Dilemma of AIDS Patients

For those infected by the deadly HIV virus, drugs cause problems for them. The question now is what really can save their lives?

By Fola Adekeye

Yemi Adebola, an AIDS patient in Lagos has stopped using Combivir, the AIDS drug that doctors at the Lagos Military Hospital prescribed for him, because his condition got worse after he took the drug for two weeks. He told Newswatch last week that he developed swollen legs, respiratory problems, abdominal pains, depressive disorders and fever after taking the drug.

“You need to have seen me before I was given the drug. I had flesh. I was not this skinny. The drug wanted to kill me before my days. I had swollen legs.  I could not breathe well. I could not sit under ceiling fans not to talk of air-conditioner. I lost appetite, I could not eat and at times my breath would cease and I would feel as if I would drop down and die. I quickly discontinued the drug and I resorted to taking aspirin tablets with multi-vitamins,” he said.

Another AIDS patient who simply introduced himself to Newswatch as Vincent in the office of the Nigeria AIDS Alliance in Lagos has a legion of complaints against most of the AIDS drugs doctors have placed him on. At different times he was prescribed Combivir and Videx also known as ddC.  As a result of taking these drugs, he suffered progressive weight loss and manifested other side effects such as dizziness, vomiting and nausea. 

“When I was finding it difficult to get down from my bed last November, I concluded the end has come. The drugs gave me fever, nausea, vomiting, abdominal pain, extreme tiredness, general ill feeling, sore throat, shortness of breath and cough. I was not fatter than the pole of a standing fan before I discontinued with the drugs and chose what I now describe as ‘living positively,’” he said.  

Combivir, Videx and Trizivir are the major antiretroviral drugs that found their ways into Nigeria ’s drug market shortly after the federal government passed a vote of no confidence on locally made anti-AIDS medicines last year. Others were: Viramune, Sustiva, Rescriptor, Epivir, Zerit, Ziagen, Hivid, Retrovir, Crixivan, Invirase, Viracept, Norvir, Agenerase and Fortovase.

Adebola and Vincent are lucky to be alive. Several others were not. Newswatch sources at the Lagos State University Teaching Hospital, Ikeja, Lagos said the drugs had quickened the death of more than 270 HIV/AIDS patients. “For once as a medical doctor, I am in delimma. My duty is to save lives but these drugs present terrible side effects. Last year alone, about 270 people died as soon as they were placed on some of these drugs,” a doctor who refused to be named in this story told Newswatch at the state hospital recently.

These drugs contain poisons and their manufacturers did not pretend that all is well with their products. In the adverts of Combivir, GlaxoWellcome, its manufacturers, admit that  “there have been no clinical trials conducted with Combivir tablets.” It also notes that fatal cases had been reported with the use of Combivir. “A majority of these fatal cases have been in women,” it says.

GlaxoWellcome then warns: “Combivir is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should be advised that the use of Combivir has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Patients should be informed that the major toxicities of Combivir are neutropenia and / or anaemia.”

Many AIDS patients who spoke to Newswatch concerning their AIDS drugs told pathetic stories. It was learnt that no AIDS patient who had taken antiretroviral drugs for unbroken three years are still living. “They all died. People will not believe me because most people believe that the drugs are safe and efficacious because they are very scarce and expensive,” Adebola said.

Yet, all available antiretroviral drugs in Nigeria are to be taken by patients for life. None of the drugs cures AIDS and the HIV virus causing AIDS. Their generic names include: nevirapine, efavirenz, delavidine mesylate, lamivudine, Zidovudine, stavudine, abacavir sulfate, didanosine, zalcitabine, indinavir, saquinavir, nelfinavir mesylate, ritonavir, and amprenavir.

Newswatch visited the Lagos office of GlaxoWellcome on four different occasions to get official reactions on the reported side effects of the drugs. Mrs Adeniji who Newswatch learnt is in charge of HIV/AIDS drugs was always said to be unavailable for comments.

A month’s dose of any of these drugs sell from N50,000. Despite their prohibitive prices, the drugs hold little or no promise of cure or longer life for AIDS patients. The manufacturers of Trizivir say in their adverts that the drug “does not cure HIV infection/AIDS or prevent passing HIV to others. At this time, it’s not known whether taking Trizivir will slow the progress of HIV disease or help you live longer.”

Trizivir is said to have caused “some people to have a life-threatening allergic reaction (hypersensitivity reaction) that can cause death.” Its advert then warns that if a patient discontinued Trizivir because of its side effects, he or she should not switch to either Abacavir or Ziagen.

“If you take any of these medicines again after you had this serious reactions, you could die within hours.  Make sure to see your doctor regularly because serious side effects can occur, such as muscle damage and a decrease in red and/ or white blood cells, especially in patients with advanced HIV disease or AIDS,” Trizivir adverts says.

It emphatically warns: “Trizivir does not cure HIV infection or AIDS. Trizivir has not been studied long enough to know if it will help you live longer or have fewer of the medical problems that are associated with HIV infection or AIDS.”

The Southern African HIV Clinicians Society, SAHCS, documented the major side effects of all existing AIDS medicines. They include myelosuppression, GI intolerance, pancreatitis, peripheral neuropathy, allergic reaction, lipoatrophy, lactic acidosis, lipodystrophy, raised cholesterol and triglyceride, insulin resistance and neuropsychiatric manifestations.

Kolawole Rufus Adigun, an AIDS specialist at the University of Lagos Teaching Hospital , Lagos , explained “myelosuppression” to mean bone marrow suppression. “Myelosuppression means depression of the function of the bone marrow and the function of the bone marrow is to manufacture blood components which include the red blood cells and the white blood cells. The red blood cells, if not produced in the required quantity, the patient will have tiredness, weakness and fatigue as a result of lack of energy. The patient would not be able to do what he is supposed to do,” he explained.

Charles Chuba Okany, special consultant on HIV/AIDS and head of hematological department in LUTH, stated that anybody can have adverse reaction to any drug. “One cannot rule it out. If one drug does not work for you, you switch to another; that is why there are other alternatives in medicine. Hundreds of people are doing fine with Combivir and they don’t have any reactions. They are not complaining. But I do not doubt what you are saying. It happens in medicine. Simple paracetamol can have adverse effects on some people. Medicine is like that. It is not a problem,” he said.

It is a problem. Many therapy failures have been traced to drug failures. SAHCS said no currently available antiretroviral drug is sufficiently potent to provide sustained benefit if used alone.  The society said HIV suppression occurs faster with five different AIDS drugs than with three drugs. It, however, noted that “the synergistic use of combinations of three agents remains the standard of care, and produces a potent and sustained reduction of viral load.”

Highly active antiretroviral, HAART, which recommends multiple drugs for the treatment of HIV/AIDS, is the new response to obvious failing of individual drugs. However, according to SAHCS’s reports, the side effects of supporting AIDS patients with multiple drugs only “increased their risk several-fold.” 

Drugs such as nevirapine, stavudine and ritonavir were more toxic and Hepatitis C and B increases patients’ risk “several-fold.” Says SAHCS: “Many of the side effects of the nucleosides appear to be cumulative, and mitochondrial toxicity is the prime suspect. Perhaps the most severe adverse event is lactic acidosis, which has been responsible for a number of deaths.”

AIDS and the HIV virus causing AIDS have been intractable and scientists and immunologists have not given up the search for their cure. In Nigeria , the preventive and curative vaccines developed by Jeremiah Abalaka, medical director of Medicrest Specialist Hospital , Gwagwalada near Abuja , were banned by the federal government. They were said to be “improperly tried or evaluated in humans before being advertised.”

Curiously, virtually all AIDS drugs imported into the country so far are guilty of that offence. Most of them were only tried on rats not humans before they found their way into Nigeria . Their clinical reports are clinical reports of rats and rabbits. Information on Lamivudine says it was orally administered to rats and rabbits “at 130 and 60 times, respectively, the usual adult dose…. Studies in pregnant rats and rabbits showed that lamivudine is transferred to the fetus through the placenta.” Lamivudine is one of the most widely recommended AIDS medicines in Nigeria .

Abalaka’s vaccines were also condemned by the Idris Mohammed committee on the likelihood that they were “impure and may cause hypersensitivity or transmit serious infectious agents such as Hepatitis C,” said to be another known cause of liver cancer. Curiously also, most existing AIDS drugs imported into the country are equally guilty of these dangerous side effects. Drugs such as nevirapine, stavudine and ritonavir contain toxicity that reportedly causes Hepatitis C and B.

Ibironke Akinsete, senior assistant to the president on HIV/AIDS and national coordinator, national action committee on AIDS, NACA, confirmed in Abuja last week that anti-AIDS medicines have severe side effects. “In the management of patients using antiretroviral drugs, you need to build the capacities of doctors to be able to use these drugs, to be able to know exactly how to monitor these drugs, to know the side effects of these drugs and to be able to deal with the side effects of these drugs. You also need to build the capacities of the patients themselves to know what using these drugs entail, what are the side effects, what to do when they have these side effects and compliance about taking the drugs. They also need support from their families, from the communities because I know a lot of these drugs have major side effects such as nausea and vomiting; their users may have swollen legs, at times they could have rashes but the person who is treating must know how to manage these side effects,” she explained.

Because available antiretroviral drugs are not curative and because they merely prevent the virus from developing into AIDS, people with HIV virus are required to take them for an indefinite period, possibly for the rest of their lives. However, the administration of these drugs is said to be “unsafe” in a country such as Nigeria with collapsed healthcare system. For instance, Nigerians taking the drugs will have the problem of irregular check-ups because only two health institutions in the country conduct such tests. These institutions are the National Institute of Medical Research, NIMR, Yaba, Lagos and the National Institute of Pharmaceutical Research and Development, NIPRD at Idu, near Abuja .

The virology laboratories inside NIPRD and NIMR reportedly do CD-4 and viral load counts, provide the needed sophisticated technical and scientific analysis “which allow treatment measures, prevention measures and cure measures to be carried out.”

Stephen Lewis, UN special envoy to Africa on HIV/AIDS told newsmen after inspecting the laboratories in August last year that they were superb facilities. Speaking specifically about the NIMR’s laboratory in Lagos , Lewis said: “I have rarely seen such laboratory so well planned and so well set out. It is opened at an extraordinarily crucial time when antiretroviral treatment is taking off in Nigeria .”

Both viral load tests and CD-4 counts reportedly cost between N30,000 and N50, 000. Doctors usually advise AIDS patients under antiretroviral treatment to do viral load and CD-4 count tests every month to ascertain their responses to treatment.

With the location of the test centres in Idu and Lagos, AIDS patients to be treated under the federal government’s national free antiretroviral treatment have no option but to travel to these places for tests to ascertain the efficacy or otherwise of the drugs given to them. Newswatch learnt from authoritative sources in Abuja last week that patients who volunteer to participate in the free AIDS treatment programme would bear the cost of treatment tests and travelling expenses to either NIMR or NIPRD. This string attached to the seemingly benevolent gesture by the federal government is said to have scared away the prospective beneficiaries of the programme, creating difficulty for the programme to take off nationwide.  

Taiwo Adewole, a clinical pathologist at NIMR said the participants were expected to undergo tests on their viral load, CD-4 counts, clinical chemistry, haematology, chest x-ray and tests for opportunistic infections. He said for the first three months, the drugs would be administered on 25 patients at each of the 18 designated centres but that the cost of monitoring the efficacy or otherwise of the new untried drugs would be borne by the patients. He said the patients were expected to undergo the various tests every three months, and were expected to pay an average of N30,000 each time they were undergoing such tests at the current rate. 

Adewole said one important criteria for selecting AIDS patients for the treatment trial was ability to continue with the drugs and conduct of essential tests after the federal government’s six-month free treatment trial had stopped. He, however, denied that the programme was essentially designed for rich Nigerians living with HIV/AIDS.   

The designated centres for the treatment trial include University of Ilorin Teaching Hospital, Ilorin; University of Nigeria Teaching Hospital, Nnamdi Azikwe Teaching Hospital, University of Ibadan Teaching Hospital, Uthman Dan Fodio University Teaching Hospital, Ahmadu Bello University Teaching Hospital, University of Port-Harcourt Teaching Hospital and University of Benin Teaching Hospital.

The federal government appeared to be cautious with the much-postponed national free treatment programme for which it has imported some generic AIDS drugs worth N40 million from a pharmaceutical company in India. For the trial of the drugs, the federal ministry of health is said to be looking for treatment-naïve patients. Adigun told Newswatch that these are patients who have never been exposed to any antiretroviral drugs. “Once we evaluate the trial to confirm that the drugs are effective without much side effects and that patients can tolerate them, the drugs would be made available to more people,” he said.

Akinsete told Newswatch in Abuja last week that it was crucially important to have treatment-naïve patients for the trial of the drugs. “If you don’t have treatment-naïve patients, you do not know the effects of the previous drugs they have taken. If you do not know the effects of the previous drugs, how then can you say that the drugs you have given have done this or that? It is better to start on a completely clean plate because this way you would not be addressing problems associated with the previous drugs the patients have taken. If you start on a clean plate, you are able to monitor, you are able to assess, you are able to evaluate patients’ responses to the drugs. It is better that way,” she argued.

More than 3.47 million Nigerians are said to be living with HIV/AIDS.  “The actual HIV epidemic in human terms has increased from 2.6 million HIV-positive adults in 1999 to 3.01 million in 2001. In the general population, it has increased from a gross total of 2.7 million in 1999 to 3.47 million in 2001,” Amina Ndalolo, the health minister of state said.

Additional reports by Eno Reuben and Tosin Omoniyi.

Newswatch Volume 35 No 8, February 25, 2002

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