[Leish-l] miltefosine for diffuse leishmaniasis

[Carlos Costa]

Dear KP,

Renal function should be tested before starting the therapy with SbV or
amphotericin B. It is also advisable to perform weekly electrocardiogram
(both drugs), evaluation of renal function (amph B) as well as liver and
pancreatic enzymes (SbV) and dosage of potassium (amph B).

Best wishes,

Carlos


2011/7/26 Chang, Kwang-Poo <KwangPoo.Chang at rosalindfranklin.edu>

> ** ** ** ** ** ** ** **
>
> Dear Jorge,****
>
> ** **
>
> Thank you so much for the information on an earlier CL case, i. e. your
> brother also in ****Panama****. It looks IM with SbV is the way to go for
> good outcome in ****Panama****.****
>
> ** **
>
> I pass on this pertinent info to Dr. Welch for his reference.****
>
> ** **
>
> KP****
>
> ** **
>  ------------------------------
>
> *From:* Arias, ****Jorge Dr.**** [mailto:Jorge.Arias at fairfaxcounty.gov]
> *Sent:* Tuesday, July 26, 2011 6:54 AM
> *To:* Chang, Kwang-Poo; **Carlos Costa
> **
> *Cc:* Berman; Josh at lineu.icb.usp.br; Mark at lineu.icb.usp.br;
> jurbina at mac.com; Pierre BUFFET; Fabiana Alves; Shyam Sundarmail; Dorcas
> Lamounier Costa; generhedin at thermosurgery.com; Robert Vinson; Abhay
> Satoskar; dagobertosilveira at superig.com.br; Fernando at lineu.icb.usp.br;
> Raimunda at lineu.icb.usp.br; joseanegodinho at yahoo.com.br; Nawacki;
> Koremblum; Sampaio; robertobadaro768 at gmail.com; Leish-L
> *Subject:* RE: [Leish-l] miltefosine for diffuse leishmaniasis
> ****
>
>  ** **
>
> Dear KP,****
>
>  ****
>
> My brother got  leishmaniasis while working for the **Panama Canal** back
> in the 70's. ****
>
> He could not get pentavalent antimony at the time so I sent him some
> Glucantime from Brasil.****
>
> He had a 10 day IM treatment (5 ml b.i.d.) and responded well.****
>
>  ****
>
> I hope this helps****
>
>  ****
>
> Jorge****
>
>  ****
>
> Jorge R. Arias Ph.D.****
>
> Disease Carrying Insects Program Supervisor****
>
> (703) 246-8474****
>
>  ****
>
> ** **
>  ------------------------------
>
> *From:* leish-l-bounces at lineu.icb.usp.br [mailto:
> leish-l-bounces at lineu.icb.usp.br] *On Behalf Of *Chang, Kwang-Poo
> *Sent:* Monday, July 25, 2011 2:59 PM
> *To:* **Carlos Costa**
> *Cc:* Berman; Josh at lineu.icb.usp.br; Mark at lineu.icb.usp.br;
> jurbina at mac.com; Pierre BUFFET; Fabiana Alves; Shyam Sundarmail; Dorcas
> Lamounier Costa; generhedin at thermosurgery.com; Robert Vinson; Abhay
> Satoskar; dagobertosilveira at superig.com.br; Fernando at lineu.icb.usp.br;
> Raimunda at lineu.icb.usp.br; joseanegodinho at yahoo.com.br; Nawacki;
> Koremblum; Sampaio; robertobadaro768 at gmail.com; Leish-L
> *Subject:* Re: [Leish-l] miltefosine for diffuse leishmaniasis****
>
> I am writing to ask for your help with information and suggestion about
> treating cutaneous leishmaniasis in ****Panama****.****
>
> ** **
>
> I have only very sketchy information about the case as follows:****
>
> ** **
>
>    1. An American young man has 2 skin lesions, one of which is on the
>    abdomen. ****
>    2. He was diagnosed to have cutaneous leishmaniasis ****
>    3. A course of 30-day intra-muscular injection of pentavalent antimony
>    is prescribed. ****
>
> ** **
>
> I wonder about the intramuscular instead of intra-lesion antimony treatment
> and also the duration of the treatment for 30 days ?****
>
> ** **
>
> Looking forward to hearing from you at your earliest convenience.****
>
> ** **
>
> KP****
>
> ** **
>  ------------------------------
>
> *From:* **Carlos Costa** [mailto:chncosta at gmail.com]
> *Sent:* Tuesday, July 12, 2011 2:46 PM
> *To:* Chang, Kwang-Poo
> *Cc:* gzischke at thermosurgery.com; Abhay Satoskar; John David;
> generhedin at thermosurgery.com; Josh Berman;
> dagobertosilveira at superig.com.br; Raimunda Sampaio; Dorcas Lamounier
> Costa; Mark Nawacki; jurbina at mac.com; Pierre BUFFET;
> joseanegodinho at yahoo.com.br; Robert Vinson; Shyam Sundarmail;
> robertobadaro768 at gmail.com; Leish-L; Fernando Koremblum; Fabiana Alves;
> Fabiana Alves
> *Subject:* Re: [Leish-l] miltefosine for diffuse leishmaniasis****
>
> ** **
>
> Hi Gena,****
>
> ** **
>
> Thanks a lot for your offer. ****
>
> ** **
>
> Our purpose is to work together with John and Abhay, who I know personally
> for a long time. May be the experience here will lead to broader
> application.****
>
> ** **
>
> I am forwarding your email to DNDi to see if they could help us in getting
> the machine into the country, since they have expertise in this kind of
> humanitarian treatment.****
>
> ** **
>
> My best regards,****
>
> ** **
>
> Carlos. ****
>
> ** **
>
> 2011/7/12 Chang, Kwang-Poo <KwangPoo.Chang at rosalindfranklin.edu>****
>
> This is good to try.****
>
>  ****
>
> KP****
>
>  ****
>  ------------------------------
>
> *From:* gzischke at thermosurgery.com [mailto:gzischke at thermosurgery.com]
> *Sent:* Tuesday, July 12, 2011 12:47 PM
> *To:* **Carlos Costa**; Abhay Satoskar; John David;
> generhedin at thermosurgery.com
> *Cc:* Josh Berman; dagobertosilveira at superig.com.br; Raimunda Sampaio;
> Dorcas Lamounier Costa; Mark Nawacki; jurbina at mac.com; Pierre BUFFET;
> joseanegodinho at yahoo.com.br; Robert Vinson; Shyam Sundarmail;
> robertobadaro768 at gmail.com; Leish-L; Fernando Koremblum; Chang, Kwang-Poo
> *Subject:* RE: [Leish-l] miltefosine for diffuse leishmaniasis****
>
>  ****
>
> Dear Dr. Costas,****
>
> Thermosurgery is committed to the research and treatment of leishmaniasis.
> We are pleased to work with you and assist your patients.  We can lend you
> an instrument to use in your program.  Our biggest hurdle is getting the
> equipment into the country.  If you work with an NGO or government agency
> that can assist us in the importation that would be helpful.  ****
>
> Lets discuss the logistics to see if it is feasible to get you the
> equipment.  I would suggest that you work with Dr David and Dr Satoskar on
> the recommended treatment protocol.  ****
>
> We would want to receive documentation regarding the use of the equipment
> and a paper so that we can educate others on the value of this treatment.
> ****
>
>  ****
>
> Warm regards,****
>
> gena****
>
>  ****
>
>  ****
>
> Gena Zischke
> Business Development
> Thermosurgery Technologies, Inc.
> 2901 ****W. Indian School Rd.****
> ****Phoenix**, **AZ** **85017****
> Phone: (602) 264-7300
>
>
> The information in this communication is confidential. It is intended
> solely for the addressee. Access to this communication by anyone else is
> unauthorized. If you are not the intended recipient, any disclosure,
> copying, distribution or any action taken or omitted to be taken in reliance
> on it, is prohibited and may be unlawful. If you have received this
> communication in error, please notify us immediately by return email, and
> destroy this communication and all copies thereof, including all
> attachments. Thank you. Thermosurgery Technologies, Inc.
>
>
> Fax: (602) 248-3809****
>
>  -------- Original Message --------
> Subject: Re: [Leish-l] miltefosine for diffuse leishmaniasis
> From: **Carlos Costa** <chncosta at gmail.com>
> Date: Sun, July 10, 2011 4:23 pm
> To: "Chang, Kwang-Poo" <KwangPoo.Chang at rosalindfranklin.edu>
> Cc: Josh Berman <Jbe9320457 at aol.com>, dagobertosilveira at superig.com.br,
> Raimunda Sampaio <rsampaio at unb.br>, Dorcas Lamounier Costa
> <dorcas.lc at gmail.com>, Mark Nawacki <mnawacki at paladinlabs.com>,
> jurbina at mac.com, Pierre BUFFET <pierre.buffet at upmc.fr>,
> joseanegodinho at yahoo.com.br, Robert Vinson <rvinson at paladinlabs.com>,
> Shyam Sundarmail <Drshyamsundar at hotmail.com>,
> robertobadaro768 at gmail.com, Leish-L <Leish-l at lineu.icb.usp.br>, Fernando
> Koremblum <fkorembl at paladinlabs.com>
>
> KP, do you have any idea about prices? Please send me the brand name to see
> if I can easily import them. Best wishes to Jean, Carlos****
>
> 2011/7/10 Chang, Kwang-Poo <KwangPoo.Chang at rosalindfranklin.edu>****
>
> Carlos will undoubtedly go with those, which are clinically acceptable and
> feasible for the sake of expediency. ****
>
>  ****
>
> In a separate message, the causative agent was said to have been identified
> as L amazonensis. Thermosensitivity of this species has been
> well-documented, suggestive of thermotherapy. There is already the
> suggestion of hot bath. One-use heat pad/heat wrap available
> over-the-counter in the ****USA**** drug stores is just as innocuous to
> consider as some topical ointments suggested.****
>
>  ****
>
> KP****
>   ------------------------------
>
> *From:* leish-l-bounces at lineu.icb.usp.br [mailto:
> leish-l-bounces at lineu.icb.usp.br] *On Behalf Of ***Carlos Costa**
> *Sent:* Saturday, July 09, 2011 10:07 AM****
>
>
> *To:* Leish-L
> *Cc:* Josh Berman; dagobertosilveira at superig.com.br; Dorcas Lamounier
> Costa; jurbina at mac.com; Pierre BUFFET; Robert Vinson; Raimunda Sampaio;
> Shyam Sundarmail; robertobadaro768 at gmail.com; Mark Nawacki; Fernando
> Koremblum; joseanegodinho at yahoo.com.br****
>
> *Subject:* Re: [Leish-l] miltefosine for diffuse leishmaniasis****
>
>  ****
>
> Dear friends,****
>
>  ****
>
> This is really a such touching and motivated community, and leish-l is
> proving to be an excellent tool for solving the leishmaniasis toughest
> problems throughout the world. The word "together" sounds really powerful in
> such a cases.****
>
>  ****
>
> What os showing up from these kind emails is a face of science coming not
> only from the bench, the hospitals, the field, but a science coming straight
> from the heart.****
>
>  ****
>
> Let me summarize some of the lessons and suggestions. Please correct me if
> I skip some.****
>
>  ****
>
> 1) Hot bath - ****Teresina**** is very hot, and hot showers are rare here.
> However, we can easily provide her an electric shower. Should it be a tube?
> How long the bath would last?****
>
>  ****
>
> 2) BCG - one or two shots.  We will do it. Any hint about the intervals
> between the shots?****
>
>  ****
>
> 3) Previous drug therapy: ImunoglucanTM (cell wall of *Saccharomyces
> cerevisiae*), and saquinavir, after her delivery (Intracellular survival
> of Leishmania species that cause visceral leishmaniasis is significantly
> reduced by HIV-1 protease inhibitors.<http://www.ncbi.nlm.nih.gov/pubmed/18816190>
> ).****
>
>  ****
>
> 4) Besides miltefosine we got a good hint where to find it (****Paladino**,
> **Canada****), which has excellent temporary effect (Zerpa et al, 2006),
> we should consider: ****
>
> a) lower/corrected doses of paramomycin (Bryceson) - we have also to find
> the drug outside ****Brazil****, since it is not distributed/approved
> here; ****
>
> b) gamma-interferon (who produces/sells it?).****
>
> c) fluconazol/itraconazol/(voriconazol?).****
>
> d) amiodarone - *in vitro* testing does not sounds so good.****
>
> e) topic imiquimod  (IxiumTM cream) - apparently easy to find.
> concentration of 5%?****
>
> f) photodynamic therapy - with Dr. Dagoberto Silveira, we are investigating
> where to do it around.****
>
> g) immunotherapy with suicide photo-inactivated *Leishmania* (KP Chang).**
> **
>
>  ****
>
> Please check what really seems reasonable. My feeling is that most of the
> suggestions can be tried.****
>
>  ****
>
> My warmest regards,****
>
>  ****
>
> Carlos.****
>
>  ****
>
>  ****
>
> 2011/7/8 Pierre BUFFET <pierre.buffet at upmc.fr>****
>
> Anthony,
>
>
> because there are only a few options left, would you consider at one point
> low dose pentamidine (3 mg/kg every week or so, as you did in DCL patinets
> in ****Ethiopia**** in the 70s if I remember)? Could be used either to
> stabilize the situation before starting on a coadministration, or as a
> maintenance after the co-administration, in both cases with careful
> monitoring of kidney function ?
>
> ****Pierre****
>
>
>  Anthony Bryceson <a.bryceson at doctors.org.uk> a écrit :****
>
>   ****
>
> Dear Carlos
> As you are well aware DCL is very difficult to treat. The big problem is
> that the defect in specific CMI is more profound than that in VL and may
> never recover, in contrast with the defect in VL which bounces back quickly.
>
> To have any chance of curing the patient, treatment  should be monitored by
> quantitative slit skin smears (as for splenic aspirates in VL) from multiple
> pre-selected sites, every week or two weeks, and treatment continued until
> negativity and for some weeks or months longer.  When slit skin smears
> become negative, hunt for any nodular or infiltrated lesions and take deep
> biopsies and look for amastigotes there. Keep on hunting and smearing.
> Sometimes, at the end of all this, evidence of CMI may appear, and cure
> becomes a possibility. I am sure that the method of treating is more
> important than the choice of drug - so long of course that the parasite is
> susceptible to the drug.
>
> Hannah Akuffo has sent you the abstract relating to 3 patients treated by
> Sabawork Teklemariam in Addis Abeba. That article details this approach.
>
> Do you know the species of Leishmania causing Maria's DCL, and its
> sensitivities? In Addis Abeba parasites were cultured from two of the
> patients and sensitivities determined and isobolograms drawn to look for
> synergy. The isolates were sensitive to paromomycin and sodium
> stibogluconate was synergistic. It would be worth while to make cultures
> before you start any new treatment and have the isolate tested in this way.
> I expect that you have a lab that could do this; if not, Simon Croft might
> be able to advise.
>
> Miltefosine has been very successful in a number of situations in South
> American CL and showed promise for DCL,  but patients relapsed despite
> prolonged treatment.
> 1. Zerpa O, Ulrich M, Blanco B, et al. Diffuse cutaneous leishmaniasis
> responds to miltefosine but then relapses. Br J Dermatol.
> 2007;156:1328-1335.
>
> In a few patients with VL-HIV confection whom I treated in ****London****,
> miltefosine worked well at first, but the patients relpased while still on
> treatment and drug resistance was supected but not tested. Miltefosine has a
> pharmacokinetic profile with a long tail that might make it susceptible to
> the devlopment of resistance, especially if the therapeutic window for a
> given isolate was narrow. So you might want to think about adding a second
> drug to go with miltefosine from the beginning. I am not sure what might be
> the best drug for combination; perhaps Josh Berman might have an opinion. It
> is of course essential to ensure contraception.
>
> You could also consider the combination of paromomycin and low dose SSG. In
> view of Maria's poor renal function you might need to modify the dose of
> paromomycin and to monitor function.
>
> Robert Vinson is CEO of Paladin Labs, and would I am sure help you locate
> miltefosine. <rvinson at paladin-labs.com>
>
> Richard Chin is CEO of One World Health,  and would, I am equally sure,
> help you locate paromomycin, should you consider that path.
> http://www.oneworldhealth.org/contact-us  Phone: +1 415-421-4700 Fax: +1
> 415-421-4747
>
> I wish you and Maria all the best in this venture.
> Anthony
>
>
> Dear Jennie
> Immunotherapy proved rather disappointing in VL. It seems that the patient
> needs a decent immune response in the first place to benefit from
> immuno-boosting.
> Sadly
> Anthony
>
>
> On 6 Jul 2011, at 20:04, **Carlos Costa** wrote:****
>
> Dear all,
>
> Maria Cleudimar has cutaneous diffuse leishmaniasis due to Leishmania
> amazonensis. She used to be a long time patient form Dr. Jackson Costa, in
> the countryside of ****Maranhão State**, **Brazil****, since she was 10
> years old, after a disease that started when she was just five. Now, she is
> under my and Dorcas care, at the age of 30, living in the city of ****
> Teresina****.
>
> Her long time DCL does not respond to the treatment antimonium anymore.
> Although we still prescribe liposomal amphotericin B at very low dose
> (3mg/kg/once a week), her situation is deteriorating progressively, her
> renal function does not allow any additional dosing since creatinine is
> presently above 3mg/dL, and previous biopsy had shown tubular damage
> apparently secondary to the drug, without evidence of amyloidosis. We tried
> several combinations of different drugs, without success. Her situation
> worsened a lot during her recent pregnancy (the baby is eight months old
> now).
>
> Our hope now stands only in miltefosine, for oral chronic use, but the drug
> is not licensed or available in ****Brazil**** yet (to my knowledge).
>
> With her permission I attached some of her pictures, hoping to sensitize
> critical people in order to help me to get miltefosine and the permission
> for prescription in ****Brazil**** (or any other oral drug with promising
> efficacy, and without nephrotoxicity, if known). Moreover, we need to know
> about the dose adjustment for the renal impairment, and how long the drug
> could safely be used.
>
> One picture shows her face before treatment, and another after the
> pregnancy, with the baby. One shows the situation of her thighs, another the
> calf of the leg and the last one the infiltration of the palate.
>
> Hoping a little from friends, my kindest regards,
>
> Carlos.
>
> PS. Please understand that the pictures are allowed not for publication or
> public presentation. Cleudimar permission is restricted to this forum.
>
>
> --
> Carlos H. N. Costa, MD, DSc.
> President
> Sociedade Brasileira de Medicina Tropical
> (Brazilian Society of Tropical Medicine)
> Instituto de Doenças Tropicais Natan Portella
> Universidade Federal do Piauí
> Rua Artur de Vasconcelos 151-Sul
> 64049-750 Teresina-PI
> ****Brazil****
> Telephones: +55 86 3221-3413 (work); +55 86 8838-3303 (mobile).
>
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>
> <cleu antes grav 13jan09.jpg><cleu e nene.jpg><cleu santada
> recorte.jpg><cleu panturrilhas.jpg><cleu
> palato.jpg>_______________________________________________
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>  ****
>
>   ****
>
>
>
>
> --
> *Carlos H. N. Costa, MD, DSc.*****
>
> *President*****
>
> *Sociedade Brasileira de Medicina Tropical *****
>
> *(Brazilian Society of Tropical Medicine)*****
>
> *Instituto de Doenças Tropicais Natan Portella
> Universidade Federal do Piauí*****
>
> *Rua Artur de Vasconcelos 151-Sul*****
>
> *64049-750 Teresina-PI
> Brazil
> Telephones: +55 86 3221-3413 (work); +55 86 8838-3303 (mobile).
> *
> Aviso: As informações contidas nesta mensagem são CONFIDENCIAIS, protegidas
> pelo sigilo legal, por direitos autorais e destinadas exclusivamente à
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> reproduction and distribution. If you are not the correct recipient, please
> notify us immediately by return e-mail and delete this message from your
> system. ****
>
>  ****
>
>
>
>
> --
> *Carlos H. N. Costa, MD, DSc.*****
>
> *President*****
>
> *Sociedade Brasileira de Medicina Tropical *****
>
> *(Brazilian Society of Tropical Medicine)*****
>
> *Instituto de Doenças Tropicais Natan Portella
> Universidade Federal do Piauí*****
>
> *Rua Artur de Vasconcelos 151-Sul*****
>
> *64049-750 Teresina-PI
> Brazil
> Telephones: +55 86 3221-3413 (work); +55 86 8838-3303 (mobile).
> *
> Aviso: As informações contidas nesta mensagem são CONFIDENCIAIS, protegidas
> pelo sigilo legal, por direitos autorais e destinadas exclusivamente à
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> notify us immediately by return e-mail and delete this message from your
> system. ****
>
>  ****
>  ------------------------------
>
> _______________________________________________
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>
>
>
>
> --
> *Carlos H. N. Costa, MD, DSc.*****
>
> *President*****
>
> *Sociedade Brasileira de Medicina Tropical *****
>
> *(Brazilian Society of Tropical Medicine)*****
>
> *Instituto de Doenças Tropicais Natan Portella
> Universidade Federal do Piauí*****
>
> *Rua Artur de Vasconcelos 151-Sul*****
>
> *64049-750 Teresina-PI
> Brazil
> Telephones: +55 86 3221-3413 (work); +55 86 8838-3303 (mobile).
> *
> Aviso: As informações contidas nesta mensagem são CONFIDENCIAIS, protegidas
> pelo sigilo legal, por direitos autorais e destinadas exclusivamente à
> pessoa ou organização para a qual a mensagem foi destinada.
> Warning: This message is meant only for the intended recipient of the
> transmission.  It is forbidden any unauthorized use, alteration,
> reproduction and distribution. If you are not the correct recipient, please
> notify us immediately by return e-mail and delete this message from your
> system. ****
>
> ** **
>



-- 
*Carlos H. N. Costa, MD, DSc.*
*President*
*Sociedade Brasileira de Medicina Tropical *
***(Brazilian Society of Tropical Medicine)*
*Instituto de Doenças Tropicais Natan Portella
Universidade Federal do Piauí*
*Rua Artur de Vasconcelos 151-Sul*
*64049-750 Teresina-PI
Brazil
Telephones: +55 86 3221-3413 (work); +55 86 8838-3303 (mobile).
*
Aviso: As informações contidas nesta mensagem são CONFIDENCIAIS, protegidas
pelo sigilo legal, por direitos autorais e destinadas exclusivamente à
pessoa ou organização para a qual a mensagem foi destinada.
Warning: This message is meant only for the intended recipient of the
transmission.  It is forbidden any unauthorized use, alteration,
reproduction and distribution. If you are not the correct recipient, please
notify us immediately by return e-mail and delete this message from your
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