Leprosy Mailing List Blog: (LML) Draft WHO Leprosy Strategy 2016-2020

Leprosy Mailing List – November 14, 2015

Ref.: (LML) Draft WHO Leprosy Strategy 2016-2020

From: Wim van Brakel, Amsterdam, the Netherlands

I would like to contribute to this important discussion. In principle, a shorter, uniform MDT regimen for all leprosy patients is excellent news. It will facilitate treatment regularity and be cheaper potentially (also to patients) and easier to manage. I am concerned about 3 things related to the introduction of UMDT.

1. As Dr Barreto rightly said, there is an issue about the efficacy of UMDT compared to regular MDT. Evidence is needed that the relapse rate is not much higher than with the current standard MB MDT regimen, especially among patients with a high BI. For PB patients this is of course not an issue, since they will get more drugs than they need.

2. How do the current PB patients feel about taking a drug that is likely to colour their skin dark, while they do not actually need it? In some countries and regions, clofazimine skin discolouration is a reason for not taking MDT, for omitting clofazimine from the regimen or for replacing is, e.g. by minocycline. All because having a darker skin is stigmatised and may cause people to have disclose their status, or may cause anxiety because of negative reactions or discrimination by the environment. Is there published evidence from several countries that PB patients treated with UMDT found it acceptable to take clofazimine?

3. Dr Ben Naafs highlighted the issue of reactions and the occurrence of reactions after treatment. An increase of ENL (Type 2 reaction) incidence after MDT was already observed after the introduction of the one-year MB MDT in the 1990s. With only 6 months of UMDT, a larger proportion of patients are likely to develop post-treatment reactions and are thus at risk of developing permanent nerve damage (and/or other tissue damage). For MB patients who have already had one or more ENL reactions and for those at risk of ENL (extensive disease; high BI, if known), additional post-MDT clofazimine may be needed, since the shortening of the clofazimine treatment in itself will increase the risk of ENL reactions.

However, also the reduced duration of surveillance is a serious concern for those at high risk of developing reactions and additional nerve damage. People who complete their MDT disappear ‘off the radar’ of the health services. For the majority of ex-patients this is good news, since they are cured and not in need of further health care. A significant minority, however, is at risk of developing further reactions, additional nerve damage, or additional impairments, if they already have nerve damage. There is evidence that disability will worsen in this group in the absence of surveillance from the health services (see e.g. van Brakel et al, 2012).

For this group, a separate registration category should be created of ‘Persons at risk of post-MDT complications and disability’. People in this category should be actively advised about the risks and should be followed up at least 6-monthly to screen for additional nerve damage, treat any reactions and check whether people know the self-care routines needed to manage existing impairments. Health workers should be required to report on this group separately, so that the magnitude is known and can be monitored. Indicators that apply to cases on treatment would apply to this group also: number or percentage of persons with Grade 2 disability, number or percentage of persons who’s EHF score has worsened, number or percentage of persons who have had a Type 1 reaction and number or percentage of persons who have had a Type 2 reaction.

In Indonesia, the National Leprosy Control Programme conducted a pilot in two provinces with so-called ‘Semi-active surveillance’, which included the above components. It was called ‘semi-active surveillance’ since health workers were asked to make a home visit if someone did not come back for the 6-monthly appointment. The pilot was successful and was subsequently scaled up to additional provinces. The duration of such semi-active surveillance will vary, depending on the condition and impairment status of the person, but 3 years should probably be enough if no post-MDT complications are experienced.

With kind regards,

Wim van Brakel

Wim van Brakel, MD MSc PhD

Head Technical Department

Netherlands Leprosy Relief (NLR)

Wibautstraat 137k

1097DN Amsterdam

Netherlands

Tel. +31 20 5950529

Email: w.v.brakel@leprastichting.nl

URL: www.leprosyrelief.org

The Netherlands