The clinical management of visceral leishmaniasis (VL) in India

To date, outside small hospital based phase III studies, no evidence exists for the field use of liposomal amphotericin B. This is particularly important considering the complexities of providing and delivering this treatment outside of tertiary level care facilities in resource limited settings. There are many questions regarding the feasibility, safety and effectiveness of using the comparatively complex liposomal preparation of amphotericin B (which requires cold chain, skilled HR able to prepare, administer intravenous infusions and monitor drug reactions) which raised major concerns considering the low level of skilled HR and capacity in the Indian rural health system. As such, I wished to demonstrate and document the outcomes of using government facilities and HR to use this treatment under routine field conditions. Prior to my work, cases of PKDL following treatment with liposomal amphotericin B had not been described in the literature, with theories that this complication would be highly unlikely following this treatment. I therefore wish to also focus on PKDL as clinical entity for which there is limited evidence in the literature regarding treatment, and offer some solutions with regards to possible treatment modalities. Additionally, although well described in East Africa, little evidence currently exists on the prevalence of HIV-VL co-infection in endemic areas of India. Considering the density and level of in-country migration from Bihar, is possible that the scale of this condition is underestimated. Noting an increasing number of patients presenting with relapsing VL who on further estimation were HIV positive, I developed a research question to determine the true prevelence of co-infection with HIV in patients routinely presenting with VL, the research question being whehter it is justified to introduce routine HIV testing for all patients presenting with VL in India – a recommendation made globally by the WHO, but not implemented in the Asian context. Co-infection with HIV was never considered to be a public health issue in the Indian context, and was not considered a threat to the elimination effort – indeed, no treatment guidelines are available for this condition, and the national programme’s position is that it not a public health problem in India. The lack of evidence is such that there exists only one report in the literature of how patients with co-infection progress over a two year period – I therefore looked to describe what the longer term progression of this chronic disease is over a 5 year period post treatment, and the relative impact of starting anti-retroviral treatment (ART). The objective is in part to develop evidence which will determine whether or not the Indian national HIV programme should recommend the use of ART in HIV-VL co-infected patients No data currently exists on patient perceptions of the variety of treatments currently available or proposed by the WHO. The main decision making processes for policy change by both WHO and regional vertical programmes have excluded patient perceptions and experiences of disease, and have been based purely on cost and effectiveness. Considering the efficacy of these new treatment modalities are similar in phase III studies, yet the different logistical requirements from the societal perspective remain very wide. For example, the societal impact of a 10 day course of combination therapy which requires the patient to travel daily to the health center to receive daily intramuscular injections is likely to be very different to treatment with a single dose therapy, or treatment with only oral medications that can be taken at home following a single point of contact with the health care provider. As such, I hope to increase the evidence base by conducting qualitative research into this domain, which will allow the policy makers to factor the patient perspectives into their decision making process. My final research question will address a lacunae in the anthropological evidence for VL in the Indian subcontinent. I plan to develop evidence of the patients experiences of suffering from VL. There is a limited amount of qualitative evidence in the literature regarding VL, and indeed none on this particular subject, which will be crucial in developing Information, Education and Communication (IEC) strategies for implementation in routine programme settings. One of the major weakenesses in the National Programme approaches towards elimination in the Indian subcontinent is the near total lack of IEC material and strategy, which is partly based on the lack of formative research that should allow better development of tools adapted to the patients understanding and experiences of disease.

Keywords:B680-public-health