Measure of adherence to direct-acting antivirals as a predictor of the effectiveness of hepatitis C treatment.

Background Adherence to direct-acting antivirals could be a predictor response to these treatments in hepatitis C. Objective To assess the ability of three methods of measuring adherence to direct-acting antivirals [pill counts, pharmacy dispensing record and Simplified Medication Adherence Questionnaire (SMAQ)] as predictors of their effectiveness. Setting Study conducted by the pharmacy department of the hospital. Methods: A retrospective study was performed. Patients ≥ 18 years with hepatitis C that started and completed treatment with direct-acting antivirals between the 1st-April-2015 and 28st-February-2016 were enrolled. To evaluate the predictive ability to obtain a response to treatment, Chi squared test, Mann-Whitney-U test and ROC-curves were used. Main outcome measure Adherence to antivirals was assessed by three methods and response to treatment, which was defined as obtaining a viral load of hepatitis C virus ≤ 15UI/ml at week 12 after the end of treatment. Results 128 patients were enrolled. The overall average adherence obtained with SMAQ (99.09%) was similar to the pill counts (96.40%, p = 0.043) and pharmacy dispensing record (91.10%, p = 0.02). There was no correlation between the percentage of patients considered as adherent by SMAQ (99.09%) and the achievement of response to treatment (96.40%, p = 0.999). The ROC-curve obtained for the pill count method shows a global area under the curve of 0.53. For pharmacy dispensing record method, patients with an adherence ≤ 66.66% have a high probability of not achieving response (sensitivity and specificity of 79.00% and 100.00%, respectively). Conclusions Pharmacy dispensing record is shown as the best indicator of adherence to predict therapeutic failure in our study.

Implementation of a pharmaceutical care program for patients with hepatitis C treated with new direct-action antivirals.

Background A pharmaceutical care program is necessary to improve the management of direct-acting antivirals in hepatitis C. Objective Describe health outcomes obtained with the implementation of a pharmaceutical care program in Hepatitis C patients treated with direct-acting antivirals. Setting This study was performed in a pharmacy department of a university hospital. Methods Retrospective study between 1st-April 2015 and 28st-February 2016. Hospital pharmacists implemented interventional measures for validation of antivirals prescriptions, detection of drug-interaction, adverse drug events, education and patient´s adherence to antiviral regimen. Main outcome measure Health and quality outcomes of the implementation of the pharmaceutical care program. Results A total 128 patients were enrolled. The overall sustained virologic response at week 12 post-treatment rate was 96.1% (95% CI 92.7-99.5). Adverse drug events occurred in 90.6% of the patients, and the majority were grade 1-2. Pharmacists made 334 pharmaceutical interventions. 35.5% of these interventions were aimed to resolve negative results of drugs. 80.9% of the negative results of drugs improved or were eliminated with the application of the measures proposed by the pharmacists (p ≤ 0.001). Pharmacists carried out 175 preventive interventions to avoid negative results of drugs. 97.3% of these interventions were accepted and managed to prevent the appearance of negative results of drugs (p = 0.453). Conclusion The implementation of a pharmaceutical care program in patients with hepatitis C treated with direct-acting antivirals has improved the safety in the use of these drugs.