[Leish-l] Warning: Drugs for human leishmaniasis used to treat dogs

Tue Dec 17 17:53:23 -03 2019

Hi,

Indeed,  if milteforan-treated dogs spread miltefosine-resistant L.
infantum, there should be no harm to humans because human VL is not treated
with miltefosine in Brazil.  However, in 2016 the Ministry of Health of
Brazil was considering introducing miltefosine for *CL *treatment here.
Since VL co-exists with *CL *in some areas, co-infected dogs may contribute
to the spread of resistant CL species (eg L. braziliensis) as well.

Therefore, after milteforan approval for CVL, it is my view that
miltefosine should never again be considered for human treatment in Brazil,
disregard of the disease form.

Best wishes,
Bartira

On Tue, 17 Dec 2019 at 16:36, Carlos Costa <chncosta at gmail.com> wrote:

> Dear,
>
> Long before the introduction of milteforan to dogs in Brazil, miltefosine
> was already poorly effective to treat VL in Brazil. Therefore, if strains
> resistant to miltefosine arise in dogs or human the treatment of dogs with
> milteforan is not to be blamed.
>
> Please check this attached paper.
>
> Cheers,
>
> Carlos.
>
> On Tue, Dec 17, 2019 at 1:06 PM BARTIRA BERGMANN <bartira at biof.ufrj.br>
> wrote:
>
>> Dear colleagues,
>>
>> In Brazil, the human use of miltefosine is not approved by the Ministry of
>> Health due to inconsistent efficacy in local VL human cases. Apparently
>> because it is not used in humans, miltefosine (Milteforan) was approved in
>> 2016 for use against canine VL. Here, Milteforan is to be given in
>> association with the leishmaniostatic alopurinol, and treatment repeated
>> every 6 months for life because of lack of sterile cure.
>>
>> Milteforan is very expensive in Brazil (~USD 300/ treatment), so it is
>> conceivable that many owners interrupt the lifelong treatment.  There is a
>> lot of merchandising pressure from both the industry and vet  clinics that
>> make a lot of money with the drug and periodical diagnostics, also very
>> expensive.
>>
>> I would not be surprised if miltefosine-resistant parasite strains are
>> already circulating in the country. That by itself should hamper
>> miltefosine approval against human CL, as recently considered by the
>> Ministry of Health based on a recent clinical trial, considering that many
>> dogs may be co-infected with VL and CL leishmanial species.
>>
>> With best regards,
>> Bartira Rossi-Bergmann
>>
>> On Thu, 5 Dec 2019 at 11:54, Rolando Oddone <roloddone at googlemail.com>
>> wrote:
>>
>> > Yes, Dr Kwang-Poo Chang. The position of health authorities and PAHO
>> > officials (at least in Paraguay) is to restrict the use of these drugs
>> only
>> > for human cases. The reason is obvious. As the Leishmania are not
>> totally
>> > killed by these drugs during treatment, they are creating resistance
>> > against these same drugs. Similar situation ocurred in India during the
>> > 1990's, with indiscriminate use of antimonials in humans. In some
>> regions
>> > of India, nearly 50% of VL cases (caused by L. donovani) were found
>> > resistant to SbV, therefore WHO speeded up the use of Miltefosine as
>> > alternative drug. But in our case, Miltefosine is not as useful as in
>> > India. It can cure VL cases (in Paraguay caused by L. infantum) but they
>> > easily relapse.
>> >
>> > The conclusions of the last WorldLeish in Spain were clear: there are no
>> > new drugs for leishmaniasis. If we are creating resistance of Leishmania
>> > against SbV, we will have very few options for all human cases. But if
>> dogs
>> > do not use antimonials, they can be treated by other drugs, as far as I
>> > understand.
>> >
>> >
>> > Rolando Oddone
>> >
>> >
>> > El mar., 5 de nov. de 2019 a la(s) 17:13, Kwang-Poo Chang (
>> > kwangpoo.chang at rosalindfranklin.edu) escribió:
>> >
>> > > Dear Rolando,
>> > >
>> > > Both drugs you mentioned have been used by veterinarians elsewhere for
>> > > treating canine leishmaniasis, although neither has been shown to cure
>> > the
>> > > disease. According to my colleagues in Naples, Italy, the diseased
>> dogs
>> > > responded positively to the treatment when used at high dosage
>> initially,
>> > > as indicated by a reduction of LD loads and alleviation of clinical
>> > > symptoms, but ~50% of them died of flare-ups eventually. Your concern
>> > seems
>> > > to be a regulatory issue of restricting the use of these drugs only
>> for
>> > > human cases in Paraguy ?
>> > >
>> > > Laura Manna is a DVM in Naples who has been trying our
>> > > photodynamically inactivated Leishmaina as non-viable whole-cell
>> vaccines
>> > > for immunotherapy of canine leishmaniasis after initial chemotherapy
>> with
>> > > evidence of some effectiveness. Let me know, should you or your
>> > colleagues
>> > > are interested in this ?
>> > >
>> > > KP
>> > >
>> > > Kwang Poo Chang, PhD
>> > > Professor of Microbiology/Immunology
>> > > Chicago Medical School/RFUMS
>> > > N Chicago, IL 60064, USA
>> > >
>> > > On Fri, Nov 1, 2019 at 4:40 PM Rolando Oddone <
>> roloddone at googlemail.com>
>> > > wrote:
>> > >
>> > >> In Paraguay we have growing proliferation of dogs with leishmaniasis
>> (L.
>> > >> infantum) since the 1990s.
>> > >> But dog owners with leishmaniasis are increasingly reluctant to
>> > sacrifice
>> > >> their animals. In recent years Glucantime and Milteforan are entering
>> > the
>> > >> country smuggled (apparently they come from France and Spain), for
>> > "free"
>> > >> use in dogs. These medications are currently being used
>> indiscriminately
>> > >> by
>> > >> veterinarians who, for profit, take advantage of the need that people
>> > have
>> > >> to want to preserve the lives of their pets.
>> > >> Under this scenario, hundreds of dogs have already been treated with
>> > these
>> > >> drugs, perhaps a thousand in a few years, and the magnitude of the
>> > problem
>> > >> will increase.
>> > >> However, the authorities of the Ministry of Health do not take any
>> > >> measures, despite the existence of recommendations that these drugs
>> are
>> > >> exclusively for human use.
>> > >> The purpose of this sharing is, dear colleagues, that you express
>> your
>> > >> position regarding this situation, at least in this way, and what
>> would
>> > be
>> > >> the impact this could have at the international level. Your joint
>> voice
>> > >> will be better heard than the simple complaint I may make.
>> > >>
>> > >>
>> > >> Rolando Oddone
>> > >> IICS-UNA
>> > >> Paraguay
>> > >> _______________________________________________
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>>
>> --
>> *Bartira Rossi Bergmann*
>> Instituto de Biofísica Carlos Chagas Filho
>> Universidade Federal do Rio de Janeiro - Brasil
>> tel: +55 (21) 2260-6963
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>
>
> --
> Carlos H. N. Costa, MD, DSc.
> President
> Instituto de Doenças do Sertão
> *Instituto de Doenças Tropicais Natan Portella*
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-- 
*Bartira Rossi Bergmann*
Instituto de Biofísica Carlos Chagas Filho
Universidade Federal do Rio de Janeiro - Brasil
tel: +55 (21) 2260-6963