02362nas a2200205   4500000000100000008004100001100001300042700001200055700001400067700001200081700001200093700001200105700001400117245012200131856009800253300001300351490000600364520177200370022001402142       2015                            d1 aRamesh V1 aSingh R1 aAvishek K1 aVerma A1 aDeep DK1 aVerma S1 aSalotra P00aDecline in clinical efficacy of oral miltefosine in treatment of post Kala-azar dermal leishmaniasis (PKDL) in India.  uhttp://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0004093&type=printable  ae00040930 v93 a<p><strong>BACKGROUND: </strong>Recent studies have shown significant decline in the final cure rate after miltefosine treatment in visceral leishmaniasis. This study evaluates the efficacy of miltefosine in the treatment of post kala-azar dermal leishmaniasis (PKDL) patients recruited over a period of 5 years with 18 months of follow-up.</p>

<p><strong>METHODOLOGY: </strong>In this study 86 confirmed cases of PKDL were treated with two different dosage regimens of miltefosine (Regimen I- 50mg twice daily for 90 days and Regimen II- 50 mg thrice for 60 days) and the clinical outcome assessed monthly. Cure/relapse was ascertained by clinical and histopathological examination, and measuring parasite burden by quantitative real-time PCR. In vitro susceptibility of parasites towards miltefosine was estimated at both promastigote and amastigote stages.</p>

<p><strong>RESULTS: </strong>Seventy three of eighty six patients completed the treatment and achieved clinical cure. Approximately 4% (3/73) patients relapsed by the end of 12 months follow-up, while a total of 15% (11/73) relapsed by the end of 18 months. Relapse rate was significantly higher in regimen II (31%) compared to regimen I (10.5%)(P&lt;0.005). Parasite load at the pre-treatment stage was significantly higher (P&lt;0.005) in cases that relapsed compared to the cases that remained cured. In vitro susceptibility towards miltefosine of parasites isolated after relapse was significantly lower (&gt;2 fold) in comparison with the pre-treatment isolates (P&lt;0.005).</p>

<p><strong>CONCLUSION: </strong>Relapse rate in PKDL following miltefosine treatment has increased substantially, indicating the need of introducing alternate drugs/ combination therapy with miltefosine.</p>
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