Serious Treatment Related Adverse Drug Reactions amongst Anti-Retroviral Naïve MDR-TB Patients

Walt, Martha van der; Lancaster, Joey; Odendaal, Ronel; Davis, Jeanne Garcia; Shean, Karen; Farley, Jason E.

doi:10.1371/journal.pone.0058817

Cited by 37 publications

(35 citation statements)

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“…These included patients who had either converted from TB to MDR-TB or were infected with MDR-TB without having had TB before. Case finding, through culture and drug susceptibility testing, and treatment routines are described in Farley et al [22] and Van der Walt et al [23]. In particular, patients received a standardized regimen which included testing for ethambutol drug resistance to determine whether it should form part of the second line drug regimen.…”

Section: Methodsmentioning

confidence: 99%

“…Adverse drug reactions data for most commonly identified drug reactions related to second line drugs treatment were also collected and are analyzed descriptively in Van der Walt et al [23]. Other treatment outcome variables collected included completion or cure, failure, default and death, which are analysed using competing risks model in Farley et al [22].…”

Section: Methodsmentioning

confidence: 99%

“…Written informed consent was obtained from each study participant before enrolment and the informed consent process was approved by the respective ethical or review boards [22,23]. …”

Section: Methodsmentioning

confidence: 99%

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Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

et al. 2013

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Background Even though highly effective drugs are available in South Africa, multidrug resistant tuberculosis (MDR-TB) patients with HIV infection have higher mortality compared to HIV-uninfected MDR-TB patients. This trend has been observed in similar countries with high HIV prevalence. This study sought to determine excess mortality attributable to HIV among MDR-TB patients in South Africa using relative survival methods. Methods Data available were from a cohort of 2079 MDR-TB patients enrolled in a Standardized Programmatic Management of MDR-TB from 2000 to 2004 in South Africa. A Poisson-based model adjusted for age, gender, year of diagnosis, TB history, and resistance to ethambutol, anti-TB injectable drugs and fluoroquinolones antibiotics was constructed to assess the excess mortality among HIV co-infected MDR-TB patients. Excess hazard ratios (EHRs) were used to describe the effect of the predictors on net mortality, controlling for the general mortality in the South African population. Results Death was recorded on 1619 patients, of whom 367 (22.7%) had died within 2 years. Out of the 1413 patients that tested for HIV infection, 554 (39.2%) tested positive. Excess mortality was higher in HIV infected, compared to HIV uninfected, MDR-TB patients (adjusted excess hazard ratio, 5.6 [95% CI, 3.2–9.7]); in patients whose TB isolates’ resistance to ethambutol and kanamycin was unknown (3.7 [2.1–6.2] and 4.87 [1.9–13.3], respectively) vs. known. There were no differences in excess mortality between age and gender of the patient, year of diagnosis and TB history. Conclusion Adjusting for some important predictors, MDR-TB patients with HIV infection experienced higher excess mortality compared to HIV-uninfected MDR-TB patients, after accounting for the general mortality in South Africa. An appropriate, though complex method has produced predictor effect estimates similar to those obtained from classical methods. Thus, the use of relative survival methods should be encouraged in the analysis of causespecific mortality, when ascertainment of cause of death is inaccurate or unknown.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

et al. 2013

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“…Treatment of MDR/XDR-TB is costly,9 toxic10 11 and prolonged. Under WHO guidelines,12 the recommended duration of therapy can be up to 2 years.…”

Section: Global Health Problem Analysismentioning

confidence: 99%

First use of bedaquiline in a patient with XDR-TB in Singapore

et al. 2015

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Drug-resistant tuberculosis (TB) continues to pose a threat to global control of TB: 3.5% of new and 20.5% of previously treated TB cases were estimated to have multidrug-resistant (MDR)-TB in 2013. Approximately 9% of patients with MDR-TB had extensively drug-resistant (XDR)-TB. A 30-year-old Vietnamese woman previously treated for TB in her home country presented with 5 months of cough and shortness of breath 1 year after migrating to Singapore. Xpert MTB/Rif testing showed rpoB gene mutation. Phenotypic drug susceptibility testing revealed XDR-TB. Second and third-line TB drugs were commenced. To strengthen the efficacy of her treatment regimen, the novel anti-TB drug bedaquiline was obtained for the patient on compassionate grounds. We report the first use in Singapore of bedaquiline for the treatment of XDR-TB.

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“…Unlike the treatment of drug-sensitive Mycobacterium tuberculosis , the treatment of MDR-TB takes a long time, is complex and is frequently associated with the occurrence of various adverse drug reactions 2–8. Some of these adverse drug reactions, such as ototoxicity, nephrotoxicity, and hepatotoxicity, could severely diminish a person’s health-related quality of life (HRQoL) 9–12.…”

Section: Introductionmentioning

confidence: 99%

Adverse events and patients’ perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia

Sagwa¹,

Ruswa²,

Mavhunga³

et al. 2016

PPA

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PurposeThe health-related quality of life (HRQoL) of patients completing multidrug-resistant tuberculosis (MDR-TB) treatment in Namibia and whether the occurrence of adverse events influenced patients’ rating of their HRQoL was evaluated.Patients and methodsA cross-sectional analytic survey of patients completing or who recently completed MDR-TB treatment was conducted. The patients rated their HRQoL using the simplified Short Form-™ (SF-8) questionnaire consisting of eight Likert-type questions. Three supplemental questions on the adverse events that the patients may have experienced during their MDR-TB treatment were also included. Scoring of HRQoL ratings was norm-based (mean =50, standard deviation =10) ranging from 20 (worst health) to 80 (best health), rather than the conventional 0–100 scores. We evaluated the internal consistency of the scale items using the Cronbach’s alpha, performed descriptive analyses, and analyzed the association between the patients’ HRQoL scores and adverse events.ResultsOverall, 36 patients (20 males, 56%) aged 17–54 years (median =40 years) responded to the questionnaire. The median (range) HRQoL score for the physical component summary was 58.6 (35.3–60.5), while the median score for the mental component summary was 59.3 (26.6–61.9), indicating not-so-high self-rating of health. There was good internal consistency of the scale scores, with a Cronbach’s alpha value of >0.80. In all, 32 (89%) of the 36 patients experienced at least one adverse drug event of any severity during their treatment (median events =3, range 1–6), of which none was life-threatening. The occurrence of adverse events was not related to HRQoL scores. For patients reporting zero to two events, the median (range) HRQoL score was 56.8 (44.4–56.8), while for those reporting three or more events, the median score was 55.2 (38.6–56.8); P=0.34 for difference between these scores.ConclusionPatients completing treatment for MDR-TB in Namibia tended to score moderately low on their HRQoL, using the generic SF-8 questionnaire. The occurrence of adverse events did not lead to lower HRQoL scores upon treatment completion.

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Serious Treatment Related Adverse Drug Reactions amongst Anti-Retroviral Naïve MDR-TB Patients

Cited by 37 publications

References 3 publications

Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

First use of bedaquiline in a patient with XDR-TB in Singapore

Adverse events and patients’ perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia

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Serious Treatment Related Adverse Drug Reactions amongst Anti-Retroviral Naïve MDR-TB Patients

Cited by 37 publications

References 3 publications

Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

Risk of Death among HIV Co-Infected Multidrug Resistant Tuberculosis Patients, Compared To Mortality in the General Population of South Africa

First use of bedaquiline in a patient with XDR-TB in Singapore

Adverse events and patients&rsquo; perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia

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Adverse events and patients’ perceived health-related quality of life at the end of multidrug-resistant tuberculosis treatment in Namibia