Source: Annual Congress 2010 - Multidrug-resistant and extensively drug-resistant tuberculosis
Disease area: Respiratory infections

Abstract

Background:
There are few data about the frequency and severity of adverse drug reactions (ADR‘s), and the impact on outcomes, in HIV-infected and uninfected patients being treated for XDR-TB.
Methods:
The records of 115 patients who initiated XDR-TB regimens in 3 centres in South Africa, between 2002 and 2008, were retrospectively reviewed. ADR‘s were graded according to the modified American NIH CTCAE criteria. Grade 3-5 events were considered severe.
Results:
ADR‘s occurred in 67/115(58 %) of patients and 161 different ADR‘s were reported: 58/161(36%) required no intervention, 69/161(43%) required modification of treatment, 23/161(16%) prompted discontinuation of the offending drug, 2/161(1.2%) were life threatening, and 6(3.7%) died. Overall, patients with severe ADR‘s had a lower sputum culture conversion rate [2/27(7.4%) vs. 24/88 (27.3%), p=0.02] and a higher death rate [13/27(48.2%) vs. 17/88(19.3%), p=0.003] compared with those without severe ADR‘s. Of the 115 patients 48 (42%) were HIV infected and had a higher ratio of serious side effects then those uninfected [15/48(31.3%) vs.12/67(17.9%), p=0.045] Sputum culture conversion occurred less frequently in HIV infected with severe ADRs compared with patients with mild/ moderate ADRs. However, there was no difference in mortality.
Conclusions:
The frequency of ADRs with XDR-TB treatment regimens is high, often severe, and frequently requires drug-specific modification or cessation of the drug. Those with severe ADRs have poorer treatment-related outcomes. HIV-infected patients are more likely to have severe ADRs. Early detection and monitoring of drug side effects is thus crucial. Less toxic drugs are urgently needed to manage XDR-TB.

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K. Shean, M. Badri, G. Symons, E. Pietersen, L. Page-Shipp, A. Burns, P. Baitiswe, M. Grobusch, P. Willcox, A. Zumla, K. Dheda (Cape Town, Johannesburg, Kimberley, South Africa; , United Kingdom). Adverse drug reactions in South African patients being treated for XDR-TB. Eur Respir J 2010; 36: Suppl. 54, 353

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