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Malarone (atovaquone + proguanil) in long-term prophylaxis

Anopheles freeborni pumping blood. Source: CDC, Division of Parasitic Diseases   http://www.cdc.gov/malaria/about/biology/mosquitoes/index.html

How long might take malaria chemoprophylaxis with atovaquone + proguanil (Malarone)?

In travelers to incur the high costs of the product, or if those costs are borne by the employer, as occurred under the obligations imposed by legislation to protect workers, the combination of atovaquone + proguanil may be interesting for the long-term prophylaxis. Initial studies were limited to 28 days of employment so that, in Europe, Malarone is registered for prophylaxis of no longer than that period of time. As is known, this information is still located on the technical effect in European countries .

However a survey conducted in 2004 among the countries belonging to TropnetEurop showed that in 15 European nations, the recommendations on the maximum duration of prophylaxis with Malarone varied considerably, in a range between 28 days and 6 months (1).

There is evidence suggesting a potential health risk resulting from the use of Malarone for trips longer than 28 days?

There is no evidence to that effect. The available evidence suggests the absence of toxic effects after prolonged use of Malarone. Have been published to date three observational studies that have shown no health risks as a result of the prolonged use of this product. The following table shows the main features of the three studies.

Target Population	Number of participants	took chemoprophylaxis	Reference
300 Danish soldiers	184 (61% of target)	6 months	(2)
154 adult travelers with contraindication or intolerance to mefloquine	154	4, 5 to 34 weeks	(3)
287 adult travelers	169 (59% of target)	4 to> 78 weeks (the Most: 4-13 weeks)	(4)

All three studies show some limitations: the involvement of a limited sample of subjects, the absence of a control group, failure to supervise the actual drug intake and the subjective component is always present when the data are collected through a questionnaire administered to the patient.

In any event, even taking into account these methodological limitations, we can say that the results of three studies do not raise concerns about possible negative health consequences if atovaquone + proguanil is used for more than 28 days.

In the U.S. the FDA has not applied restrictions on the use of Malarone, as the technical details that apply in the Country (5). In Europe, the influential National Travel Health Network and Centre (NaTHNaC) hereby pronounce on the subject:

There is no evidence of harm to a long-term use, [Malarone] can be assumed with certainty until a year or more. However, atovaquone / proguanil should be prescribed long term with a focus until further data become available (6).

And in the case of persons whose activities require extra vigilance and attention?

workers are generally engaged in activities in which the focus can not be compromised, such as the pilots who for a time engaged in areas at risk of malaria.

Until now it has been only one published study on this issue, which involved 28 subjects belonging to the Canadian Air Force, of which some parameters were examined in relation to neuro treatment with Malarone. There were no adverse effects on psychomotor performance, mood, sleep and fatigue (7).

Bibliography

1. Wichmann O, Behrens RH and Jelinek T. Malarone for malaria prophylaxis – differences in national recommendations across Europe . Euro Surveill. 2004;8(11):pii=2403. Available online: http://www.eurosurveillance.org/images/dynamic/EQ/v04n01/v04n01.pdf

2. Petersen E. The safety of atovaquone/proguanil in long-term malaria prophylaxis of nonimmune adults. J Travel Med ,2003 May;10 Suppl 1(--):S13-5; discussion S21

3. Overbosch D.   Post-marketing surveillance: adverse events during long-term use of atovaquone/proguanil for travelers to malaria-endemic countries.

J Travel Med ,2003 May;10 Suppl 1(--):S16-20; discussion S21-3

4. van Genderen PJ, Koene HR, Spong K, Overbosch D. The safety and tolerance of atovaquone/proguanil for the long-term prophylaxis of plasmodium falciparum malaria in non-immune travelers and expatriates [corrected]. J Travel Med ,2007 Mar-Apr;14(2):92-5

    

5. Malarone U.S. Prescribing Information. September 2009. http://us.gsk.com/products/assets/us_malarone.pdf

6. HPA Malaria Reference Laboratory and the National Travel Health Network and Centre (NaTHNaC). Frequently Asked Questions on Malaria Prevention. Revised 14 March 2008. http://www.nathnac.org/pro/misc/faq_malaria.htm

7. Paul MA, McCarthy AE, Gibson N, Kenny G, Cook T, Gray G. The impact of Malarone and primaquine on psychomotor performance. Aviat Space Environ Med, 2003 Jul, 74 (7) :738-45