Therapeutic drug monitoring of levetiracetam: Method validation using high-performance liquid chromatography-ultraviolet detector technique and usefulness in patient care setting.

Objectives: To develop and validate a modified HPLC-UV method for the estimation of serum levetiracetam levels and to assess the usefulness of serum levetiracetam estimation in epileptic patients. Materials and Methods: Modification of a previously existing HPLC-UV method was performed using liquid- liquid phase extraction and processing using reverse phase analytic HPLC-UV detector technique followed by method validation. Serum samples of patients attending our hospital's Therapeutic Drug Monitoring Outpatient Department services were analyzed for levetiracetam levels using the study method. Data of the past 6 years (2015-2020) were descriptively analyzed. Results: The modified HPLC-UV method was validated as per ICH Q2 (R1) 2005 guidelines. Usefulness of levetiracetam estimation was assessed in 1383 patients (635 children, 683 adults, 40 elderly, and 25 pregnant women). Levetiracetam levels were within the therapeutic range (TR) in 520 children, 543 young adults, 35 elderly patients, and nine pregnant women. In 112 of 232 patients with low levetiracetam levels, poor compliance was elicited. Of 641 patients on polytherapy, 446 patients had levetiracetam values within TR, whereas 29 had values above and 166 patients had values less than TR. Sodium valproate, phenytoin sodium, and carbamazepine affected levetiracetam levels when given concomitantly. Levetiracetam dose was adjusted in 61 patients with abnormal levels for better clinical response. Good seizure control was noted in 913 (82.47%) patients whose levels were within TR, whereas 136 (58.62%) patients with low levels reported an increase in seizure frequency. Conclusions: The modified HPLC-UV method is simple, rapid, efficient, and reliable for assaying serum levetiracetam.

Beyond 'cure' and 'treatment success': quality of life of patients with multidrug-resistant tuberculosis.

SETTING: Two drug-resistant tuberculosis (DR-TB) sites (MSF Clinic, Jupiter Hospital) in Mumbai, India. OBJECTIVE: To assess health-related quality of life (HRQoL) and associated factors among DR-TB patients and explore their perspectives about HRQoL. DESIGN: We used a mixed-methods design: a quantitative cross-sectional questionnaire (the World Health Organization's Quality of Life Brief Questionnaire [WHOQoL-BREF]); and qualitative in-depth interviews for purposively selected patients. Assessments were conducted between April and November 2016. RESULTS: Ninety-five patients completed WHOQoL-BREF; 12 were interviewed. The psychological and physical health domains were the most affected (mean scores 56.2 ± standard deviation [SD] 18.3, and 56.5 ± SD 15.1, respectively; maximum 100). The social relations and environmental domains mean scores were respectively 68.6 (SD ±21.1) and 60.3 (SD ±15.9). Loss of jobs due to TB adversely affected the social relations and environmental domains. Qualitative analysis showed that support was the most important theme affecting quality of life. Other themes were physical factors (e.g., treatment adverse events), psychological factors (e.g., depression), social functioning (e.g., fear of stigmatisation) and environmental factors (e.g., health systems). CONCLUSION: HRQoL was lower among study participants, but not as low as previously reported among TB patients. Support was the main factor that positively affected HRQoL, although both disease and treatment were physically and socially challenging.