Indian J Lepr 2008, 80 : 331-344 http://www.ijl.org.in
Original Article

Long Term Follow-up Results of 1 Year MDT
in MB Leprosy Patients Treated with Standard
MDT + once a Month Minocycline and Ofloxacin


K Katoch1, VM Katoch2, M Natarajan1, UD Gupta3,
VD Sharma4, HB Singh4
 

    1K Katoch, MD, Scientist F and Head, Medical Unit I; Model Rural Health Research Unit, Ghatampur, Kanpur, India
    2VM Katoch, MD, Secretary, Department of Health Research, Ministry of Health and Family Welfare, Government of India and Director-General, Indian Council of Medical Research, Ansari Nagar, New Delhi-110029, India
    1M Natrajan, MBBS, DVD, PhD, Scientist F, Medical Unit I
    3UD Gupta, PhD, Scientist E, Animal Experimentation Facility
    4VD Sharma, PhD, Scientist E, Department of Microbiology and Molecular Biology
    4HB Singh, PhD, Scientist B, Department of Microbiology and Molecular Biology

    National JALMA Institute for Leprosy and Other Mycobacterial Diseases (ICMR), Department of Health Research, Ministry of Health and Family Welfare, Government of India, Dr M Miyazaki Marg, Tajganj, Agra-282001, India


    Correspondence to : Dr K Katoch, Email : kirankatoch@rediffmail.com




Abstract

Background : This study was initiated in consultation with the National Leprosy Eradication Programme (NLEP) in mid nineties to try new treatment regimens for leprosy which were more robust in terms of control of reactions, long term relapses, operationally easier to undertake and feasible in field conditions. It was also envisaged to see if the addition of newer bactericidal drugs would be beneficial.

Objectives : (i) To test the feasibility, safety and response of the patients to the new regimen. (ii) To observe the incidence of reactions during and after stoppage of therapy, for a period of 8-10 years after release from treatment.

Materials and Methods : A total of one hundred skin smear positive MB patients (15 LL, 35 BL and 50 BB) patients were included in this study. All the patients received the standard MDT + once a month supervised 100 mg of Minocycline and 400 mg of Ofloxacin for 12 months during the treatment phase. Thereafter, the treatment was stopped in all the patients which were followed-up on placebo (B complex tablets). Of these, 70 patients completed the treatment schedule of one year therapy and the post treatment follow-up of 9 to 10 years.

Results : All the patients tolerated the drugs well. The clinical response of the patients to the treatment was very good of which 32.85% of cases had history of reactions before starting treatment. During treatment, the incidence of reactions increased marginally to 38.5%, but these were easily controlled with concurrent administration of steroids. Aftercompletion of treatment the incidence was much less i.e. 10% and 3% after 1 and 2 years of post treatment follow-up respectively. The overall relapse rate is 5.7% (4/70) with an incidence density of 0.05/100 patient years. Relapses were confirmed by clinical, bacteriological, molecular biological (rRNA probes and 36 kD targeting PCR) as well as ATP bioluminescence. The relapsed patients presented with the appearance of new lesions, slit-skin smears were again found to become positive after becoming negative. Three of the four cases who relapsed had the initial mean BI of 2 to 2.9+ whereas one had the initial mean BI of 1.5+. Also, 2 of the 4 relapsed patients had positive PCR signals at the time of stoppage of treatment.

Tentative conclusions : The addition of Minocycline and Ofloxacin to the standard FDT has been observed to be a well tolerated regimen. The results of 1 year fixed duration MB-MDT have not been published yet and therefore cannot be compared. Overall as of now, the incidence of reactions observed with the newer treatment regimen is found to be significantly lower than that of 2 years fixed duration MB-MDT. The efficacy of this regimen regarding bacteriological clearance and relapse rates could not be compared due to non-availability of the results of experience with standard 1 year MDT regimen. However, this regimen appears to be operationally feasible and safe for the users.

Key words : MB leprosy, MDT, FDT, Minocycline, Ofloxacin