Title: Assessment of Treatment Outcome in Visceral Leishmaniasis (VL) Patients with Reference to Efficacy and Safety – A Record-Based Observational Study in a Speciality Public Hospital

Authors: Dr Syed Mohammad Naser, Dr Parvin Banu, Dr Rama Prasad Goswami, Dr Santanu Kumar Tripathi, Dr Sukanta Sen

 DOI: https://dx.doi.org/10.18535/jmscr/v7i4.167

Abstract

Background: Study was done to assess the outcome of pharmacotherapy in visceral leishmaniasis (VL) patients in a specialty public hospital in Kolkata.

Materials & Methods: The hospital records of all consecutive VL patients admitted at Calcutta School of Tropical Medicine (CSTM), Kolkata during the last five years - 2010-2014, were reviewed and the relevant information inputs as documented studied to realize the noted objectives. Clinical presentation on admission including presence of co-infections (particularly HIV), trends and patterns of treatment regimens and rationale thereof, if available; treatment (anti-leishmaniasis) outcomes in reference to efficacy, safety and tolerability, fatality like serious complications and mortality and adverse drug reactions (for anti-leishmaninal drugs primarily), if any was noted.

Results: Commonest age group was from 18 to 45 years. Mean age was 30.02 ± 15.88 years and the range was 2 to 75 years. Fever was the presenting symptom of 85.4% of VL cases. In 2010 maximum (46.67%) cases got the combination regime of L-AmB and miltefosine followed by 26.67% L-AmB and 20% AmB.

Conclusion: VL was treated with conventional and liposomal AmB as well as with SSG, miltefosine and combination therapy. Among the regimens short course L-AmB was found to be the most efficacious and tolerable in respect to ADRs and hospital stay. ADRs were common with SSG, AmB, Miltefosine and almost absent with L-AmB. 

Keywords: Kala-azar, Visceral leishmaniasis, Anti-leishmaninal drugs, Liposomal AmB, Sodium Stibogluconate, Miltefosine, ADRs

References

  1. WHO (2010) Control of the Leishmaniasis, Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases.
  2. Thakur C., Kumar K.  Post kala-azar dermal leishmaniasis: a neglected aspect of kala-azar control programmes. Ann Trop Med Parasitol.1992; 86: 355–359. 
  3. Balasegaram M, Ritmeijer K, Lima MA, et al. Liposomal amphotericin B as a treatment for human leishmaniasis. Expert Opin Emerg Drugs. 2012;17(4):493–510.
  4. Sundar S, Chakravarty J. Liposomal amphotericin B and leishmaniasis: dose and response. J Glob Infect Dis. 2010;2(2):159–166.
  5. Agrawal VK, Singh Z. Miltefosine: First Oral Drug for Treatment of Visceral Leishmaniasis. Med J Armed Forces India. 2011;62(1):66–67.
  6. Sundar S, Chakravarty J. Liposomal amphotericin B and leishmaniasis: dose and response. J Glob Infect Dis. 2010;2(2):159–166.
  7. Operational guidelines on kala-azar (visceral leishmaniasis) elimination in india - 2015 national vector borne disease control programme ministry of health & family welfare directorate general of health services.
  8. Thakur C, Singh R, Hassan S, Kumar R, Narain S, Kumar A. Amphotericin B deoxycholate treatment of visceral leishmaniasis with newer modes of administration and precautions: a study of 938 cases. Trans R Soc Trop Med Hyg.1999; 93: 319–323.
  9. Sundar S, Mehta H, Suresh A V, et al. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis. 2004;38(3):377–383. 
  10. Olliaro PL, Guerin PJ, Gerstl S, Haaskjold AA, Rottingen JA, Sundar S. Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004. Lancet Infect Dis. 2005;5(12):763–74.
  11. Sundar S, Chakravarty J.  An update on pharmacotherapy for leishmaniasis. Expert Opin Pharmacother. 2015; 16: 237–252. 
  12. Bhattacharya S, Sinha P, Sundar S, Thakur C, Jha T, Pandey K, et al.  Phase 4 trial of miltefosine for the treatment of indian visceral leishmaniasis. J Infect Dis.2007; 196: 591–598. 
  13. Burza S, Nabi E, Mahajan R, Mitra G, Lima M.  One-year follow-up of immunocompetent male patients treated with miltefosine for primary visceral leishmaniasis in Bihar, India. Clin Infect Dis. 2013; 57: 1363–1364. 
  14. Sundar S, Singh A, Rai M, Prajapati V, Singh A, Ostyn B, et al.  Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. Clin Infect Dis. 2012; 55: 543–550. 
  15. Sundar S, More D, Singh M, Singh V, Sharma S, Makharia A, et al. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 2000; 31: 1104–1107. 
  16. Ritmeijer K, Dejenie A, Assefa Y, Hundie T, Mesure J, Boots G, et al.  A comparison of miltefosine and sodium stibogluconate for treatment of visceral leishmaniasis in an Ethiopian population with high prevalence of HIV infection. Clin Infect Dis. 2006; 43: 357–364. 
  17. Sundar S, Chakravarty J.  Investigational drugs for visceral leishmaniasis. Expert Opin Investig Drugs. 2015; 24: 43–59. 
  18. Sundar S, Sinha P, Rai M, Verma D, Nawin K, Alam S, et al.  Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011; 377: 477–486.
  19. Sundar S, Sinha P, Verma D, Kumar N, Alam S, Pandey K, et al.  AmBisome plus miltefosine for Indian patients with kala-azar. Trans R Soc Trop Med Hyg. 2011; 105: 115–117. 

Corresponding Author

Dr Parvin Banu

Ph-9433133027, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.