Is Africa Ready for PrEP?
Adebisi Ademola Alimi
(Updated 08APR11) – One of the biggest breakthrough in HIV clinical research, since the outbreak of the epidemic 30 years ago, is the recent success in a clinical trial of a new HIV prevention approach based on the daily use of the antiretroviral drug Truvada by HIV negative person to prevent HIV transmission (Called PrEP, for Pre-Exposure Prophylaxis).
The results of the iPrEX trial raised hope but also many questions and concerns as showed by the ensuing debate about what the next step should be. Divergences culminated with the Aids Health Foundation (AHF) petitioning the FDA not to consider Gilead’s request for a licence to use Truvada for the prevention of HIV infection and a joint counter response by a number of HIV advocacy organisations. Despite differences, the debate emphasises the importance of the discovery and confirms that we have a very vibrant community of both HIV advocates and clinicians passionate and determined to find a lasting solution to end the HIV epidemic.
But for me as an advocate and an African living in Europe, the most important thing on my mind is “Will Africa be able to access PrEP?” Providing ARV to HIV negative people in Africa needs to be considered in light of the challenge of accessing treatment in Africa, where more than 50% of HIV positive people in the world live (UNAIDS report).
During a community forum organised by AVAC in parallel to the CROI conference in Boston, Julie Davids from the HIV Prevention Justice Alliance asked about the future availability of PrEP for those who needed it most, stressing the danger of PrEP being a “boutique intervention available only to the privileged few”. This point was later repeated by Jim Pickett, director of advocacy for the AIDS Foundation of Chicago, who added that “PrEP is an intervention that has a number of moving parts that all need to be working for it to be safe and effective”. Shouldn’t one of the main concerns be to ensure that the drug would be available for those who need it worldwide? With an estimated cost of the Truvada put at $36 a day or up to $14,000 a year (in the US), what are the chance of millions of poor people in Africa to access what might be a life saving drugs?
What’s more, the new EU trade agreement with India on intellectual property on ARVs and generic drugs that is set to extend protection of Intellection Property for innovation and drug research, will limit further the production and availability of generic drugs in low-income countries. If the war of intellectual property between EU and India is anything to go by, then it is obvious that as far as Africa is concerned, PrEP will most likely be a “boutique intervention” and just another dream for Africans. With African countries currently providing the testing grounds for new HIV prevention approaches we should therefore ask now how and what advocacy can do to ensure that Africa will benefit from contributing to the development of these new interventions. Though this might be a very big question, it will need a proactive African advocacy and the recognition by other well establish advocacy organisations that their advocacy efforts, as well as their concerns, need to go well beyond their borders and that what they advocates (more research, more options) have an impact beyond their borders. Western advocacy for PrEP needs to extend to the rest of the world and take into account that in many African countries advocacy is still in its infancy or does not even exist at all.
Even if PrEP drugs become available, what are the mechanisms in place to ensure that it will not be tribalized in a continent where there are some indications that access to ARVs is based on political and ethnical loyalty and where there are evidences of bribery at the delivery point, misused of funds and a non-negligible ARVs black market leading to ARVs being dispensed to increasing numbers of patients at the periphery of the health system. One has to be skeptical about the PrEP implementation process in this context.
The whole idea of PrEP is to make it available to the person that needs it most. In Africa the dynamics of “people that needs it most” is different from America and Europe. For the latter, the most at needs group is Men who have Sex with other Men (MSM), but in Africa HIV transmission is mostly through heterosexual sex and new infections occurs mostly among young women aged 19-24. However, research has shown (when available as this is a difficult area to research) that the ongoing and increasing criminalization and stigmatisation of MSM all over the African continent results in a higher number of infections in this group than national average. Therefore MSM are becoming a growing concern for HIV prevention as it is very hard to reach MSM and deliver services, thereby failing to control an important part of the epidemic.
PrEP might be a good thing, but the underlying issues of access, human rights, cost, political and moral will power to act will not go away. Despite hope and guidelines designed for countries who could eventually afford it, the people that most need it in Africa will not have access to PrEP before long. If PrEP becomes the basis for prevention as we have seen with condoms, or even just part of HIV prevention, then Africa is not ready for PreP, and that will be another missed opportunity. The forthcoming International Conference in HIV and STI in Africa ICASA 2011 which bring together African advocates, clinicians, government officials and international advocates, and will be a key event to discuss PrEP in Africa and might, hopefully, prove me wrong.
| Editor’s Notes: There are currently five ongoing clinical trials of PrEP running in Africa: VOICE (MTN003), FEM-PrEP, IAVI E001& E002, TDF2/CDC 4940 and Partners PrEP (see AVAC table). A number of ARV-based microbicides trials following in the steps of CAPRISA 004 are also in the planning/funding stage.The cost of Tenofovir, one of the two ARVs present in Truvada is less than USD$8 per month in South Africa (New tender price as of 2011). |
Can you submit an abstract on this for ICASA 2011
With the many side effects of that drug, I’m really not seeing the point of taking Truvada every day. That thing causes some nasty kidney failure. I’m still not getting this whole concept of using Truvada as a daily prophylaxis against HIV. Who are supposed to be taking this drug and why does it have to be a daily thing? Once in 3, 6 OR 12 months should be their target not daily.
We seem to be forgetting these ARVs ain’t like other drugs in the market. They come with some life threatening side effects which I’ve witnessed first hand 🙁
In as much as I would love to agree with you, I beg to seriously differ on the argument you have put forward. Based on what you just said, should we then say that we should not explore treatment and prevention options that are available? Yes Truvada might give kidney failure in some, isn’t it more like the type of health care available in the country you are talking about? In the UK for example, HIV+ people get to see their doctor every month to monitor kidney and other related side effect of HIV drugs and with this they are controlled and reduce the risk. I will love to know if there is anything like that in Nigeria, and if not, could that be the reason then why you witness those incidents you talked about and not that Truvada is a “killer pill”?
I can understand the excitement about Truvada PrEP but these are early days. Exaggerating the results by highlighting the best and sidelining the worst goes against responsible research procedures and even ethics. In the real world, some people will take the drugs as prescribed, some will not. Those who will may even be people who take other precautions or avoid risks, while the contrary may be true of those who will not.
Gilead have left people confused and misinformed and the AHF are right to object to giving Gilead a licence under present conditions. This is not to say PrEP will never work, but it doesn’t work yet.
As for Africa, most people with HIV die of curable conditions like TB and cancer (and not just aids defining cancer, either). Many on antiretrovirals are lost to follow up, a substantial number develop resistance over time, or because of inadequate adherence and few ever get the care they need, they just get the drugs, and sometimes that’s only if they are lucky.
One of the earliest ‘mass’ HIV programs was condoms. Kenya has never been able to create a credible demand for condoms and it has rarely been able to meet the existing demand. A recent article claims people who are short of condoms wash them and use them again, demonstrating a lack of knowledge about contraception, among other things. It also says a lot about the country’s supply chains and infrastructure.
PrEP has not yet been fully teseted for heterosexual prevention and Truvada has not been approved for prevention at all. Perhaps Gilead are already rubbing their hands together at the thought that far more HIV negative people will eventually be taking their drugs than HIV positive people, but so far, this is a theoretically effective drug that will probably only be useful for recreational purposes, allowing wealthy people to have unprotected sex with a slightly better chance of not being infected. But this is still not clear.
The issue of the EU trade agreement with India demonstrates exactly what is going on. Drugs are for profit, even if that means protectionism and that’s all intellectual property is, protectionism. Drugs are not primarily to make people better. And PrEP is not even to make people better, it is for healthy people that, in Africa, are considered to be at risk of HIV just because they are sexually active.
PrEP may or may not protect a few people from HIV infection, at great expense, but this has yet to be demonstrated.
I am on the LGBTI Health Africa listserve. And, someone posted a simple question, is PrEP for Africa? The overwhelming response was no. We dont have enough condoms. We dont have enough water based lubricants. We do not have mosquito nets. We dont have paracetamol. We dont have….. the list goes on and on and on. Most of our seropositive populations are not on ARVs. That is a simple fact. That is the reality of the vast expanse of the population in Africa.
Good day all
Antiretroviral use in Africa is a contentious issue. Not long ago effective ways to control HIV infection did not exist and more recently the roll out of antiretroviral therapy (ART) in Africa seemed unlikely. The development of solutions for global health issues is a dynamic process. It is never easy to find new solutions to health problems. The input and support from individuals, communities, government and international agencies is required for meaningful solutions to be developed.
The health needs of our communities need to be met, and in contemporary Africa, HIV is clearly a priority. Today effective HIV management strategies exist, and despite huge barriers to access, the number of Africans who benefit from ART is increasing. The recent UN report, “Uniting For Universal Access” highlights some of the developments and needs to date. What is clear is that huge steps have been made, even in Africa. The new focus is on achieving universal access – access to HIV care for all, which includes HIV prevention interventions.
In the long term, prevention will always be more important than cure – in terms of cost and sustainability. Current prevention interventions have not been overwhelmingly successful, hence the persistence of the HIV epidemic. A comprehensive package of new, novel, prevention interventions is required, and is under development. New technologies will build on what already exist and what we know to work – condoms, behaviour change etc. An HIV vaccine would be ideal, but is a long way off. Microbicides show promise and so to does the use of ART for prevention.
In order for safe, new technologies to be developed, rigorous scientific research is required, which often needs to occur in a wide variety of situations and geographical areas. PrEP has shown to be efficacious (provide benefit in a clinical trial) among men who have sex with men, part of which occurred in South Africa, as a result of the recent iPrEX trial. This is a promising sign. Other PrEP studies will help answer some of the questions about dosing, use in other populations and safety.
Concerns have been raised over safety, cost and accessibility – these are all valid concerns. However, these are the same concerns raised for all new products, including the use of ART for HIV management. With the commitment of all partners (individuals, communities, governments & international partners) many of these issues can be addressed.
Decreasing drug costs, improved supply chains and improved access to ART for HIV treatment has occurred – and will improve. This same process could be expected of new prevention technologies. Constructive support and criticism can support this process – but current barriers are often overcome through effective partnerships and the use of global determination.
PrEP is a potential component of a novel HIV prevention package. New data will supply answers to many of our questions. New HIV solutions have the potential to be used for the benefit of all – including ourselves as Africans.
Warm regards,
Andrew
Andrew Scheibe | DESMOND TUTU HIV FOUNDATION MBChB, Dip HIV Man (SA) Programmes Manager Men’s Research Division
http://www.desmondtutuhivfoundation.org.za