Aim and objectives To compare the feasibility and clinical relevance of QT advice guided by the original and adapted QT guideline. Material and methods QT advice provided by the pharmacist was analysed. This retrospective analysis included: number of times QT advice was given according to the original (April 2018 to January 2019) and the adapted guideline (May 2019 to October 2019), number of QT drugs (defined as drugs on the CredibleMeds list KR) per prescription and QTc interval >500 ms (if known). For 1 month (15 May to 14 June 2019), the acceptance rate of the pharmaceutical advice, including the QT advice was registered. Results Differences between the original and adapted guideline are: (1) threshold for advising an ECG (original: !2 prescribed QT drugs or 1 QT drug in combination with a drug that inhibits the metabolism of a QT drug; adapted: !1 prescribed QT drug) and (2) definition of a recent ECG (original: maximum 1 year old; adapted: during hospitalisation). If no recent ECG is available or the QTc interval is >500 ms, advice is given to the physician.The number of times advice was given using the original and adapted guideline were 78 (8 advices/month) and 243 (41 advices/month), respectively. On average, using the adapted guideline, advice related to QTc interval !500 ms was given 5 times per month compared with once using the original guideline. The acceptance rate of QT advice was 40% with an overall acceptance rate of 79% for all pharmaceutical advices. Conclusion and relevance Adapting the QT flow resulted in a fivefold increase in the number of times advice was given in relation to QT. The rather low acceptance rate may be explained by the fact that the pharmacist only selected patients on QT drug prescriptions. To enhance the number of times clinically relevant advice is given, patient related risk factors (hypokalaemia, age, gender, cardiovascular comedications) should be included. It is therefore necessary that personalised risk assessment systems help the pharmacist to identify patients at greatest risk for QT prolongation.
BackgroundThe efficacy of triple therapy (pegylated-interferon/ribavirin with boceprevir (BOC) or telaprevir (TVR) in phase III trials is known but not the effectiveness of HCV treatment in clinical practice.PurposeTo investigate the effectiveness and safety of triple therapy with protease inhibitors TVR or BOC in the treatment of patients with Hepatitis C Virus (HCV) in clinical practice.Material and methodsA retrospective observational study with HCV-infected patients treated with TVR or BOC who had completed 60 weeks from the start of treatment in six public hospitals serving 1,100,000 inhabitants. Patients who started treatment between January 2012 and March 2013 were included. We assessed the percentage of patients with a 12-week sustained viral response (SVR12) and the percentage of treatments discontinued due to adverse effects.Results160 patients were treated; 9 patients were excluded as SVR12 had not been recorded, leaving 151 patients for analysis.Characteristics: male 66%, age 51 years (range 28–70); 98% genotype-1; 73% HCV-RNA > 800,000 IU/ml; Previous treatment: 48% treatment-naïve, 25% relapsers, 13% partial responders, 11% null responders, 1% post-transplant reinfection and 1% unknown. Fibrosis stage: 55% F4, 33% F3, 9% F2, 2% F1, 1% unknown. 87% with TVR and 13% with BOC.Of the patients, 57% achieved SVR12 (60% naïve, 68% relapsers, 40% partial responders, 37% null-responders or unknown, 100% post-transplant reinfection). According to fibrosis stage the response was 0% F1, 28% F2, 62% F3, 61% F4.Treatment was discontinued in 17 patients (11.3%) due to severe adverse effects.ConclusionAlthough the treated population presented an advanced stage of fibrosis (88% F3–F4), 57% achieved SVR12, lower than the pivotal TVR study. Compared to the International Telaprevir Access Program (similar to this cohort), we achieve a lower response in almost all types of patients, especially in partial responders (15% lower response rate). The side effect profile was slightly lower than other published series.References and/or AcknowledgementsNoneNo conflict of interest.
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