Day 1 :
The Royal Melbourne Hospital Clinical Trials Pharmacy, Melbourne Health, Australia
Time : 10.00-10.45
Eugenia Hong is a senior pharmacist in charge of clinical trials pharmacy at the Royal Melbourne Hospital, Melbourne Health, Australia. She leads clinical trials pharmacy which provides a wide-range of clinical research services for over 300 studies conducted in Melbourne Health. Eugenia Hong is a committee member of Specialty Practice (COSP) in Investigational Drugs in The Society of Hospital Pharmacists of Australia and published the Standards of Practice for Pharmacy Investigational Drugs Services in Australia and Clinical Trials Starter Kit as a member of COSP.
The adherence of participants on study medication is critical to the accurate interpretation of study results. As patient education and counselling are important responsibilities for pharmacists in all practice settings, clinical trials pharmacists should also be actively involved in counselling the participants on study medications. The effects of clinical trials pharmacist counselling on medication adherence were previously studied and the results were presented at the Pharmacovigilance conference in 2012 (99% in participants with counselling from pharmacists vs 89% in participants without (p>0.05)). A replication study was conducted in 2015 and the adherence rate for participants who received counselling from pharmacists was 98% compared to 76% for participants who did not. This assures the positive effects of counselling by clinical trials pharmacist on participant adherence in clinical trials medication. It was also noted that the participant adherence declined as the dosing frequency was increased. The decrease was more significant (81% to 67%) when the participants had not been counselled by the pharmacist (p<0.05). For those participants who received counselling by the pharmacist, the decrease (98% to 97%) was not significant (p>0.1). The results signify the importance of participant counselling by pharmacist when the treatment regimen are more complicated. In the clinical trial setting where the measurement of medication adherence is essential for interpretation of the results, counselling by the pharmacist could contribute to more accurate outcomes. Often the role of pharmacist in clinical research is somewhat limited to drug management, but it should be recognized that the clinical trials pharmacist has an in-depth knowledge of pharmacotherapy and study protocol and is capable of providing comprehensive clinical services for study participants.
Mayo Clinic, USA
Keynote: Investigation of Efavirenz discontinuation in multi-ethnic populations of HIV-positive individuals by genetic analysis
Time : 10.45-11.30
Nathan Cummins completed his MD at the University of Kentucky, and Internal Medicine and general Infectious Diseases training at the University of Cincinnati. He completed further subspecialization fellowship training in Transplant Infectious Diseases at the Mayo Clinic Rochester. He is currently an Assistant Professor of Medicine in the Mayo Clinic College of Medicine, and Senior Associate Consultant in the Division of Infectious Diseases, Department of Medicine, Mayo Clinic. He has published more than 30 peer-reviewed scientific papers in reputed journals.
Efavirenz (EFV) based antiretroviral therapy is expanding worldwide. However discontinuation of EFV containing regimens is common, due most often to neuropsychiatric side effects. We genotyped CYP2A6, CYP2B6 and CYP3A4, which encode enzymes principally involved in EFV metabolism, from HIV positive patients enrolled in multinational studies, for whom outcome data of treatment adherence was available. Patients with loss or decrease of function single nucleotide polymorphisms (SNPs) in the above genes were assigned a risk score based upon the number of SNPs present. Cox regression models were used to study the association between high genetic risk and time from initiation to EFV discontinuation other than for virologic failure or protocol determined discontinuation. Patients with highest pharmacogenetic risk had an increased risk of discontinuation of EFV containing therapy compared to patients with lower genetic risk scores (adjusted HR 1.9, P=0.009). High genetic risk score was not associated with an increased risk of discontinuing atazanavir or nevirapine. High genetic risk was present more often in blacks compared to non-blacks (Adjusted OR 4.5), and treatment discontinuation was also increased in blacks overall (Adjusted HR 1.4). However, high genetic risk was more associated with treatment discontinuation than race alone for both blacks (Adjusted OR 1.9) and non-blacks (Adjusted OR 5.3). Premature discontinuation of ART delays the time to effective long term viral suppression, and is associated with significant morbidity. Pharmacogenetics may predict those at high risk of EFV discontinuation, and therefore should be considered in patients in whom initiation of EFV based ART is being considered.
BIOCAD, Russian Federation
Keynote: Postmarketing safety surveillance program results of the first Russian interferon beta-1b biosimilar
Time : 11.45-12.30
Alexey Skripkin, MD. He graduated from Rostov State Medical University (Rostov-on-Don, Russia) in 2005, passed Residency in neurology (2005-2007) and postgraduate training program (2007-2010) at the Moscow State Medical Academy n.a. I.M. Sechenov (Moscow, Russia). He continues his neurological practice. Alexey has 6 years of experience in pharmacovigilance, has passed a number of comprehensive pharmacovigilance and pharmacoepidemiology trainings in 2010-2016. He was an neurolology medical affairs manager at BIOCAD in 2010-2012. He is the BIOCAD’s Qualified Person for Pharmacovigilance since 2010, and the Head of Drug Safety Department since 2013.
The first Russian interferon beta-1b biosimilar was registered by CJSC BIOCAD in September of 2009 in the territory of the Russian Federation, and by the end of 2015 the exposure was 14 789 patient-years. BIOCAD initiated an intensive monitoring program. By the April of 2016 there were 1903 ICSR processed. The bulk of notifications, 58.5% (n=1115) was received by the company specialists: 805 notifications (42.3%) were received from the patients, 300 notifications (15.7%) – from the patient support team members, 10 notifications (0.5%) – from the healthcare specialists. There were 788 notifications (41.1%) received from the national regulatory authority (Roszdravnadzor). Additionally, BIOCAD has initiated a non-interventional observational study. 650 patients were included, at this stage the study database is being prepared for the final analysis. Most often the patients had injection site reactions (n=1256), general reactions (n=1189), as well as the nervous system reactions (n=383). There were 8 cases of injection site necrosis, that, taking into account exposure and intense monitoring, is a low value. 41 notifications on the lack of efficacy do not contradict the information about the drug product as about 25% of patients had no response. There were 8 reports of pregnancy. Four of them resulted in a birth of a healthy child, three were spontaneously interrupted (one in the stage of 5 weeks because of thrombocytopenia, two – in the stage of 14 weeks), one pregnancy still continues. Unexpected reactions have low levels of causality, new risks have not been identified. The received information confirms the known risk/benefit ratio.