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While millions are spent on HIV/AIDS research geared towards patients in the developed world, very little research is conducted to address the specific needs of populations infected with the virus in developing countries.

Dr. Alexandra Calmy has worked in MSF's HIV projects in Mozambique, Malawi, Cameroon and Cambodia, and is a consultant for the MSF Access Campaign. She explains why HIV/AIDS in the developing world can be considered a neglected disease, what some of the most pressing needs are, and what needs to change.

Why do you call AIDS a neglected disease, when there is so much research going on?
The discovery of antiretrovirals (ARVs) and their combination into a complex triple regimen in 1996 was a real therapeutic revolution in HIV/AIDS, one that saved the lives of the people infected in wealthy countries. Now, the face of the epidemic has changed and there are more than 30 million infected, and 95% of whom live in developing countries.
When a disease affects developing countries, there's no commercial incentive, no trigger to do R&D. Without the R&D, treatment regimens, the management of HIV disease and delivery of care used in developing countries are just adapted from European and US guidelines, without proper evaluation or adapted research.

But there are still so many challenges and we don't really know who will tackle them. AIDS is well studied, the funds are there and we have drugs that are more and more effective in the developed world. The epidemic in wealthy countries is stable. The flipside of this success is that some challenges for the West have disappeared – such as HIV/AIDS in children – leaving little incentive to develop new tools or work on adapting tools for developing countries, where the needs are different.

How are the needs different?
It's an entirely different HIV-infected population, in a different setting, in a different environment and sometimes with a different virus subtype.

Patients frequently also have TB, malaria or other infectious diseases, which are very different from what we see in Western countries. We don't exactly know how these diseases impact HIV and ARVs, and vice versa.

More than half of the people infected in developing countries are women – but very few studies have addressed the way AIDS drugs work in pregnant or lactating women. We don't exactly know how to treat TB in pregnant women with HIV, for example. Children are another critical issue. A child infected at birth needs years and years of treatment, but we just don't have the data, since very few children are infected with HIV in developed countries.

What we've learned and discovered in the developed world is a massive, great revolution, but we still don't have the answers to the big research questions in the developing world.

What about the tools? What tests and drugs does MSF need to be able to better treat patients with HIV?
AIDS requires life-long treatment, which means long-term management of the disease. In wealthy countries, every three months you do CD4 white blood cell counts, and also 'viral load' testing – to see how a patient is responding to treatment. You can't do that in Africa: it's expensive, and you need to send your viral load samples to a reference laboratory in the capital; there's a practical barrier.

We need easier ways to measure viral load, and CD4 counts. Without them, we can't know if a treatment is successful or not, we can't determine when a patient's therapy needs to be switched to a new therapy. And we need diagnostic tests that work in little babies; today we can't detect with a simple test whether babies under 18 months are infected or not when they are breastfed.

For drugs, we lack paediatrics drugs, and drugs that can be used during breastfeeding. We need certain drugs to be heat-stable, since many places don't have access to refrigeration. We need more fixed-dose combination options: for second-line treatment, for babies, as a once-a-day pill for pregnant women.

As you can see it's a long list of needs, and this just some of them.

What are the big difficulties in getting the best available drugs to our patients?
On one side is the access problem - the cost. MSF has mostly been using the most affordable triple fixed-dose combination treatment available. This was developed in India, because before India complied with the WTO TRIPS Agreement, there were no patents on the individual compounds there, so the manufacturers could make a generic three-in-one which really helped us treat many more patients.

But we now know other treatments are less toxic, so we've wanted to replace one of the drugs, stavudine, which can cause significant side effects, with tenofovir. The problem with tenofovir is the cost; it is more expensive than stavudine in part  because there is less competition. We also do not have a generic three-in-one pill with tenofovir.

So the question then becomes: do you want to treat more patients on a more affordable combination, or do you want fewer patients on a better combination, but that is more expensive. It's a terrible kind of decision, but this is the reality for international funders today.

The other side is the delay issue, between the time a drug comes out in the West, and the time we get it to the field. We need the newer treatments to be made available to us quickly to treat our patients. But that takes us back to the R&D problem: what is really difficult is how to use these drugs, as they have not been properly tested in populations we treat. You cannot use a drug if you don't know how it will interact with pregnant women, with children… All this means there are often significant delays – years.

So what would you like to see governments address, as they look into the problems with the research and development system?
We run into the same R&D challenges for AIDS in the developing world as we do with diseases such as leishmaniasis or Chagas. Take HIV in children, it's a disease that doesn't really exist in wealthy countries. So there's little incentive to conduct research for a population that 'doesn't exist'. This needs to change. Innovation that answers developing world needs has to happen. But we don't know who will pay for it; that needs to be addressed.

We're running into a wall when it comes to future AIDS regimens. Newer drugs will now be patented in places like India, where we source over 80% of our ARVs, as affordable generics. India has only been able to make these generics because the drugs were not patented there. But this is changing, and our source of affordable medicines is drying up.

This needs to be addressed urgently, there needs to be a plan to systematically use compulsory licensing to ensure the sources of generic supply are there and fixed-dose combinations can be developed and produced.