International Activity Report 2004
MSF and HIV/AIDS: Expanding treatment, facing new challenges
By Alexandra Calmy, M.D., Advisor to MSF's Campaign for Access to Essential Medicines

Signs of success, but a long road ahead Six million people are in urgent need of life-extending antiretroviral (ARV) therapy. Today only 440,000 of them, or a mere seven percent, have access to it in developing countries.

Koeut Chrel (38) is HIV positive and receives antiretroviral treatment from MSF in Cambodia. He lost his leg in a landmine explosion while serving in the army. He did not know his HIV status when he married. Both he and his wife were tested for HIV, found positive and sent to MSF's chronic diseases unit in Siem Riep. Thanks to his faithful adherence to treatment, he can now work. The couple has three children. Two of them have tested negative for HIV, the youngest has yet to be tested. Photo © Espen Rasmussen

MSF has been caring for people living with HIV/AIDS since the mid-1990s. In 2001, the organization started offering ARV treatment to patients in Cameroon, Thailand and South Africa. A sharp decrease in prices caused by generic competition and the simplification of treatment protocols, including the use of three-in-one "fixed-dose combinations" (FDCs) enabled MSF to rapidly increase the number of patients using ARVs in its programs. In the past two years, MSF's AIDS treatment programs have jumped from 1,500 patients in 10 countries to 13,000 patients in 25 countries. ARVs have transformed the lives of those receiving them, allowing them to work and have normal lives. If these 13,000 patients had not begun ARV treatment, MSF estimates that at least half of them would have died within one year.

MSF's patients live in capital cities, slums, remote rural areas and regions in the midst of armed conf lict. More than half of all of those treated by MSF are women of childbearing age, and there are high numbers of children in need of ARV treatment. Patients tend to be in very advanced stages of HIV/AIDS before they seek treatment and are often affected with one or more complex co-infection such as tuberculosis (TB).

The aim of MSF's ARV programs is to provide comprehensive care for those living with HIV/AIDS. That means projects include prevention efforts (health education, prevention of mother-to-child transmission of HIV, condom distribution), voluntary counseling and testing, nutritional and psychological support, care and prevention of opportunistic infections and ARV treatment.

MSF has gained substantial knowledge and learned important lessons from its hands-on experience treating people with HIV/AIDS, but the organization does not pretend to have developed a unique model for implementing large-scale ARV treatment programs. The responsibility for scaling up comprehensive HIV/AIDS treatment programs rests with governments which have a responsibility to provide adequate health care to their people. Of course these governments will continue to need massive sustained technical and financial support from international donors and the World Health Organization if real progress is going to be made.

The fact that more than 13,000 people are now receiving life-extending antiretroviral (ARV) treatment through MSF is encouraging. However, huge numbers of people still lack treatment – far beyond MSF's capacity for providing care. Doctors and nurses today face real challenges in giving urgently needed treatment. Limitations on existing care options continue to block treatment for the millions who need it now. MSF is calling for more to be done to dismantle these barriers now.

The need for more treatment options MSF promotes fixed-dose drug combinations (FDCs) to treat people with severe AIDS. By combining various medicines within a few tablets, FDCs improve treatment compliance, simplify usage guidelines and help prevent dosage errors. Yet there is only one triple FDC now available in our programs and this does not solve all of the related treatment problems. For example, patients co-infected with tuberculosis (TB), the most common opportunistic infection affecting people living with HIV/AIDS, cannot use this simple treatment. This situation has to change as TB is intrinsically linked to AIDS by the growing number of co-infections. Globally an estimated 12 million people are now living with both diseases. In some southern African countries with high HIV prevalence, up to 70 percent of the people who have TB also have HIV/AIDS. Diagnosing TB is difficult in HIV-positive patients. Clinical diagnosis is also more difficult in co-infected patients as weight loss, swelling of the lymph nodes and pulmonary infections can be caused by various AIDS-related infections as well as TB.

Every year an estimated 2.2 million women with HIV/AIDS give birth. Treatment is now available to prevent transmission of the virus from mother to child. But experience has shown that exposure to a single dose of the drug, nevirapine, used at delivery to protect the newborn may induce resistance in the mother and therefore reduce the effectiveness of ARV therapy if the mother needs treatment later.

A glaring lack of medicines for children

The estimated worldwide number of children living with HIV/ AIDS was more than 2.5 million in 2003. Around 50 percent of all children with HIV/AIDS die before reaching the age of two. Efforts to prevent transmission of the virus from mother to child have been largely successful in developed countries meaning that relatively few children are born with HIV. Ironically, the low number of pediatric patients in developed countries means there is little profit to be made by developing and manufacturing pediatric treatment formulations there. As a result, these formulations are not available in developing countries despite the growing need for them. This means children with HIVAIDS do not benefit from active research and have no access to affordable and easy-to-take treatment.

" HIV treatment for adults is slowly becoming easier, with increased availability in developing countries of a three-drug cocktail in one tablet. But children who need treatment still have to drink large amounts of foul-tasting syrup or swallow large tablets – that's if they can actually access treatment at all." – David Wilson, M.D., medical coordinator, MSF, Thailand

While MSF began treating children with ARVs in early 2002, only five percent of the organization's patients were children under 13 by March 2004. MSF is now attempting to include more children in its AIDS projects but those efforts are frustrated by the lack of proper tools. Most methods used to diagnose HIV are unreliable in children younger than 18 months old. The lack of pediatric ARV formulations makes determining and administering doses complex and burdensome. Doctors are forced to break tablets in two or crush and dissolve them. Care providers have to give small children foul-tasting syrups and large pills. Syrups and oral solutions are not suitable for older children because of the large amounts needed, but low-dosage tablets and capsules are not produced for most ARVs. What pediatric formulations do exist come at a high price. Both first and second-line ARV treatments for children cost several times more than those for adults.

When first-line treatment is not enough

As a medical humanitarian organization, MSF feels a responsibility not only to start people on ARVs but to ensure that their lives are improved and prolonged. This means being able to detect when a first-line treatment no longer works and it is necessary to switch to second-line drugs. From experience in developed countries, MSF knows that the benefit of a first-line combination treatment will not be indefinite for most AIDS patients. People can develop resistance to the medicines they are taking. Patients can also develop side effects that cause them to discontinue treatment. Yet there are few therapeutic choices beyond the first-line and the challenge is to know how long patients can be kept on first-line regimens without threatening their future treatment options and their long-term prognosis. In developing countries, monitoring treatment effectiveness remains very difficult due to the largely unaffordable or impractical equipment that is commonly used.

" If we have no way of telling when first-line treatment no longer works and no affordable alternative for people to switch to, we will have failed our patients." – Alexandra Calmy, M.D., MSF

However, there is no point in diagnosing treatment ineffectiveness if there is no affordable second treatment combination to prescribe instead. Second-line treatments can be more than 20 times more expensive than first-line therapies. Unless things change, the cost of treatment will increase dramatically over the next few years in most countries because of the need to switch patients to expensive second-line treatment. Mortality will also increase if people and the health systems that serve them cannot afford the treatment they need once first-line treatment no longer works. With treatment costs already a concern, second-line treatments only increase the problem. MSF and others must continue to fight for price cuts on new treatments and in particular, on second-line treatments, as they become an indispensable part of our programs.

In an ideal world, there would be one universal FDC that would be suitable for patients with co-infections (such as TB) and for children and other groups with special needs. It would be non-toxic, lack side effects and be highly effective. However, this perfect tool does not exist. For that reason, health care providers need more options to treat HIV-positive patients who also have TB, who are children, who are pregnant or for whom first-line treatment no longer works.

Protecting access to treatment

After the World Trade Organization's TRIPS Agreement on intellectual property rights is implemented in 2005, access to new drugs will become more difficult. All new drugs will be subjected to 20 years of patent protection in all but the least developed countries. This will affect producers in key manufacturing countries such as India. It will drive up prices and make new medicines more difficult to obtain. Generic producers will be blocked from developing FDCs until patents expire. MSF believes patents should never be a barrier to treatment. This means the public health safeguards in intellectual property law, affirmed in the 2001 Doha Declaration on the TRIPS Agreement and Public Health must be used to protect access to treatment.

Increased attention on the need to expand treatment has not yet been translated into real action in countries hit hard by the epidemic. Governments, international donors and health care providers, including medical NGOs must mobilize the necessary financial and human resources to make ARVs available to those who need them.

The HIV/AIDS pandemic won't be defeated with existing tools. Yet ARVs are the only option we now have to prolong life. Innovative strategies to provide ARVs more efficiently to patients who need them have to be developed. We must be more ambitious and invest resources into vaccine research, immunotherapy and other easy-touse therapeutic approaches too. At the same time we need to boost efforts to simplify current treatment and monitoring tools. MSF's experience in the field shows that ARV treatment is possible, even in the poorest and most difficult settings, despite the challenges ahead. With more than 13,000 patients on ARVs and about five times as many AIDS patients in our consultation rooms, there is no time to lose in addressing these treatment obstacles.