|
ARTECOM clinical malaria trials require urgent funding
2006-10-17 08:50:46
By Dr Stan Kebwe (Col.)
Malaria has been a stubborn disease and has claimed many lives with Africa bearing the brunt. The disease which is caused by protozoa called plasmodium and transmitted by Anopheles mosquitoes in the torrid zones of the tropics and Savannah,
is treatable and preventable if scientific pieces of advice are not taken for granted.
For this matter some local researchers and scientists have been experimenting with many combinations to tame the disease and this gave birth to ARTECOM.
ARTECOM is the trade name of an anti-malarial drug combination consisting of tables with dihydro artemisinin (32mg), piperaquine (320mg) and trimethoprim (90mg).
In the 1980s China had developed this combination drug which was found to be curative against Plasmodium falciparum, P.vivox, P. malariae and chloroquine resistant plasmodia infections in China and South East Asia.
The combination was found to treat malaria within 32 hours of administration (less than two days) without serious adverse effects.
Before 1946 malaria was being treated by the use of quinine extracted from the Cinchona plant. In 1946 Chloroquine was synthesized and during the last fifty years chloroquine was the mainstay of malaria chemotherapy.
In the 1990s the malaria parasite plasmodium developed resistance to overcome chloroquine efficacy and the Ministry of Health in Tanzania selected Sulphadoxine Pyrimethamine (SP) to replace the chloroquine therapy.
However, in the year 2004 it was generally recognised that SP failed to cure malaria in the country and focus was directed on artemisinin combined anti-malarial obtained from the plant species Artemisia annua from China.
The high efficacy and synergistic action of ARTECOM were demonstrated by pharmacodynamic studies on mice and monkeys.
In the studies of 975 cases of falciparum malaria with follow up for 28 days, the cure rate of falciparum malaria was 96.9 per cent with recrudescence of 3.1 per cent, randomly compared with mefloquine 1250mg (cure rate 82.5 per cent) 3 tablets of fansimef (cure rate 82.9 per cent), artesunate 600mg/ 5 days (cure rate 86.2 per cent), and mefloquine 750mg + artesunate 150mg (cure rate 70.7 per cent). These clinical studies were conducted in China, Vietnam and Cambodia.
In the therapeutic evaluation of ARTECOM, the drug combination showed the following attributes:
Rapid reduction of Clinical symptoms; fast clearance of plasmodium bio mass; reduction of infective gametocyte; clearance of multi-drug resistant plasmodia; effects treatment within 32 hours; amount of tablets taken by adults is 8 tablets in total; children preparation is in the form of yellow granule with a sweet taste; there are no reports of serious adverse effects during therapy and the cost of the combination therapy being the cheapest among Artemisinin based medicines.
Subsequently the management of TANZANSINO PHARMACEUTICALS found information on the attributes of the Chinese ARTECOM with a view to introducing the drug into the country.
As a result of the meeting held in the Ministry of Health on 8th May 2004, under the Chief Medical Officer attended by the management of TANZANSINO, TFDA (Tanzania Food and Drugs Authority), NIMR (National Institute of Medical Research) and Officers of the Armed Forces.
In the meeting it was resolved that a clinical trial (Phase III) be conducted for Artecom as produced by TANZANSINO and the project was mandated to NIMR (however events have shown that the clinical trial has been inactive due to lack of funds to reach realistic conclusions).
Since the advent of Chloroquine resistance malaria in Tanzania in the 1990s, to date the available malaria regimens have not performed to the satisfaction intended.. The introduced SP therapy was confronted with adverse effects and malaria became resistant in hollow, particularly in endemic areas.
The Ministry of Health was faced with the malaria treatment crisis. But during this period the whole world had focused on artemisinin combined anti-malarials.
Therefore, Artemether (20mg) plus lumefantrine (120mg) is the only artemisinin based combination registered for use in Tanzania since 2001.
There is a strong need for the country to have several efficacious malaria regimens in its drug arsenal rather than entirely basing its dependence on Artemether plus lumefantrine therapy alone.
Because of this phenomenon, WHO has encouraged the clinical evaluation of combination therapy (CT) to improve efficacy and decrease development of resistance to individual drug of the combination. This approach includes Artemisinin based combination therapy (ACT) such as ARTECOM.
Strategically the added value of Artemisinin based combination therapy (ACT), is to increase efficacy and simultaneously delay the onset and spread malarial resistant to partners of the drug combination as observed in South East Asia. It is not yet clear that similar results can be observed in endemic areas of Africa.
Studies reveal that ARTECOM reflects several advantages including a combination of drug increasing efficacy and reducing malarial resistance, its short course of treatment of 32 hours (less than 2 days, its application to both adults and children , lacks serious adverse effects ,registers low cost of purchase with maximum dosage regimen of 8 tablets and decimation of gametocytes.
Based on this discussion, the Ministry of Health on behalf of the government should take urgent action to complete the clinical trial of ARTECOM with NIMR mandate to make available another alternative significant drug regimen.
The writer is a Pharmacologist at Mgulani JWTZ, Dar ws Salaam.
|
