5PSQ-047 Serious adverse reactions and sustained viral response related to 3d regime: purpose of a case

• Published in: European journal of hospital pharmacy. Science and practice Vol. 25; no. Suppl 1; p. A186
• Main Authors: Vega, B Proy, García, MC Conde, Lluch, MT Gómez, Dongil, C Notario, Serrano, JL Sánchez, Sierra, P Nieto-Sandoval Martín de la
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.03.2018; BMJ Group
• Subjects: Anemia; Creatinine; Hepatitis C; Pleural effusion; Section 5: Patient safety and quality assurance
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2018-eahpconf.401

BackgroundNew hepatitis C virus (HCV) antivirals are characterised by their efficacy (achievement of sustained viral response (SVR)) and safety with remarkable adverse drug reactions (ADR), such us hepatic decompensation, hypersensitivity reactions or hyperbilirubinaemia.PurposeDescribe ADR, due to direct-acting antivirals, not described so far.Material and methodsElectronic medical records were reviewed: clinical and pharmacological history and dispensations (collected from the outpatient dispensing software).ResultsA 79-year-old female with chronic HCV genotype 1b infection, currently in compensated cirrhotic phase, with excellent quality of life and without previous cardiovascular risk factors. No usual home treatment.In 2003, she was treated with double therapy (interferon +ribavirin), suspended after the first month of treatment due to severe anaemia, without obtaining SVR (undetectable viral load, VL).Currently, she initiated a combination therapy of ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg two tablets/day, and dasabuvir 250 mg one tablet/12 hour, known as 3D regimen, for 12 weeks, without associating ribavirin because of the risk of previous anaemia. Initial VL was 1,120,000 copies/ml (6.04 log).After 4 weeks of treatment, she was admitted for congestive heart failure (CHF), hypoxaemic respiratory insufficiency and acute respiratory alkalosis. She developed atrial fibrillation with rapid ventricular response, moderate pulmonary hypertension and massive bilateral pleural effusion. In addition, she developed acute renal failure (with creatinine of 2.1 mg/dl) and direct hyperbilirubinaemia (total bilirubin 5.8 mg/dl and direct bilirubin 4.8 mg/dl). Subsequently, she evolved favourably after antiviral drugs withdrawal, and with active and supportive treatment during admission, with the improvement of analytical values (creatinine 0.6 mg/dl, bilirubin 1.7 mg/dl). No microorganisms were isolated from the pleural fluid simple .At discharge, 5 weeks’ post-admission, and 24 weeks’ later, the patient maintained a SVR, despite receiving only 4 weeks of treatment.ConclusionTo date, there are no reported cases of patients who have developed CHF, severe pleural effusion and acute renal failure following the 3D regimen instauration. This is the first described case of SVR after only 4 weeks of treatment with 3D triple therapy in patients with genotype 1b and F4 grade of fibrosis.No conflict of interest