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When officials with a German pharmaceutical firm announced in July 2000 that the company would make its HIV antiretroviral drug nevirapine (Viramune) available to any pregnant women in sub-Saharan Africa who need it for the prevention of mother-to-child transmission (MTCT) of HIV, they thought their biggest problem would be to meet the flood of demand.
They were wrong.
"When we began, we thought our supply chain would be overwhelmed by the number of requests," says John Wecker, PhD, an HIV specialist and coordinator of HIV activities in the developing world for Boehringer Ingelheim of Ingelheim, Germany. "What happened was that in the end it turned out we’ve given away very little drug to date, although it is increasing," Wecker says. "The major obstacle has been the lack of quality health care capacity within most of these developing countries."
Boehringer Ingelheim’s experiences can serve as both a model for and a lesson to other drug manufacturers who plan to make HIV medications available at no or very low cost to the developing nations hit hardest by the pandemic. "Preventing mother-to-child transmission is not just having the drugs available; it’s much more," says Dirk Buyse, MD, international program officer for the Elizabeth Glaser Pediatric AIDS Foundation in Washington, DC. "The essential components are, first, to have voluntary testing and counseling on HIV and MTCT," Buyse says. "When you look at an MTCT program, the cost of the drug component is less than 5% of the total budget of the MTCT program."
Programs that seek to prevent MTCT also could serve as models and leaders for future HIV antiretroviral therapy treatment in the developing world, says Connie Osborne, MB.Ch.B, the MTCT voluntary counseling and testing focal point for UNAIDS in Geneva, Switzerland. (See "MTCT programs work in a variety of ways," in this issue.) "Initially, we were overly enthusiastic and we thought countries would just jump at it, but MTCT programs in developing countries are relatively new," Osborne says.
Now as more pregnant women are being reached through the programs that will distribute free nevirapine, perhaps the next step will be to provide follow-up care to these women so they might also receive antiretroviral therapy, Osborne says.
UNAIDS is promoting such an extension of MTCT prevention programs through its new MTC Plus initiative, which advocates drugs for the treatment of mothers who are living with HIV. This may also help slow the sub-Saharan region’s tremendous growth in orphans. But none of these programs are cheap or easy, as Boehringer Ingelheim has learned.
In the case of providing nevirapine, an economic analysis by Boehringer Ingelheim and the German government showed that to prevent MTCT in Uganda, Kenya, and Tanzania, the value of the drug represented only 1.2% of the total investment needed to establish MTCT programs, Wecker says.
The other expenses come from identifying, hiring, and training counselors; making physical/ medical services available; providing necessary transportation and information to bring pregnant women into the health care system; providing women with antenatal care; providing nevirapine therapy; and providing quality postnatal care, Wecker says. Then there’s the issue of infant feeding: Is it safer for women to nurse their babies, even when there’s the potential for transmitting HIV, or do women have clean water available with which to mix infant formula?
However, as Boehringer Ingelheim officials learned, the key is to take what little infrastructure is available and work with it. The German pharmaceutical company has begun to work with nongovernmental organizations (NGOs), physicians, charitable organizations, and others who directly provide health care services to the poor in developing nations. Also, the company hired Axios International of Dublin, Ireland, to organize the distribution of nevirapine to sub-Saharan Africa.
"When we went to the NGO level, we heard that the number of applications for the drug will begin to increase dramatically," Wecker says. "And so that’s one thing Axios will do for us: Help us manage the sheer load of applications we’re hoping to get."
Axios will ensure that the requests for nevirapine match the organization’s ability to distribute the drug, says Joseph Saba, MD, chief executive officer of Axios. "We basically open the dialogue in programs, discuss ethical issues, and make sure we’re comfortable that these programs have established an infrastructure and will be able to implement what they say they can implement," Saba explains. "Many of these programs have a good idea and are well thought through," Saba adds. "But some of them are coming from people who have their hearts in the right place and want to do something, but they don’t have experience in calculating doses correctly."
There have been examples of programs in a country where the HIV prevalence rate is 6% that made a forecast of needing 20,000 doses of nevirapine. Then when the situation was further explored, it was discovered that the program really could only handle 800 doses at the start, Saba says. "We don’t want drugs expiring on the shelves," Saba adds.
The logistics of distributing even a simple therapy of nevirapine can be difficult. The therapy to prevent MTCT of HIV involves giving the pregnant woman one 200 mg tablet during labor, followed by a less than one milliliter of suspension drug given to the infant within 72 hours after birth, Wecker says.
But here is where such simple therapy for an affluent nation becomes complicated for a poor country: The pregnant woman may see a physician at some point before her due date, but there is little guarantee that the woman will return to the same clinic when she is in labor, Saba says. Further complications involve the fact that only an estimated 5% to 10% of pregnant women in sub-Saharan Africa and other parts of the developing world know whether they are HIV-positive, and their clinicians have no fast way to discover their serostatus as the women go into labor. This means that for a drug giveaway program to prevent MTCT successfully, it would need to include testing and counseling facilities for pregnant women.
"They would need to hire counselors and very simply have a private room where the counselor can sit down with the women and discuss HIV and testing, and then, with HIV-positive women, explain to them what it means to be HIV-positive and how they can get help," Saba says.
Now, more than a year since beginning the program, Boehringer Ingelheim is making progress in distributing the drug to pregnant women. So far there are 19 projects in 12 countries that are part of the Viramune Donation Program for the prevention of MTCT, and these projects have ordered enough drug to treat 49,800 mother-child pairs. The countries involved include Congo Brazzaville, Ghana, Guyana, Kenya, Namibia, Nigeria, Rwanda, Senegal, Sierra Leone, Uganda, Zambia, and Zimbabwe.
Wecker’s advice to other pharmaceutical companies offering free or deeply discounted antiretroviral drugs to poor nations is to anticipate these types of infrastructure problems before starting the program. "You can’t underestimate the lack of health care capacity," Wecker says. "Whenever you set your goals, you have to take into consideration the realism and the reality of what’s there and what’s not there."