BackgroundAgents targeting the vascular endothelial growth factor receptor (VEGF) pathway may induce many toxicities. The European Medicines Agency (EMA) recommended a starting dose of 5 mg twice daily in renal cell carcinoma.PurposeTo describe the data regarding the effectiveness and safety of therapy with axitinib in patients with advanced renal cell carcinoma treated in our hospital.Material and methodsRetrospective observational study that included all patients treated with axitinib until October 2015. The variables collected using electronic medical records were: sex, age, location of metastases, therapeutic positioning, ECOG Scale, initial dose, dosage adjustment, progression free survival (PFS), grounds for suspension-interruption and clinical variables associated with adverse effects.Results26 patients were included, with a mean age of 64.55 years (±12.71); 54.85% were men. The diagnosis in 80.77% of patients was clear cell renal cell carcinoma, and metastatic lesions were located mainly in the lungs (69.23%), bones (53.85%), lymph nodes (38.46%) and liver (34.61%).The median number of lines of treatment was 3 (range 2–6). The median of the ECOG Scale was the same at the beginning and end of the study (ECOG=0). 64.54% of patients began treatment with a dose of 10 mg/day axitinib and median PFS was 11 months (95% confidence interval 6.673 to 15.327).Regarding the safety profile, 88.46% suffered an adverse reaction associated with axitinib, including: general disorders (60.87%), gastrointestinal (52.17%), vascular (47.82%) and skin (34.78%), increase in TSH (26.09%) and cardiac (17.39%). 19.23% of patients experienced dose reduction at some time during treatment due to drug intolerance and gastrointestinal upset (42.86%) being the main cause. Temporary interruption of treatment was observed in 57.69% of patients associated with axitinib, and 15.37% of treatments were suspended indefinitely because of side effects (one case with severe congestive heart failure and another with renal impairment). The rest of the suspensions were for clinical progression of the disease.ConclusionOnly half of the patients began treatment at a dose of 10 mg/day, as recommended by the EMA.Median PFS in our patients was similar to that of clinical trials.Nearly 3 of 4 patients treated with axitinib experienced adverse effects that led to a temporary or permanent suspension of treatment. Therefore, the role of the pharmacist may be of special interest for the provision of special pharmaceutical care in drugs with a safety profile as relevant as axitinib.References and/or AcknowledgementsPhase 3 AXIS trial.No conflict of interest.

BackgroundRiociguat is a relatively new drug that has been on the market for a short time. Most of the information available on the drug comes from clinical trials that led to its commercialisation.PurposeResults based on clinical practice often differ from results obtained in clinical trials. The purpose of this study was to evaluate the safety profile of riociguat in clinical practice as well as to analyse possible interactions riociguat may have when administered with other medicines used by HAP patients.Material and methodsA retrospective observational study was conducted in all patients treated with riociguat from September 2015 to 2016. Interactions were identified and classified according to their clinical relevance. The reason for suspension–interruption of treatment and clinical variability associated with adverse effects were also analysedResults43 patients were included, mean age 66±16.09 years, 65.12% women. 140 potential interactions with riociguat were recorded, belonging to 26 different drugs. 97.67% of patients had at least one interaction and the median number of interactions per patient was 3 (range 0–7). The most frequently involved drugs in these interactions were: furosemide (24.29%), omeprazole (20%) and spironolactone (18.57%). Depending on their relevance, potential interaction distribution was: 24 moderate (92.31%) and 2 severe (7.69%). In the registered interactions, the primary mechanism involved was based on the risk of hypotension (61.54%). The two most serious potential interactions were with phenytoin, which can decrease levels of riociguat, and calcium+cholecalciferol carbonate, which can modify the solubility of riociguatRegarding the safety profile, 39.53% of patients suffered any adverse reaction associated with riociguat: nervous system (30.95%), digestive (26.19%) and vascular (19.05%). 2 patients had dose reduction, 1 due to congestive heart failure, associated with the drug. A case of syncope forced suspension of the treatment.ConclusionMost of the patients included in the study had at least one potential interaction between their own medication and riociguat. Only 3 patients had dose reduction or suspension due to adverse effects related to riociguat. According to the results, it can be assumed that riociguat may be a safe drug despite the high number of potential interactions found in patients with polypharmacy.References and/or acknowledgementsCLINICAL TRIALS:PATENT-1,CHEST-1,PATENT-2 and CHEST-2.No conflict of interest

BackgroundHepatitis C is a serious disease with a high prevalence, being the leading cause of liver transplantation. There is now rapid development of new drugs for this disease. During the period of this study, only the following anti-hepatitis C agents were available: peg-interferon, telaprevir, boceprevir, simeprevir, sofosbuvir daclatasvir and ribavirin.PurposeTo analyse the effectiveness of sofosbuvir associated with other antiviral against hepatitis C, and identify adverse reactions produced.Material and methodsA descriptive study including patients that started therapy with sofosbuvir from August 2014 to January 2015. Data collected were: viral genotype, treatment duration with sofosbuvir and negativisation time to viral load.ResultsDuring the study period, 37 patients began treatment with sofosbuvir. Of these, 28 had genotype 1b (17 were treated for 12 weeks and 11 during 24 weeks), 3 had genotype 1a, 2 had genotype 3 and 4 had genotype 4. Patients with genotypes 1a and 4 were treated for 12 weeks and those with genotype 3 for 24 weeks.With respect to treatment for 12 weeks, the associations used most were sofosbuvir with simeprevir and ribavirin in 65.22% of patients. This was also the most prescribed combination in patients with genotype 1b, being used in 11.45.5%. Genotype 1b patients treated with this combination had a rapid virological response (RVR), which means an undetectable viral load in week 4 of treatment.In the 24 week treatment, 76.92% of patients (10 patients) received sofosbuvir with daclatasvir. Of these patients, 9 had genotype 1b. 55.5% of patients with genotype 1b and the above combination had a RVR.37 patients had undetectable viral load at the end of treatment. All patients achieved a sustained viral response at 4 weeks post-treatment (SVR4), and also showed a sustained viral response at 12 weeks post-treatment (SVR12), which means cure.ConclusionIn our patient population, using sofosbuvir associated with other antihepatitis C drugs available at the time of the study, helped to reduce the time required to neutralise the viral load, and present a good safety profile, which can improve adhesion.References and/or AcknowledgementsGutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis. J Viral Hepat 2015No conflict of interest.