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Mefloquine and Artemesia: A Prospective Trial of Combination Therapy in Chronic Babesiosis

Hartford Marriott Farmington, CT 24–26 March 2000
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Background:

Babesiosis has previously been regarded as a benign self-limiting illness; however recent evidence has shown that patients who are either immuno-compromised or co-infected with Borrelia burgdorferi and/or HGE are at risk for a more severe chronic disease state (Krause et al, JAMA 1996 June 5: 275(21): 1657-1666). Krause also noted persistent parasitemia after acute Babesiosis (NEJM 7/98, Vol 339, 160-165) when patients received Cleocin+Quinine (C+Q), and Horowitz described chronic persistent Babesiosis after acute treatment with Cleocin+Quinine (C+Q) and Atovaquone and Azithromycin (M+Z) (Abstract, 12th International Scientific Conference on Lyme Disease and Other Spirochetal & Tick-Borne Disorders, April 1999, NYC), with persistence of Babesial DNA despite repeated courses of both antibiotic regimens. This report describes clinical improvement in a cohort of co-infected Lyme patients using Mefloquine (Lariam) + Artemesia (L+A) as either first-line treatment for infections with Babesia microti, or after having filled standard regimens with C+Q or M+Z.

Methodology:

Babesia microti infections were diagnosed among a cohort of 70 chronic Lyme patients using IFA and/or PCR analysis. Patients were divided into 2 treatment groups: 52 patients (Group l) took 5 weeks of L+A, and 18 patients (Group 2) took 12 weeks of L+A. The first group was further subdivided into 25 patients taking L+A alone, and 27 patients using L+A with 1 dose of sulfa 1500mg (Gantricin) and Pyrimethamine 25mg (Daraprim) at the beginning of therapy. Patients received a loading dose of Mefloquine 250mg 5 capsules lx, followed by 1 capsule per week with Artemesia 250mg, 2, 3x per day. Group 2 received L+A for 12 weeks in combination with other antibiotics for Lyme and/or Ehrlichiosis. Patients received Compazine 10mg and Antevert (Meclizine) 25mg 1 hour before the loading dose, and subsequently every 6-8 hrs prn for nausea and dizziness. Patients filled out the Karnofsky scale after completing their therapy to evaluate ongoing symptomatology.

Results:

All patients completed the treatment regimen as prescribed. The most common side effects were dizziness and nausea, lasting for up to 3 days after the loading dose of 5 pills, with rare neuropsychiatric symptoms (anxiety/depression). Administration of the loading dose over 34 days decreased these side effects. In Group 1, among the 25 patients taking L+A alone for 5 weeks, there was a 21.5% mean improvement in symptoms (decreased fatigue, joint and muscle pain, sweats, fevers, or chills, headaches, and cognitive difficulties) with a 12.5% median improvement as evaluated by the Karnofsky scale. Among the 27 patients taking L+A+sulfa/pyrimethamine, there was an 18.5% mean improvement, and a 12.5% median improvement in symptoms. 37 patients from Group l were tested by PCR analysis at least 4 weeks post therapy, and 3/37 (8%) were found to be PCR positive. Among 18 patients taking L+A for 12 weeks (Group 2), there was a 10.3% mean improvement with a 12.5% median improvement, with 2/9 (22%) patients tested remaining PCR positive post therapy .

Conclusion:

Mefloquine+Artemesia is a new and improved treatment regimen for chronic persistent Babesiosis. This regimen has been studied and shown to be effective in malaria (Antimalarial Activity of Mefloquine and Qinghaosu (Artemesia): Lancet, Aug 1982, 285-289), but has never been studied in patients with infections with Babesia microti, a malarial-like illness. Optimal effectiveness was seen with a 5-week cours; however certain patients were PCR positive post therapy, and needed retreatment with either a different regimen, longer course, or higher doses of L+A (2q 5-7 days), which occasionally was of clinical benefit. Treatment failures have therefore been seen with all presently available antibiotic regimens for Babesia microti and may reflect an exoerythrocytic stage of infection establishing a chronic carrier state. Further research is necessary into the role, diagnosis, and treatment of piroplasms in co-infected Lyme patients.

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