Personally, what do you feel towards
PrEP? How have your feelings changed or evolved from the beginning of this year to now?
DM:
This project has been the most unbelievable learning experience for me. I’ve gotten to sit and speak with the experts in the country about these topics that are very hot right now (learn about the various HIV prevention studies here). So I’ve been very shaped by the interviews that I’ve done and the data that I’ve seen coming out. My feeling is that I’m hopeful and excited by the results, and in the absence of a working microbicide and a working vaccine, I think PrEP has the potential to be an important tool (once we have consistent data on its efficacy, that is). But at the moment, I just don’t know how this is going to happen.
For my doctorate, I looked at adherence to antiretrovirals and interviewed patients before they started ARVs and then followed them for the first two years of their treatment. And I just saw how challenging it is for HIV positive people, who are motivated, to take their pill –how challenging adherence was for them. So what happens when you give a healthy person a pill that makes them feel not too great (though most side effects generally resolve after a month), and they’re not even feeling sick from the disease? What happens if they don’t adhere to the treatment so well, and then you run into the problem of resistance and the overlapping concerns of drug availability, lack of resources, etc. So I’m concerned about how PrEP is actually going to be implemented, what adherence will be like, the potential for resistance, who’s going to pay for it, and where’s it going to happen. It just seems like the implementation of PrEP in the general population will bea minefield. But I think antiretrovirals seemed that way 20 years ago, so I’m hopeful that we can overcome these challenges. We just need to work harder at mapping out a country-specific way of doing this.
In your interviews, did anyone have any specific ideas on how to go about implementing PrEP?
DM: I think there’s a general feeling that we need to understand the data’s inconsistencies, and before that we don’t move into the “how”. Though, even were the data to be consistent, there’s a remaining fear around the “how” – mainly because we can’t even follow the lead of the countries we normally follow sinceour situation with the HIV epidemic is so different. In South Africa, all you need to do to find people at risk is go into a township community and find adults who are sexually active. That’s the state of the epidemic in this country. So, during the course of my interviews, there weren’t a lot of specific ideas about implementation because people are stumped about how, and how financially, and who do we give PrEP to in a country with a generalised epidemic and limited resources?
Interestingly, people were more hopeful about microbicides. The feeling was that we are probably further away in terms of an effective working microbicide, but it might be more feasible if the microbicide was something that didn’t need a doctor to administer it. And this is something I hadn’t even thought about. To me, I always thought of microbicides as the same as PrEP, that you would need a doctor to prescribe and manage it, but a few experts seem to feel that it’s something that might be made available in the same way that condoms are available—you could then just pick it up like a condom or a lube and use it. And if that were to be the case, and I don’t know if it is, then many of the resource and logistical challenges would fall away.
People also liked the fact that microbicides could be used in secret, without disclosure and the risk of stigma. The concern around PrEP is that it would be similar to taking antiretrovirals, in that it’s quite visible—you’d need your pills, and people might hide them to avoid the stigma of being thought of as HIV-positive by others. Whereas a microbicide could look like a sex toy; it could look like a lube and not seem quite so invasive.
Though, in the South African context, a few people did mention how microbicides might run into a cultural challenge as far as adherence is concerned. In some African cultures, one of the things that people like is dry sex, which is the opposite of lubrication. In such a case, a microbicide would go against that, since it would likely be in the form of a lube or gel. So, within some African cultures, when seen in the context of enhancing sexual pleasure, microbicides might not always be seen as a good thing (Learn more about microbicides within the South African context here and here).
What do you think the big trends or questions about PrEP will be for 2012? What are people looking forward to learning or waiting to learn more about?
DM:
People are waiting for WHO guidelines because people aren’t sure how to interpret the data on PrEP from the various trial results (learn more about the various HIV prevention studies here). Also, South Africa in December is going to be releasing our next set of guidelines, which happens every three years and is a big milestone. Essentially, this next set of guidelines is going to dictate what happens in the next three years in South Africa in terms of HIV. So there’s a timing question. We have got some data, but is it enough to implement anything? Should we be rolling out PrEP in men who have sex with men (MSM) who are self-identified high-risk? Should treatment move to 500 CD4 count? Are there little things that we can action? Or do we need more data?
We’re just waiting for more efficacy data around PrEP and microbicides specifically. We’re also waiting for more country-specific implementation data. There’s a general feeling that we need implementation studies, because even if the scientific data is not quite there, we can still work on things like, “If a microbicide becomes available, how will we roll it out?” So the next step is implementation studies—for modalities that are ready, like early treatment for prevention, and for modalities that are still in the pipeline, like microbicides.
What do you think the South African guidelines coming out in December are going to say? Are there any rumours or thoughts about them amongst the people you spoke with?
DM:
I’m not sure what the guidelines are going to say. I think they might say that we’re going to move treatment up to 500 CD4 count, and I think they might say, “Oral PrEP in MSM, who are self-identified, high-risk, and who come forward.” Which, when you think about it, is really all that the guidelines can say. A lot of these discussions that we’re having are theoretical at the moment because we don’t have a working microbicide and we don’t have a PrEP drug with great efficacy.
I think what will be needed going forward are comparisons between the different modalities—it would be fantastic if we could have a trial that compares not necessarily efficacy, but just acceptability and feasibility of an early treatment vs. PrEP vs, microbicides vs. PEP even, and how these would work in the South African context. This is the research we need to start doing, though it requires a bit of a mind shift. We normally start doing implementation studies once we know that something works. But in the case of HIV, every day counts in terms of infection, certainly with an incidence rate like South Africa’s. So HIV might be a unique disease in that it requires implementation studies running concurrently with efficacy studies. We need to get cracking on these implementation studies!
Any other thoughts or observations you’d like to share?
DM: After speaking with so many different people, what was interesting to me was how they all had strongly different points of view. The thing is, if we want to start implementing these strategies, this is a huge undertaking. It’s like saying, “Alright, we’re climbing Mount Everest”, and so we need the team to be on board and we need the team to be walking in the same direction. And I don’t know how we are going to get that consensus. For instance, if you’re talking about early treatment, you’ll have one person saying, “This is a quantum leap from where we are now, and it’s operationally impossible.” And then you’ll have another person saying, “Well, if you have cancer, the doctor doesn’t wait till you’re half dead to give you the treatment, and so we should have been doing this years ago.” And both are very valid points, it’s just how do you get those two people, who are equally important in making this happen, make it happen? I think guidelines might help—if WHO puts out a nice set of guidelines, people might get in line.
Read the first part of Daniella’s interview here. And stay tuned to the Mapping Pathways blog for a detailed snapshot of the various opinions amongst the South African HIV prevention community.
20 JULY 2012 | GENEVA / WASHINGTON DC - WHO has issued its first guidance to countries that are considering offering HIV medications, known as antiretrovirals (ARVs), to protect people who do not have the virus but who are at high risk of HIV infection.
"The authors conclude, “in ART programmes [in sub-Saharan Africa] switching patients to second-line regimens based on WHO immunological failure criteria appears to reduce mortality, with the greatest benefit in patients switching immediately after failure is diagnosed.”"