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ANNOUNCEMENTS:::

TIPS ON MALARIA

  • HOW CAN MOSQUITOES BE CONTROLLED?

    Mosquitoes around the home can be reduced significantly by minimizing the amount of standing water available for mosquito breeding. Residents are urged to reduce standing water around the home in a variety of ways.

  • HOW CAN I PROTECT MYSELF FROM MOSQUITO-BORN DISEASES?

    The best way is to avoid being bitten by mosquitoes.This can be accomplished using personal protecting  while outdoors when mosquitoes are present. Treated bed nets should be used sleeping. Mosquito repellent should be used when outdoor.

  • WHO ARE AT RISK?


    Nearly half of the world’s population is at risk of getting malaria. Pregnant women are particularly at risk of malaria. Children under 5 years are at high risk of malaria.
     

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After the long wait

It is refreshing to hear that after many months of uncertainty a new artemisinin-combination therapy (ACT) is now set to join the collection of recommended drugs for the treatment of uncomplicated malaria in Sub-Saharan Africa where the disease wreaks the most havoc.

When the new ACT drug Eurartesim received approval from the European Medicines Agency (EMA) last year, there were assurances and expectations that African communities would see its early deployment to save lives. That did not happen.

What transpired later was the unconfirmed report that Eurartesim was ready for delivery to Cambodia, the first malaria endemic country to place an order for the newly approved treatment.

Eurartesim, a fixed-dose combination of two antimalarials, dihydroartemisinin and piperaquine (DHA-PQP), is said to be generally well-tolerated and is administered once a day for 3 days instead of twice a day, making the drug more patient-friendly.

Clinical trials reportedly showed that compared to other approved ACTs, Eurartesim provides better and longer protection from new malaria infections.

This was said to be good news for children in high transmission areas who often succumb to another life-threatening malaria episode after they have recovered from the first.

Cambodia was said to have prioritized the use of DHA-PQP as a first line drug and was awaiting EMA approval to allow procurement of this product using international donor funds. 

Eurartesim is already available in France, UK, Germany, Belgium and Portugal, where the number of malaria cases have been the highest in Europe. 

Having submitted the drug for quality and efficacy pre-qualification by the WHO, Sigma Tau mentioned plans to submit Eurartesim for registration in key African countries like Burkina Faso, Mozambique, Tanzania, Ghana and others. 

The million dollar question is how soon.

According to the Principal Investigator of INDEPTH Effectiveness and Safety Studies of anti-malarias (INESS),  Professor Fred Binka, the drug is expected to be looked at in terms of its safety, efficacy and effectiveness in real-life conditions after it has been released on the market.

Eurartesim, developed collaboratively by Sigma Tau Group of Italy and Medicines for Malaria Venture (MMV), is to be tested at the various INESS research sites in Burkina Faso, Ghana, Mozambique and Tanzania.

Prof Binka, Africa’s celebrated epidemiologist, pointed out that a new drug needs to be tested under real conditions in African countries if decisions are to be taken on its use as national policy across the continent.

“It is not realistic that the majority of drugs available in Africa today have been deployed on the basis of safety data generated in Europe, the USA or Australia. Equally bad is the fact that patients are usually not followed-up over a longer period of time to check how they cope with treatment.”

The independent Phase 4 study INESS is going beyond the research by its manufacturer Sigma-Tau which was carried out under controlled conditions and among a smaller size of participants.

In the Phase 3 studies, Eurartesim was tested in about 2,700 patients in Burkina Faso, Zambia, Kenya, Mozambique and Uganda in Africa and in Thailand, India and Laos in Asia. About 1,036 African children aged 6 months to 10 years affected by uncomplicated plasmodium falciparum malaria were tested with the drug.

“Clinical studies carried out on patients treated with Eurartesim have confirmed high cure rates, above 95 per cent” said Marco Corsi, Sigma-Tau’s Medical Director.

“Moreover, compared to other drugs, Eurartesim has shown a secondary protective effect giving almost 50% reduction in the number of new infections in the 2 months following treatment.”

“In highly-endemic countries, where treated patients often become newly infected, this secondary protective effect might have a positive outcome on public health. The marketing authorization for Europe will allow us not only to provide a highly effective treatment to vulnerable populations of endemic countries, where malaria has a devastating impact on health and socio-economic systems, but also to European citizens.”

Eurartesim is said to meet the WHO standards which recommends the combination of two active ingredients in the same tablet - an artemisinin derivative with a high antimalarial efficacy (dihydroartemisinin) and a second antimalarial drug (piperaquine), which helps protect the artemisinin component from the risk of resistance.

Professor Trevor Jones of the Sigma-Tau Group Board of Directors said "Eurartesim is a major innovation in the fight against malaria,” adding that “Although priority areas remain malaria-endemic countries, Sigma Tau is planning to roll-out Eurartesim across Europe, for use by travellers to malaria-endemic countries and for imported cases of malaria in the case of returning travellers.

One stakeholder who has eagerly awaited the introduction of this new drug in Ghana and Africa is Prof Alex Dodoo, Safety Task Team Leader of INESS

Prof Dodoo has eagerly awaited the availability of Eurartesim to enable his safety team to conduct Phase 4 studies to see how it really works.

This he said is necessary because in clinical trials the sample size of study participants is smaller. But after the drugs have been licensed there is the need for what is known as Phase IV trials that.

The INESS project aims to provide national, regional and international health decision- makers with independent evidence on the safety and effectiveness of new antimalarial drugs as a basis for malaria treatment policy in Africa.

Prof Dodoo, who is also the Director of the Centre for Clinical Pharmacology, University of Ghana Medical School, said under the safety module, INESS monitored 20,000 people who had taken artesunate-amodiaquine to document their experience.

Data collection started in October 2009 on a number of modules. These include safety, patient adherence, provider compliance and population parasite prevalence.

“Our modules focus mainly on new or newly-deployed products. “Because it was registered by the EMA, Eurartesim should have no problem with pre-qualification.”

INESS has collected data on effectiveness and safety studies on the current ACTs (ALU, ASAQ) in Tanzania and Ghana.

The INESS platform will be able to provide the evidence needed for informed decisions on policy choices and inclusion of new ACTs into existing anti-malarials policies.

Drug effectiveness and safety are critical for a number of reasons. Most ACTs on the market are efficacious, but estimated to be only 30 per cent effective because of system issues, which include cost, adherence, provider behaviour, acceptability, availability, quality and safety.

There is the need to examine why this happens within the context of the existing health system

Large scale real-life studies hold the key but these are rarely done in Africa. INESS fills this gap and will provide objective country-specific effectiveness and safety data to inform global and national policy and practice.

- By Carlton Cofie- Ghana

 

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