United Press International - July 15, 2004
Ed Susman, United Press International

Critics had said such a program couldn't work because state-of-the-art, highly active antiretroviral therapy was too difficult to administer; because patients would not adhere to treatment schedules and resistant virus would emerge; and because of the stigma of AIDS, a lack of political will, and a shortage of trained healthcare workers.

Since January 2002, however, more than 27,000 people in Botswana infected with the human immunodeficiency virus, the pathogen that causes AIDS, have enrolled in a nationwide program to receive combination therapy. Of that total 17,387 remain on treatment.

About 86 percent of the patients who have been on treatment for more than six months have viral levels in the blood that are so low they cannot be detected by standard assays -- a marker that they have controlled replication of the virus.

About 85 percent of the patients adhere to their medical regimens, a level of compliance similar to what is seen in clinical trials conducted in the United States and Europe, and a level of compliance rarely seen in real world programs.

"We are showing that not only can we treat people on a large scale, but the people adhere to treatment and they do well on treatment," said Dr. Ernest Darkoh, director of the Masa program, Botswana's attempt to treat everyone in the country infected with the disease that causes AIDS.

"About 300,000 people between the ages of 15 and 49 are infected with HIV in Botswana, about 38 percent of the population in that age group," Darkoh told United Press International.

The program began by treating the sickest of the sick, he said, including many patients with CD4-positive cell counts below 50. CD4-positive cells are a marker of the health of a person's immune system. Since beginning treatment CD4 cells counts, on average, have increased about by 166 cells after 12 months of treatment.

When the count falls below 200, patients begin to experience uncommon infections that are hallmarks of AIDS. Healthy individuals have CD4-positive cells counts above 500.

The Botswana program is a partnership of its government, pharmaceutical giant Merck and Co. and the Bill and Melinda Gates Foundation of Seattle. The group decided to attack the AIDS infection rate by rolling out a nationwide treatment program in rural and urban locations, often opening treatment centers after giving new healthcare workers a one-week crash course in treatment counseling.

To see how well they were doing, Darkoh said: "We took a national sample of 5,000 patients and tested 3,000 of them. We found that 86 percent have undetectable viral loads. We think that is pretty good."

He is not alone.

"The program in Botswana and others, including one in Mozambique, prove that we can accomplish state-of-the art treatment and state-of-the-art results in Africa," said Dr. Stefano Vella, director of the Department of Drug Research and Control of the Italian National Institute of Health in Rome. "To those who doubt this can be done we can say: 'You were absolutely wrong.'"

Vella, a former president of the International AIDS Society, told UPI, "The adherence to treatment seen in Botswana is about as good as you see in clinical trials conducted in the U.S. and Europe, and better than we have seen in clinical practice in the real world. This treatment works and it works well."

Darkoh said patients are treated with a first line HAART therapy -- the dual nucleoside reverse transcriptase inhibitor Combivir (zidovudine and lamivudine) and the non-nucleoside reverse transcriptase inhibitor efavirenz or nevirapine. Efavirenz is given to men and post-menopausal women. Nevirapine is given to women of child-bearing age.

The second line treatment consists of the nucleoside reverse transcriptase inhibitors didanosine and stavudine and the protease inhibitor nelfinavir. Third line treatment replaces nelfinavir with either ritonavir or saquinavir. Presently, he said 85 percent of patients are on first line therapy.

"We are enrolling about 1,000 people a month into the program," said Darkoh, who also is the director of BreachReach Healthcare, based in Washington, D.C.

Vella said while it took too long for antiretroviral drugs to be used in Africa, where 25 million people are infected with HIV, the new treatment programs have an advantage of being able to do it right.

"The use of combination therapy reduces the risk of developing resistant virus because HIV cannot mutate as easily as it did when we were giving people monotherapy in the 1980s and early 1990s," Vella said. "Africa will not have to suffer through the mistakes that we made. The patients in Africa are very compliant with treatment. They are starting the right way."

Ed Susman covers medical issues and research for UPI Science News. E-mail sciencemail@upi.com
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