ARVs: Side effects under probe

However, they do not understand why they are all of a sudden ill, yet the same drugs had seen them getting back on the path to recovery.
Stalanev — which is made up of stavudine, lamuvidine and nevirapine — has had severe side effects in some patients.
In some patients it has been so bad that their condition deteriorated instead of taking a turn for the better.
Stavudine has long been shelved in the developed world due to its severe side effects.
Zimbabwe as a developing country and the free programme relying on donations, the drug is still in stock and is dispensed.
A doctor speaking on condition of anonymity said that he stopped prescribing it to his patients three years ago.
“I stopped prescribing stavudine to all my patients three years ago and I replaced it with combivar which is user-friendly,” he said recently.
Pauline, not her real name is a female, aged 30.
She had used Stalanev successfully for one-and-a-half years without any problem.
She started to feel a tingling sensation and numbness of the toes and finger tips.
She said she ignored it initially since it was not painful.
The numbness spread to the palms and the toes of her feet.
That got her worried and she visited her local clinic.
The nurses referred her to Parirenyatwa Hospital.
She said there she did not get much joy, as she was told that it was a phase and could wear off.
Unfortunately, this did not come to be, Pauline’s health took a turn for the worse and she developed a splitting headache.
She was admitted into the same hospital and several tests were run.
X-rays and CAT scan images were clear.
She did not have meningitis which they suspected neither did she have TB, which if affecting the brain presented in a similar way as meningitis.
For a full month she wriggled in pain and in the process will lose her memory.
The family said it was a very difficult time, as they could tell that medical personnel too were baffled.
That she is HIV+ is not refuted, but had responded well to medication for the initial period.
Pauline’s sister said all tests and scans were done without any success.
In the end, visiting her in hospital became a nightmare as she cried that her head was splitting.
“The nurses got fed up with her to an extent that you would find tablets not taken on her table side, so how could she have recovered if there was no adherence, maybe, they had given up since she was HIV positive,” she said.
“The nurses could not believe that she was losing her marbles because she could take a bath and even read when she felt better — but we knew she was not because she kept asking why our mother was not visiting her at such a difficult time, our mom died decades ago,” she said.
The family was asked to take the patient home because there was nothing much that medicine could do to improve the situation.
Sadly, Pauline passed away just before Christmas and the family said they would have loved her to be around but the pain was getting unbearable.
Two weeks ago, I came across a nursing sister who asked me to do a piece on patients suddenly getting ill after they had been doing fine on ART.
I told her that I knew of someone who had reacted badly to ART. I asked why that was so and she said that is what the study was looking at.
The Study-UZ-CRC is researching and evaluating all such cases with the aim of putting them on second line therapy.
In a pamphlet distributed by the study these questions are posed?
1. Are you on ARVs for more than one year?
2. Are you sick or have had problems with thrush?
3. Are you losing weight?
4. Have you had TB or pneumonia?
5. Is your CD4 count falling by large numbers?
If your answer is yes, then you are a potential candidate for the study they are conducting that offers second line anti-retroviral therapy to people who are failing, because of on-going sickness or a large fall in CD4 count.
The study is offered free of charge and they are located at the Clinical Research Centre, Parirenyatwa Annexe Hospital, Cnr J Tongogara/Mazowe St in Harare.
The service is offered on working days, Monday to Friday from 8am to 4pm.
In an interview with Professor J Hakim who is the principal investigator of the EARNEST Study, he pointed out that among other factors poor adherence to medication played an important part in one failing when on ARVs.
There are many other factors which are important in the management of patients on ARVs including proper nutrition .
Prof Hakim answering on the effects of Stalanev clarified the isssue.
“ Stalanev — this is a locally produced combination of Stavudine, Lamuvidine and Nevirapine in one tablet. All ARVs can cause complications, but Stavudine is known to cause many long term complications.
“The pins and needles that you refer to are known as peripheral neuropathy which is an affection of nerves. There are many causes including several drugs, nutritional deficiencies, etc.
“In the case you refer to, the most likely cause is stavudine, but as always a doctor or other health professional needs to carefully look at all the clinical evidence,” said Prof Hakim.
“Secondly headaches can be caused by many conditions. In HIV infection meningitis such as cryptococcal meningitis is important.
“Other causes include TB of the brain, abscesses in the brain, lymphoma (lymph node cancer) of the brain and so on,” said Prof Hakim.
“One should not forget other common non-HIV conditions such as high blood pressure.
“Again careful history, physical examination and appropriate tests including CT scan (computerised tomography scan) are helpful,” he added.
Prof Hakim said the above two cases are very common.
He reiterated the importance of having a CD4 count taken but pointed out that in some case it was foregone.
“CD4 counts are an indicator of how far the immunity has deteriorated. An HIV positive patient who is not on ARVs will have deterioration in CD4 count. Once treatment is started CD4 counts begin to rise.
“If the treatment fails the CD4 count falls. Hence monitoring of CD4 count is a good way to determine these parameters,” said the Professor.
Professor Hakim said the proper way will be to constantly have a CD4 count after a period to monitor one’s health. He also said a patient could be put on ARVs straight away and have the CD4 count done later if the case was bad.
“It is useful to have a CD4 count before starting ARVs if the patient is well.
“But there are certain medical conditions which indicate that the patient is highly immuno-suppressed, so one should not wait for a CD4 count before treatment as long as one has confirmed that the patient is HIV positive.
“A CD4 count done once every 6 months to one year is helpful. It should also be done if one suspects treatment failure,” said Professor Hakim.
“Most public hospitals are overwhelmed by patients and have limited resources as you have observed, they are therefore not always able to do CD4 count as often as required.”
The professor pointed out that Stavudine has many side effects (adverse effects) including peripheral neuropathy (chiwewe) as in (Pauline’s case) above.
“The body shape changes (thinning of face, legs and arms, enlargement of upper back and abdomen, etc known as lipodystropy), and lactic acidosis,” he said.
This is not the first clinical study to be taken at UZ-CRC. Several other studies including the DART study have been successfully implemented at the UZ-CRC.
After the trials, the research will endeavour to ensure continuity and availability of drugs with the help of the Ministry of Health and Child Welfare, since ARVs are not a one-off thing.
In all you endevour to get may you get understanding.
Till then God bless.
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