opportunity to talk about HIV prevention and providing them the opportunity to get tested so they know their status. So I think we are doing well, although we still need to do more to ensure that men who are circumcised do not resume sexual activity early, which could also put them at risk. Also, ensuring that they understand the message that this procedure reduces their risk, but it does not eliminate it, so that they do not thereafter engage in high-risk activities that could then put them at risk of still getting HIV. MC reduces risk but it does not mean that somebody is totally immune and cannot get HIV just because they are circumcised.
What about drug stock-outs?
We haven’t had as many of the challenges in regard to stock-outs of antiretrovirals as our neighboring country Uganda has, from what I read in the news. But it is something that we are taking very seriously and watching out for. I think there is a lot that is being done to ensure that we do not experience stock-outs and the challenges that remain from the implementing side, but so far I have not seen anything to indicate that we have faced challenges in regard to stock outs, but there is a potential danger if we don’t take care.
What we did have a stock out of was condoms a short while ago. An important lesson was yes we did have some challenges in procurement and among all the different coordinating agencies ensuring that we had them on time, but there was a very rapid response that ensured that we did get the condoms at very short notice. For me the lesson was it’s great that people recognize that a condom shortage is a major issue, it’s a national sort of disaster. And it also shows that there is enough education that has gone out, that people are so aware, that there’s a human cry that forms that people cannot get access to condoms. That shows that maybe people are taking decisions about their sexuality and what they want to do with ensuring that they are protecting themselves.
All-in-all, to me, it was a good thing. That it made us aware that people are making choices about what they want to do with their lives.
What has been the impact of the President’s Emergency Plan for AIDS Relief (PEPFAR) program, and do you see the need for continuing investment from PEPFAR?
PEPFAR has been great because it has really provided us with the opportunity to do what we needed to do. It was very, very timely. And the continued support for the PEPFAR programs has been very, very critical. I think all the PEPFAR programs are moving toward trying to ensure their own sustainability and ensuring that there’s ownership within the ministries of health of the PEPFAR countries. So that’s a clear goal
Do I think that the governments will be completely ready to take it over? That’s a difficult question for me, as an implementer. But what I can say is that clearly they are talking about it. And they are talking about how can we make sure, how can the government make sure that they take adequate responsibility for their citizens and provide for them. And they are talking about where would they get that money from, and how can they make sure that the money is available and that the services continue.
What I do know is that it needs a very timely and clear transition so that it won’t be one day the support is available and the next day the support isn’t. That would cost the lives of many, many, many people – I think millions of people if you look at all the PEPFAR countries. And that would be a tragedy. But I think a clear transition plan would ensure that the governments that need to take responsibility are able to and the ministries can take responsibility for providing that care.
A gentleman at the event asked if we are paying enough attention to chronic illnesses, which he said are responsible for about 60 percent of deaths around the world, and whether we should be spending more time and money addressing those diseases. What is your response?
I believe that chronic illnesses are a concern, especially in countries where they have populations that are aging and growing old. But in a lot of sub-Saharan Africa right now the concern is that the younger population doesn’t have the opportunity to get to the point where they can develop some of those diseases that he was talking about – the chronic diseases, the heart conditions or the diseases that are associated with hypertension and cancer. Many of them, rather, are dying of infectious diseases, of diarrhea, of malaria, of complications of HIV. They don’t even get the luxury of being concerned about developing a disease when they are much older. The average age of those that would be considered “older” has dropped significantly in sub-Saharan Africa, so that in some villages if you live to be 50 or 54 you are definitely one of the lucky people because you are considered one of the elders. Life expectancy drops significantly, so that is a concern.