In contrast to dolutegravir/lamivudine, a higher than expected risk of viral failure with development of cross-resistance integrase mutations occurred with dolutegravir maintenance monotherapy.

BackgroundThe new co-formulated drugs for HIV have made great strides in treating the disease and have achieved excellent health outcomes in patients.PurposeTo analyse the use of dolutegravir/abacavir/lamivudine co-formulated (DTG/ABC/3TC) 50 mg/600 mg/300 mg in HIV infected patients and to evaluate short term effectiveness.Material and methodsA retrospective observational study was conducted in all patients who started DTG/ABC/3TC in our hospital. The variables included were: age, gender, number of previous antiretroviral regimens, patient type (naïve, pretreated), reason for prescription (treatment initiation, switch strategies and virological failure) and viral load (VL) pretreatment and after 4 and 12 weeks.Results33 patients started treatment with DTG/ABC/3TC, and in 3 it was discontinued it. Mean age of the patients was 51 (±13.4) years and 75.7% were men. 81.9% of patients had been previously treated with at least one antiretroviral regimen. Regarding reasons for prescription we found: treatment naïve patients in 18.1%, presence of virologic failure in 15.1% and switch strategies in 66.8%. The switch strategies included 39.5% of prescriptions in order to improve the toxicity and management of comorbidities, 21.3% to avoid drug–drug interactions (mainly with future treatment of hepatitis C), 3% to improve adherence and 3% to avoid enhancing the haematologic toxicity of chemotherapy. Regarding treatment effectiveness: in naïve patients, after 12 weeks of treatment, VL decreased in 3 patients to <20 copies/mL, and 3 achieved undetectable VL. In patients with virological failure, 1 patient achieved <50 copies/mL, 2 patients <20 copies/mL and 2 patients undetectable VL. In the rest of the patients, 11 had undetectable VL, 9 patients <20 copies/mL and only 2 patients had increased VL at week 12.ConclusionDTG/ABC/3TC was used principally in pretreated patients, and switch strategies was the main reason for the prescriptions. In most patients, low or undetectable viral loads were obtained, thus achieving good disease control.References and/or acknowledgementsClinic guide GESIDA2016.Data Sheet TRIUMEQSpanish Medicines Agency.No conflict of interest

BackgroundThe off-label drugs use in paediatrics is high and there are few studies undertaken on off-label drug use in Spain.PurposeTo analyse off-label drugs use in paediatrics services, to analyse which clinical units requested more often off-label drugs and which were the causes that led to the consideration of off-label treatment.Material and methodsDescriptive observational study from October 2009 to September 2014. We included all individual requests of off-label drugs received in the Pharmacy Department by the different paediatrics clinical units. Individualised assessment reports were developed with an analysis of efficacy, safety, convenience and cost, which were referred to hospital medical administration to make the decision to authorise or deny its use.ResultsA total of 141 requests were analysed, of which 95.1% (134) were finally authorised and 4.9% (7) were denied. The most petitioned drugs were Levosimendan with 14.9% (14 requests in cardiac surgery using extracorporeal circulation and 7 in diastolic dysfunction), Adalimumab with 8.5% (6 requests for juvenile idiopathic arthritis, 3 in ulcerative colitis and 3 for Crohn’s disease), Palivizumab with 6.4% (6 requests for prophylaxis of Human respiratory syncytial virus (RSV) in immunocompromised patients and 3 in treatment of RSV) and Pegfilgrastim with 4.9% (7 requests for neutropenia after chemotherapy in paediatric patients).According to cause which led to the consideration of off-label, in 58.2% (82) was due to an unauthorised indication. Furthermore, the reason for off-label in 41.8% (59) due to unauthorised indication for patient age.The most petitioned paediatrics clinical units were oncology with 46.1% (65), rheumatology with 12.1% (17), cardiology with 9.9% (14) and paediatric Intensive Care Unit with 8.5% (12).ConclusionThere is a variety of off-label drugs used in paediatric clinical units. Off-label drugs were requested mostly in the field of oncology and rheumatology. There were a high number of requests for drugs approved in adults but not in paediatric indications.References and/or acknowledgementsNo conflict of interest.

BackgroundAvoiding errors related to drug development, which can compromise the patient’s life, is essential in our profession.PurposeTo describe the quality of sterile intravenous mixtures (IVM) after implantation of a double check and to evaluate the effectiveness of the measures adopted since its implementation.Material and methodsRetrospective observational study in which double check record sheets were revised for 3 periods of 15 days, made over a year. The aspects evaluated were: name and concentration of the drug used, prepared dose and mL of drug used, number of new vials started, checking calculations of used and surplus mL, expiration of vials used, labelling, physicochemical characteristics of IVM, packaging, and sheets duly signed and filled out by the pharmacist and nurse. In addition it was confirmed that preparation labels contained lot and caducity of the vials used to ensure traceability of the IVM. The double check was by nursing staff on the ward; this nurse was different from the nurse who made the IVM and after the pharmacist checked correct completion of the form.Results712 IVM were developed during the 3 study periods (169, 219 and 324, respectively). They were revised 98.2%, 99% and 100% of the IVM and non-conformity with the double check was 20.7%, 20.5% and 12.6%. The most common errors produced were incomplete double checks in 62.8%, 33.3% and 82.1%, errors in calculations in 17.4% 22.2% and 7.1%, and no annotation of the lot and expiration in 14.2%, 28.8% and 3.6%, respectively. IVM with the record sheet but with a blank checklist were 1.8%, 3.2% and 1.2%. The measures introduced were: reinforcing the training of nurses to insist on the importance of the correct performance of the double check for the prevention of medication errors, to underline the importance of being able to perform the traceability of IVM, to check with automatic methods the calculations made and to visualise the correct volume of the mixture with higher optical precision.ConclusionDouble check provides greater security in the prevention and correction of problems related to drugs. Implementation of specific measures continuously has gradually reduced the number of errors.References and/or AcknowledgementsBest practice guidelines for preparation of drugs in the pharmacy servicesNo conflict of interest.

BackgroundThe development of direct acting antiviral agents (DAAs) represents a significant improvement in hepatitis C virus (HCV) treatment, particularly in allowing interferon free therapy. HIV coinfection is common, with genotypes 1 and 4 being the most prevalent. It is important to decide which treatment is best in coinfected patients.PurposeTo evaluate the effectiveness and safety of treatment with different combinations of DAAs in HIV/HCV coinfected patients.Material and methodsA retrospective observational study was conducted of coinfected patients who initiated therapy with DAAs from April 2015 to March 2016. We included only patients with HCV genotype 4. Data were collected from electronic clinical history, electronic prescribing software and drug therapy follow-up. Variables included: sex, liver fibrosis stage, type of patient (pretreated/treatment naive), treatment duration, and RNA viral levels before starting treatment and at 4 and 12 weeks. We considered that the drug was effective if the patient achieved SVR12, which was defined as undetectable RNA viral level 12 weeks after treatment completion.Results11 patients (2 women, 9 men) started treatment with sofosbuvir/ledipasvir (SOF/LDP). 7 were treatment naïve and 4 had been pretreated. Hepatic fibrosis stage F4/F3/F2 corresponded to 3, 5, 3 patients, respectively. Duration of treatment was 12 weeks. 81.8% of patients achieved an undetectable viral load after 4 weeks, maintained after 12 weeks in all cases but SVR12 was achieved in 10 patients. No patient discontinued treatment for adverse events although 6 patients experienced adverse effects: asthenia (2), headache (4) and insomnia (1).14 patients (3 women, 11 men) were treated with ombitasvir/paritaprevir/ritonavir (OTV/PTV/r) plus ribavirin (RBV). 9 were treatment naïve patients. For hepatic fibrosis stage: 1 patient was F4, 6 F3 and 7 F2. Duration of treatment was 12 weeks. 57.1% of patients achieved an undetectable viral load after 4 weeks, 100% after 12 weeks and SVR12 was achieved in all patients. Regarding safety, 8 patients reported some adverse events (most frequent was pruritus) and 1 of these discontinued treatment because of pruritus, anaemia, diarrhoea and vomiting before 4 weeks.Conclusion90.9% of patients treated with SOF/LDP achieved SVR12 and 100% of patients treated with OTV/PTV/r plus RBV. The adverse effects profile indicated both combinations appeared safe and well tolerated in general.No conflict of interest