U.N. Drug Initiative Hits the Ground
The Joint United Nations Programme on HIV/AIDS (UNAIDS) announced the pilot phase of its HIV Drug Access Initiative last November (see Treatment Issues, Winter 1997/1998). The program addresses the inadequacy of medical care and treatment in the developing world. Four nations were selected to participate in the initial phase: Uganda, the Ivory Coast, Chile and Vietnam. Other countries may use the program as a prototype. The Initiative is about to start in Uganda and the Ivory Coast and will be launched in the other two participating nations a few months from now.
Treatment Issues recently interviewed the coordinator of the Initiative, Joseph Saba, M.D., who spoke about the progress that has been made in the last six months.
Implementing the Drug Distribution Program
Advisory boards in each country will oversee the Initiative, work on national policy and develop criteria to insure that drugs are prescribed properly to eligible participants. In Uganda and the Ivory Coast, the boards are already established at the Ministries of Health. They are comprised of Ministry officials, local public health experts, clinicians, social scientists, community members and personnel coordinating drug distribution.
The Initiative provides broad availability to drugs for opportunistic infections and sexually transmitted diseases to a large number of people. However, due to financial constraints and inadequate health infrastructures, only a limited number of participants will have access to anti-HIV drugs through referral centers.
Although Uganda has 1.6 million HIV-positive people, there are currently only six to eight referral centers. Dr. Saba acknowledged, "By definition it's unfair. But if we realistically tried to treat the 1.6 million Ugandans at once, then it would not be possible. So we have to start here and progressively move forward. Even for a vaccine as simple as polio it took 20 years to reach the entire population."
Securing funding is another obstacle. The budgets for national health are limited and there are many other priorities aside from AIDS. Fortunately, there is some economic growth in these countries that may enable certain individuals to afford the anti-HIV treatments provided through the Initiative at reduced prices. At the onset, the drugs will still be too expensive for all but a small fraction of the population, but the goal is to work toward greater access. An effort is also being made to improve and develop insurance systems to offset the cost of medical care. An additional funding mechanism is being explored in the Ivory Coast to raise money through taxes on gas, alcohol or tobacco.
UNAIDS is contributing medical training for the health care providers on current practices of managing HIV disease and antiretroviral use. The Initiative is also addressing the issue of adherence through psychosocial support. There will be training workshops to develop a standardized approach for providing such support. In Uganda, one of the recommendations of the advisory board is to post social workers and health educators in each center. Participants will receive treatment education and assistance with administrative and social problems.
A computerized system will be used to track participants and drug distribution. Physicians will complete prescription forms that include patient information such as disease stage, viral load and CD4 cell count. Drugs will be managed by the clinic pharmacist who will enter prescription and dispersal data in the stock management system. The program automatically checks the balance of the stock and issues a warning when it is time to reorder.
Clinical experts and advisory boards in the participating countries have made clear recommendations for treatment. Most clinicians prefer starting with double-combination therapy and switching to triple combinations when necessary. In cases of prior treatment or viral rebound, triple-combination therapy is recommended. The double combination is preferred for financial reasons, but also because the triple combination is so difficult. Dr. Saba stated, "From our perspective, the idea is to go ahead cautiously." As with the U.S. guidelines drafted by the Public Health Service, the ultimate goal in developing countries is to reduce viral load.
Pharmaceutical Company Involvement
Discussions are ongoing with pharmaceutical companies to provide drugs at subsidized prices during the Initiative's two-year pilot phase. Companies are not donating the drugs on a charity basis because such an arrangement could not be sustained. The program focuses on balancing the need for a commercial incentive for the companies to remain and the infrastructure requirements and financial environment of each country.
While someone in Uganda could not pay the same price as someone in Europe or the United States, the pharmaceutical companies still need to make a profit doing business in the developing world. Dr Saba stated, "As a public health person, I would like to see the minimum price for the drugs, but we need to be realistic and make it happen over the long run. We need to accept that companies are working for money."
The goal is to provide the widest range of available drugs and diagnostic tests at subsidized prices. Glaxo Wellcome and Hoffman-LaRoche have already promised to participate, and other companies are participating in discussions. The level of involvement and the amount of the subsidy varies from company to company and from country to country.
Efforts to Reduce Mother-to-Child TransmissionAccording to a June 1997 report released by UNAIDS fewer than 500 infants in the U.S. are infected with HIV from their mothers each year. In contrast, 1,000 children are infected with HIV each day in developing countries, virtually all by vertical transmission (mother-to-child transmission). This February, the CDC announced that a Thai study, coordinated by UNAIDS, demonstrated that short-course AZT treatment administered orally after 36 weeks of pregnancy and continued through delivery, but not given to the newborn, reduced the rate of vertical transmission by 51% (see Treatment Issues, March 1998). The wholesale cost for the drugs in the short regimen is about $200, as opposed to $1,000 for the longer course of treatment recommended in the U.S.
The controversial placebo arms were discontinued in all international vertical transmission trials following the CDC announcement. Dr. Saba commented, "I would say I am relieved that the placebo arms have been dropped. I thought this was the way to go until the end since it was the only means of gathering accurate data, but it's not that I was happy with it."
Trials are still in progress to examine even shorter regimens in women who present for health care very late in pregnancy. One regimen starts at delivery and gives both the mother and the child treatment for one week. There are some data indicating that such a regimen could be effective. An observational study presented at the 5th Retrovirus Conference (abstract 244) by the New York State Department of Health demonstrated that AZT administered during delivery or to the infant within 48 hours of birth reduced the rate of transmission to 9.5% (from 31.6% without AZT).
In response to the results of the Thai trial, Glaxo Wellcome offered to reduce the cost of AZT for treating pregnant women in developing countries by as much as 75%. This will bring the cost of the short-course regimen to about $60. Glaxo also announced it would reduce the price of 3TC if that drug proves similarly effective in reducing vertical transmission. A recent study conducted by the University of California, San Francisco, in conjunction with UNAIDS examined the economic feasibility of short-course antiretroviral regimens with AZT/3TC to prevent vertical transmission in sub-Saharan Africa (see E. Marseille et al. AIDS. May 1998; 12(8):939-48). The study found that a reduction in the price of both drugs could make the therapy a cost-effective intervention.
In collaboration with UNAIDS, Doctors Without Borders, UNICEF and other organizations are moving to launch pilot projects in a small number of centers in ten countries (see following article for more information). AZT will be offered to HIV-positive pregnant women to prevent vertical transmission in a context of adequate pre- and postnatal care. Women will be given the choice to breast-feed, although this is a proven means of transmission. (The impact of breast-feeding on the efficacy of the AZT regimen is being studied in ongoing trials). Formula may be provided to those who opt to bottle-feed. The projects are starting in some sites in the next few months and, if feasible, may expand progressively in time.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.