Patients with visceral leishmaniasis (kala-azar, Leishmania donovani) may relapse after therapy. Thus it is important for patients to meet criteria for cure before the success of a treatment can be determined.
Agents used to treat visceral leishmaniasis:
(1) pentavalent antimony
(2) antimony plus interferon-gamma
(3) sodium stibogluconate
(4) pentamidine
(5) amphotericin B lipid complex
Parasitologic cure:
(1) amastigotes in smear of bone marrow or spleen (grade > 0) before treatment
(2) splenic aspirate grade post-treatment = 0 (no amastigotes seen in 1,000 oil immersion fields during examination of the splenic aspirate smear)
Apparent cure:
(1) clinical improvement, including return of temperature to normal. Absence of fever is not used as a criteria if the patient is receiving an antipyretic agent. Some of the regimens are associated with drug-induced fever.
(2) decrease in spleen size (as measured in anterior axillary line from costal margin to the splenic tip). Patients who respond to treatment tend to show increases in blood parameters (hemoglobin, white blood cell count, platelet count) as the splenomegaly resolves.
(3) splenic aspirate grade (parasite density score) of 0
Definitive cure: determined at followup 6 months after treatment:
(1) absence of any clinical evidence of relapse
(2) bone marrow aspirate showing no parasites
Response to treatment:
(1) fast responders: become afebrile during the first week of treatment
(2) slow responders: may take 4-5 weeks to respond to treatment
WHO definitions of unresponsiveness to a regimen:
(1) primary: no clinical or parasitological improvement during or after the first course of treatment
(2) secondary: relapse after one or more courses of seemingly successful therapy
Criteria for discontinuation of a drug treatment:
(1) deterioration of the patient's condition
(2) onset of serious drug side effect
Specialty: Infectious Diseases