PURPOSE: Adverse drug reactions to anti-tuberculosis therapy remain clinically challenging. Tolerability to these agents is lower in HIV patients. These reactions are less well studied in multiethnic Asian populations. We looked at the prevalence and profile of major adverse drug reactions between HIV and non-HIV patients on anti-TB treatment in such a population.
METHODS: A retrospective study was done of the medical records of all adult patients treated for TB in Penang Hospital, Malaysia from 2008 to 2009.
RESULTS: 931 patients (72% male; mean age 45 years; 33% Malays, 46% Chinese, 12% Indians) were included. 128 (15.9%) were HIV-positive. Mean CD4 count was 121cells/mm3 (95% CI: 95.6-145.6). 29 (3.1%) patients [12 (9.4%) HIV and 17 (2.1%) non-HIV] had cutaneous adverse drug reactions (CADR). Most were maculopapular (86%), required drug withdrawal (82%), and managed as outpatients (75%). Rifampicin and pyrazinamide were common offending agents (48 and 34%). Factors independently predictive of CADR were HIV [adjusted OD (95% CI): 5.3 (2.4-11.6); p<0.001] and ‘non-standard’ anti-TB treatment regimens [8.24 (2.16-31.3); p=0.002]. 38 (4.1%) patients [13 (10.2%) HIV and 25 (3.1%) non-HIV] had drug-induced hepatitis (DIH). All were symptomatic and required drug withdrawal. Lab findings (isolated raised transaminases, cholestasis and mixed liver function picture) were 44, 13 and 42%. Pyrazinamide and rifampicin were common offending agents (68 and 23%). 21 (57%) were managed as inpatients and 3 (7.9%) died. Factors independently predictive of DIH were HIV [adjusted OD (95% CI): 3.2 (1.5-7.0); p=0.002] and chronic renal failure [4.6(1.5-14.5); p=0.008]. Other adverse reactions included IRIS (1%), severe gastrointestinal disturbance (1%), visual toxicity (0.3%), ototoxicity (0.1%) and hematological abnormality (0.1%). More HIV patients had IRIS (3.9 vs. 0.5%; p<0.001) and severe gastrointestinal disturbance (3.9 vs. 0.5%; p<0.001).
CONCLUSIONS: The spectrum of adverse drug reactions in our study are generally comparable to published data with no discernible ethnic differences found. HIV remains highly predictive of CADR and DIH.
CLINICAL IMPLICATIONS: Our findings add to the increasing bulk of Asian patient data valuable in the management of TB.
DISCLOSURE: The following authors have nothing to disclose: Wei Lyn Chung, Choo Khoon Ong, Wooi Chiang Tan, Abdul Razak Muttalif, Li-Cher Loh
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