AFRICANEWS

Kenya

Generic AIDS drugs only a first step

AIDS

Kenyan legislation now makes it possible for the government to import cheap generic AIDS drugs, a development hailed by Kenyans and activists around the world. But unless the proper infrastructure and personnel to monitor the use of these drugs is put into place, these drugs might do more harm than good.

Kenyans and AIDS activists around the world greeted the June 12 passage of the country's Industrial Property Bill with joy. The bill - which follows on the heels of similar 1997 groundbreaking legislation in South Africa - enables the Kenya government to import generic AIDS drugs at a fraction of the cost of brand-name medicines.

For the 76 children at Nyumbani Children's Home, a Nairobi facility that cares for children with AIDS, that was especially great news. Before the possibility of parallel importation of generic AIDS drugs, it cost US$500 to medicate every child every month; as a result of this exorbitant cost, only 12 children were able to get the treatment they needed.

After the introduction of generic drugs, the cost has plummeted to an average of US$20 to $30 per child per month, up to a maximum of US$110 for those children with high combinations. Nyumbani has become the first institution in Africa to use generic antiretroviral drugs.

Currently, approximately 2,000 Kenyans suffering from AIDS can afford to use AZT and other antiretroviral drugs that prolong their lives and ease their suffering, according to Dr. Omu Anzala, program manager of the Kenya AIDS Vaccination Initiative (KAVI) and University of Nairobi medical micro-biology lecturer.

With the advent of generic antiretrovirals, drug costs could be up to 90 percent cheaper, says Dr. Margaret Ogola, National Secretary of the Kenya Episcopal Conference's Commission for Health and Family Life. Anzala estimates that the introduction of generic antiretrovirals in the country will allow more than 5,000 Kenyans to take the drugs they need. More than two million Kenyans are living with AIDS, while 700 die each day from the disease.

However, many of the ailing people - Anzala puts the amount as high as 50 percent - will stop the medication prematurely because they feel better, will skip or delay the times when they are supposed to take their pills, will share their medicines with other family members and friends to cut down on costs, or do other things to be non-compliant with the strict drug regimen they are supposed to follow.

And that will bring about a disaster far worse than the current situation, experts warn: the HIV/AIDS found in Kenya could become resistant to the 14 or so antiretrovirals currently on the market to manage the disease.

Antiretrovirals inhibit the production and transmission process of the enzymes and proteins involved in the growth of HIV. When patients misuse antiretrovirals, says Anzala, the process is interrupted, which enables the HIV virus to mutate, multiply, and eventually develop resistance to the drugs used, usually within a three-month period.

When an HIV-positive person is first diagnosed, the doctor measures what is known as the patient's "viral load" (the number of viral particles per milligram of blood) and CD4 count. After assessing the patient's viral load and CD4 count, the doctor then prescribes a particular combination of drugs to inhibit the enzyme and protein production and transmission process.

The viral load and CD4 count should be measured every three months. If the medication is working, the viral load should decrease and the CD4 count should increase. If that is not the case - usually because the patient stops taking, or misuses, the drugs - then the doctor has to come up with a new combination of drugs, as the virus has mutated and become resistant to the medication. This resistant strain can also be passed along to other people, says Anzala.

"We are making them [the drugs] cheaper, but without the information that these are not just your everyday medications," says Anzala. "HIV as it is, without any drugs, mutates so quickly," concurs Ogola. And the result of resistance to the drugs is disastrous, say Ogola and Anzala.

Once upon a time, Chloroquin and Fansidar were effective medicines to treat malaria. However, because people ended up using them to cure headaches, muscle pains, and other conditions that were not confirmed by the doctor to be malaria, these medicines are now virtually useless to treat malaria; many now die of the disease. The same happened with tuberculosis, and now, HIV.

To prevent wide scale resistance to antiretrovirals, medical officials have to come up with several strategies. One of the most important is what Anzala calls "lines of defence." Patients are initially prescribed a certain combination of drugs. If they develop resistance to that combination, there is the next level of combination that they can take. If that doesn't work, there is a third level, and so on. The most powerful drugs are held back as a last resort so as to prevent their resistance.

However, no such plan exists on the books, says Anzala. "We are using all the drugs at the same time. We are not keeping anything behind in case that, should we have a problem, this is what we are going to offer." It takes an average of 10 years for a new antiretroviral to hit the market, he says, whereas the country could develop resistance to AIDS drugs within five years.

Consistent and competent monitoring is another vital strategy. To carry out this monitoring, all major urban centres (such as Kisumu, Mombasa, and other cities) across Kenya need: the facilities to measure patients' viral loads and CD4 counts at least twice a year; competent doctors and other medical personnel to carry out these measurements and prescribe the proper combination of drugs to treat a patient's particular HIV; and medical staff or counsellors to ensure that patients are taking the drugs in the amounts, and at the times, they are supposed to.

But Kenya is a long way from being able to implement this strategy. There are only four centres in the whole country - all located in Kenya's capital, Nairobi - where patients can get their viral loads, CD4 counts monitored, and get the AIDS drugs they need, says Anzala. HIV testing is available even in small villages, but once they've tested positive, patients have to go to Nairobi for follow-up. Even if people can get to Nairobi, the cost of the monitoring - on top of the drugs - is beyond the reach of most people.

Dorothy Onyango, programme director at the non-government organization Women Fighting AIDS in Kenya (WOFAK), says that when patients go to get their antiretrovirals at these centres, they have to stand in "long queues." This discourages many people from going, as they can be publicly identified to be HIV-positive.

Many of the doctors involved in HIV/AIDS care are poorly informed and trained, Onyango charges. She speaks of one WOFAK member whose doctor prescribed the antiretroviral drug Crixivan for two weeks all on its own. "It's an antiretroviral that's supposed to be taken with two other drugs," she says. "She's very ill now. This has come as a result of this medication that she was given."

What happens is that many private doctors will receive samples or donations of antiretrovirals and will give these to the patient in the private clinics, says Onyango. However, when the patient returns some months later, the doctor would have run out of the supply of that drug and would instead give the patient whatever was available in their stock at that moment.

"Our doctors need to be educated on how antiretrovirals can be taken. At the same time, we don't have the facilities for [measuring] CD4 counts and viral loads," she says.

And, it is very difficult for patients to stick to their regimen, especially in the rural areas, says Onyango. For instance, many working women will have taken their drugs in the morning, but miss the afternoon schedule because they were unable to bring their drugs with them. Some people are illiterate, and others have difficulty understanding that, unlike other illnesses that can be treated in a certain time period by drugs, HIV/AIDS will never go away, says Onyango.

"The thing that everybody is forgetting is that you have to take the drugs for the rest of your life," explains Ogola. "It is very hard for me, a doctor, to take drugs for the rest of the seven days of this week, let alone someone else."

On top of all of these obstacles is the fact that unscrupulous businesses and individuals might start coming up with their own quack cures and labelling them as "generic antiretrovirals," experts warn. All generics in use must be rigorously tested, they say.

However, the funding and facilities to do this are simply not available, according to Prof. Gilbert Kokwaro, chairman of the National Quality Control Laboratory, the body responsible for testing drugs. The Daily Nation, Kenya's national newspaper, quoted Kokwaro on May 12 as saying that the laboratory lacked the chemical reagents needed to test the effectiveness and toxicity levels of generic antiretrovirals.

"We require at least US$280,000 to effectively test the efficacy of ordinary generic drugs, excluding the antiretrovirals, for the next two years," Kokwaro told The Nation. "However, since ministry has only allocated an annual budget of US$48, 000, we are currently having a backlog of untested drugs in our stores."

The experts are calling on the Kenya government to come up with standards and guidelines on the procurement and use of generic antiretrovirals. Dr. P. Orege, technical deputy director of the National AIDS Control Council under the Office of the President, says that the council has heard the experts concerns and is discussing the issues, especially installing monitoring facilities in different areas of the country. He says the Ministry of Health has recently released its Antiretroviral (ARV) Guidelines, although AFRICANEWS was unable to track down a copy.

The challenge will be to find the money to put these facilities and services in place, says Orege. He estimates that the Kenya government needs at least US$16 million to make this happen, money that the government plans to ask donors to provide, he says.

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