Treatment Outcomes of Single-Dose Liposomal Amphotericin B–Treated Visceral Leishmaniasis Patients and Factors Affecting Outcome in Bihar, India

Niyamat Ali Siddiqui Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Niyamat Ali Siddiqui in
Current site
Google Scholar
PubMed
Close
,
Mohd. Zahid Ansari Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Mohd. Zahid Ansari in
Current site
Google Scholar
PubMed
Close
,
Sanjay Kumar Sinha Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Sanjay Kumar Sinha in
Current site
Google Scholar
PubMed
Close
,
Biplab Pal Department of Pharmacology, School of Pharmaceutical Science, Lovely Professional University, Phagwara, India;

Search for other papers by Biplab Pal in
Current site
Google Scholar
PubMed
Close
,
Ashish Kumar Singh Department of Microbiology, School of Sciences, RK University, Rajkot, India

Search for other papers by Ashish Kumar Singh in
Current site
Google Scholar
PubMed
Close
,
Subhankar Kumar Singh Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Subhankar Kumar Singh in
Current site
Google Scholar
PubMed
Close
,
Roshan Kamal Topno Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Roshan Kamal Topno in
Current site
Google Scholar
PubMed
Close
,
Vidya Nand Rabi Das Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Vidya Nand Rabi Das in
Current site
Google Scholar
PubMed
Close
, and
Krishna Pandey Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India;

Search for other papers by Krishna Pandey in
Current site
Google Scholar
PubMed
Close
Restricted access

An assessment of the treatment outcomes of single-dose liposomal amphotericin B, implemented in 2010, had not been conducted until this study. This prospective cross-sectional study encompassed 527 cases, comprising 470 (89%) cases of visceral leishmaniasis (VL) and 57 (11%) cases of post–kala-azar dermal leishmaniasis (PKDL). The male proportion was higher (55% for VL), and the mean (±SD) age was 39.2 (±33.9) years. Among VL cases (426) treated with single-dose liposomal amphotericin B, 402 cases were cured at the 6-month follow-up, resulting in a cure rate of 95%, whereas fewer than 1% (0.9%) experienced unsuccessful outcomes and 4.1% faced relapse. A statistically highly significant difference in treatment outcomes (successful versus unsuccessful) was observed between males and females (P = 0.0005). Males had higher odds of successful outcomes compared with females, with an odds ratio of 5.03 (95% CI: 1.84–13.74). Those aged ≤23 years had higher odds of successful outcomes than unsuccessful outcomes, with an odds ratio of 6.82 (95% CI: 2.29–20.33). Patients with PKDL had a mean (±SD) age of 28.5 (±10.6) years, with 63% being male. Among the 57 PKDL cases, 21 (37%) had been treated with single-dose liposomal amphotericin B, whereas others had received alternative drugs. The median duration of PKDL development for single-dose liposomal amphotericin B was significantly shorter (14.5 months), with a statistically significant difference (P <0.001) compared with other drugs. The current treatment strategy necessitates continuous close monitoring and reviews to ensure consistent and improved outcomes.

Author Notes

Disclosures: The study received approval from the ICMR-RMRIMS (Rajendra Memorial Research Institute of Medical Sciences) Ethics Committee and the Scientific Advisory Committee, Patna. Written informed consent was obtained from all selected health facilities and adult participants during door-to-door visits. For participants under 18 years old who were able to read, written assent was obtained following written consent from their parent or guardian. All study data were anonymized before analysis, and confidentiality was maintained in accordance with the principles of the Declaration of Helsinki (as amended in Tokyo, Hong Kong, and Somerset West, South Africa).

Current contact information: Niyamat Ali Siddiqui, Mohd. Zahid Ansari, Sanjay Kumar Sinha, Subhankar Kumar Singh, Roshan Kamal Topno, Vidya Nand Rabi Das, and Krishna Pandey, Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India, E-mails: niyamatalisiddiqui@yahoo.com, zahidstatistics@gmail.com, sinhask70@yahoo.com, sksrmri@yahoo.com, roshanktopno@yahoo.co.in, drvnrdas@yahoo.com, and drkrishnapandey@yahoo.com. Biplab Pal, Department of Pharmacology, School of Pharmaceutical Science, Lovely Professional University, Phagwara, India, E-mail: biplab2006pal@gmail.com. Ashish Kumar Singh, Department of Microbiology, School of Sciences, RK University, Rajkot, India, E-mail: ashish.drug.research@gmail.com.

Address correspondence to Niyamat Ali Siddiqui, Department of Biostatistics, Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Agamkuan, Patna 800007, India. E-mail: niyamatalisiddiqui@yahoo.com
Save