Sundar S , Loscalzo J , Fauci A , Kasper D , Hauser S , Longo D & Jameson JL Harrison’s Principles of Internal Medicine. 21st ed. New York, NY: McGraw-Hill, 1741–1748.
Addy M , Nandy A , 1992. Ten years of kala-azar in West Bengal, Part I. Did post-kala-azar dermal leishmaniasis initiate the outbreak in 24-Parganas? Bull World Health Organ 70: 341–344.
Napier LE , Das Gupta CR , 1931. An epidemiological investigation of kala-azar in a rural area in Bengal. Indian J Med Res 19: 295–341.
Singh OP et al., 2021. Xenodiagnosis to evaluate the infectiousness of humans to sandflies in an area endemic for visceral leishmaniasis in Bihar, India: A transmission-dynamics study. Lancet Microbe 2: e23–e31.
Mondal D et al., 2019. Quantifying the infectiousness of post-kala-azar dermal leishmaniasis toward sand flies. Clin Infect Dis 69: 251–258.
Thakur CP , Kumar K , Sinha PK , Mishra BN , Pandey AK , 1987. Treatment of post kala-azar dermal leishmaniasis with sodium stibogluconate. Br Med J (Clin Res Ed) 295: 886–887.
Thakur CP , Kumar M , Pandey AK , 1991. Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate. Indian J Med Res 93: 103–110.
Thakur CP , Narain S , Kumar N , Hassan SM , Jha DK , Kumar A , 1997. Amphotericin B is superior to sodium antimony gluconate in the treatment of Indian post-kala-azar dermal leishmaniasis. Ann Trop Med Parasitol 91: 611–616.
World Health Organization , 2002. New Therapy for Visceral Leishmaniasis: India Licenses Miltefosine, the First Oral Drug for Visceral Leishmaniasis. Available at: https://www.who.int/publications/i/item/who-wer7725. Accessed June 12, 2022.
World Health Organization , 2010. Control of the Leishmaniases: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases. WHO Technical Report Series 949. Geneva, Switzerland: WHO.
Sundar S , Singh J , Dinkar A , Agrawal N , 2023. Safety and effectiveness of miltefosine in post-kala-azar dermal leishmaniasis: An observational study. Open Forum Infect Dis 10: ofad231.
Maruf S , Nath P , Island MR , Aktar F , Anuwarul A , Mondal D , Basher A , 2018. Corneal complications following post kala-azar dermal leishmaniasis treatment. PLoS Negl Trop Dis 12: e0006781.
Saurabh S , Mahabir M , 2020. Adverse ocular events on miltefosine treatment for post-kala-azar dermal leishmaniasis in India. Trop Doct 50: 37–42.
Maurya R , Singh RK , Kumar B , Salotra P , Rai M , Sundar S , 2005. Evaluation of PCR in the diagnosis of Indian kala-azar and assessment of cure. J Clin Microbiol 43: 3038–3041.
National Cancer Institute, Division of Cancer Treatment and Diagnosis , 1999. Cancer Therapy Evaluation Program: Common Toxicity Criteria. V. 2.0. Available at: https://ctep.cancer.gov%20›%20docs%20›%20ctcv204-30-992. Accessed March 31, 2023.
World Health Organization , 2020. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Available at: https://www.who.int/publications/i/item/9789240010352. Accessed March 17, 2023.
Ramesh V , Singh R , Avishek K , Verma A , Deep DK , Verma S , Salotra P , 2015. Decline in clinical efficacy of oral miltefosine in treatment of post kala-azar dermal leishmaniasis (PKDL) in India. Plos Negl Trop Dis 9: e0004093 [erratum in Plos Negl Trop Dis 9: e0004289].
Ghosh S , Das NK , Mukherjee S , Mukhopadhyay D , Barbhuiya JN , Hazra A , Chatterjee M , 2015. Inadequacy of 12-week miltefosine treatment for Indian post-kala-azar dermal leishmaniasis. Am J Trop Med Hyg 93: 767–769.
Dorlo TP , Balasegaram M , Lima MA , de Vries PJ , Beijnen JH , Huitema AD , 2012. Translational pharmacokinetic modelling and simulation for the assessment of duration of contraceptive use after treatment with miltefosine. J Antimicrob Chemother 67: 1996–2004.
den Boer M , Das AK , Akhter F , Burza S , Ramesh V , Ahmed B-N , Zijlstra EE , Ritmeijer K , 2018. Safety and effectiveness of short-course AmBisome in the treatment of post-kala-azar dermal leishmaniasis: A prospective cohort study in Bangladesh. Clin Infect Dis 67: 667–675.
Ramesh V , Dixit KK , Sharma N , Singh R , Salotra P , 2020. Assessing the efficacy and safety of liposomal amphotericin B and miltefosine in combination for treatment of post kala-azar dermal leishmaniasis. J Infect Dis 221: 608–617.
Sundar S , Pandey K , Mondal D , Raja S , Singh BP , Singh A , Singh OP , Alvar J , Rijal S , Alves F , 2022. Efficacy and Safety of Short Course Combination Regimens of Liposomal Amphotericin B and Miltefosine for Treatment of PKDL in the Indian Subcontinent (abstract No. O15-05). World Leish 7. August 1–6, 2022, Cartagena, Colombia.
Rabi Das VN , Siddiqui NA , Pal B , Lal CS , Verma N , Kumar A , Verma RB , Kumar D , Das P , Pandey K , 2017. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PLoS One 2: e0174497.
World Health Organization , 2023. WHO and Gilead Sciences Extend Collaborative Agreement to Treatment for Visceral Leishmaniasis. Available at: https://www.who.int/news/item/26-01-2023-who-and-gilead-sciences-extend-collaborative-agreement-to-enhance-access-to-treatment-for-visceral-leish maniasis#:~:text=The%20World%20Health%20Organization %20(WHO,their%20previous%20agreement%20to%202025. Accessed January 15, 2023.
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Post–kala-azar dermal leishmaniasis (PKDL) is widely prevalent in the endemic regions of India, but its treatment remains unsatisfactory. The WHO recommends a 12-week treatment with oral miltefosine, but its ocular toxicities are a serious concern. The late 1980s and early 1990s saw the use of sodium stibogluconate and amphotericin B (AmB) for a brief period. Both drugs had frequent adverse events and were expensive, and the duration of treatments was unacceptably long. This retrospective study evaluated, analyzed, and reported the outcomes of PKDL patients treated with a shorter course of AmB, the most effective antileishmanial drug. The hospital records of PKDL patients treated with AmB by 30 alternate-day infusions over 60 days (instead of conventional 60–80 infusions over 100–120 days) between September 2010 and August 2016 were reviewed. Only patients with confirmed parasitological diagnosis were included. Their records were studied for treatment-related adverse events, end-of-treatment parasitological status, and 12-month follow-up results. One hundred two patients were eligible for this study between September 2010 and August 2016. After therapy, 92/102 (90.2%) patients improved; 3 (2.9%) had to cease treatment owing to severe adverse effects, and one died of severe diarrhea unrelated to AmB. Six (5.9%) patients withdrew consent before the treatment was complete. At the 12-month evaluation, 89/102 (87.3%) patients attained a final cure. A 30-infusion regimen of AmB remains highly effective in PKDL. Without a shorter, safer, and more economical regimen for the treatment of PKDL, it should be used until a better regimen is available.
Disclosure: The study was approved by the Ethics Committee of KAMRC, Muzaffarpur, with the condition that the patients’ identity would not be disclosed.
Authors’ addresses: Shyam Sundar, Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India, and Kala-Azar Medical Research Center, Muzaffarpur, India, E-mail: drshyamsundar@hotmail.com. Jaya Chakravarty and Jitendra Singh, Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India, Emails: tapadar@gmail.com and drjitengsvm@gmail.com. Deepak Verma, Kala-Azar Medical Research Center, Muzaffarpur, India, E-mail: kamrcmfp@gmail.com. Neha Agrawal, Department of Medicine, University of Florida, Jacksonville, FL, E-mail: agrawal.neha84@gmail.com. Anju Dinkar, Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India, E-mail: dranjudinkar@gmail.com.
Sundar S , Loscalzo J , Fauci A , Kasper D , Hauser S , Longo D & Jameson JL Harrison’s Principles of Internal Medicine. 21st ed. New York, NY: McGraw-Hill, 1741–1748.
Addy M , Nandy A , 1992. Ten years of kala-azar in West Bengal, Part I. Did post-kala-azar dermal leishmaniasis initiate the outbreak in 24-Parganas? Bull World Health Organ 70: 341–344.
Napier LE , Das Gupta CR , 1931. An epidemiological investigation of kala-azar in a rural area in Bengal. Indian J Med Res 19: 295–341.
Singh OP et al., 2021. Xenodiagnosis to evaluate the infectiousness of humans to sandflies in an area endemic for visceral leishmaniasis in Bihar, India: A transmission-dynamics study. Lancet Microbe 2: e23–e31.
Mondal D et al., 2019. Quantifying the infectiousness of post-kala-azar dermal leishmaniasis toward sand flies. Clin Infect Dis 69: 251–258.
Thakur CP , Kumar K , Sinha PK , Mishra BN , Pandey AK , 1987. Treatment of post kala-azar dermal leishmaniasis with sodium stibogluconate. Br Med J (Clin Res Ed) 295: 886–887.
Thakur CP , Kumar M , Pandey AK , 1991. Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate. Indian J Med Res 93: 103–110.
Thakur CP , Narain S , Kumar N , Hassan SM , Jha DK , Kumar A , 1997. Amphotericin B is superior to sodium antimony gluconate in the treatment of Indian post-kala-azar dermal leishmaniasis. Ann Trop Med Parasitol 91: 611–616.
World Health Organization , 2002. New Therapy for Visceral Leishmaniasis: India Licenses Miltefosine, the First Oral Drug for Visceral Leishmaniasis. Available at: https://www.who.int/publications/i/item/who-wer7725. Accessed June 12, 2022.
World Health Organization , 2010. Control of the Leishmaniases: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases. WHO Technical Report Series 949. Geneva, Switzerland: WHO.
Sundar S , Singh J , Dinkar A , Agrawal N , 2023. Safety and effectiveness of miltefosine in post-kala-azar dermal leishmaniasis: An observational study. Open Forum Infect Dis 10: ofad231.
Maruf S , Nath P , Island MR , Aktar F , Anuwarul A , Mondal D , Basher A , 2018. Corneal complications following post kala-azar dermal leishmaniasis treatment. PLoS Negl Trop Dis 12: e0006781.
Saurabh S , Mahabir M , 2020. Adverse ocular events on miltefosine treatment for post-kala-azar dermal leishmaniasis in India. Trop Doct 50: 37–42.
Maurya R , Singh RK , Kumar B , Salotra P , Rai M , Sundar S , 2005. Evaluation of PCR in the diagnosis of Indian kala-azar and assessment of cure. J Clin Microbiol 43: 3038–3041.
National Cancer Institute, Division of Cancer Treatment and Diagnosis , 1999. Cancer Therapy Evaluation Program: Common Toxicity Criteria. V. 2.0. Available at: https://ctep.cancer.gov%20›%20docs%20›%20ctcv204-30-992. Accessed March 31, 2023.
World Health Organization , 2020. Ending the Neglect to Attain the Sustainable Development Goals: A Road Map for Neglected Tropical Diseases 2021–2030. Available at: https://www.who.int/publications/i/item/9789240010352. Accessed March 17, 2023.
Ramesh V , Singh R , Avishek K , Verma A , Deep DK , Verma S , Salotra P , 2015. Decline in clinical efficacy of oral miltefosine in treatment of post kala-azar dermal leishmaniasis (PKDL) in India. Plos Negl Trop Dis 9: e0004093 [erratum in Plos Negl Trop Dis 9: e0004289].
Ghosh S , Das NK , Mukherjee S , Mukhopadhyay D , Barbhuiya JN , Hazra A , Chatterjee M , 2015. Inadequacy of 12-week miltefosine treatment for Indian post-kala-azar dermal leishmaniasis. Am J Trop Med Hyg 93: 767–769.
Dorlo TP , Balasegaram M , Lima MA , de Vries PJ , Beijnen JH , Huitema AD , 2012. Translational pharmacokinetic modelling and simulation for the assessment of duration of contraceptive use after treatment with miltefosine. J Antimicrob Chemother 67: 1996–2004.
den Boer M , Das AK , Akhter F , Burza S , Ramesh V , Ahmed B-N , Zijlstra EE , Ritmeijer K , 2018. Safety and effectiveness of short-course AmBisome in the treatment of post-kala-azar dermal leishmaniasis: A prospective cohort study in Bangladesh. Clin Infect Dis 67: 667–675.
Ramesh V , Dixit KK , Sharma N , Singh R , Salotra P , 2020. Assessing the efficacy and safety of liposomal amphotericin B and miltefosine in combination for treatment of post kala-azar dermal leishmaniasis. J Infect Dis 221: 608–617.
Sundar S , Pandey K , Mondal D , Raja S , Singh BP , Singh A , Singh OP , Alvar J , Rijal S , Alves F , 2022. Efficacy and Safety of Short Course Combination Regimens of Liposomal Amphotericin B and Miltefosine for Treatment of PKDL in the Indian Subcontinent (abstract No. O15-05). World Leish 7. August 1–6, 2022, Cartagena, Colombia.
Rabi Das VN , Siddiqui NA , Pal B , Lal CS , Verma N , Kumar A , Verma RB , Kumar D , Das P , Pandey K , 2017. To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL). PLoS One 2: e0174497.
World Health Organization , 2023. WHO and Gilead Sciences Extend Collaborative Agreement to Treatment for Visceral Leishmaniasis. Available at: https://www.who.int/news/item/26-01-2023-who-and-gilead-sciences-extend-collaborative-agreement-to-enhance-access-to-treatment-for-visceral-leish maniasis#:~:text=The%20World%20Health%20Organization %20(WHO,their%20previous%20agreement%20to%202025. Accessed January 15, 2023.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 1865 | 1865 | 54 |
Full Text Views | 79 | 79 | 9 |
PDF Downloads | 105 | 105 | 11 |