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Jitendra Gupta MSF- Spain

Efficacy and Safety outcomes: Liposomal Amphotericin B (Ambisome) treatment for Visceral Leishmaniasis (VL) under routine programme conditions in Bihar, India. Jitendra Gupta MSF- Spain. Facts about VL. A major neglected disease.

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Jitendra Gupta MSF- Spain

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  1. Efficacy and Safety outcomes: Liposomal Amphotericin B (Ambisome) treatment for Visceral Leishmaniasis (VL) under routine programme conditions in Bihar, India. Jitendra Gupta MSF- Spain

  2. Facts about VL • A major neglected disease. • Worldwide around 500,000 new cases/ year. • Only 5 countries have more than 90% of cases (India, Bangladesh, Nepal, Sudan and Brazil). • Leishmania donovani, Kala-Azar in Indian subcontinent. • Fever, weight loss and enlarged spleen. • If untreated, anemia and wasting, fatal illnesses in 95% of cases.

  3. INDIA

  4. Bihar background • Second poorest state of the country. • Around 60 – 75% VL cases of India are in Bihar alone.

  5. Available Treatment Options • Sodium Stibogluconate (SSG) • Pentamidine Isethionate • Paromomysin (also called Aminosidine) • Miltefosine • Amphotericin B • Liposomal Amphotericin B

  6. Liposomal Amphotericin B (Ambisome) • Safest available drug for VL treatment. • First line treatment for VL in resource rich settings. • Phase II studies showed: • High efficacy (89-100%). • Low safety risk. • No phase III or IV study data available. • High cost of the drug.

  7. MSF-Spain VL project in Bihar

  8. Objectives • To evaluate effectiveness of first line AmBisome, at a total dose of 20mg/kg body weight. • To evaluate tolerability and safety of first line AmBisome treatment, at above dosage, under routine programme conditions.

  9. Methodology • Prospectively monitored and evaluated a cohort of VL patients. • Ambisome 20 mg/kg body weight on day 0, 1, 4 & 9 (WHO recommended, 2005). • Inclusion: • The first 250 patients diagnosed with primary VL. • Clinically & Rk 39 dipsticks positive. • Exclusion: • Patients previously treated with Ambisome. • Patients with relapse, <2 years, HIV or TB co-infected.

  10. Continued… • Safety monitoring: • Clinical assessment • Hemoglobin, Weight • End points: • At the end of treatment (day 10). • 3-months after the treatment. • Final cure at 6-months. • Clinically well • If clinically suspected, parasitological clearance

  11. Characteristics on Admission:

  12. Main Adverse Events

  13. Outcomes

  14. Clinical Markers for Improvement

  15. Odds Ratio (Intention to Treat)

  16. Conclusion • Ambisome (20 mg/kg bw) shows high effectiveness (96%), under routine programme conditions. • Extremely safe: only 0.23 adverse event per treatment. • High tolerability.

  17. Key Issues & Recommendations • High drug cost. • New implementation programmes with Ambisome 15 mg and closely monitored under field conditions should be undertaken. • Further combination studies with Ambisome as the main drug, to be combined with other drugs, should be urgently explored.

  18. Acknowledgements Thank you!! MSF Spain MSF Spain, India, Hajipur RMRI, Patna Manica Balasgaram

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