Leprosy Post-Exposure Prophylaxis(LPEP) with Single-Dose Rifampicin (SDR)
Over the past decade the annual number of newly detected leprosy cases globally has stagnated at around 200,000 – 250,000, including children. This indicates that transmission is on-going and new tools are needed to break the transmission. In the COLEP study, Chemoprophy laxis with SDR was shown to be most effective in protecting contacts who were at a moderately elevated risk of developing leprosy compared to the general population, such as neighbors and social contacts of the leprosy patient and contacts of patients with paucibacillary disease. COLEP trial was followed by the three year Leprosy Post-Exposure Prophylaxis (LPEP) program which evaluated the feasibility and impact of SDR-PEP in eight countries (Brazil, Cambodia, India, Indonesia, Myanmar, Nepal, Sri Lanka and Tanzania).
In 2018, the World Health Organization (WHO) included& recommended LPEP in new guideline for Diagnosis, Treatment and prevention of leprosy.
The LPEP project was designed to provide evidence on the feasibility and impact of chemoprophy laxis using SDR. The LPEP Study Group consists of the implementing partners (International Federation of Anti-Leprosy Associations (ILEP) members and national leprosy programs), the funder (the Novartis Foundation) and academic partners (Erasmus Medical Center and Swiss Tropical and Public Health Institute). Preliminary results from all LPEP countries (except Cambodia and Lingat village in Indonesia, which follow a slightly different protocol) showed that of over 6,600 enrolled leprosy patients, 120,000 contacts were listed, from which 99% could be successfully traced. Following application of exclusion criteria and screening,90% were eligible and received SDR. Among those who were excluded from SDR, 406 new leprosy patients could be identified and referred for MDT treatment.Overall, only 0.3% contacts refused SDR. Based on these figures, together with the low refusal rates of leprosy patients (0.7%) to reveal their status to contacts and the high acceptance among the health workforce, it can be concluded that the operational feasibility of the integration of contact tracing and PEP with SDR into national leprosy control programs has been convincingly demonstrated across the different health systems. Furthermore, the LPEP program has invigorated local leprosy control through introduction or strengthening of contact tracing, and increased motivation of health staff trough training and supervision, and specifically also through the availability of a preventive tool that can be offered to the population at risk. This evidence led to the endorsement of the WHO Global Leprosy Programme (GLP) of leprosy PEP for endemic countries. However, further studies are needed to add experiences from other settings on SDR-PEP and possibly using different approaches for contact tracing and screening, such as skin camps, pictorial aids to identify leprosy signs etc.
In India, NLR conducted a pilot at Dadra & Nagar Haveli (DNH) which is a small Union Territory in the west central part of India, with a population of 3,42,853 (Census 2011). Despite being well-structured and best-run leprosy program there, the PR, ANCDR and other indicators show a disturbing trend. ANCDR & PR show a rising trend. On 31st March 2013, the Prevalence rate was around 3.6/10,000 population and ANCDR was 98/100,000 population, for the year 2012-2013. Child proportion among new cases was 26% (indicating the transmission of disease), which is very high compared to the national average of 9%, no disability Gr II was reported among new cases detected for last many years barring one detected in 2010-2011. The big concern here is: No decline in the number of new cases with a high proportion of child cases indicating the continued transmission of disease.
The following were the salient points of the LPEP program at DNH
- Started in 2015 & completed in 2018
- 30,295 contacts of 1662 index cases given SDR during 3 years.
- No serious adverse effect in any case.
- Apart from feasibility, 3 side studies were also carried out which are -perception study, Acceptability study and study on Cost Effectiveness.
Based on the project, LPEP with SDR was integrated into the National Leprosy Eradication Program with rolling out the program nationally .The National operational guidelines on PEP was developed and issued by CLD-NLEP. The listing & screening of contacts of new cases has been started in 163 endemic districts of the country. Most of the states have started LPEP. With continuous efforts, this LPEP will certainly bring down the incidence of Leprosy in the near future.