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Treatment of Visceral Leishmaniasis HIV-Related Dr. Fernando Laguna Hospital Carlos III Madrid

Treatment of Visceral Leishmaniasis HIV-Related Dr. Fernando Laguna Hospital Carlos III Madrid. TREATMENT OF VISCERAL LEISHMANIASIS HIV-RELATED. Which drug?. Length?. Dose?. PATIENTS and METHODS (I). Inclusion/Exclusion. Randomization. Treatment B. Treatment A. Parasitological cure

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Treatment of Visceral Leishmaniasis HIV-Related Dr. Fernando Laguna Hospital Carlos III Madrid

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  1. Treatment of Visceral Leishmaniasis HIV-Related Dr. Fernando Laguna Hospital Carlos III Madrid

  2. TREATMENT OF VISCERAL LEISHMANIASIS HIV-RELATED Which drug? Length? Dose?

  3. PATIENTS and METHODS (I) Inclusion/Exclusion Randomization Treatment B Treatment A Parasitological cure Toxicity Relapses

  4. PATIENTS and METHODS (II) Design:multicentre, open-label with blinded centralised randomisation, parallel, active-controlled clinical trial. Setting: Tertiary Hospitals in Spain. Exclusion criteria: Study Population: • HIV-infected patients with a first episode of VL • >18 years old. • Pancreatitis. • Protrombin activity <40%. • Aminotransferase>10 times. • Creatinin >2 times. • Miocardiopathy... • Allergy... • Pregnant woman...

  5. PATIENTS and METHODS (III) • Endpoint: • Treatment was considered successful if no parasites were detected in a bone marrow aspirate performed 1 month after the end of therapy. • Statistical analysis: • The primary analysis was performed following an intention-to-treat principle.

  6. BACKGROUND • We unknewn the efficacy and safety of pentavalent antimonials. • Amphotericin B was useful in immunocompetent patients with VL and it is very potent in vitro

  7. AIM To compare the efficacy and safety of pentavalent antimonials with amphotericin B in HIV-infected patients with VL.

  8. TREATMENT • Amphotericin B 0,7 mg/kg/d, 28 days • Meglumine antimoniate 20 mg Sbv/kg/d, 28 days

  9. =19 RESULTS (I): Baseline data MA AmB n=45 Age 31 32 90 80 Gender (M, %) CD-4 T cells count 29 (1 - 203) 18 (0 - 231) Risk practice for HIV (%) Previous AIDS (%) n=44 70 67 23 13 IVDU Homo/Bisexual men 64 62

  10. =19 RESULTS (II) : Outcome MA AmB n=45 n=44 Uncompleted treatment 10 15 Toxicity5 5 Death5 5 AbandonedTreatment0 5 Completed Treatment34 30 Cured29 (66%) 28 (62%) Notcured4 2 Losttofollow-up1 0

  11. =19 RESULTS (IV): Toxicity MA AmB n=45 n=44 Pts. with at least one AE(%) 25(55) 27(60) Pts. With suspension of Treatment due to an AE 5(11) 5(11) Cardiotoxicity 6(14) 0 Hyperamylasemia 13(20) 0 Nephrotoxicity 2(5) 16(36)

  12. CONCLUSIONS • Amphotericin B presents a similar efficacy than meglumine antimoniate administered for 28 days. • Treatment-related adverse events leading to therapy discontinuation were similar in both groups.

  13. BACKGROUND Amphotericin B lipid complex, an amphotericin B lipid formulation, is very effective in immunocompetent Indian patients with visceral leishmaniasis

  14. AIM To compare the efficacy and safety of amphotericin B lipid complex (ABLC) versus meglumine antimoniate in HIV-infected patients with a first episode of VL.

  15. PATIENTS and METHODS (I) • Treatment groups: • ABLC 3 mg/kg/d for 5 days (ABLC-5). • ABLC 3 mg/kg/d for 10 days (ABLC-10). • Meglumine antimoniate 20 mg Sbv/kg/d for 28 days (MA-28).

  16. RESULTS (I): Baseline data MA-28 ABLC-5 ABLC-10 n=20 n=19 n=18 Age 34.0 ± 5.2 34.1 ± 6.0 33.7 ± 5.8 16/3 15/3 Gender (M/F) 17/3 CD-4 T cells count 76 ± 142 75 ± 90 110 ± 175 CD-4 T cells <200 / >200 17 / 2 16 / 2 17 / 3 Nº of patients under HAART theraphy 7 5 3 HIV stage (n): A B C 1 2 16 3 5 10 2 5 13

  17. =19 RESULTS (II): Outcome MA ABLC-5 ABLC-10 n=19 n=18 n=20 1 1 17 6 (33%) 10 1 9 5 3 1 10 7 (37%) 2 1 Not confirmed VL No efficacy assessment Toxicity Death Lost follow-up Efficacy assessment Cured Not cured Major P. Violation 1* 2 1* 1 18 8 (42%) 10

  18. RESULTS (III): EFFICACY - ITT population

  19. =19 RESULTS (II): Adverse Events Treatment Related MA ABLC-5 ABLC-10 7 1 1 1 1 8 1 2 3 Death Infusion-related AEs Phlebitis Vomiting Pancreatitis Hyperamilasemia Kidney failure Anemia worsening 1 0 4 4 2 1

  20. CONCLUSION • Amphotericin B lipid complex for 5 or 10 days presents a similar efficacy than meglumine antimoniate administered for 28 days, with a lower frequency of adverse events and a better tolerability. • Treatment related adverse events leading to discontinuation were more frequent in antimonial group than in ABLC groups.

  21. Investigators (alphabetic order): • Dr. J. Altés H. de l´Alt Penedés, Barcelona. • Dr. J. Alvar y C. Cañavate C. Nacional de Microbiología, Majadahonda. • Dr. JR. Arribas y E. Torres H La Paz, Madrid. • Dr. V.Boix H. General, Alicante. • Dr. JM. Gatell y JM. Miró H. Clínic, Barcelona. • Dr. J. Gómez Rodrigo H. Severo Ochoa, Leganés. • Dr.M Górgolas F. Jiménez Díaz, Madrid. • Dr. F. Laguna y P.Martínez H. Carlos III, Madrid. • Dr. R. López-Vélez y JA. Pérez Molina H. Ramón y Cajal, Madrid. • Dr. M. Marquez H. Virgen de la Victoria, Málaga. • Dr. FJ. Medrano y ME. Jiménez Mejías H. Virgen del Rocío, Sevilla. • Dr. J. Pasquau H. Virgen de las Nieves,Granada. • Dr. F. Pulido y R. Rubio H. 12 de Octubre, Madrid. • Dra. G. Picó H. Can Misses, Ibiza. • Dr. E.Ribera y C. Azuaje H. Vall d´Hebron, Barcelona. • Dra. A. Salas H. Son Dureta, Palma. • Dr. J. Sanz H. de la Princesa, Madrid. • Dr. G. Sirera y B.Clotet H. German Trias I Pujol, Badalona. • Dr. J. Torre-Cisneros y JM. Kindelán H. Reina Sofía, Córdoba. • Dr. S.Videla y M.Sust L. Pensa-Esteve, Barcelona.

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