In an effort to control the fast growing Visceral leishmaniasis (kala-azar) in India a group of scientists has came out with a study showing paromomycin, an aminoglycoside antibiotic, to be cost effective alternative for the present standard of care, amphotericin B.
Paromomycin injectable- initially used to treat intestinal parasites - has shown to be non-inferior to amphotericin B for the treatment of visceral leishmaniasis in India, according to the phase III study conducted in Bihar to test the safety and efficacy of the drug for the particular disease. The report of the study, conducted from June 2003 to November 2004 has come out in June 2007.
The study was conducted in four treatment centres in Bihar, the Kala-azar Research Centre and Kala-azar Medical Research Centre at Muzaffarpur along with Kala-azar Research Centre and Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna. The study was sponsored by World Health Organization (WHO) and the US based non profit pharmaceutical company Institute for OneWorld Health.
The study was conducted with a total of 667 patients between five and 55 years of age who were negative for the human immunodeficiency virus and had parasitologically confirmed visceral leishmaniasis were randomly assigned in a 3:1 ratio to receive paromomycin (502 patients) at a dose of 11 mg per kilogram of body weight intramuscularly daily for 21 days or amphotericin B (165 patients) at a dose of 1 mg per kilogram intravenously every other day for 30 days.
Paromomycin was shown to be non-inferior to amphotericin B with final cure rate of 94.6 per cent as against cure rate of 98.8 per cent promised by the latter, noting a difference of 4.2 percentage points. Mortality rates in the two groups were less than one per cent.
According to the study findings, duration of treatment with paromomycin (daily for 21 days) is shorter than the treatment time of amphotericin, which is administered in every other day for 30 days, sodium stibogluconate induced daily for 30 days, or miltefosine administered daily for 28 days. The shorter treatment time will make the product affordable to the patients in a cheaper price.
"This finding is important in Bihar, where the failure of sodium stibogluconate therapy is due primarily to drug resistance of only one per cent of the patients in the paromomycin group had renal dysfunction, as compared with 25 per cent of those in the amphotericin group," adds the study. The post treatment follow up was only for six months, which is the standard for visceral leishmaniasis trials, because most relapses occur during this period.
On the basis of this study, paromomycin was approved by the Indian government in August 2006 for the treatment of patients with visceral leishmaniasis and is now available as a public health tool in a nationwide programme to eliminate visceral leishmaniasis.
Kala-azar is one of the fast growing diseases in rural, resource-poor populations in South Asia, Africa and Brazil. The disease, if ignored, will kill 100 per cent of the victims and it is estimated that it plagues half a million people, 90 per cent of whom live in poor villages in India, Bangladesh, Sudan, Brazil and Nepal every year. According to WHO studies, the disease kills 57,000 annually.
At present, the Hyderabad based Gland Pharma Limited is manufacturing the product for OneWorld Health and WHO as it received regulatory approval from the Drug Controller General India for Paromomycin IM Injection as a treatment for VL on August, 2006. According to sources, the company has also agreed to act as the global manufacturer of Paromomycin to ensure access at a markedly reduced cost.