Abstract
Objective: To assess adherence, adverse drug reaction and Sustained Virological Response (SVR) in the therapy for hepatitis C. This follow-up retrospective observational study was conducted in a specialized center for hepatitis treatment in Southern Brazil. Methods: This research included 257 patients under hepatitis C treatment with all‐oral direct‐acting antivirals in a clinical setting from March to August 2016. The data was obtained from medical records. Adherence was measured by medicines refill and Medication Possession Ratio. Results: Of the 253 patients evaluated, 8,7% had some problem with adherence to the treatment. No cases of treatment discontinuation due to adverse drug reaction was observed. However, 1433 adverse drug reactions were identified and classified as mild, with an average of 5,6 per patient. The most frequent reactions were headache (55,7%), asthenia (47,3%), altered appetite (41,9%), dry skin (37,2%), and nausea/vomiting (35,9%). The overall SVR rate was 90,9%. Other outcomes were no response to treatment (2,0%), relapsed (2,0%), dead (0,4%), dropout (0,4%) and lost to follow-up (4,3%). In the multivariate analysis, hepatitis C virus and human immunodeficiency virus co-infection and longer treatment time were associated with higher SVR (p = 0,028 and p = 0,020, respectively). Conclusion: The treatments evaluated have high response rate and were well tolerated by the patients. Adherence to treatment proved to be adequate and contributed to the results. The care offered in a specialized center provides the appropriate management of the patients’ needs, contributing thus to a successful therapy.
Highlights
During this first appointment with the patient, the clinical pharmacist discusses the importance of medication adherence, what to do in the case of a missed dose, medication storage, management of potential adverse effects (AE), possible drug-drug interaction (DDI) with prescription and over-the-counter medicines (OTC), laboratory monitoring, and likelihood of hepatitis C cure
Two patients were excluded for choosing another treatment center, and two patients under treatment were transferred to another center, totaling 253 patients
The mean age of the patients was 58,7 years old (SD = 9,6). Those who were under treatment for 24 weeks had previously received telaprevir or boceprevir, except for two patients who had advanced cirrhosis, according to current protocols
Summary
In 2016, the World Health Organization (WHO) released a document, signed by the Brazilian government, establishing global strategies to eliminate viral hepatitis as a public health problem by 2030, reducing new cases by 90% and associated mortality by 65% (WHO, 2018a). In this sense, access and adherence to hepatitis C treatment are important to achieve these goals. The medicines to treat hepatitis C – interferon, ribavirin, peginterferon and the first-generation direct-acting antivirals (DAAs) (boceprevir and telaprevir) – caused frequent and severe adverse effects. Due to these adverse reactions, the dropout rates are high, contributing to lower effectiveness rates (CLEO STUDY GROUP et al, 2016; GOMES et al, 2018; MIOTTO et al, 2016; WEHMEYER et al, 2014)
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