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• W4386234003 abstract "“A good intention, with a bad approach, often leads to a poor result.” Thomas A. Edison Tuberculosis prevention treatment (TPT) for multi drug resistant tuberculosis (MDR-TB) contacts with 6 months of daily levofloxacin (6Lfx) was first discussed in the World Health Organization (WHO) consolidated tuberculosis (TB) guidelines based on “low-quality evidence with the conditional and cautious recommendation.”[1] Programmatic management of drug-resistant tuberculosis (PMDT, India) 2021 carries forward the same recommendations[2] without accounting for the multiple challenges faced in a high-TB burden country like India. The recent directive of the Joint Director of Health Services, Government of Maharashtra, to implement TPT for all household contacts of MDR-TB patients (with proven FQ (fluoroquinolone) sensitivity) with 6Lfx,[3] has already begun to be implemented in many directly observed therapy short term (DOTS) centres across the state. We agree that household contacts of MDR-TB patients are at high risk of TB infection and disease, and offering these exposed contacts appropriate treatment is a huge priority if we are to ever achieve TB elimination goals. A meta-analysis of 25 studies evaluated a median of 111 household contacts and found that almost 10% of household contacts had active TB and almost 50% were infected.[4] However, despite these considerable risks to contacts there remain many unanswered questions about the efficacy of any treatment in this patient population. Some of the many reservations need to be discussed and debated before such recommendations become enshrined as policy: 1. All transmission does not occur at home: Contacts in high-burden settings are equally likely to be infected by sensitive strains of mycobacterium tuberculosis (M.TB) in their crowded communities, or be infected by unrecognized patients with active disease at their schools (children), or workplaces (adults). Thus, not every contact with a putative index case contracts infection from the index case at home. Indeed, it is impossible to be sure without DNA fingerprinting (RFLP) whether the contact is infected with the same strain as the index case or infected outside the home. A study from South Africa by Verver and colleagues,[5] using such genotypic techniques, showed that there was only 20% concordance between households, with the rest of the infections being acquired in the community due to “extensive social mixing.” Treating such contacts infected by a sensitive strain, as if they had MDR-TB, would clearly be inappropriate. 2. Treatment is of questionable benefit: A Cochrane review[6] of all the studies and available regimens showed that the balance of benefit versus harm in household contacts was far from clear. These authors concluded that drugs should only be offered in the context of well-designed randomized control trials (RCTs). Another systematic review found that there was no evidence to support policy development for the management of contacts of MDR-TB patients.[7] 3. Frequent adverse effects and poor completion rates were found: Another review by Langendam et al.[8] suggested that any form of therapy in healthy contacts of MDR-TB cases was associated with adverse effects requiring stopping treatment in 58–100% of contacts. Thus, treatment completion rates even with 6 months of therapy are very poor in this apparently healthy population, and if treatment is commenced, it would need to be carefully supervised. 4. The ideal drugs to be used are unclear: We do not have clear answers on the optimal agents we should be offering household contacts exposed to a patient with MDR-TB. There are no clear data on a) whether a single agent will suffice or we should use combination therapy or b) whether the drug (s) chosen should be standardized or individualized as per the drug sensitivity test (DST) of the index case. The later approach would hugely add to the complexity. 5. The duration of treatment is also unclear: There are no data to support the 6-month approach the current government directive has advised. 6. The potential development of future resistance could occur if FQ is used inappropriately: It has been estimated that a course of FQ, as short as 13 days in duration, can subsequently predispose to FQ-resistant TB if the patient is to develop MDR-TB later.[9] Thus, while there is little doubt that offering treatment to the hundreds of thousands of MDR-TB household contacts globally remains a burning research priority, there is insufficient current data available to justify such a rapid rollout in our country. Two clinical trials (TB-CHAMP and V-Quin)[10,11] of levofloxacin treatment in this patient population are ongoing, and the results are expected soon. Until these are published, the recommendations seem hasty and premature, and we would urge caution for the reasons outlined. We would instead argue that all household contacts of MDR-TB patients should be very carefully followed up and promptly treated as soon as they are known to be infected. This is a better strategy than all healthy contacts receiving treatment of unknown efficacy with toxic drugs, which may predispose them to possible future resistance. The current WHO guidelines would also seem to endorse this more prudent approach. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest." @default.
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• W4386234003 date "2023-01-01" @default.
• W4386234003 modified "2023-10-07" @default.
• W4386234003 title "Treating household contacts of MDR-TB patients: Are we being too hasty?" @default.
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• W4386234003 doi "https://doi.org/10.4103/lungindia.lungindia_377_23" @default.
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