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European Journal of Medical Research - Deutsche AIDS ...

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76 EUROPEAN JOURNAL OF MEDICAL RESEARCH<br />

June 27, 2007<br />

leishmaniasis and after courses <strong>of</strong> liposomal amphotericin B<br />

and short term miltefosine for up to 4 weeks a long-term therapy<br />

with miltefosine was started. Based on chronic damage <strong>of</strong><br />

the kidneys, which might have been impaired by previous indinavir<br />

administration, terminal renal insufficiency developed<br />

as a typical side effect <strong>of</strong> therapy with the polyene amphotericin<br />

B. Independent <strong>of</strong> the renal function and miltefosine<br />

ART was continued with a combination <strong>of</strong> LPV-ritonavir<br />

(RTV) (dosage 2 cps bid, than 1 tbl. bid) and a 2-NRTI backbone<br />

including abacavir and lamivudin. After 8 months <strong>of</strong> follow<br />

up a continuous complete suppression <strong>of</strong> viral replication<br />

(viral load < 50 copies/l) could be documented and CD4 cell<br />

count remained stable (165 - 232 copies/l). 20 trough levels<br />

before haemodialysis have been determined, revealing sufficient<br />

antiviral activity with a mean <strong>of</strong> 5979 ng/ml (standard<br />

deviation (SD) 2339 ng/ml). A mean peak concentration after<br />

medication and haemodialysis in 12 samples has been 12177<br />

ng/ml, SD 2470 ng/ml.<br />

Conclusions: Here we could demonstrate a successful ART<br />

with reduced dosage <strong>of</strong> LPV-RTV in a HIV patient despite<br />

chronic haemodialysis and concomitant medication <strong>of</strong> miltefosine.<br />

In cases like this drug monitoring is appropriate and<br />

dose adjustment may be helpful to avoid side effects.<br />

C.16 (Poster)<br />

Successful treatment <strong>of</strong> visceral leishmaniasis (VL)<br />

with long-term miltefosine in a HIV-patient with<br />

terminal renal insufficiency<br />

Heinz W. 1 , Guhl C. 1 , Winzer R. 1 , Langmann P. 2 ,<br />

Klinker H. 1<br />

1 Medizinische Klinik und Poliklinik II der Universität<br />

Würzburg, Schwerpunkt Infekiologie, Würzburg, Germany,<br />

2 Praxis für Gastroenterologie und Infektiologie, Karlstadt,<br />

Germany<br />

Objective: Immunosuppression due to HIV-infection can<br />

support a broad spectrum <strong>of</strong> infectious diseases. Beside the<br />

common opportunistic infections other acute and chronic infectious<br />

diseases can have a more severe and complicated<br />

course. In addition treatment <strong>of</strong> HIV and the secondary infection<br />

might directly interact or have cumulative toxic effects.<br />

VL as a chronic disease caused by the parasite Leishmania<br />

donovani is rare in Western-Europe and usually treated with<br />

liposomal amphotericin B (L-AmB) or sodium-stiboglucanate.<br />

New data support good efficacy <strong>of</strong> miltefosine, a<br />

membrane-active alkyl phospholipid.<br />

Here we describe the case <strong>of</strong> a HIV patient with severe reduction<br />

<strong>of</strong> CD4 cells and VL refractory to prolonged therapy<br />

<strong>of</strong> L-AmB.<br />

Case: In a 40 year old patient HIV was diagnosed 1989. Despite<br />

effective antiretroviral therapy since 1999, with a viral<br />

load below 400 copies/l, he showed persistent immunosuppression<br />

with CD4-count below 100 cells/l in 2003. In August<br />

2003 fatigue, pancytopenia and a polyclonal gammopathy<br />

developed and a VL with involvement <strong>of</strong> the intestine and<br />

the bone marrow was diagnosed. After first treatment with<br />

miltefosine for 28 days the patient showed incomplete remission<br />

and in April 2004 therapy with L-AmB was started for 20<br />

days with good clinical response and clearance <strong>of</strong> the germs<br />

in bone marrow. This was followed by a secondary prophylaxis<br />

with L-AmB in a 4-week interval. For a further relapse<br />

with skin infiltrates he received a second course <strong>of</strong> L-AmB<br />

for 3 weeks followed by miltefosine for one month. Secondary<br />

prophylaxis with L-AmB was continued. Hereunder,<br />

he developed a terminal renal insufficiency on the bases <strong>of</strong><br />

chronic kidney damage, needing haemodialysis. In addition, a<br />

relapse with ocular manifestation and predominantly a general<br />

disfiguring skin involvement appeared. Therefore continuous<br />

therapy with miltefosine was started in June 2006. Seven<br />

months later he still shows clinical remission <strong>of</strong> all manifestations.<br />

Conclusions: Here we report <strong>of</strong> a case <strong>of</strong> VL with multiple<br />

manifestations, relapsing after L-AmB therapy and secondary<br />

prophylaxis, which could be successfully treated with continuous<br />

miltefosine administration, despite persisting HIV related<br />

immunosuppression.<br />

C.17 (Poster)<br />

Comparison <strong>of</strong> Ribavirin plasma concentrations in<br />

HCV-monoinfected and HCV/HIV coinfected<br />

patients with or without concomitant HAART<br />

Guhl C. 1 , Rasche S. 1 , Kubisch A. 1 , Schirmer D. 1 ,<br />

Heinz W. 1 , Winzer R. 1 , Langmann P. 2 , Klinker H. 1<br />

1 Medizinische Klinik und Poliklinik II der Universität<br />

Würzburg, Schwerpunkt Infekiologie, Würzburg, Germany,<br />

2 Praxis für Gastroenterologie und Infektiologie, Karlstadt,<br />

Germany<br />

Objective: Patients coinfected with Human Immunodeficiency<br />

Virus (HIV) and Hepatitis C Virus (HCV) taking HAART<br />

are on higher risk to die <strong>of</strong> liver-related problems than <strong>of</strong><br />

HIV-related illnesses. Therefore, treatment <strong>of</strong> HCV in HIVpatients<br />

is important but difficult, especially due to a higher<br />

risk <strong>of</strong> toxicities and pharmacological interactions with<br />

HAART. Ribavirin (RBV) drug levels might play a crucial<br />

role not only in deteriorating drug addicted side effects like<br />

hemolytic anemia but also in effectiveness <strong>of</strong> treatment and<br />

early virological response. Orally taken, RBV is quickly resorbed.<br />

Maximal plasma concentration (PC) can be reached<br />

after 1.5 hours and a steady state is reached after 4 weeks <strong>of</strong><br />

treatment. Measuring PC <strong>of</strong> RBV can help optimizing the<br />

HCV-treatment. Here we investigated the RBV PC in<br />

HIV/HCV-coinfected patients regarding a comedication with<br />

HAART.<br />

Methods: A high performance liquid chromatography<br />

(HPLC) was established to determine PC <strong>of</strong> RBV after solid<br />

phase extraction. Plasma samples from patients treated for<br />

HCV have been collected and PC have been determined. The<br />

results were analyzed in correlation to possible HIV-coinfection<br />

and comedication <strong>of</strong> HAART.<br />

Results: A total <strong>of</strong> 178 samples <strong>of</strong> 78 patients has been collected<br />

and PC have been measured during steady-state, i.e. after<br />

4 weeks <strong>of</strong> treatment and 8 to 16 hours after having taken<br />

the pills. 67 patients (n=136 samples) had HCV only (group<br />

1) and 11 patients (n=42 samples) have been coinfected with<br />

HIV and HCV. 7 <strong>of</strong> the HCV/HIV-coinfected patients were<br />

treated only against HCV (group 2, 20 samples) and 4 received<br />

concomitant HAART, respectively (group 3, 22 samples).<br />

The plasma trough level for RBV in all samples was<br />

1702 ± 582,5 ng/nl. In group 1 (HCV) the trough level was<br />

1724 ± 590 ng/ml, in group 2 (HCV/HIV without HAART)<br />

1721 ± 623 ng/ml and in group 3 (concomitant d HAART)<br />

1302 ± 225 ng/ml. Due to the small number <strong>of</strong> patients in<br />

group 2 and 3 significances testing has not been performed.<br />

Conclusions: In this retrospective analysis we could show a<br />

trend that HAART reduces PC <strong>of</strong> RBV whereas the HIV-in-

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