ABSTRACT
BACKGROUND: Honorary and ghost authorship, as well as competing interests, are well documented concerns related to the publication of scientific articles. Guidelines for writing and publishing scientific manuscripts are available, including those of the International Committee of Medical Journal Editors (ICMJE). OBJECTIVES: The primary objective of this descriptive cross-sectional study was to identify, in the instructions for authors of pharmacy practice journals, guidance on authorship and competing interests. The secondary objective was to suggest suitable corrective measures for more transparent authorship. METHODS: The first step of the project was to identify journals in the area of pharmacy practice. The instructions for authors of each journal were then reviewed to determine recommendations for avoiding problems related to authorship and competing interests. Finally, the members of the research team formulated potential corrective measures for researchers. RESULTS: Of 232 pharmacy journals identified, 33 were deemed to focus on pharmacy practice. A total of 24 (73%) of these journals mentioned that they followed ICMJE policies, 14 (42%) asked authors to complete a competing interests disclosure form at the time of submission, 17 (52%) had a formal definition of authorship, and 5 (15%) asked for details of each author's contribution. A list of 40 criteria was developed to define authorship status. CONCLUSION: Fewer than half of the journals asked authors to provide a competing interests disclosure form upon submission of an article, and only half had a formal definition of authorship. The scientific publication of papers relevant to pharmacy practice is not free from issues related to publication transparency. Publishing articles online and using a checklist to detail each author's contribution may help to limit the associated risks. [Publisher's translation].
ABSTRACT
The objective of this study was to evaluate the switch to once-daily darunavir/ritonavir 800/100 mg in treatment-experienced patients with suppressed HIV-1 replication on a twice-daily ritonavir-boosted protease-inhibitor (bid PI/r) containing regimen, that is in a setting where genotypic resistance test cannot be performed. In this open label, non-comparative, multicenter study, patients on a bid PI/r-containing triple combination, with suppressed viral replication, were switched to once-daily darunavir/r 800/100 mg containing triple combination. The primary endpoint was the proportion of patients with plasma HIV-RNA < 50 copies/ml 24 weeks after the switch. Intensive darunavir pharmacokinetic evaluation was performed at Week 4 (W4) in 11 patients. Eighty-five patients were enrolled. All had HIV-RNA < 50 copies/ml at screening with a pre-exposure to a median of 2 PI/r (1-5). By intent-to-treat analysis (missing = failure), 78/85 patients (92%, 95% CI [83;96]) maintained an HIV-RNA < 50 copies/ml at W24. Seven patients experienced protocol-defined treatment failure between baseline and W24: Two had confirmed low-level viral rebound, one discontinued study treatment for adverse event, three withdrew their consent, and one was lost to follow-up. By on-treatment analysis, 78/80 patients (97%, 95% CI [91;99]) maintained an HIV-RNA < 50 copies/ml at W24. Results were similar at Week 48. The median area under the darunavir plasma concentration-time curve measured in 11 patients was 61,380 ng hr/ml; darunavir median trough concentration 1,340 ng/ml and darunavir half-life was 12.2 hr. Tolerability of once-daily darunavir/r 800/100 mg was excellent. Optimally suppressed, treatment-experienced patients can switch safely from a twice-daily PI/r regimen to a once-daily darunavir/r 800/100 mg containing regimen.
