17
Treatment Failure
56. Immunocompetent persons with VL who do not respond to therapy
with L-AmB should be treated with an alternative drug or with a
higher dose or a longer course of L-AmB (S-L).
57. Immunocompetent persons with VL who do not respond to initial
therapy with miltefosine or a pentavalent antimonial compound
should be treated with L-AmB or an alternative drug if L-AmB is
unavailable (S-L).
58. Immunocompetent persons with VL who respond to initial therapy
but subsequently have a relapse should be treated with an
alternative drug or with another, potentially longer, course of therapy
with the initial drug. If L-AmB was the drug used for initial therapy,
use of a higher dose can be considered (S-L).
59. Combination therapies may be considered but have not been well
studied after therapeutic failure in persons with VL (W-L).
Immunocompromised Hosts
In these guidelines, immunocompetent VL refers to persons with VL without an
identified immune defect.
60. Liposomal amphotericin B (L-AmB) is recommended for the
treatment of VL in immunocompromised persons in North America
(Table 3) (S-L).
Remark: The FDA-approved dosage regimen of L-AmB for such persons, including
those with concurrent HIV/AIDS, is 4 mg/kg/day IV, on days 1–5, 10, 17, 24, 31,
and 38 (10 doses over a 38-day period), for a total dose of 40 mg/kg.
61. Combination therapy (eg, L-AmB plus miltefosine) might be
considered, especially for persons with refractory cases of VL (W-VL).
Remark: The efficacy and optimal duration of miltefosine monotherapy (and
combination therapy) for HIV/AIDS-associated VL have not been established.
62. Because of the importance of effective immune reconstitution in
HIV-VL-coinfected persons, antiretroviral therapy (ART) should be
initiated or optimized as soon as the person is sufficiently stable to
tolerate it (eg, either during or soon after the initial course of therapy
for VL) (S-L).
63. Leishmania infection that becomes clinically manifest or worsens
after initiation of ART should be treated with antileishmanial (and,
if indicated, corticosteroid) therapy. Leishmaniasis-associated
immune reconstitution inflammatory syndrome (IRIS) reactions after
initiation of ART have been reported occasionally (S-VL).